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MeiraGTx
Raised approximately $60 million in a private placement in May 2023 with investors consisting of several of the Companys top shareholders
On track for BLA submission of botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) in 2024
Company will present 12-month data from bilateral treated cohorts from the AQUAx AAV-hAQP1 Phase 1 study for treatment of Grade 2/3 radiation-induced xerostomia in the second quarter of 2023
Upcoming poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting highlight the depth and novelty of MeiraGTxs technology platforms for gene and cell therapy
LONDONandNEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc(Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial and operational results for the first quarter ended March 31, 2023, and provided a corporate update.
We are off to a strong start this year with progress across multiple clinical-stage programs and a growing body of data supporting our proprietary gene regulation technology, said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. Enrollment of the pivotal Lumeos Phase 3 study is going well and we remain on track for a BLA filing in 2024. We are also excited to be progressing towards later stage studies in our wholly-owned programs, including a randomized, double-blind, placebo-controlled, Phase 2 study for the treatment of Grade 2/3 radiation-induced xerostomia, and our randomized, sham-controlled bridging study for our Parkinsons disease program.
Dr. Forbes continued, At this years ARVO Annual Meeting, we presented data from our AI-driven promoter discovery platform illustrating our ability to precisely target specific cells and expression levels with synthetic promoters. In addition we presented immune-response data from the Phase 1/2 trial for the investigational gene therapy bota-vec in patients with XLRP associated with mutations in the RPGR gene. We are also pleased that nine poster presentations showcasing our novel gene and cell therapy platforms will be presented at the upcoming ASGCT Annual Meeting, including the application of our riboswitch technology to precisely regulate CAR-Ts. We are also presenting data demonstrating efficacy in animal models of vector delivered human growth hormone and anti-HER2 antibody in tight dose response to an orally dosed small molecule inducer. This provides support for the broad applicability of our riboswitch gene regulation platform for therapeutic delivery of a range of biologic drugs and cell therapies with enhanced safety and efficacy.
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Recent Development Highlights and Anticipated Milestones
Bota-vec for the Treatment of XLRP:
In late April, immune-response data from a Phase 1/2 MGT009 clinical trial (NCT03252847) were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting.
Dosing in the pivotal Phase 3 LUMEOS clinical trial of bota-vec continues and the program remains on track for a BLA submission in 2024.
AAV-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia:
MeiraGTx reported positive clinical data from the AQUAx Phase 1 clinical trial in December 2022, and remains on track to present the full data from the AQUAx Phase 1 study in the second quarter of 2023, including the 12 month data from bilaterally treated subjects.
Based on the favorable safety and efficacy profile of AAV-hAQP1 in the AQUAx Phase 1 study, the Company intends to initiate a randomized, double-blind, placebo-controlled, Phase 2 study evaluating the bilateral administration of two active doses of AAV-hAQP1 in the second quarter of 2023.
AAV-GAD for the Treatment of Parkinsons Disease:
The Company is now dosing patients in the AAV-GAD clinical trial under a new IND with material manufactured in its cGMP facility in London, United Kingdom using MeiraGTxs proprietary production process.
The AAV-GAD trial is a three arm randomized Phase 1 clinical bridging study with subjects randomized to sham control or one of two doses of AAV-GAD.
The objective of the AAV-GAD trial (NCT05603312) is to evaluate the safety and tolerability of AAV-GAD manufactured at MeiraGTxs cGMP facility in London, United Kingdom when delivered to the subthalamic nucleus (STN) of patients with Parkinson's disease.
Completion of enrollment is anticipated in the third quarter of 2023.
Riboswitch Gene Regulation Platform & Vector Engineering:
The Company will exhibit nine poster presentations at the ASGCT 2023 Annual Meeting, including data demonstrating the ability to regulate CAR-T driving increased efficacy and reduced exhaustion in vitro.
ASGCT posters will also show data demonstrating rescue of B.little mouse model via hGH activated using an orally delivered small molecule, as well as AAV-mediated riboswitch-controlled delivery of anti-HER2 antibody suppressing HER2-positive tumorigenesis in a dose response to an orally delivered small molecule.
The Companys next-generation riboswitch-based gene regulation platform can be used to precisely control the expression of any gene delivered in any context with an unprecedented dynamic range using novel, synthetic, orally delivered small molecules.
The Company now has over 40 novel orally available small molecules with high specificity and potency to its riboswitch aptamers moving through PK, biodistribution, and toxicology studies, with the first GMP material for IND currently being manufactured. Two of these small molecules show good brain penetrance to enable activation of genes within the blood brain barrier.
Recent Corporate Developments In May 2023, MeiraGTx closed the previously announced private investment in public equity (PIPE) financing, raising approximately $60 million in aggregate gross proceeds. The financing was entirely led by several of the Companys top holders Perceptive Advisors, Adage Capital, Prosight Management, and 683 Capital Management.
For more information related to our clinical trials, please visit http://www.clinicaltrials.gov
In addition to the proceeds from the PIPE financing, MeiraGTx had cash and cash equivalents of approximately $68.8 million, as well as approximately $36.3 million in receivables due from Janssen. The Company believes that with such funds, as well as anticipated milestones from Janssen, it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second quarter of 2025.
Financial Results
Cash and cash equivalents were $68.8 million as of March 31, 2023, compared to $115.5 million as of December 31, 2022.
License revenue was $3.3 million for the quarter ended March 31, 2023, compared to $5.6 million for the quarter ended March 31, 2022. This decrease represents decreased amortization of the $100.0 million upfront payment as well as decreased amortization of the $30.0 million milestone payment received in connection with the Janssen collaboration.
General and administrative expenses were $12.8 million for the three months ended March 31, 2023, compared to $11.3 million for the three months ended March 31, 2022. The increase of $1.5 million was primarily due to an increase in legal and accounting fees, consulting fees and other office related costs. These increases were partially offset by decreases in share-based compensation, insurance costs and payroll and payroll-related costs.
Research and development expenses for the three months ended March 31, 2023 were $22.3 million, compared to $23.1 million for the three months ended March 31, 2022. The decrease of $0.8 million was primarily due to a decrease in expenses related to our preclinical programs primarily due to the timing of expenses in our gene regulation program and a decrease in other research and development expenses primarily due to a decrease in share-based compensation, as well as an increase in research funding provided under our Janssen collaboration primarily due to the increase in expenses incurred related to our program for bota-vec for the treatment of XLRP. These decreases were partially offset by an increase in clinical trial expenses primarily due to an increase in expenses related to our Phase 3 Lumeos clinical trial of bota-vec and our expanded Phase 1 clinical trial and Phase 2 clinical trial for AAV-hAQP1, as well as an increase in manufacturing expenses primarily due to the commencement of operations at our Shannon, Ireland manufacturing facility in 2022.
Foreign currency gain was $3.9 million for the three months ended March 31, 2023, compared to a loss of $2.6 million for the three months ended March 31, 2022. The change of $6.5million was primarily due to an unrealized gain on the quarterly valuation of intercompany payables and receivables due to the weakening of the U.S. dollar against the pound sterling and euro during the three months ended March 31, 2023.
Net loss attributable to ordinary shareholders for the quarter ended March 31, 2023 was $30.4 million, or $0.62 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $31.0 million, or $0.70 basic and diluted net loss per ordinary share for the quarter ended March 31, 2022.
About MeiraGTxMeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology that allows precise, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring, and developing technologies that give depth across both product candidates and indications. MeiraGTxs initial focus is on three distinct areas of unmet medical need: ocular diseases, including both inherited retinal diseases as well as large degenerative ocular diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.
For more information, please visit http://www.meiragtx.com
Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated milestones regarding our pre-clinical and clinical data, reporting of such data and the timing of results of data and regulatory matters, as well as statements that include the words expect, will, intend, plan, believe, project, forecast, estimate, may, could, should, would, continue, anticipate and similar statements of a future or forward-looking nature. These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contacts
Investors:MeiraGTxInvestors@meiragtx.com
or
Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(unaudited)(in thousands, except share and per share amounts)
FortheThree-Month Period Ended March31,
2023
2022
License revenue - related party
$
3,334
$
5,633
Operating expenses:
General and administrative
12,772
11,268
Research and development
22,322
23,099
Total operating expenses
35,094
Continued here:
MeiraGTx Reports First Quarter 2023 Financial and Operational Results - Yahoo Finance
Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant ERIC LIRA pled guilty today for his role in providing banned performance-enhancing drugs (PEDs) to Olympic athletes in advance of the 2020 Olympic Games held in Tokyo in the summer of 2021. LIRA is the first defendant to be charged under the Rodchenkov Anti-Doping Act, signed into law on December 4, 2020, which proscribes doping schemes for the purpose of influencing international sports competitions, including the Olympic Games. LIRA pled guilty before U.S. Magistrate Judge Valerie Figueredo.
U.S. Attorney Damian Williams said:This conviction is a watershed moment for international sport. Lira provided banned performance-enhancing substances to Olympic athletes who wanted to corruptly gain a competitive edge. Such craven efforts to undermine the integrity of sport subverts the purpose of the Olympic games: to showcase athletic excellence through a level playing field. Liras efforts to pervert that goal will not go unpunished.
According to the allegations contained in the Complaint, the Indictment, other filings in this case, and statements during court proceedings:
The charges in this case arise from an investigation of a scheme to provide Olympic athletes with PEDs, including drugs widely banned throughout competitive sports, such as human growth hormone and the blood building drug erythropoietin, in advance of and for the purpose of corrupting the 2020 Olympic Games, which convened in Tokyo in the summer of 2021. LIRA, who claims to be a kinesiologist and naturopathic doctor operating principally in and around El Paso, Texas, obtained unapproved versions of these, and other, prescription drugs from sources in Central and South America before bringing those drugs into the United States and distributing them to, among others, the two athletes referred to in the Indictment. Throughout the scheme, LIRA and an athlete competing for Nigeria communicated via encrypted electronic communications regarding the sale, shipment, and use of LIRAs illegal drugs and specifically discussed the testability of those drugs by anti-doping authorities. LIRA separately communicated with an athlete competing for Switzerland, also via encrypted electronic communications, discussing the use of human growth hormone and erythropoietin. Both athletes tested positive for prohibited substances, and in both cases, LIRA directly and indirectly advised that the athletes should blame the positive drug test on contaminated meat, knowing full well that the drug tests had accurately detected the presence of banned, performance-enhancing drugs.
LIRA is the first defendant charged and convicted pursuant to the recently enacted Rodchenkov Act. On December 4, 2020, the Rodchenkov Act was signed into law, Pub. L. 116-206, and incorporated into Title 21 of the United States Code at sections 2401 through 2404. The Rodchenkov Act prohibits any person, other than an athlete, to knowingly carry into effect, attempt to carry into effect, or conspire with any other person to carry into effect a scheme in commerce to influence by use of a prohibited substance or prohibited method any major international sports competition. 21 U.S.C. 2402.
* * *
LIRA, 43, of El Paso, Texas, pled guilty to violating the Rodchenkov Act, which carries a maximum potential sentence of 10 years in prison.
The maximum potential sentence is prescribed by Congress and is provided here for informational purposes only, as any sentencing of the defendant will be determined by a judge.
Mr. Williams praised the outstanding investigative work of the Federal Bureau of Investigation (FBI) and the FBIs Integrity in Sports and Gaming Initiative. Mr. Williams also thanked the United States Anti-Doping Agency for their support of this investigation.
This case is being handled by the Offices Money Laundering and Transnational Criminal Enterprises Unit. Assistant U.S. Attorneys Sarah Mortazavi and Benjamin Gianforti are in charge of the prosecution.
Original post:
First Defendant Charged With Violating Anti-Doping Act Pleads ... - Department of Justice
The global healthcare specialty enzymes market size was USD 1.86 Billion in 2022 and is expected to reach USD 3.5 Billion by 2032, and register a CAGR of 7.2%
Specialized enzymes are utilized in a broad range of processes, such as the production of food and beverages, textiles, detergents, paper and pulp, and animal feed, among others. In healthcare, enzymes are employed for research, diagnostics, medicines, and biotechnology. The pharmaceutical industry uses enzymes to produce biologics, which are increasingly being used to treat chronic diseases like cancer, autoimmune disorders, and rare genetic diseases. Enzyme replacement therapy (ERT) is also becoming more popular, with successful treatment of genetic disorders like Gaucher disease, Fabry disease, and Pompe disease, among others.
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Market revenue growth is also being driven by the rising demand for personalized treatment. Enzymes play a crucial role in creating biologics tailored to an individual's unique needs, as they are employed in the development of personalized medicine. Additionally, increasing research and development expenditures and the emphasis on creating novel specialty enzymes are driving market revenue growth. Industry participants are investing heavily in R&D to develop new specialty enzymes that can be used in a variety of ways. However, new entrants may face entry barriers due to the technical and specialized nature of the industry, the focus on R&D, and the scarcity of skilled professionals.
Segments Covered in the Report
Type Outlook:
The global healthcare specialty enzymes market can be segmented into four types: protease, lipase, carbohydrase, and others. Protease, which is used in the breakdown of proteins, is expected to generate the highest revenue during the forecast period. In 2019, the revenue generated from protease was USD 0.6 billion, which is projected to reach USD 1.1 billion by 2032. Lipase, which breaks down fats, is the second-largest revenue-generating type, with a projected revenue of USD 0.9 billion by 2032. Carbohydrase, which breaks down carbohydrates, is expected to experience significant growth during the forecast period, with a projected revenue of USD 0.6 billion by 2032.
Application Outlook:
The healthcare specialty enzymes market can also be segmented based on application into four categories: digestive health, pharmaceuticals, research and biotechnology, and others. Digestive health is expected to generate the highest revenue during the forecast period, with a projected revenue of USD 1.3 billion by 2032. The increasing prevalence of digestive disorders and the demand for digestive enzyme supplements are the primary drivers of revenue growth in this segment. The pharmaceutical industry uses specialty enzymes to create biologics, and the segment is projected to generate revenue of USD 0.9 billion by 2032. The research and biotechnology segment is expected to experience significant growth, with a projected revenue of USD 0.8 billion by 2032. Enzymes are utilized in a variety of research applications, including genomics, proteomics, and drug discovery. The "others" segment, which includes applications in the food and beverage industry and animal feed, is projected to generate revenue of USD 0.5 billion by 2032.
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Strategic development:
Roche Holding AG made a significant move in its diagnostic portfolio and the molecular diagnostics market by acquiring TIB Molbiol GmbH, a top supplier of PCR assays. This acquisition, which took place on September 9, 2021, is expected to enhance Roche's presence in the field.
Bristol-Myers Squibb Company announced a strategic partnership with Schrdinger, a well-known provider of sophisticated molecular simulations and Machine Learning (ML) software, on June 17, 2021. The collaboration was aimed at speeding up drug discovery and development by combining Schrdinger's expertise in computational chemistry with Bristol-Myers Squibb's experience in drug discovery and development.
Competitive Landscape:
The global healthcare specialty enzymes market is highly competitive and has numerous large and medium-sized players that contribute a significant share of market revenue. The report includes several major companies that are involved in the market, including Abbott Laboratories, BASF SE, Bristol-Myers Squibb Company, Danisco A/S, DSM N.V., E. I. du Pont de Nemours and Company, Johnson & Johnson, Lonza Group AG, Neutrogena Corporation, Novo Nordisk A/S, and Roche Holding AG.
These major players are employing a variety of strategies to remain competitive in the market, such as mergers and acquisitions, strategic agreements and contracts, and the development, testing, and introduction of more effective products. These strategies allow them to expand their market presence and increase their revenue.
Furthermore, these companies are also investing heavily in research and development to create innovative and advanced products that can cater to the increasing demand for personalized treatment and specialized enzymes. This is expected to help the companies to maintain their market position and increase their market share.
The global healthcare specialty enzymes market is highly competitive and has numerous large and medium-sized players that contribute a significant share of market revenue. The report includes several major companies that are involved in the market, including Abbott Laboratories, BASF SE, Bristol-Myers Squibb Company, Danisco A/S, DSM N.V., E. I. du Pont de Nemours and Company, Johnson & Johnson, Lonza Group AG, Neutrogena Corporation, Novo Nordisk A/S, and Roche Holding AG.
These major players are employing a variety of strategies to remain competitive in the market, such as mergers and acquisitions, strategic agreements and contracts, and the development, testing, and introduction of more effective products. These strategies allow them to expand their market presence and increase their revenue.
Furthermore, these companies are also investing heavily in research and development to create innovative and advanced products that can cater to the increasing demand for personalized treatment and specialized enzymes. This is expected to help the companies to maintain their market position and increase their market share.
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Overall, the global healthcare specialty enzymes market is expected to witness significant growth during the forecast period due to the increasing prevalence of chronic diseases and the growing demand for personalized medicine. The major players in the market are well-positioned to take advantage of this growth by implementing effective strategies and investing in research and development.
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Healthcare Specialty Enzymes Market to Reach USD 3.5 Billion by 2032 with 7.2% CAGR: Reports and Data - EIN News
A former Playboy model and television personality, Anna Nicole Smith was "famous for being famous" then she was found dead of an accidental drug overdose.
On February 8, 2007, 39-year-old model, actress, and former Playboy Playmate of the Year Anna Nicole Smith died in Hollywood, Florida. She was declared dead shortly after being found unresponsive in her room at the Seminole Hard Rock Hotel and Casino. In the days leading up to her death, Smith had suffered from multiple health issues, including stomach flu, a fever that reached 105 degrees, and an infection on her backside.
But instead of going to the hospital, she took a cocktail of at least nine different prescription medications, including chloral hydrate, a powerful liquid sedative that had also likely played a role in legendary Hollywood star Marilyn Monroes death. It was bitterly ironic as Anna Nicole Smith had always dreamt of becoming the next Marilyn Monroe someday.
Like Monroe before her, Smith dominated news headlines. Her blonde hair and curves captivated the public, and the media took a deep interest in her personal life. Part of this interest was likely due to Smiths ongoing legal battle to acquire a share of her deceased husbands fortune the 90-year-old oil tycoon J. Howard Marshall II, whom she married in 1994.
Smith, like Monroe, also appeared in several movies, mostly comedies, including Naked Gun 33 1/3: The Final Insult alongside Leslie Nielsen and Priscilla Presley and The Hudsucker Proxy alongside Tim Robbins and Paul Newman. She later starred in her own reality television series in 2002, The Anna Nicole Show, which followed her through her daily life.
During the early 2000s, Smiths star continued to rise, and she was ecstatic to give birth to her daughter Dannielynn on September 7, 2006. But just three days later, her older son, 20-year-old Daniel, died of a drug overdose. Soon afterward, a series of legal battles complicated her life once again.
And just six months after her sons untimely demise, Anna Nicole Smiths death from a drug overdose would make headlines all over the world.
Anna Nicole Smith was born Vickie Lynn Hogan on November 28, 1967, in Houston, Texas. Her father, Donald Hogan, wasnt around much while she was growing up, leaving her mother Virgie Arthur to take care of her.
Speaking with ABC News, Vickie Lynn Hogans childhood best friend Jo McLemore recalled, Vickies childhood life was tough. [Her mother] was very forthright and very strict. And when Hogan turned 15, her mother sent her to live with her aunt in the small town of Mexia, Texas.
Vickie Lynn Hogan didnt mesh with Mexia. She struggled with being bullied, and she longed to get out and make something of herself. Eventually, though, shed had enough with school and dropped out during sophomore year, taking a job at a local fried chicken joint, Jims Krispy Fried Chicken.
When she started working here, we immediately hit it off, McLemore said. One of the memories I have of her is, wed sit here together and stare out the window, and just watch traffic go by. She was so perfect to me.
It was at Krispys that Vickie Lynn Hogan met her first husband Billy Smith, a fellow dropout. She was 17, and he was 16 when they first started dating. Soon, the teens were married, and Vickie Lynn Hogan became Vickie Lynn Smith. The couple welcomed a son, Daniel, when Vickie Lynn was 18.
But another year later, the couple separated, and Vickie Lynn Smith took Daniel with her back to Houston. Smiths mother looked after Daniel while Smith took a job as a dancer at a local strip club to provide for her son.
Then, in 1991, an 86-year-old billionaire named J. Howard Marshall II was wheeled into that club. His wife had recently died, and so had his longtime mistress. Smith agreed to dance for the wealthy octogenarian, and soon enough, he was showering her with gifts and asking her to marry him.
At first, she said no. Before Smith got married again, she wanted to try to make a name for herself on her own. And just one year later, she did.
In 1992, two major milestones happened in the future Anna Nicole Smiths life. Playboy hired her after she mailed in naked photos of herself, and later that year, the fashion brand Guess asked her to model in a series of ads. Her image in the ads was remarkably similar to Marilyn Monroes look.
It was around this time that an agent suggested that Vickie Lynn change her name to Anna Nicole to further help her career, and she agreed to do so.
As a profile on Smith at Biography says, her image drew tons of attention across America. She was the ultimate blonde bombshell.
She was so popular, in fact, that in 1993 she was named Playboys Playmate of the Year. The next year, she made the move into small film roles. Meanwhile, celebrity magazines and tabloids couldnt get enough of her.
Smith, for her part, didnt seem to mind, saying, I love the paparazzi. They take pictures, and I just smile away. Ive always liked attention. I didnt get very much growing up, and I always wanted to be, you know, noticed.
But life as a Hollywood celebrity wasnt all glamorous.
In 1994, Anna Nicole Smith finally agreed to J. Howard Marshall IIs marriage proposal. By then, he was 89 years old. Smith was only 26. Naturally, the marriage came with media scrutiny accusing Smith of marrying Marshall to get her hands on his fortune, knowing that he would probably die soon.
The marriage was indeed short-lived. Marshall died at age 90 in 1995, but he had not included Smith in his will. His son E. Pierce Marshall had been given power of attorney, and Smith spent several years battling him in court for her share of her late husbands estate, claiming that E. Pierce had been the reason why she hadnt been included in the will. The case eventually found its way to the U.S. Supreme Court in 2006. But as The Guardian reported, this issue was still unresolved at the time of Anna Nicole Smiths death.
Amid the ongoing legal battle with her deceased husbands family, however, Smiths personal life remained a focal point for the press especially when she was treated for substance abuse. Smith had been prescribed a variety of medications to treat migraines, stomach problems, seizures, and back pain that she was experiencing as a result of her breast implants. The media latched onto this and simultaneously attacked Smith for gaining weight.
Its hard. I mean, I went through a lot. You know, people, when I gained a lot of weight people thought I was just like, partying, doing this and that, she said in 2000. I mean, Im having seizures, Im having panic attacks.
Still, Anna Nicole Smith remained in the public eye, jumping headfirst into reality TV on E! Television Network. Her series, The Anna Nicole Show, drew in curious audiences and offered insight into Smiths daily life.
The show ran for 28 episodes between 2002 and 2004, but Smith still found herself directionless and searching for the next big thing. And many viewers noted that she frequently seemed confused or disoriented on the show.
In 2003, Smith worked with the weight loss brand, TrimSpa, as a spokesperson. During the course of the campaign, she lost 69 pounds and found renewed energy in her career. Her love life seemed to be looking up, too. She began dating a photographer named Larry Birkhead, and although Birkhead was smitten with her, their relationship didnt last.
At the time, Smith was living with her son Daniel, her assistant, and her attorney/publicist/manager Howard K. Stern. Birkhead moved into the home with Smith, and shortly thereafter, Smith became pregnant with her second child. But around this time, she started to push Birkhead away.
Toward the end of her pregnancy, she and Stern moved to the Bahamas. There, on September 7, 2006, she gave birth to her daughter Dannielynn. Stern, who was said to be the father, was with Smith in the delivery room.
Smiths son Daniel joined her two days later as she was in recovery, but the next day, Smith woke up to find Daniel dead next to her. He had died of a drug overdose, but it was never made clear where he got the drugs from. The loss devastated her. The media reported on Daniel Smiths death heavily.
Anna Nicole Smith then became embroiled in another legal battle, this time over her newborn daughter. Birkhead, now Smiths ex-boyfriend, claimed that he was Dannielynns father. Smith insisted that Dannielyns father was her current partner Howard K. Stern. But while Stern was officially listed on Dannielynns birth certificate, the issue of her paternity was far from settled.
In early 2007, Anna Nicole Smith was interested in purchasing a boat and decided to go to Florida with Stern and a group of friends to buy one there. But while traveling to Hollywood, Florida on February 5th, she became ill. Her backside began to ache, likely because she had just gotten injections for vitamin B12 and human growth hormone there before she left.
By the time she arrived in Florida, she had a fever of 105 degrees. This was likely brought on by the pus-filled infection on her buttocks from the injections of so-called longevity drugs, according to The New York Times.
Over the course of a few days, Smith suffered a number of other health issues in her room at the Seminole Hard Rock Hotel and Casino, including stomach flu and pungent sweating. Though many of her friends who she had traveled with urged her to go to the hospital, Smith refused.
Birkhead, Smiths ex-boyfriend, later speculated that she didnt go to the hospital out of fear that there would be a big headline in the news about her poor health and she didnt want her illness to be publicized.
Instead, she chose to self-medicate with at least nine different prescription drugs, including chloral hydrate, a powerful sleep aid that was popular in the 19th century but is rarely prescribed in modern times. According to TODAY, Smith was known to drink this liquid sedative directly out of the bottle.
Sadly, this would lead to Anna Nicole Smiths death on February 8, 2007. That day, Stern had briefly left the hotel to keep the couples appointment about the boat they wanted to buy. Smiths friends remained to keep an eye on her and they eventually realized that she was unconscious and not breathing.
The wife of Smiths bodyguard called her husband, who then alerted Stern. The bodyguards wife then tried to resuscitate Smith. It wasnt until the bodyguard arrived that 911 was called, and about 40 minutes total passed before first responders came to transport Smith to the hospital. By then, it was too late Anna Nicole Smith had died of an accidental drug overdose.
And even after her death, the drama surrounding Smiths life continued. The question of Dannielynns paternity went to court, and in April 2007, a DNA test confirmed that the girls biological father was Larry Birkhead. Stern did not contest the ruling and supported Birkhead gaining custody of the girl.
However, Stern later faced legal trouble for his role in enabling Smiths prescription drug addiction. According to ABC News, both he and Smiths psychiatrist Dr. Khristine Eroshevich were both found guilty of conspiracy to give prescription drugs to a known addict in 2010. Smiths doctor Sandeep Kapoor was also charged in connection with the case, but he was acquitted.
In the years since then, Anna Nicole Smiths life has remained a subject of fascination. Like many other famous women before her, Smith is seen as a prime example of a woman who died far too young, and whose troubled life contrasted sharply with her public persona. In the end, her dream of becoming the next Marilyn Monroe was, unfortunately, realized a bit too fully.
After reading about the life and death of Anna Nicole Smith, read about the tragic death of her idol, Marilyn Monroe. Then, explore the tragic life and infamous death of another iconic Hollywood actress, Lupe Vlez.
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Inside The Tragic Death Of Anna Nicole Smith And The Drug ... - All That's Interesting
FDA approval logo | Image Credit: Calin - Calin - stock.adobe.com.
The FDA recently approved a new indication for somapacitan-beco (SOGROYA; Novo Nordisk), a once-weekly subcutaneous injection, to treat children aged 2.5 years and older with growth hormone deficiency (GHD), according to a press release from Novo Nordisk.1
Somapacitan-beco is the first and only once-weekly growth hormone (GH) treatment for children and adults, following this indication approval. The prescription medicine injection (5 mg, 10 mg, or 15 mg) contains human growth hormone, the same growth hormone made by the body, according to Novo Nordisk.1
Somapacitan-beco will be provided in a premixed, prefilled, and portable pen that is stable at room temperature, up to 77 F, for up to a maximum of 72 hours. According to Novo Nordisk, children with GHD can experience short stature and can have an increased risk for other growth-associated problems. GH replacement has been the standard care to improve growth outcomes, however, patients can struggle with a daily injection routine over time.1
A once-weekly growth hormone treatment like Sogroyamay offer a therapeutic alternative for patients and their caregivers interested in a once-weekly option, said Stephanie Seremetis, MD, CMO, and CVP, Rare Disease, Novo Nordisk.1
The expanded indication of somapacitan-beco for children aged 2.5 years and older with GHD is based on phase 3 results demonstrated in the REAL4 study (NCT03811535).2 In the study, 200 treatment-nave patients aged 2.5 to 11 years with GHD were either given once-weekly somapacitan-beco (n = 132) or daily somatropin (n = 68) for 52 weeks.1 Results demonstrated that somapacitan-beco (11.2 cm/year) was comparable to daily somatropin (11.7 cm/year) for the primary endpoint of annualized height velocity. Nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reactions were adverse reactions in the REAL4 study, occurring in more than 5% of patients.1
According to Novo Nordisk, somapacitan-beco leverages albumin-binding technology, which delays elimination of somapacitan-beco. As a result, in vivo half-life and duration of action is prolonged.1
Children with closed bone growth plates and children with Prader-Willi syndrome that are severely obese or have breathing problems, should not use somapacitan-beco. Novo Nordisk plans to make somapacitan-beco available for both adult and pediatric patients in the coming months.1
References:
1. FDA approves once-weekly Sogroya for the treatment of children living with growth hormone deficiency. Novo Nordisk. April 28, 2023. Accessed May 1, 2023. https://www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=166098
2. A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin once a day (REAL4). clinicaltrials.gov. Updated April 25, 2023. Accessed May 1, 2023. https://clinicaltrials.gov/ct2/show/NCT03811535
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FDA expands approval of somapacitan-beco injection to children ... - Contemporary Pediatrics
Modified May 03, 2023 16:52 GMT
Former pitching star Roger Clemens' wife Debbie Clemens testified that she had been given a shot of human growth hormone by her husband's former trainer Brian McNamee, who claimed to have also given Clemens the same injection.
Debbie in 2012 disclosed that she allegedly took PEDs prior to the Sports Illustrated Swimsuit shoot with the former Red Sox star to appear youthful.
According to McNamee, Roger Clemens requested that McNamee inject Debbie Clemens with the human growth hormone in 2003 before a photo shoot for Sl magazine.
Clemens said that she had trouble falling asleep the night after getting the shot because of circulation problems. She talked about notifying her husband about the injection over the phone. She claimed that Roger "wasn't happy with Brian" about the situation, and wasn't present during the consumption of the drug.
According to Jason Grimsley, a former pitcher who filed a federal lawsuit, Roger Clemens was one of numerous athletes who reportedly used PEDs in 2006.
Former New York Yankees pitcher Andy Pettitte, a former teammate of Roger Clemens, testified that Clemens admitted to using the human growth hormone between 1999 and 2000. The use of drugs by his wife was something he was alluding to.
Following his denial of using performance-enhancing drugs, Roger Clemens was facing a second trial on federal charges of lying to a U.S. congressional committee.
The Oversight and Government Reform Committee of the House of Representatives was looking into drug use in Major League Baseball at the time.
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When former Red Sox star Roger Clemens' wife was caught in PED scandal to appear youthful on SI Cover - Sportskeeda
Picture this: You've been driven and motivated to hit the gym or get your miles in day in and day out. You've got your post-workout recovery dialed in with a quality massage gun and stretching regimen. Your diet and supplementation are on point. Yet despite having put in all this work, you still feel like you're lagging behind. Why?
Probably because you're a terrible sleeper or at least, haven't given your nighttime habits enough thought.
Sleep can be one of the most vital keys to your overall fitness, affecting everything from your cognitive state and energy levels to how well your muscles bounce back to normal post-workout. But to make the most of your bed time each and every night, your sleep hygiene needs to be in order.
The phrase "sleep hygiene" refers to the habits you practice in relation to your normal sleep behavior. These include keeping a proper environment for slumber, abstaining from influential food and drink prior to bed, reducing stress throughout the day and more.
A good comparison would be how regular brushing and flossing affects your oral health. Like your typical toothbrushing habits, sleep hygiene can be improved upon. All that's necessary is to invest in the practice and remain dedicated to improvement.
A good night's sleep can help you awaken with a recharged battery and clear mind, but the benefits of a Zs-catching session aren't just reserved to cognitive function. Your muscles and aches can greatly benefit from your dedication to healthier sleep hygiene, too.
During your slumber, your body is still at work repairing cells, restoring energy and releasing molecules like hormones and proteins. One of those hormones, according to the National Academy of Sports Medicine (NASM), is the human growth hormone (HGH). This surge of the vital hormone can occur roughly every two hours during sleep, leading to better healing, recovery and growth across your musculature and more.
Yet, it's plenty difficult to reap the benefits of this hormone secretion and cellular repair if you're tossing and turning night in and night out. This begs the question, how can you make it so every night isn't an RPE 10 to catch some Zs? Here are a few tips to help make nighttime a more approachable endeavor, and how you can set yourself up for the best sleep ever with every PM session.
As an adult, its advised to shoot for at least seven hours of sleep per night. Well, like any other endeavor, how can you expect to meet that quota if you dont have a plan in place?
To give yourself a better shot of meeting your nighttime slumber numbers, try to develop a routine that sees you getting into bed (and getting up in the morning) at the same times each and every day. This can help reinforce your bodys sleep-awake cycle as it learns to adapt to your schedule. Soon enough, youll find yourself getting tired at the right time before bed and naturally rising without the added stress of a buzzing alarm clock.
Power naps might sound great on paper, but when it comes time to really hit the hay, these small breaks from your normal daytime routine can spell nothing but trouble. Naps lasting longer than two hours throughout the day have been shown to cause sleep deprivation during regular nighttime slumber, so it's best to save the sheep counting for when it matters most.
Of course, we all have different personal schedules, and a small nap may be vital to keep you running at peak performance throughout the day. If you feel your napping habits are interfering with your slumber, consider swapping out your normal nap time for shorter breaks of roughly 30 minutes. Additionally, try to keep your naps to earlier in the day, as this can allow your body to naturally tire itself down to a depleted state ideal for nighttime rest.
We all know your diet plays a role in your physical fitness while awake, but did you know it can affect your evening performance, too? To help set your body up for sleeping success, try to avoid large meals immediately before hitting the pillow. This can allow for more efficient digestion as the nutrients make their way into their proper locations without keeping your engine running longer than needed.
Its also best to avoid stimulants and other inhibitors before bed, including caffeine, nicotine and alcohol. While a nightcap beverage may make you feel tired at first, its effects on cognitive function can leave you tossing and turning more often than not.
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Most if not all of us have an unhealthy relationship with our tech tools, but trust me you can sacrifice a few scrolls for the sake of better sleep. Many of our smartphones, TVs, tablets and other devices omit whats known as blue light, and prolonged exposure can lead to negative impacts on our Circadian rhythms.
In addition to lessening blue light exposure, turning off your electronics before hitting the hay and subsequently leaving them alone throughout the night can lessen the number of distractions your brain encounters. This can allow your mind to power down more easily, creating a level, quiet state that further promotes drifting off to sleep.
Comfort plays a big role in how effective your night shift is, too, and your brain and body are more likely to turn down for the evening if the conditions are prime for counting sheep. This means giving your bed a few quick upgrades with a new mattress, pillows, bed sheets, and other linens for a cozier nighttime experience. You can also expand this makeover to your entire room with dimming shades, white noise machines and more.
It can also help to keep your bedroom a little chillier than the rest of your abode for the sake of better sleep. Studies show that temperatures between 60 and 67F can be great for allowing your body to cool down properly as you lie down with enough heat to promote wakefulness when you rise. Cooling blankets and pillows can also be helpful for these circumstances.
Like your kitchen, garage or home office, your bedroom should also have a role to play in regards to your daily habits. While it might sounds enticing to stay under the comforters as you work from home, doing so can actually trick your brain into a more active state, associating wakefulness with your bed itself. This association can be hard to break when you go to truly use your mattress, sheets and pillows for their intended activity rest.
Its best to leave your sleeping arrangements for just this purpose by keeping your active hours separate from the location entirely. If you do find yourself struggling to nod off at the end of the day, a helpful tip is to leave the room for roughly 20 minutes, then returning once your mind has had time to turn down further. This can promote that notion of bed equals sleep more, resulting in a smoother transition to slumber time.
While its not a great idea to stare at your phone for hours before bed, these devices can still help you create a soothing sleep environment through a number of pathways. Plenty of sleep apps are designed to help with meditation, journaling, soundscapes and more. Using these tools to your advantage can put you in a better state for slumber, creating an effective, efficient relationship between your devices and your sleep hygiene.
To go a step further, some sleep apps utilize your phone or smartwatchs accelerometer to track your body tendencies throughout the night, charting your sleep data for a detailed look at how well youre resting from a qualitative and quantitative perspective. This style of digital tool can also be great to inform you of other pre-bed habits and how theyre truly impacting your rest.
Yes, your rest can actually benefit from the activity its trying to help, too. A proper exercise regimen can boost serotonin levels in the brain and decrease the presence of cortisol, resulting in improved sleep duration and quality. There are some parameters, however, to create the best relationship between sleep and training.
For one, studies show that early morning workouts can be more positive for sleep than later evening sessions. Additionally, your activities should be vigorous, but not overly aggressive or intense. Overtraining has been linked to poor sleep quality in the past, so while your body may be clamoring for a rest in these scenarios, said slumber may be less impactful.
Play around with your workouts and schedule to find what generates the best results for you. Doing so can create a cyclical, symbiotic relationship between your sleep and fitness where everyone wins especially you.
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Your Sleep Hygiene Needs Work Here's How to Improve Your ... - Gear Patrol
Intermittent fasting is fast becoming the go-to diet for achieving different health goals, most importantly, weight loss. Many celebrities, business tycoons, and famous entrepreneurs have endorsed this transformative fasting strategy as the sure-shot way to a healthier mind and body.
Intermittent fasting is an eating pattern where you fast for a certain number of hours a day and reserve calorie intake to a small eating window. When you do this, in the fasting period, your body uses up the glycogen stores it utilizes for energy and undergoes a metabolic switch. With this metabolic switch, the body enters a state known as ketosis, where the liver produces ketones from the stored fat reserves to use as an energy source.
There are several intermittent fasting techniques, the most common being 16/8, where you fast for 16 hours and eat calories in the eight-hour feeding window. Some fasters like to do the 5/2 fasting schedule, where they eat normally for five days of the week, and on two non-consecutive days, they limit calorie intake to 500-600 calories. Yet more advanced fasters prefer to go for OMAD fasting (one meal a day), 36-hour fasts, and monk fasts, with extreme fasters also taking it as far as a 60-hour fast.
Many variants of intermittent fasting exist, like water fasting and fat fasting, each with its own special benefits. People also work out towards the end of the fasting period to lose fat and gain muscle simultaneously.
Despite its growing popularity, one of the most overlooked benefits of intermittent fasting is its significant impact on collagen production within the body. We need collagen, a protein, for healthy skin, nails, joints, and hair. Recent research suggests that intermittent fasting can assist in stimulating the bodys production of collagen. This article examines the relationship between intermittent fasting and collagen production, supporting the theory with scientific studies and research. Keep reading to discover the connection between intermittent fasting and collagen synthesis.
Among the different kinds of proteins in the human body, collagen is the most abundant, accounting for 30% of the total protein composition. It is a building block for muscles, skin, tendons, bones, ligaments, and other kinds of connective tissue. You can also find collagen in the blood, intestinal lining, and organs.
All proteins are made from amino acids, and collagen is no exception. Proline, glycine, and hydroxyproline are collagens main amino acids. These three amino acids are grouped to form protein fibrils in the famous triple helix structure.
The main role of collagen is to provide strength, structure, and support to the body. Its specific roles are:
To date, researchers have identified 28 types of collagen. The differentiation is based on the molecule assembly, the cell components, and the location of the collagen in the body. All these different collagen fibrils consist of a triple helix structure.
Here are the main types of collagen as well as their various functions:
Here are the different factors that can affect collagen production in the body:
Apart from these factors, it has also been found that fasting, especially intermittent fasting, can increase collagen production. We shall take a look at this phenomenon now.
Intermittent fasting can stimulate collagen synthesis in multiple ways. Check them out here:
It has been proven that intermittent fasting can increase and enhance the secretion of an important hormone, Human Growth Hormone (HGH). HGH is a very important regulator of collagen production in the body. HGH stimulates collagen production in two ways. Firstly, it helps the fibroblasts differentiate into myofibroblasts, cells that produce collagen. Secondly, HGH upregulates collagen gene expression.
A study published in the Nutrition Research journal revealed that 24-hour intermittent fasting led to an immense increase in HGH levels in both women and men [1]. Another study proved that a 37.5-hour fast elevated basal HGH concentration by 10-fold and additionally reduced the metabolic clearance of HGH. [2]
As we know, HGH is essential for collagen synthesis. This increase in HGH levels during intermittent fasting suggests that the latter is a very useful tool for increasing collagen production in the human body.
Cancer.gov defines autophagy as A process by which a cell breaks down and destroys old, damaged, or abnormal proteins and other substances in its cytoplasm (the fluid inside a cell). The breakdown products are then recycled for important cell functions, especially during periods of stress or starvation.
As the body ages, it gets increasingly exposed to free radicals from the food we eat, the air we breathe, and the different products we use daily. This stresses out the individual cells and causes them to get damaged faster than normal. These damaged cells can linger in connective tissues and organs, causing inflammation and disease. Autophagy removes the task of maintaining these useless and inefficient cells in the body. It frees it to fight inflammation, deter diseases, and line the body up for optimal functioning.
After age 30, the fibroblasts in the skin begin to store more waste, slowing down the collagen-producing and autophagy rates. This then causes a deterioration of the fragility and integrity of the skin and leads to sagging and wrinkled skin. Hence, an increased autophagy rate will help clean the fibroblasts, removing unwanted cellular debris and slowing down the signs of skin aging.
A study found that intermittent fasting induced autophagy in mice, helping remove dead and damaged cells and produce healthy and new cells. [3]
As we know, autophagy is crucial for collagen synthesis, and increased autophagy rates brought about by intermittent fasting lead to improved and increased collagen synthesis by inference.
Intermittent fasting can reduce body inflammation in many ways. It reduces oxidative stress by producing antioxidants, promotes autophagy, lowers insulin levels, activates anti-inflammatory pathways, and modulates the gut microbiome, all contributing to reduced inflammation.
A study found that intermittent fasting reduces chronic inflammation in mice by activating an anti-inflammatory pathway known as the Nrf2 pathway. [4]
As we know, inflammation is a big cause of collagen breakdown. Hence, the above reduction in inflammation in the mice suggests that intermittent fasting can help protect collagen.
There are several ways in which intermittent fasting can improve gut health. Firstly, it improves the motility of the gut, helping the digestive system move food through the GI tract. Secondly, it improves the gut microbiota, modulating the composition of the trillions of microorganisms residing in the gut. Thirdly, it refines the gut barrier function by increasing mucus formation, reducing inflammation, and finally enhancing the absorption of nutrients from the gut.
A study has conclusively shown that intermittent fasting improves overall gut health. [5]
Now, the gut is where most of the nutrients necessary for collagen synthesis get absorbed. Hence, a healthy gut can ensure that the body has all the ingredients it needs for the production of collagen, and this can be made possible through intermittent fasting.
Collagen is a great way to help you achieve your weight loss goals, but youre probably using it wrong. When used correctly, it can help prevent snacking, reduce cravings, and help you get to your weight loss goals.
The biggest mistake that you are making is that you are using collagen as your main protein source. If you do this, you will lose weight, but it will be in the form of a loss in muscle and bone mass, leading to a decrease in metabolism, which you do not want.
To achieve healthy weight loss, use collagen supplements in tandem with a rich protein source. Suppose you are making a collagen supplement smoothie. We suggest you reinforce this smoothie with a rich source of protein, like Greek yogurt or even another protein supplement.
If you use bone broth, you can sip on it but do not use it as a replacement for protein. Rather, use it as an add-on to a meal. For example, you can sip on bone broth while relishing a chicken salad. This gives you collagen and a complex protein.
Strictly speaking, yes. Collagen intake during fasting periods will break your fast. Even if you eat hydrolyzed and unflavored collagen peptides, remember that each scoop of collagen contains 30 calories.
The collagen tissues in our body are responsible for forming tendons, ligaments, and bones. However, you can lose collagen in your body if you are exposed to UV rays, if you consume tobacco, or if you take excessive sugar, as well as with age. Additionally, chronic stress can make you lose collagen.
It has been observed that new collagen growth can take anywhere from 4 to 12 weeks to complete.
Collagen supplements can make you feel satiated. This helps with weight loss and the prevention of hunger pangs when you are doing intermittent fasting. Collagen has this effect because it is a form of protein.
The top foods rich in collagen are bone broth, eggs, meat, fish, and spirulina.
The link between intermittent fasting and collagen production is multi-faceted and complex. Collagen is a crucial protein that is indispensable to the human body as it maintains the function and structure of different organs and tissues. Studies have shown that fasting can increase the secretion of human growth hormone and promote the process of autophagy, both of which directly or indirectly influence the production of collagen.
The intricate relationship between collagen synthesis and intermittent fasting impacts longevity and health. If we can increase collagen production by fasting intermittently, it could help arrest age-related issues with skin, joint health, and the density of our bones. Again, nowadays, collagen supplements are quite popular, and their efficacy can be increased if we better understand the relationship between fasting and collagen production.
Collagen production is influenced by various factors, including lifestyle, exercise, and nutrition; intermittent fasting is one of many ways collagen synthesis can be promoted. The fascinating link between intermittent fasting and collagen production needs further exploration and study so that we can come to a better understanding of their complex relationship.
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Intermittent Fasting and Collagen Production Fitness Volt - Fitness Volt
Editor's note: This article has been corrected to state in all instances that TransCon PTH (palopegteriparatide) is meant to treat adults with hypoparathyroidism.
Shares of Ascendis Pharma (ASND 6.48%) rose more than 19% Monday morning after the Danish pharmaceutical company received a critical response letter (CRL) from the Food and Drug Administration (FDA).
The biotech company specializes in therapies to treat rare endocrinology diseases and various cancers. Its shares are down more than 30% so far this year.
The reason the stock went up rather than down following a CRL is it gave some clarity to the situation around TransCon PTH (palopegteriparatide), which is in phase 3 clinical trials to treat adults with hypoparathyroidism. While the FDA cited concerns about the company's manufacturing control strategy, it did not say it had concerns about the clinical data from Ascendis and did not request any additional clinical studies.
All this means the problem is something Ascendis can more easily fix, while the need for more clinical trials could easily delay the drug's launch by two years, and that's if Ascendis satisfied any FDA concerns. Ascendis said it plans to request a Type A meeting soon with the FDA.
"We are committed to working collaboratively with the FDA and, because the agency did not suggest that additional phase 3 studies may be needed to demonstrate the product's safety and efficacy, we believe we are well prepared to address their concerns," said Jan Mikkelsen, Ascendis Pharma president and CEO, in a press release.
Ascendis only has one FDA-approved therapy, Skytrofa. It is a once-weekly human growth hormone to treat pediatric growth hormone deficiency. In the first quarter, thanks mainly to Skytrofa, the company reported revenue of 31.6 million euros ($34.8 million), up 394% year over year.
The company had a net loss of 110.9 million euros ($122.4 million), thanks mainly to higher expenses related to the company's clinical oncology programs. Ascendis said it had, as of March 31, 585.7 million euros ($646.2 million), which is enough at its current burn rate to fund operations into early 2025.
Jim Halley has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
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Why Shares of Ascendis Pharma Are Climbing Monday - The Motley Fool
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As an athlete, you know how to bring the heat to your training regime. But bring too much (literal) heat to your sleep routine, and you risk sabotaging your sports-specific goals.
Theres a temperature sweet-spot for optimal sleep and exercise recovery, says Pete McCall, an exercise physiologist. And slumbering in a room outside of that range may cause your recovery to suffer, he says.
It may also lead to performance issues. One 2020 review published in the International Journal of Sports Medicine found that inadequate sleep can decrease reaction time and accuracy, as well as worsen judgment and decision making. But logging Zzzs isnt just important before a long day on the trail, its also essential following a day of exercise.
When you exercise, you create tiny microscopic tears in your muscle fibers, McCall explains. As concerning as that sounds, the fibers repair themselves while you sleepand become stronger through the process. Without adequate rest, your recovery is hindered.
One 2023 review published in Current Issues in Sports Science found that a lack of sleep decreases human growth hormone levels. Without the requisite levels of this hormone, which triggers the release of a protein essential for muscle regrowth, the repair process is impeded. Additionally, a 2015 study published in the Journal of the American Medical Directors Association found that testosterone levels, which regulate the rate at which amino acids can do work on the torn muscle fibers, decreased in individuals who experienced sleep disturbances.
Temperature is one of the main things that can lead to sleep struggles, says sleep psychologist and the director of sleep health at Sleepopolis Shelby Harris. People typically get the most optimal shut-eye in 60- to 67-degree rooms, she says. If youre dozing off in a room much cooler than that, you risk impacting your cardiac autonomic response, and if youre snoozing at a temperature above that, you risk night sweats, wakefulness, and decreased REM. Rapid eye movement sleep is the stage of sleep when testosterone production is at its highest, explains McCall. If that stage is hijacked by high temperatures, your athletic recovery will suffer, he says. Youll also be at an increased risk for injury, chronic stress, and overtraining syndrome. So, how exactly can you avoid that?
Twisting your thermostat to the left each evening is the easiest routine when it comes to sleep temperature regulation. However, you may live in an environment, such as an apartment complex with a central temperature control or an older home without air conditioning, where that isnt possible. These alternative options allow you to ensure youre able to sleep at the optimal temperature.
Sometimes the simplest trick can be the best one. Assuming you live somewhere where it gets cooler at night, opening your windows may be all you need to keep yourself from overheating, says McCall.
You may be overlooking another built-in temperature regulator: your ceiling fan. According to the Department of Energy, overhead fans can help rooms feel 4 degrees cooler. If you dont have a ceiling fan, a well-placed store-bought fan can also do the trick. Plus, a fan can double as a sound machine, helping you drift off easily.
Beyond your built-in sleeping aids, a slew of sleep gizmos and gadgetsranging from cooling sheets and breathable pillows to gel-infused mattress toppers and temperature adjusting mattressescan help keep you comfortable all night long. Mattresses and other devices that regulate temperature while you sleep are sound investments, Chris Winter, a sleep specialist and neurologist, says.
If your partner runs cold, but you dont, opt for a single-person cooling option, such as the Brooklyn Bedding Luxury Cooling Memory Foam Pillow or Moona Cooling Pillow Pad. The former uses a cool gel infusion and copper to promote greater breathability, while the latter uses water and a heat pump. These and similar products keep your overall body temp down by regulating head and neck temperature.
However, if you sleep alone or you and your partner both find yourselves sweating at night, consider purchasing a mattress cooler like ChiliSleep Sleep System or Eight Sleep Pod Cover, or a temperature-regulating mattress like PerformaSleep or Helix Sleep Midnight Luxe.
Its important to note that while temperature regulating devices can be great, they need to be paired with other healthy sleep habits in order to be effective, Winter says.
Beyond regulating your sleep temperature, make sure youre mastering the basics of a solid bedtime routine. Winter recommends strategies such as waking up at the same time every day, limiting exposure to blue light in the evening, and getting sunlight within the first hour of waking.
Its about more than eliminating those restless nights. With better sleep, youll maximize your recovery and performancebe it at the office or on the trail.
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What You're Forgetting When It Comes to Your Sleep - Outside
