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Wednesday, GSK plc (NYSE:GSK) revealed data from the ZOSTER-049 long-term follow-up phase 3 trial, which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV). The final trial data demonstrate that RZV has maintained efficacy against shingles in adults over 50 for over a decade. ZOSTER-049 included over 7,000 participants. The results from ZOSTER-049, an extension from two phase 3 clinical trials in adults aged 50 and over (ZOE-50 and ZOE-70), include: 79.7% vaccine efficacy (VE) in adults aged ≥50 cumulatively from year six to year 11 after vaccination. 82.0% VE in...

The Food and Drug Administration on Wednesday approved the world's first RSV vaccine: a shot for adults ages 60 and up, made by pharmaceutical giant GSK. The milestone was decades in the making. Researchers first attempted to develop a vaccine for respiratory syncytial virus roughly 60 years ago. In a late-stage clinical trial, the single-dose shot lowered the risk of symptomatic illness by 83% and of severe illness by 94%. The Centers for Disease Control and Prevention must still recommend the vaccine before it becomes available to the public. A CDC advisory committee is scheduled to meet in June to...

A new COVID-19 vaccine has achieved 100 percent efficacy against severe disease and hospitalizations, announced manufacturers Sanofi and GSK on Wednesday. The companies are now set to apply for regulatory authorization from bodies like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to release the vaccine as both a two-dose vaccine and booster shot. Unlike vaccines based on mRNA technology, the new Sanofi-GSK offering is a protein-based vaccine – a “well-established approach that has been applied widely to prevent infection with other viruses including pandemic flu,” said GSK President Roger Connor in a statement today. “We...

A new vaccine manufactured in Europe by Sanofi and GSK claims 100% efficacy against severe disease and hospitalizations, and it could be an effective booster after other COVID-19 shots, according to the manufacturers. The companies received billions of dollars from Donald Trump’s brainchild, “Operation Warp Speed.” Since Biden isn’t calling it that anymore, how are they going to describe where the money came from? The two-shot Sanofi-GSK vaccine is expected to be approved by the FDA for emergency use in next few weeks.New York Times:In laboratory studies, two doses of the Sanofi-GSK vaccine stimulated the production of more neutralizing antibodies...

The monoclonal antibody treatment from GlaxoSmithKline (GSK) and Vir BioTechnology protects well against the Omicron subvariant that is becoming more prevalent in the United States, the companies said Feb. 10.Preclinical data suggest that sotrovimab, the monoclonal, “retains neutralizing activity against the BA.2 subvariant of Omicron ,” the companies said in a press release.The data, based on pseudovirus and pharmacokinetic testing, was not made public. A Vir spokesperson didn’t respond when asked why. The companies said the results are being shared with government authorities around the world and that they plan on publishing them on the preprint server bioRxiv in the...

Following the Biden administration’s surprise announcement that Health and Human Services (HHS) is taking over the distribution of monoclonal antibody infusion treatments for COVID-19—reducing the number of doses in several red states by 50 percent—a spokesperson for Florida Gov. Ron DeSantis said he has reached out to GlaxoSmithKline to “fill the deficit.” Some states are set to receive fewer doses of monoclonal antibody treatments after the Biden administration switched the distribution system this week. Florida, Alabama, Texas, Tennessee are among the states targeted to have their monoclonal antibody (mAb) doses restricted by HHS. “HHS will determine the amount of product...

The defense team of Joseph DeAngelo has verified that the accused serial killer has offered to plead guilty to the charges against him if he could get a lifetime sentence. DeAngelo, the suspected murderer and rapist known as the Golden State Killer and the East Area Rapist, is accused of killing at least 13 people, raping upward of 50 women and burglarizing dozens of homes in the 1970s and '80s. He is slated to appear in Sacramento County court March 12. The former police officer was arrested in Citrus Heights in 2018, thanks to DNA technology, after decades of eluding...

SACRAMENTO, Calif. – A judge on Tuesday weighed how much information to release about the arrest of a former police officer accused of being the Golden State Killer. Sacramento County Superior Court Judge Michael Sweet began considering the issue after a hearing where attorneys for suspect Joseph DeAngelo argued that sharing the details could lead to an unfair trial. Sweet indicated he's likely to release some information and is working with prosecutors and defense attorneys to determine how much to redact, which would continue to shield some details from public view. The Associated Press and other news outlets are pushing...

A third pharmaceutical giant said Sunday it is being investigated by Britain's Serious Fraud Office (SFO) over alleged breaches of the United Nations oil-for-food programme in Saddam Hussein's Iraq. Eli Lilly and Company Limited said it had been asked to hand over documents to the SFO, a day after British peer GlaxoSmithKline (GSK) and Anglo-Swedish firm AstraZeneca announced they had received similar requests.

Gripe as we might, consumers understand that price increases do happen. What’s not as easily understood is how the price for something can go from $13.50 one day to $750 the next — especially when it’s a generic drug used to save lives. For decades, Daraprim (pyrimethamine), an anti-parasitic used to treat malaria and toxoplasmosis, had been made by GlaxoSmithKline and sold for as little as $1/tablet until not that long ago. Then in 2010 GSK sold the drug to CorePharma, which began to raise the price. Within a year, revenue from Daraprim jumped nearly ten times even though the...

A GlaxoSmithKline executive and a British private detective and his wife, who were initially hired by GSK to investigate smears, face prison in a tale akin to a spy mystery The story has all the makings of a sensational spy thriller, from allegations of corruption by one of the world’s biggest pharmaceutical firms and the appearance of a sex tape involving a senior executive, to the arrest of British citizens by a foreign power. It certainly cannot have been what Mark Reilly expected when he was promoted to head-up GlaxoSmithKline (GSK) pharmaceuticals division in China, in 2009. A 25-year veteran...

WASHINGTON -- GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday. Accompanying the criminal case was a civil settlement in which the government said the company's improper marketing included providing doctors with expensive resort vacations, European hunting trips, high-paid speaking tours and even tickets to a Madonna concert. The $3 billion combined criminal-civil fine will be the largest penalty ever paid by a drug company, Deputy...

FDA NEWS RELEASE For Immediate Release: March 9, 2011 Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov; Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves Benlysta to treat lupus First new lupus drug approved in 56 years The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought...

Go to http://www.thestreet.com/story/10921534/1/human-genome-fda-panel-live-blog.html to view the live blog of the event.

An influential psychiatrist who was the host of the popular public radio program “The Infinite Mind” earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program. The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by Senator Charles E. Grassley, Republican of Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first news media figure to be investigated. Dr. Goodwin’s weekly radio programs have often touched on...

Met 'to investigate Galloway for taking cash from Saddam'Last updated at 10:27am on 14th February 2007 George Galloway is likely to be investigated by the Met Police over claims he broke US sanctions by receiving oil money from Saddam Hussein. The Serious Fraud Office has recommended that Scotland Yard open an investigation and talks are currently taking place with the Crown Prosecution Service. The Respect MP for Bethnal Green and Bow has denied any impropriety and will not be investigated on separate offences of corruption. Under UN sanctions oil sales were only permitted for approved humanitarian purposes. To prosecute,...