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GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they're the only companies with an antibody that appears to be truly effective against omicron...The FDA...cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab)...Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year...READ MORE

...federal judge in Texas has denied attempts by the U.S. Food and Drug Administration to conceal data on Pfizer’s COVID-19 vaccine. The judicial rule overturned the regulatory agency’s plan to withhold data for up to 55 years...The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit...the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed...The judge’s ruling demands that the FDA make the data publicly available within a span of eight months...READ MORE

Holmes faced 11 total counts, and the jury found her guilty of four of them. Each carries a maximum sentence of 20 years in prison...Theranos founder and former chief executive officer Elizabeth Holmes, who once promised "lab on a chip" technology to upend the diagnostics industry...The verdict follows months of testimony, including some from doctors, former Theranos employees and board members, patients, and Holmes herself, about their experiences with the once-vaunted blood-testing startup..."​​Holmes and [former Theranos chief operating officer Ramesh] Balwani used advertisements and solicitations to encourage and induce doctors and patients to use Theranos' blood testing laboratory services, even though, according to the government, the defendants knew Theranos was not capable of consistently producing accurate and reliable results for certain blood tests," read the indictment...READ MORE

Paxlovid and molnupiravir are the first oral treatments for COVID-19, potentially valuable new tools as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S...The Food and Drug Administration...authorized the first pill for COVID-19, clearing for emergency use an antiviral treatment from Pfizer at a precarious moment in the two-year-old pandemic. One day later...the agency cleared a second pill developed by Merck & Co...READ MORE

Millions of Britons in England may soon be charged for their medication, as the Government plans to raise the qualifying age for free NHS prescriptions to 66, in line with the state pension age. But what does this mean for others entitled to free prescriptions? And can you get free prescriptions if you receive Universal Credit?...Most treatments on the NHS are free, but notable exceptions include paying for prescriptions...Most Britons have to pay for their prescriptions, but there are exceptions including those for people of certain ages, people receiving benefits and pregnant women...Anyone aged under 16, between 16 and 18 but in full-time education, or over 60 is automatically eligible for free prescriptions...For older people, the Government is planning to raise the qualifying age for free prescription from 60 to 66, which could come into force as early as April 2022...READ MORE

The Biden administration has officially pulled a controversial model that would have tied prices for drugs reimbursed under Part B to prices paid by countries overseas...The Centers for Medicare & Medicaid Services issued a final rule last week that pulls the demonstration approved at the tail end of the Trump administration. Providers had slammed the Most Favored Nation model due to concerns over reimbursement...CMS said in the final rule published on Dec. 29 that the model sparked four lawsuits from the drug industry, which resulted in a legal stay delaying it from going into effect...READ MORE

Reality has again failed to cooperate with the politically motivated cries of “skyrocketing drug prices” or anecdotes about companies “jacking up prices” (as President Biden recently claimed)...Brand-name drug prices continue to decline, while the prices of other healthcare products and services continue to rise. For 2021, brand-name drugs’ net prices dropped for the fourth consecutive year. Meanwhile, brand-name drug list prices grew more slowly than overall inflation. What’s more, we project that the gross-to-net bubble for patent-protected brand-name drugs will exceed $200 billion in 2021...The factors that drive declining brand-name drug prices remain for 2022, suggesting that these trends will continue...READ MORE

Elizabeth Holmes, the Theranos founder convicted of four counts of felony criminal fraud by a jury earlier this month, probably will not receive her sentence until after Labor Day...The filing describes the reason for the delay as related to “ongoing proceedings in a related matter.” The federal fraud trial of Holmes’ co-accused, former Theranos chief operating officer Sunny Balwani, is expected to start in March...She is free on a $500,000 bond secured by her signature, but the filing said her lawyers have agreed with the prosecution to have the bond secured by property...READ MORE

Ex-GlaxoSmithKline researcher Lucy Xi has pled guilty to conspiracy to steal trade secrets from her former company to help a rival firm launch a business in China. She is the fourth person to plead guilty to the offense...Xi and co-defendants Yan Mei, Yu Xue, Yan Mei, and Tao Li created Renopharma in the guise of conducting research and development of anti-cancer therapies. However, it was found that Renopharma had been operating as a repository of stolen GSK information and was receiving compensation and subsidies from the People's Republic of China to do so...READ MORE

One of the two drugs in the antiviral cocktail could cause serious interactions with widely used prescriptions, including statins, blood thinners and some antidepressants...the first antiviral pills for Covid-19 promise desperately needed protection for people at risk of severe disease. However, many people prescribed Pfizer’s or Merck’s new medications will require careful monitoring by doctors and pharmacists, and the antivirals may not be safe for everyone, experts caution...could cause severe or life-threatening interactions with widely used medications, including statins, blood thinners and some antidepressants. And the FDA does not recommend Paxlovid for people with severe kidney or liver disease...READ MORE