Tag Archives: pharma

NPR reports: U.S.-based pharmaceutical giant Merck & Co. said it will license drugmakers worldwide to produce its potentially lifesaving antiviral pill for treatment of COVID-19 in adults. The drug, known as molnupiravir, has shown promise in treating the disease, and the agreement to license its production could help millions of people in the developing world gain access to it. Merck …

The New York Times reports: A key advisory committee to the Food and Drug Administration voted overwhelmingly to recommend the use of Pfizer-BioNTech’s coronavirus vaccine in 5- to 11-year-olds, bringing the vaccine a big step closer to about 28 million children. Shots could be offered as early as next week. The panel endorsed giving the age group one-third of the …

NPR reports: Moderna says a study in kids 6 to 11 found two doses of the company’s COVID-19 vaccine given 28 days apart produced a strong antibody response. The study, conducted in collaboration with the National Institutes of Health, used shots containing a 50 microgram dose of the vaccine, half the dose of the Moderna shots authorized for adults. More …

ABC News reports: Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group. The shots could begin in early November — with the first children in line fully protected by Christmas — if regulators …

Bloomberg News reports: Merck & Co. and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir, moving the pill closer to becoming the first oral antiviral treatment for Covid-19. An application was submitted with the Food and Drug Administration for molnupiravir to treat mild-to-moderate Covid-19 in adults at risk of developing a severe illness that …

CNBC reports: Merck and Ridgeback Biotherapeutics plan to seek emergency authorization for their oral antiviral treatment for Covid-19, after the medicine showed “compelling results” in clinical trials. The drug, molnupiravir, reduced the risk of hospitalization or death by around 50% for patients with mild or moderate cases of Covid-19, the companies announced on Friday. Molnupiravir is administered orally and works …

Reuters reports: Pfizer Inc said on Monday it has started a mid-to-late-stage study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.  The company and its rivals, including Merck & Co Inc and Roche Holding AG, have been racing to develop the first antiviral pill for COVID-19. Pfizer …

USA Today reports: Pfizer is voluntarily recalling all lots of its popular anti-smoking drug Chantix for high levels of nitrosamine, which can increase the risk of cancer. According to the notice posted on the Food and Drug Administration website, the recall is for all lots of 0.5 mg and 1 mg varenicline tablets. The recall notice says that long-term ingestion …

The New York Times reports: The Pfizer-BioNtech coronavirus vaccine has been shown to be safe and highly effective in young children aged 5 to 11 years, the companies announced early Monday morning. The news should help ease months of anxiety among parents and teachers about when children, and their close contacts, might be shielded from the coronavirus. The need is …

The Washington Post reports: More than two decades after Purdue Pharma launched its blockbuster pain pill OxyContin, preceding a deadly overdose crisis, a judge approved a bankruptcy plan Wednesday that will resolve thousands of lawsuits against the drugmaker and grant sweeping legal immunity to its billionaire owners. Negotiated until the 11th hour, the final terms of the settlement confirmed by …

CNBC reports: Moderna said its Covid-19 vaccine booster shot produced a “robust” antibody response against the highly contagious delta variant, according to details of a study released Thursday with the company’s second-quarter earnings report. In a phase two trial, Moderna is testing a 50-microgram dose of three vaccine booster candidates in previously vaccinated individuals. The booster shots produced a promising …

CNBC reports: A one-of-a-kind album by the hip-hop group Wu-Tang Clan that was once owned by notorious “Pharma Bro” Martin Shkreli finally has been sold by the U.S. government, three years after Shkreli forfeited the record as part of his conviction for securities fraud. The buyer and the sale price of the album, “Once Upon a Time in Shaolin,” were …

Reuters reports: Pfizer Inc has agreed to pay $345 million to resolve claims by consumers who claim they overpaid for EpiPens due to anti-competitive and unfair practices by the drugmaker and the company that markets the emergency allergy treatment, Mylan. The proposed class action settlement was disclosed in a filing in federal court in Kansas City, Kansas. The deal, which …

Reuters reports: The rollout of Biogen Inc’s Alzheimer’s drug is hitting new roadblocks as some large hospitals decide not to use it and many health insurers await coverage terms from Medicare, the U.S. health plan for people aged 65 and older, before setting their own policies. Cleveland Clinic, one of the country’s best-known health systems, and New York’s Mount Sinai …

The Washington Post reports: The Food and Drug Administration on Thursday limited the recommended use of a controversial new Alzheimer’s drug to patients with mild cognitive impairment or early dementia from the disease — a major change from the original label that included everyone with the illness. The revised label clarifies that the drug, called Aduhelm, is intended for patients …

NBC News reports: Pfizer is about to seek U.S. authorization for a third dose of its Covid-19 vaccine, saying Thursday that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant. Research from multiple countries shows the Pfizer shot and other widely used Covid-19 vaccines offer strong protection against the highly …

The Wall Street Journal reports: An experimental Covid-19 vaccine from Novavax was 90.4% effective at preventing symptomatic disease in adults in a large clinical trial, the company said, results that move the shot a step closer to global use. The 29,960-person study conducted in the U.S. and Mexico also found that the vaccine was similarly effective against newer coronavirus strains, …

CNBC reports: Biogen CEO Michel Vounatsos told CNBC on Monday that the list price of $56,000 per year for the company’s FDA-approved Alzheimer’s disease drug aducanumab is “fair.” That being said, the Massachusetts-based biotech company has vowed to not increase the price of the medication, which is marketed under the name Aduhelm, for the next four years, Vounatsos said. The …

CNBC reports: The Food and Drug Administration on Monday approved Biogen Alzheimer’s drug aducanumab, making it the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades. The FDA’s decision was highly anticipated. The drug, which is marketed under the name Aduhelm, is …

The New York Times reports: The Food and Drug Administration is on the verge of announcing one of its most contentious decisions in years: the fate of an Alzheimer’s drug that could be the first treatment approved after nearly two decades of failed efforts to find ways to curb the debilitating disease. On Monday, the agency will rule on the …