Tag Archives: pharma

Merck Seeks FDA Approval For Oral COVID Treatment

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 …

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Merck To Seek Authorization For Oral COVID Treatment

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 …

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Pfizer Begins Study Of Oral COVID-19 Preventive

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 …

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Anti-Smoking Drug Chantix Recalled Over Cancer Risk

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 …

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STUDY: Pfizer Vax Is Highly Effective In Children 5-11

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 …

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Oxy-Peddling Sackler Family Given Civil Immunity

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 …

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Moderna: Booster Candidate “Robust” Against Delta

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 …

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US Sells “Priceless” Album Seized From Pharma Douche

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 …

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Pfizer To Pay $345 Million In EpiPen Anti-Trust Lawsuit

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 …

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Major Hospitals Won’t Carry New Alzheimer’s Med

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 …

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FDA Limits Usage Of New Alzheimer’s Medication

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 …

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Pfizer To Seek US Approval For Third Vaccine Dose

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 …

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STUDY: Novavax Jab 90% Effective Against Variants

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, …

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CEO Defends $56K Annual Cost Of Alzheimer’s Med

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 …

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FDA Approves Biogen’s New Alzheimer’s Medication

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 …

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FDA To Rule Tomorrow On New Alzheimer’s Medication

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 …

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Moderna Reports Vaccine Is 100% Effective In Teens

CNBC reports: Moderna said Tuesday its Covid-19 vaccine was 100% effective in a study of adolescents ages 12 to 17, making it the second shot behind Pfizer’s to demonstrate high efficacy in younger age groups. The company said it plans to ask the Food and Drug Administration to expand the emergency use of its Covid vaccine for teens early next …

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COVID Vax Boosters May Be Needed By September

Axios reports: The first Americans to be vaccinated against the coronavirus could require a third “booster” shot as early as September, the CEOs of Pfizer and Moderna told Axios. “The data that I see coming, they are supporting the notion that likely there will be a need for a booster somewhere between eight and 12 months,” Pfizer CEO Albert Bourla …

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Feds Accuse Pharma Douche Of Destroying Evidence

Law & Crime reports: The Federal Trade Commission accused disgraced pharmaceutical executive Martin Shkreli on Tuesday of having destroyed evidence relevant to a lawsuit that could lead to his lifetime ban from the industry. Regulators claim that the convicted fraudster invoked his Fifth Amendment right against self-incrimination when asked about a phone he used to conduct business from prison. “It …

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FDA Approves Pfizer Vaccine For Kids Ages 12 To 15

CNBC reports: The Food and Drug Administration approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis, allowing states to get middle school students vaccinated before the fall. The U.S. agency granting use of the shot in adolescents will also accelerate the nation’s efforts to drive …

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