Day: July 12, 2021

STAT+: Biden’s executive order would pause a Trump rule forbidding march-in rights to lower drug costs

In a little-noticed move, the Biden administration has hit the pause button on a rule that would prevent the federal government from using a controversial legal provision for combating the high prices of products developed with taxpayer dollars. The move amounts to an about-face after the White House left the rule, which was proposed earlier […]

Powerful House Democrats demand documents from Biogen about coordination with FDA on new Alzheimer’s drug

WASHINGTON — Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and pricing of its controversial new Alzheimer’s drug. The letter is the latest move in a congressional investigation into Aduhelm’s approval and pricing spearheaded by House Committee on Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and […]

STAT+: Medicare starts process that could limit access to Biogen’s new Alzheimer’s drug

WASHINGTON — Federal officials on Monday announced Medicare will start a process that could limit seniors’ access to the controversial new Alzheimer’s drug, Aduhelm — the first signals from the key health program about what will be an enormously consequential decision for Biogen, the Medicare program itself, and people with the disease. The process, called […]

J&J’s Covid-19 vaccine may trigger neurological condition in rare cases, FDA says

Johnson & Johnson’s Covid-19 vaccine may trigger a rare neurological condition in a small number of people who receive the vaccine, the Food and Drug Administration said Monday. Reports to a database operated jointly by the agency and the Centers for Disease Prevention and Control suggest there may be a link between the inoculations and […]

STAT+: Dozens of generic makers and pharmacies won’t face lawsuits over Zantac and cancer risks

A federal court judge dismissed all claims against dozens of generic manufacturers and retailers in sprawling litigation over allegations that the Zantac heartburn pill may contain a carcinogen, although brand-name drug makers will continue to face more than 1,400 lawsuits over the issue. The ruling is the latest chapter in an ongoing saga over the […]

WHO director-general slams notion of Covid-19 vaccine booster doses given global health needs

The director-general of the World Health Organization on Monday issued a stinging rebuke to Pfizer and other vaccine manufacturers focused on developing — and selling — Covid-19 vaccine booster shots to high-income countries, saying they should focus instead on providing vaccine to nations that have had little access to first doses. Tedros Adhanom Ghebreyesus’ statement […]

STAT+: Pharmalittle: U.S. officials and Pfizer to meet over Covid-19 booster shots; FDA full approval for vaccines may not be a game changer

Good morning, everyone, and nice to see you again after we took an extended break. We hope the weekend respite was relaxing and invigorating. Certainly, it was interesting to watch the much-ballyhooed space tourism industry get a lift, of sorts. How many of you have booked a flight? As for us, we are coping with […]

World Health Organization advisers urge global effort to regulate genome editing

On Monday, a World Health Organization advisory committee called on the world’s largest public health authority to stand by the 2019 statement of its director-general urging a halt to any experiments that might lead to the births of more gene-edited humans. The committee — established in December 2018, weeks after news broke of the birth […]

Landmark gene therapy trial points to a wider window to alter course of rare disease

The suspicion that something was wrong started when the 1-year-old girl’s parents noticed she had trouble holding up her head. It was just the first of what would be many missed developmental milestones. By the time she was 8, the little girl still couldn’t sit up on her own, hold a toy, or say hello. […]

Experts warn full Covid-19 vaccine approval is no quick fix for hesitancy

WASHINGTON — The Food and Drug Administration issuing full approval for two Covid-19 vaccines might not be the game-changer it’s chalked up to be, according to a number of leading public health experts. Increasingly, some leading academics and physicians have pushed back on the popular narrative that the FDA is needlessly delaying full approvals for […]

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