Day: July 19, 2021

STAT+: Advocates urge Biden to name patent office director that could transform drug pricing

As the White House readies to name a new head of the U.S. Patent & Trademark Office, a coalition of advocacy and nonprofit groups see an opportunity to overhaul the approach to issuing patents that may sometimes prevent Americans from accessing needed medicines. For the past several years, patent protection has become a flashpoint in […]

STAT+: Dutch authorities fine drug maker $23 million for ‘excessive’ pricing of a rare disease drug

Antitrust regulators in the Netherlands have fined a drug maker $23 million for years of “excessive” price hikes for a rare disease medicine, the latest instance in which European authorities cracked down on the pharmaceutical industry for harming consumers and taxpayers. In this case, the Netherlands Authority for Consumers and Markets cited Leadiant for a […]

STAT+: Pharmalittle: Pfizer seeks full FDA approval for its Covid-19 vaccine; CT attorney general calls some Sacklers ‘entitled thugs’

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because …  sure enough … here we are again, staring down the laptop and sorting out the growing to-do list. But what can you do? The world keeps spinning — unless you subscribe to flat-earth conspiracies, among […]

STAT+: Kadmon wins approval for drug to treat chronic graft-versus-host disease

Kadmon Pharmaceuticals won approval from the Food and Drug Administration on Friday to market a new treatment for chronic graft-versus-host disease — a debilitating immune condition that can affect as many as half of the blood cancer patients who undergo bone marrow transplants. The newly approved drug, called Rezurock, is Kadmon’s first internally developed medicine […]

STAT+: Cytokinetics drug improves blood flow in patients with inherited form of heart disease

Cytokinetics said Monday that its experimental drug demonstrated statistically significant improvements in blood flow for patients with an inherited form of heart disease — a result that compares favorably to a competing heart drug recently acquired by Bristol Myers Squibb. In a small, mid-stage clinical trial, 13 of 14 patients, or 93%, treated with a […]

How Delta is pushing the U.S. into a new phase of the Covid-19 pandemic

For the first year of the Covid-19 pandemic, hospitalizations and deaths followed infection patterns by a few weeks, as sure as night follows day. Vaccines promised to sever those metrics. While they might not prevent all Covid-19 infections, vaccines would, experts predicted, dramatically reduce hospitalizations and deaths. And they have. Read the rest…

Too close for comfort: FDA shouldn’t loosen conflict rules for its expert panels

Never mind the conflicts, there are drugs to approve. In a sorry turn of events, the Food and Drug Administration is facing a confidence-draining debacle thanks to its controversial approval of a pricey Alzheimer’s drug for which evidence appears suspect, at best. Read the rest…

Opinion: Lessons learned — and lost — from a Vietnam-era study of addiction

Opioids like heroin, morphine, OxyContin, and fentanyl occupy a spot in the public imagination as particularly dangerous and addictive substances. Amid an addiction epidemic with no end in sight, this class of drugs has been given special attention in the news, funding bills, and the 2017 President’s Commission on Combatting Drug Addiction and the Opioid […]

STAT+: Atul Gawande, bureaucrat: A tough job would await the renowned surgeon at USAID

Atul Gawande has been a renowned surgeon, an award-winning magazine writer and author, a Rhodes scholar, a recipient of a MacArthur “genius grant,” and the CEO of a briefly ballyhooed health care company. Now he is hoping to be a bureaucrat. Continue to STAT+ to read the full story…

Messenger RNA vaccine pioneer Katalin Karikó shares her long journey to Covid-19 vaccines

In the span of the Covid-19 pandemic, and thanks to the success of two of the currently available vaccines for SARS-CoV-2, messenger RNA, or mRNA, went from being an obscure cell biology concept understood and mentioned only by scientists to being a household term. But the technology behind the mRNA vaccines from Moderna and Pfizer […]

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