Policy
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Illumina plans to continue to pursue its acquisition of Grail Inc. despite the objection of the U.S. Federal Trade Commission.
AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
Merck is having a very busy week. Here’s today’s news.
Servier was found guilty of manslaughter and deceptive marketing practice for its Mediator drug for weight loss. The Paris-based company was fined $3.12 million.
The report listed four scenarios in order of likelihood, with the top being from bats through another animal.
The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.
The Orphan Drug Act passed in 1983 and granted tax credits, subsidies and fee waivers for rare disease drug development in areas of unmet need. It also guaranteed seven years of market exclusivity following approval, longer than the five years typical for most new chemical entities.
As this week’s FDA Action Alert emphasizes, not everything goes as planned with the U.S. FDA. With three PDUFA dates, two of them ran into issues. Read on to find out more.
There appears to be some evidence that the agency is cracking down in general, although there’s debate among analysts about what exactly is going on.
What has been learned about SARS-CoV-2, the virus that causes COVID-19, in only about 15 months, is truly a historical scientific achievement. And new information continues to come in.