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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The disclosure comes the day before the WHO is expected to plan for the next phase of investigations into the origins of COVID-19.
It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.
Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.
X-Vax Technology is ready to submit an IND application to the U.S. FDA for its experimental herpes vaccine against HSV-1 and -2. Here’s what you need to know.
House Oversight and Reform Committee slammed AbbVie for price increases on its drugs Humira Imbruvica. It said the company profited from patients and taxpayers.
FDA says it is possible booster shots would be necessary for fully vaccinated individuals within a year even though vaccines are highly effective at COVID-19 prevention.
The U.S. FDA scolded CytoDyn for misrepresenting its clinical trial results for Leronlimab in COVID-19. Here’s what FDA has to say regarding CytoDyn Leronlimab.
The high court’s decision will prevent Sandoz from launching its biosimilar to Amgen’s blockbuster rheumatoid arthritis drug.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 18, 2021.