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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.
“Today’s announcement puts another building block in place as the Nation moves toward a safe and effective COVID-19 vaccine,” stated Robert Redfield, director of the U.S. Centers for Disease Control and Prevention.
Phase III clinical trials for Russia’s Sputnik V vaccine for COVID-19 began Wednesday, one day after the Russia Direct Investment Fund (RDIF) launched a new website to share the details of the vaccine with the public and scientists around the world.
With a busy August on the U.S. Food and Drug Administration’s schedule, this week is no exception. Here’s a look at some of what’s on the agency’s calendar.
Novavax entered into an agreement to provide the United Kingdom with 60 million doses of the vaccine should it be approved, as well as a late-stage efficacy study in that country.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 14, 2020.
Passage Bio’s first attempt to develop a GM1 gangliosidosis gene therapy treatment has run into a roadblock in the form of a clinical hold.
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
Moderna signed a contract worth up to $1.525 billion with the U.S. government to supply 100 million doses of mRNA-1273, the company’s experimental COVID-19 vaccine.