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 government of Russia has approved a vaccine for COVID-19, marking the first preventative treatment for the novel coronavirus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 12, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 10, 2020.
Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
In an aim to create a strong domestic supply chain, President Donald Trump signed an Executive Order on Thursday that calls for federal agencies to purchase “essential drugs” and medical supplies that are produced in the United States, rather than from abroad as is the current practice.
The FDA set a PDUFA target date of March 7, 2021 for aducanumab, Biogen said.
Although August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar for PDUFA dates, this week’s dates were almost all approved ahead of schedule. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
Eliquis generic was approved by FDA to prevent strokes, blood clots etc. But there were some legal issues which recently got stave off. Know more about it here.
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.