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.
FEATURED STORIES
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
It’s a busy news day for COVID-19-related stories. Read on for more.
On Monday, the House passed a bipartisan bill designed to reportedly boost scientific research and increase the scientific competitiveness of the U.S. to that of China.
The deal was originally inked in 2005, where U.S.-based Chiron Corp. made payments to Genentech, a Roche company.
Here’s a look at some of the top COVID-19-related stories for today.
Although the COVID-19 pandemic is waning in the U.S., it’s not completely over and there are some concerns, particularly with the delta variant, which originated in India. Here’s a look.
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of the drug. Biogen, on its part, has defended its pricing.
Adamis has sent a letter to stockholders urging them to re-elect all the five board members as part of a strategic move to continue and maintain its current growth initiatives.
Ahead of the July Fourth holiday, the U.S. Food and Drug Administration has two PDUFA dates on the calendar. Here’s a look.
The U.S. Food and Drug Administration (FDA) has made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration (FDA), has voted 13-to-4 against supporting the accelerated approval of Incyte’s PD-1 inhibitor for squamous cell carcinoma.