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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Three days after U.S. Food and Drug Administration staff raised safety concerns over Pfizer’s and Eli Lilly’s NGF osteoarthritis drug tanezumab, an advisory panel has also posted its own objections.
Moncef Slaoui was fired as chairman of the board of directors of Galvani Bioelectronics following allegations of sexual harassment and inappropriate conduct.
AbbVie has filed a legal complaint against Icelandic pharmaceutical company Alvotech for the latter’s alleged misappropriation of trade secrets involving the development of a generic version of AbbVie’s rheumatoid arthritis drug Humira.
Boston Scientific’s settlement was not an admission of misconduct or liability. In a brief statement cited by Reuters, the company said the financial agreement was in its shareholder’s best interest.
Keytruda (pembrolizumab) won another regulatory victory, making it the first checkpoint inhibitor approved by the U.S. FDA for first line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinomas regardless of PD-L1 expression.
With widespread distribution of various vaccines against COVID-19 vaccine ongoing, companies are still refining their vaccines and therapies and generating new data. Here’s a look at two recent updates.
The announcement by the NIAID, a part of the National Institutes of Health (NIH), is very unusual.
Change is coming to the pharmaceutical supply chain. The supply chain review ordered by President Biden virtually guarantees it with its attempts to understand and improve issues related to supply chain transparency, security and overreliance on a few suppliers in a few regions.
A briefing document from the U.S. FDA cites critical safety concerns with Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab, despite the fact that clinical trials have demonstrated the agent can help patients with osteoarthritis.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 23, 2021.