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
When it comes to a novel virus like SARS-CoV2, a certain amount of “rolling with the punches” is required, and governments and global organizations like the World Health Organization are beginning to dismiss certain treatments and devote themselves wholeheartedly to others.
The company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration for two more years.
Abbott is suing their former VP Jerome Clavel over allegations of trade secret theft with intent to share with his new employer, rival diagnostics company Bio-Rad.
While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses.
The COVID-19 pandemic changed the biopharma industry and the world irrevocably. The challenges will reverberate even after the pandemic ends, according to panelists at the Cell and Gene Meeting on the Mesa in mid-October.
Both sides claim to be pleased with arbitration results in dispute over Prevail CEO’s alleged breach of contract from time with Allector.
Three biopharma companies recently shuttered their clinical programs after either their compounds failed clinical trials or interim futility analysis suggested they were unlikely to meet their clinical endpoints. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 3, 2020.
During a Sunday campaign event in Florida, President Donald Trump appeared to hint to the crowd that following the Nov. 3 election, he would terminate the decades-long tenure of Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
The U.S. – and global – response to the COVID-19 pandemic has been volatile at best. This is fair, considering that SARS-CoV-2 is a novel virus with a lethality we haven’t seen in more than a century.