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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Grail presents its first data from the interventional PATHFINDER trial of Galleri, its multi-cancer early detection blood test. Galleri is now available in the U.S. by prescription.
June is turning out to be a busy month for PDUFA dates for the U.S. Food and Drug Administration. Here’s a look at this week’s dates.
On June 5, the world marks the 40th anniversary of the HIV epidemic. Biopharma researchers continue to develop safe and effective treatments with an eye to a potential cure.
With the 2021 American Society of Clinical Oncology meeting held late last week, there is plenty of clinical trial news.
While several countries rely on Sinovac Biotech to end the pandemic, concerns regarding the shot’s efficacy continue to shroud the vaccine. Currently, it is the second most used vaccine worldwide.
It didn’t take too long before a lawsuit was filed over Bristol Myers Squibb’s failure to meet a deadline for a $9 Contingent Value Rights agreement tied to the company’s merger with Celgene.
AbbVie has been the target of multiple legal inquiries and challenges of its pricing and patent protections. Now, a U.S. senator is taking a gander at the company’s taxes.
The nation’s top science adviser believes the country’s renewed enthusiasm for science may pave the way for plug-and-play vaccines that can nullify the next pandemic before it starts.
A flurry of COVID-19 research news came out today. Here’s a look.
Calliditas is developing Nefecon, a down regulator of IgA1 and proprietary, novel oral formulation of budesonide – a potent and established immunosuppressant – for the treatment of IgAN.