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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AstraZeneca said in an earnings announcement on Thursday it will seek authorization for its COVID-19 vaccine in the U.S. sometime in the second half of this year.
Pfizer has reported several highlights regarding its mRNA COVID-19 vaccine. As the world deal with rising Delta variant cases, Pfizer-BioNTech is still arguing that a third booster shot will be likely.
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed toward opioid use disorder (OUD).
Moderna continues to assess its COVID-19 vaccine in juveniles, the company is expanding the study to include protocols to detect the potential of rare side effects, including heart inflammation.
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
A recent report suggests that cross-contamination is not all that uncommon of an issue, and maybe inevitable.
In a filing with the U.S. Securities and Exchange Commission earlier this month, Rosenbaum and his investment group nominated five directors to elect the CytoDyn board.
A vaccine for herpes is under development and Rational Vaccines are going to make this a reality very soon. Here’s everything you need to learn about it.
Novartis claimed the patents held by Plexxikon were invalid. Unfortunately for the company, the jury found it was unable to prove these claims.
As COVID-19 begins yet another surge across the U.S., there is some promising news about the effectiveness of vaccines. Here’s a look at some top COVID-19 stories.