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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The U.S. Food and Drug Administration (FDA) has several solid PDUFA dates in the middle of February. Here’s a look.
A long-running court battle over PCSK9 antibodies between Amgen and Sanofi and Regeneron has come to an end, for now at least.
The U.S. FDA approved Regeneron’s monoclonal antibody Evkeeza (evinacumab-dgnb) as an add-on treatment for adult and pediatric patients ages 12 and above with homozygous familial hypercholesterolemia (HoFH).
The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court.
The U.S. FDA has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® for the treatment of patients with advanced basal cell carcinoma with a history of treatment with a hedgehog pathway inhibitor or in patients with advanced BCC who are considered ineligible for an HHI.
The U.S. FDA Oncologic Drugs Advisory Committee voted against recommending the drug as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery, at least for now.
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The choice for the new FDA commissioner will tell the public about the Biden administration’s battle plan with regards to handling the global pandemic.
London-based Freeline Therapeutics announced that after receiving feedback from the U.S. Food and Drug Administration (FDA), it was modifying its clinical trial program for FLT180a for Hemophilia B.
A Portland, Oregon biotech consultant is facing two counts of insider trading charges, with federal prosecutors and securities regulators claiming the defendant made profitable stock trades using confidential information he learned during his time consulting for Abeona Therapeutics.