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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Loncastuximab tesirine-lpyl just got accelerated approval from the U.S. Food and Drug Administration (FDA). This is a systemic therapy for people with diffuse large B-cell lymphoma (DLBCL).
A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.
Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC’s recommendation if booster shots are necessary.
Lilly said it is cooperating fully with the DOJ and is in the process of conducting its own investigation into the allegations made against the company.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
LION-101 is a novel recombinant AAV being developed as a one-time intravenous infusion for the treatment of adult and adolescent patients with Limb-Girdle Muscular Dystrophy Type 2I/R9.
The UK’s Competition and Markets Authority (CMA) will determine if the deal is anti-competitive.
The White House has also called for an independent investigation and more information from China about the pandemic’s origins.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 25, 2021.