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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Although the beginning of March was fairly slow, the end of the month shows a busy schedule for PDUFA dates for the U.S. FDA. Read on to see what’s on the calendar for this week.
The approval was for Arcalyst (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
Two years after uBiome announced it was filing for bankruptcy and closing its doors, the company’s co-founders and former co-chief executive officers have been indicted for fraud and money laundering.
The U.S. Senate confirmed Xavier Becerra as Secretary of the Department of Health and Human Services in a 50-49 vote.
The results published in the NEJM state that pegcetacoplan met the study’s primary endpoint for efficacy, demonstrating an advantage over eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p<0.001). An impressive 85% of patients were transfusion free at 16 weeks, in contrast to only 15% of eculizumab-treated patients.
According to an interview with Soumya Swaminathan, the WHO’s chief scientist, the new investigational COVID-19 vaccines rely on alternative technologies and systems of delivery. Some include oral and nasal administration, while others use skin patches.
The HHS will limit the use of Bamlanivimab antibody treatments developed by Regeneron and Eli Lilly due to concerns the medications are not effective against these new strains.
More than a dozen countries have suspended deployment of the AstraZeneca-Oxford University vaccine after cases of blood clots were reported.
Algernon Pharmaceuticals has requested a pre-Investigational New Drug meeting with regulators in the hopes of launching a clinical trial in stroke patients for n,n-dimethyltryptamine, a naturally derived psychedelic compound.
The goal is to “identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers.”