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 guidance takes effect immediately and will remain in effect throughout the pandemic.
New pandemic guidelines from the CDC nearly eliminates mask-wearing requirement for fully vaccinated people.
Researchers are calling for a “paradigm shift” in indoor ventilation systems to combat COVID-19 and other airborne pathogens.
Proxalutamide, a selective high-affinity silent antagonist of the androgen receptor, is being developed by Chinese biotech, Kintor Pharmaceutical Limited (9939.HK).
Overall, the researchers claim this “Disinformation Dozen” generate approximately 65% of the anti-vaccine misinformation on these platforms.
Stem cell therapy has been available for decades, but the medical field hasn’t fully used its treatment for all applications. In fact, the U.S. FDA has been warning people about using some stem cell therapies and deemed them illegal while others have strict restrictions on their use.
Pfizer’s clinical trials diversity report showed the disproportionate way the virus impacted minority communities in the U.S., increasing the calls for racial and ethnic diversity in clinical studies.
Shares of Heron Therapeutics climbs after it announced the U.S. FDA approved its non-opioid drug for extended pain relief following some surgeries.
Emergent company executives Fuad El-ibri and Robert Kramer will be testifying before a congressional probe after a botched batch of 15 million doses of J&J’s COVID-19 vaccine.
Comments on social media provide a glimpse at the deep divide in trust of public health agencies, and now a new survey demonstrates the breadth of that distrust.