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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A Sackler family heir said in a court appearance that the family, which owns OxyContin drug maker Purdue Pharma, holds a “moral responsibility” to lend its help in combating the U.S. opioid crisis but noted it will not give billions of dollars to a legal settlement unless broad legal protections are provided in exchange.
Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.
The latest biopharma insider trading scandal stems from Pfizer’s acquisition of Medivation in 2016.
As COVID-19 surges to earlier pandemic levels in the U.S., federal health officials are expected to authorize a third booster shot eight months after receiving the second of the Moderna and Pfizer-BioNTech vaccines, and probably the Johnson & Johnson vaccine as well.
In the past few weeks, China reminded the world that it is, first and foremost, a Communist nation. The recent crackdowns on the high-tech and education industries make some wonder what other changes will be next.
In a patent infringement lawsuit filed against Eli Lilly, Teva Pharmaceuticals won three and lost six patents. The patent lawsuit was over Teva’s Ajovy (fremanezumab-vfrm) to prevent migraines.
As the COVID-19 pandemic continues with surges in the U.S. in unvaccinated people, biopharma companies are still working on new vaccines and therapies against the disease.
Patient enrollment in the Phase I study will resume, the company announced this morning.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.