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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Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.
On Friday April 23, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) lifted the restrictions on the Johnson & Johnson COVID-19 vaccine.
The fate of three cancer immunotherapies that had been authorized under the U.S. Food and Drug Administration’s Accelerated Approval pathway will be determined next week following failures in confirmatory trials.
Molecular Partners announced yesterday it has filed for a $100 million initial public offering with the Securities and Exchange Commission in the U.S., funding which will go toward supporting the company’s work in the development of protein-based treatments for COVID-19 and various cancers.
The long and strange journey of Biogen’s Alzheimer’s drug aducanumab is coming to an end. Whether it will be a complete ending—with the U.S. FDA rejecting it—or a new chapter, with an approval, remains to be seen.
A $25 million grant from the National Institutes of Health Helping to End Addiction Long-term Initiative (HEAL) is funding new research to develop a vaccine that may help patients overcome their addiction to opioids, a class of highly addictive pain medications.
The U.S. FDA has requested that Emergent BioSolutions temporarily pause production of ingredients for the Johnson & Johnson COVID-19 vaccine at their facility in Baltimore.
ApiJect’s syringe is designed to be prefilled with a dose of a vaccine before it is shipped out to be used by doctors, pharmacists, hospitals, and many of the vaccination centers set up across the country. NBC noted that the prefilled technology had not been approved in the U.S.
Amgen announced the U.S. FDA awarded Breakthrough Therapy Designation to the bemarituzumab as a first-line treatment for certain types of gastric cancer.
The agency is requesting additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.