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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
Three months after joining forces to develop an adjuvanted vaccine for COVID-19, Sanofi and GlaxoSmithKline reached an agreement with the U.K. government to provide up to 60 million doses of the preventative medication.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
Less than one week after forging a vaccine manufacturing agreement with Novavax, FUJIFILM Diosynth Biotechnologies announced its College Station, Texas facility was selected by the federal government to support COVID-19 vaccine candidate manufacturing.
The U.S. House of Representatives approved a $3.2 billion budget proposal for the U.S. Food and Drug Administration (FDA) that will boost the agency’s abilities to approve new medicines and medical devices, as well as protect the nation’s food supplies.
The IGNITE DMD study is assessing the company’s microdystrophin gene therapy asset SGT-001 as a potential treatment for DMD.
Stéphane Bancel, Moderna’s chief executive officer, stated, “We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19.”
On Friday, President Donald Trump signed four executive orders in hopes of lowering prescription drug prices in the United States, which was a 2016 campaign promise.
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.