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 settlement stems from multi-year criminal and civil investigations into Purdue’s marketing practices related to its powerful prescription painkiller, OxyContin, which critics have argued facilitated the opioid epidemic.
The U.S. arm of the trial has been paused for more than a month while the U.S. Food and Drug Administration investigates a serious illness that occurred in a patient who received the experimental treatment.
In a challenge trial, people are given a vaccine then intentionally dosed with the virus or bacteria that causes the disease.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 20, 2020.
Catalyst Pharmaceuticals has filed new patent infringement lawsuits against Jacobus Pharmaceuticals and PantherRX Rare LLC over a treatment for the rare autoimmune disease Lambert-Eaton Myasthenic Syndrome.
The U.S. FDA granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The grant was awarded by the U.S. Dept. of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA).
The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.
The WHO’s SOLIDARITY clinical trial evaluated remdesivir and three other drugs in 11,266 hospitalized COVID-19 patients and found that none of the drugs “substantially affected mortality” or decreased the need to ventilate patients.
Putin touts efficacy and safety of new vaccine without the data to back him up.