Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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In the BioSpace poll, 55.17% of respondents said, Yes, companies should be allowed to sue competitors to prevent generic versions of their drugs, and 41.38% said no. A much smaller group, 3.45%, said they were unsure.
Citing unnamed sources “familiar with the matter,” Reuters said that the company will have no choice but to file for bankruptcy should a settlement not be agreed upon.
Esperion announced that, on August 27, 2019, the Compensation Committee of Esperion’s Board of Directors granted non-qualified stock options to purchase an aggregate of 39,500 shares of its common stock and 35,388 restricted stock units to eighteen new colleagues under Esperion’s 2017 Inducement Equity Incentive Plan.
Akari Therapeutics, Plc announced that the U.S. Food and Drug Administration has granted orphan drug designation for nomacopan for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy.
In an ongoing battle between Regeneron Pharmaceuticals and Sanofi versus Amgen over PCSK9 inhibitors to treat high cholesterol, a U.S. district court invalidated Amgen’s patents for Repatha.
Researchers from A*STAR’s Institute of Bioengineering and Nanotechnology have developed a customisable hydrogel that cultivates patient-derived tumour organoids which can better mimic the original.
Vivoryon Therapeutics AG announced its financial results for the first six months of 2019 ending June 30.
Zensun USA, Inc., a wholly-owned subsidiary of Zensun Sci & Tech Co. Ltd., Shanghai, announced that the investigation of NEUCARDIN, its Recombinant human neuregulin-1 fragment, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of Chronic Heart Failure (CHF).
The first half of the year has been characterized by continued work to develop the company’s innovative projects in two treatment areas, both of which have significant medical needs because the current treatment options are less effective or non-existent.
In the first two weeks of September there were three scheduled PDUFA dates. One of those dates, for Celgene’s myelofibrosis drug, was approved early. Here’s a look.