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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Despite the approval, Samsung Bioepis’ Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.
Retrophin, Inc. announced it will report second quarter 2019 financial results on Tuesday, August 6, 2019 after the close of the U.S. financial markets.
Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, announced that it will host a conference call on Thursday, August 1, 2019 at 5pm ET to discuss second quarter 2019 financial results and provide a corporate update.
For LENVIMA plus KEYTRUDA Combination Treatment as Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment
Low cost production and superior product purity of the diabetes drug liraglutide with NUMAFERM’s unique technology platform
Recipharm AB will publish its interim report for January - June 2019 on 25th July at 07:45 am CET.
Revenue and EBITDA for full year 2019 expected to be ahead of market expectations
Myxredlin is intended for use only in acute care settings under medical supervision.
The drug is approved for use for management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 17 years of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.
The FDA approval marks the first for oral ulcers associated with Behçet’s Disease and the third for Otezla.