Policy
The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
The approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.
Novartis said it will work diligently with the FDA to resolve the partial clinical hold and resume the study.
Makena has been approved to decrease preterm birth in pregnant women with a previous spontaneous preterm birth.
Reynolds claimed that his company’s product, called NeuroRelease, could essentially end paralysis.
STA Pharmaceutical Co., Ltd., – a subsidiary of WuXi AppTec – announced today that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency with no critical and no major findings.
The plaintiffs in the case alleged that Forest intentionally attempted to delay and impair generic competition of its immediate-release formulation of Namenda.
The U.S. Department of Justice said the two charitable organizations, Good Days and Patient Access Network Foundation, allowed seven pharmaceutical companies to funnel money through their organization to provide Medicare patients with assistance in paying for medications developed by those companies.
Arcutis Also Announces Enrollment of Last Patient in 52-Week Long-term Safety Study of ARQ-151 Cream as a Potential Topical Treatment for Plaque Psoriasis
Motif Bio plc announced that the Company has signed an agreement with the Walter Reed Army Institute of Research to conduct pre-clinical testing to evaluate novel combinations with iclaprim to improve safety and efficacy administered by a novel enhanced aerosol technology.
In its announcement on Thursday, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing.