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BioSpace
2 天
Teva to Pay $450M in Settlement With DOJ Over Kickback and Price-Fixing Allegations
The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is ...
BioSpace
2 天
Roche Wins First-Line Breast Cancer Nod for Oral PI3K Blocker, Projects $2.3B in Peak Sales
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K ...
BioSpace
2 天
Pressure Mounts on Novo’s $16.5B Catalent Buy Amid FTC Review
Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could ...
BioSpace
2 天
Sanofi, Denali Abandon Mid-Stage Multiple Sclerosis Study on Disappointing Data
Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic ...
BioSpace
2 天
Upstream Raises $255M IPO for Inflammatory Drugs; CAMP4 Nets $75M for RNA Work
Two biotechs set out for the public markets this week, with Upstream Bio raising $255 million for its inflammatory disease ...
BioSpace
2 天
Turnstone Biologics to Lay Off 60% of Workforce, Overhaul C-Suite
Turnstone is shifting resources to focus on clinical advancement of its selected tumor-infiltrating lymphocyte therapy as ...
BioSpace
2 天
Stealth Wins Adcomm’s Unexpected Support for Ultra-Rare Disease Drug Candidate
Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor ...
BioSpace
3 天
From Argentina to America: A Physician’s Journey to Pharma and AstraZeneca
Carlos Doti has moved countries and changed jobs, but one thing hasn’t changed. Making an impact on patient care has always ...
BioSpace
3 天
GSK Settles Zantac Lawsuits for $2.2B, Analysts Now Shift Focus to Vaccines
The settlement, which is at the low end of Jefferies analysts’ $2 billion to $3.5 billion estimate, will resolve 93% of the ...
BioSpace
5 天
Cell and Gene Therapy Investment Ticks Up After Hard Few Years
Tim Hunt, CEO of the Alliance for Regenerative Medicine, said Monday at the 2024 Cell & Gene Meeting on the Mesa that ...
BioSpace
3 天
Gritstone Files for Bankruptcy in Effort to Save Clinical Research
Vaccine biotech Gritstone bio is filing for bankruptcy while securing a stalking horse bid from an unnamed party, which the ...
BioSpace
4 天
Zealand Hit With CRL for Ultrarare Genetic Disease Treatment
The rejection is related to the timing of the FDA’s reinspection of Zealand’s third-party manufacturer, which previously had ...
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