Policy
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.
FEATURED STORIES
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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
Gossamer Bio sold shares of its common stock to pave its runway through mid-2024 while Teva and AbbVie reach deals in opioid settlements.
BioSpace takes a look at some of the recent legal battles and settlements related to the opioid epidemic across the industry.
Aldeyra Therapeutics announced results from a crossover clinical trial, showing that its drug candidate reproxalap was effective in improving ocular redness and tear production in patients with dry eye disease.
Exelixis’ Cabometyx, in combination with two BMS-owned drugs, hit the primary endpoint of progression-free survival but missed the secondary endpoint of overall survival in renal cell carcinoma.
Vertex Pharmaceuticals plans to acquire ViaCyte for $320 million in cash. ViaCyte focuses on stem cell-derived cell replacement therapies that they hope will cure type 1 diabetes (T1D).
HRA Pharma, a Perrigo company, has submitted an application to the FDA seeking approval for the country’s first-ever over-the-counter (OTC) birth control pill.
Sanofi announced positive data for its therapeutic, fitusiran, for treating patients with hemophilia A and B, as well as efanesoctocog alfa therapy for treating hemophilia A.
Last year, the FDA’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.
Ramesh “Sunny” Balwani, Elizabeth Holmes’ former business and romantic partner, was found guilty of all 12 fraud charges brought against him for his role in the Theranos scandal.