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After pocketing positive phase 3 topline results, Novartis will ask regulators to approve its checkpoint inhibitor tislelizumab as first-line add-on therapy for patients with previously untreatable esophageal squamous-cell carcinoma (ESCC). Read More
Johnson & Johnson (J&J) subsidiary Janssen has become the second big pharma company to go after drug distributors to stop the sale of counterfeit versions of its HIV drugs. Read More
Sen. Elizabeth Warren (D-Mass.) has written to ask Health and Human Services Secretary Xavier Becerra to lower prescription drug prices using an obscure and controversial regulatory authority known as “march-in rights.” Read More
In a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP) yesterday, ranking member Sen. Richard Burr (R-N.C.) characterized the funding in the FDA’s reauthorization agreements as “double the money for mediocre performance.” Read More
Sponsors are still not where they should be on meeting postmarket trial requirements and commitments, the FDA’s latest analysis shows: 24 percent of annual status reports for required or agreed upon postmarket trials were either late or unfiled in fiscal 2020. Read More
Shionogi’s investigative COVID-19 therapy is showing some promise in early laboratory studies, rapidly clearing viral levels and decreasing the period of active shedding, the company reported at the European Congress of Clinical Microbiology and Infectious Diseases. Read More
A large postmarket study suggests that some patients with multiple sclerosis (MS) who are stable on Biogen’s Tysabri (natalizumab) can safely extend their dosing interval from four to six weeks. Read More
The five members are asking for disclosure regarding the price of the vaccine’s unit, advance payments, donations, liability and indemnification. Read More