Merck & Co.
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33 Avenue Louis Pasteur, Boston, MA
320 Bent St, Cambridge, MA
NEWS
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
The pharma giant’s anti-PD-1 therapy met its dual primary endpoint of overall survival as a treatment regimen for non-small cell lung cancer patients, as the FDA’s Oct. 16 PDUFA date looms.
Keytruda’s winning streak in bladder continues with positive data from the Phase III AMBASSADOR study, showing significantly better disease-free survival in muscle-invasive urothelial carcinoma.
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
Despite lawsuits by some companies challenging the negotiations under the Inflation Reduction Act, the manufacturers of the first 10 drugs selected for Medicare price talks will participate in the program.
The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.
ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
While an initial analysis showed improvements in progression-free survival and objective response rate, a second analysis saw no improvement in overall survival.
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