Merck & Co.
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Merck said it will lower the cost of one drug by 60 percent and several other drugs by 10 percent.
Roche’s Tecentriq, in combination with chemotherapy, hit its co-primary endpoint of progression-free survival in a Phase III trial for non-small cell lung cancer patients. But, the Swiss pharma giant said the combination has so far failed to achieve statistical significance in overall survival, a co-primary trial endpoint.
July can be a notoriously slow period for FDA activity, and this year is no different. There are only five PDUFA dates scheduled for the month, and the first one was a supplemental approval for Merck’s Keytruda. The PDUFA date was July 3, but it was approved June 13. At this point in the month there are only four more approvals on the docket, here are the remaining approvals scheduled for July.
Shares of Advaxis are skyrocketing this morning after the company announced the U.S. Food and Drug Administration lifted the clinical hold on its Investigational New Drug Application for a Phase I/II cancer study.
It’s been a big year so far for activity in the U.S. biopharma market—record IPOs and plenty of big acquisitions. But things may be heating up in Europe as well.
Boston, New York, San Diego and San Francisco are the typical spots that people refer to when they think about biotech hotspots in the United States. But don’t discount New Jersey.
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