Phase III
The U.S. Food and Drug Administration (FDA) approved Portola Pharmaceuticals’ Andexxa, an antidote for blood thinners rivaroxaban and apixaban.
Regeneron has halted high dose treatment of a Phase III osteoarthritis drug following a risk-benefit assessment conducted by an Independent Data Monitoring Committee.
Ahead of June’s annual American Society of Clinical Oncology meeting Merck said this morning that its Phase III lung cancer trial met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis.
Iterum Therapeutics filed with the U.S. Securities and Exchange Commission (SEC) to initiate an initial public offering (IPO). The company hopes to raise $92 million.
In 2015, Bristol-Myers Squibb acquired Flexus Biosciences for about $1.25 billion, picking up F001287, Flexus’ IDO1 inhibitor in the bargain, as well as its IDO/TDO discovery program. Now, Bristol-Myers has dropped two Phase III clinical trials of the IDO1 inhibitor it acquired.
Ironwood Pharmaceuticals will split into two independent companies, Ironwood and what is currently being dubbed R&D Co.
Overall, Pfizer posted a good first quarter, with sales slightly higher and a 14 percent increase in profits due to lower restructuring costs and a significantly lower tax rate. However, revenue was below Wall Street expectations.
Shares of Newton, Mass.-based Karyopharm Therapeutics is skyrocketing in premarket trading after the company announced late Monday it will seek U.S. Food and Drug Administration approval for its investigational drug selinexor following strong top-line results from a Phase IIb trial.
Biopharmaceutical companies are focusing their drugs for smaller and smaller and more clearly delineated patient populations. No longer is a drug for lung cancer or even non-small cell lung cancer, but a much smaller segment.
Merck appears to be on the way to securing an additional approval for Keytruda, its blockbuster checkpoint inhibitor. The company is seeking new regulatory approval for Keytruda, an anti-PD-1 therapy, in combination with Eli Lilly’s Alimta and platinum chemotherapy as a first-line lung cancer treatment.
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