Regulatory Roundup: Top News Stories – Week Ending May 12, 2017

There has been a lot of big news in the industry this week and here are some of the key regulatory highlights:

The U.S. Senate confirmed Dr. Scott Gottlieb as the next commissioner of the FDA. Gottlieb, 44, served as an FDA deputy commissioner during the George W. Bush administration. He has also worked as a physician, an investor, a conservative policy analyst, and a consultant to the biopharma industry. Full article here

On Friday May 5th the FDA approved Mitsubishi Tanabe’s treatment for ALS, the first such U.S. regulatory approval for ALS treatment in more than two decades. Full article here

Altor BioScience has received FDA fast track designation for its investigational bladder cancer drug:

The FDA also granted Fast Track designation to XyloCor Therapeutics’ cardiovascular angiogenic gene therapy program.

Myovant Sciences reported that its Phase 2 study met its primary endpoint for the treatment of uterine fibroid symptoms

The FDA approved Merck’s immunotherapy/chemo combo for lung cancer

The past month has been very challenging for OncoMed. On the heels of recent clinical failures, this week the company announced that its lead drug just failed a Phase II study for non-small cell lung cancer:

Kite Pharma reported the death of a cancer patient in April from brain swelling following treatment with the company’s CAR-T therapy KTE-C19. The FDA was notified but the study was not placed on any clinical hold.

Roche announced that the Phase III study for Genentech’s TECENTRIQ did not meet its primary endpoint for advanced bladder cancer. Now the FDA will have to review whether the drug should stay on the market. This program had won fast-track approval last May in the US but full approval hinged on further trials.

Array BioPharma announced positive pop-line results from their Phase 3 cancer combination drug study:

In other industry news…

Parexel is laying the groundwork for a major cut in staff amid rumors of a potential buyout.

Durect Corporation announced a development and commercialization agreement with Sandoz to develop and market their Phase III non-opioid analgesic in the US.

Horizon Pharma announced an agreement to acquire River Vision Development Corp and its teprotumumab program, a biologic in late-stage development for rare eye disease.

INC Research and inVentiV Health will be merging this year. The combined company will have 22,000 employees and will be valued at approximately $7.4 billion.

Pfizer reached an agreement with Sangamo Therapeutics for rights to its gene therapy programs to treat the rare blood-clotting disorder hemophilia A.

Adamas raised $100 million through a royalty agreement with a private investment firm. Under this agreement Adamas will receive $35 million at closing and an additional $65 million upon FDA approval of their Parkinson’s drug (which is currently under review)

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