Top Stories Wednesday, November 9, 2016 Late last night, seemingly in an effort to minimize exposure to the news as the U.S. election dominates, small cap Arrowhead Pharmaceuticals announced that the FDA has hit the biotech with a clinical hold for a small test of its hep B med ARC-520, which has previously been touted as a possible cure for the infection. Tuesday, November 8, 2016 CureVac has raised another $29.5 million to fund the advance of its mRNA pipeline. The fresh funding comes one year after CureVac tapped The Bill & Melinda Gates Foundation and others for $110 million. Wednesday, November 9, 2016 Innate Pharma has posted a look at Phase I/II data on a combination of its lirilumab and Bristol-Myers Squibb’s Opdivo in head and neck cancer. The mix outperformed historic trials of Opdivo in isolation but by less than some hoped, causing the share price of Innate to slide then bounce back as investors digested the data. Wednesday, November 9, 2016 Bristol-Myers Squibb has added another study to its burgeoning roster of combination trials featuring PD-1 drug Opdivo. The latest deal will see Bristol-Myers add Opdivo to an existing trial of Infinity Pharmaceuticals’ PI3K-gamma inhibitor IPI-549 in solid tumors. Wednesday, November 9, 2016 California has been ground zero in the industry battle against state drug pricing laws, and pharma can now declare victory. After a tough, expensive campaign, voters soundly rejected a contentious ballot measure, Prop 61, that would have clamped down hard on drug prices. Tuesday, November 8, 2016 While scientists have long studied mutations of the RAS oncogene as a target for new cancer drugs, they have been unable to pinpoint a drug that safely blocks its effects. Now, a team from the University of Illinois at Chicago has identified a monobody that can block the oncogene’s activity. Wednesday, November 9, 2016 Branded drugmakers may have one less tool to delay generic competitors--and, crucially, biosimilar versions of some of the industry's top-selling products--with Tuesday’s decision by the FDA to amend citizen petition rules. | This week's sponsor is Catalent. | | | eBook | Healthy Aging: Improved Dose Forms for Aging Population
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| | | Kite Pharma plans to start a rolling submission of its BLA for CAR-T candidate KTE-C19 with the FDA for aggressive non-Hodgkin lymphoma in December. Release Ocular Therapeutix says in its Q3 today that it is preparing to resubmit its NDA for Dextenza for eye pain after ophthalmic surgery in the U.S. by year’s end. Statement Small cap Sorrento Therapeutics has now closed its acquisition of Scilex. Release | |
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