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Home » Newsletters » BioWorld

BioWorld

Dec. 8, 2016

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Other news to note

Kitov Pharmaceuticals Holdings Ltd., of Tel Aviv, Israel, said lead drug candidate, KIT-302, met the FDA standards to establish six-month stability. The study, conducted by Kitov's manufacturing partner, Dexcel Pharma, showed that nine pivotal batches of KIT-302 – three in each dosage form (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg and 200 mg/2.5 mg) – met six-month stability criteria, enabling the inclusion of registration batches in the company's new drug application submission, planned for the first quarter of 2017. Read More

Financings

Xencor Inc., of Monrovia, Calif., said it completed an underwritten public offering of 5.27 million shares of its common stock at $24 each, including 687,750 shares sold following the full exercise of an option previously granted to the underwriters to purchase additional shares of common stock. The gross proceeds were approximately $126.5 million with the net proceeds to be used for working capital and general corporate purposes, including additional investments in advancing its lead compound XmAb 5871 through later stages of clinical development and additional investment in its immune-oncology pipeline and technology. Read More

In the clinic

Cascadian Therapeutics Inc., of Seattle, said that following a meeting with the FDA and discussions with their external steering committee, it has amended the HER2CLIMB phase II trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration. Read More

Cures Act sails through Senate in 94-5 landslide

The 21st Century Cures Act needed three days to get through a procedural vote and a final vote on the floor of the U.S. Senate, but the legislation performed well on arrival, passing by a margin of 94-5 to the applause of the life science industries. The bill, which would pump $500 million into the FDA's coffers and $6.3 billion into the NIH account, needs only President Obama's signature to become law, providing what proponents say will be a new era of hope for patients afflicted by a variety of diseases, including cancer. Read More

MIT team reduces beta amyloid plaques in mice with light therapy

LONDON – A new frontier has opened up in the search for Alzheimer's therapies, with researchers at Massachusetts Institute of Technology reporting they can reduce beta amyloid plaques in mouse models using lights flickering at specific frequencies to stimulate neural circuits. Read More

Blisibimod prospects look brighter as data mature

One month after shares of Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) took a 30 percent haircut following a phase III miss by blisibimod in the lead indication of systemic lupus erythematosus (SLE), investors did an about-face on maturing data from the phase BRIGHT-SC proof-of-concept study of the same agent in individuals with IgA nephropathy (IgAN), also known as Berger's disease. Read More

In the big picture, CAR crash is likely a fender bender

SAN DIEGO – It's the best of times and the worst of times for CAR T cells. Read More

Hutchison's Epitinib passes BBB in lung cancer patients who have brain tumors

SHANGHAI – Shanghai-based Hutchison Medipharma Co. Ltd. presented phase I data for epitinib at the World Conference on Lung Cancer in Vienna showing that epitinib is a safe EGFR inhibitor with the ability to cross the blood-brain barrier (BBB). Read More

Neurimmune, TVM back single-asset play in ALS

DUBLIN – Neurimmune AG and TVM Capital Life Science formed a joint venture, AL-S Pharma AG, a single-asset play that will take on a preclinical Neurimmune program in amyotrophic lateral sclerosis (ALS). Read More

Sanofi China, Taiwan's JHL Biotech enter $236M partnership

HONG KONG – Sanofi SA entered a strategic alliance with Taiwan's JHL Biotech, Inc. which could provide a cash infusion and speed up the commercialization of JHL Biotech's biosimilar drugs in China. Read More

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