In a big news day for Duchenne muscular dystrophy (DMD) companies, Capricor Therapeutics Inc. CEO Linda Marbán told BioWorld that investors will "see news coming in the next week or two with a clearly delineated path to registration" for CAP-1002. "We have a trial design; we have a plan on what has to be done." Read More

Brainstorm Cell Therapeutics Inc., of Hackensack, N.J., said it signed definitive agreements with Massachusetts General Hospital and California Pacific Medical Center to enroll patients in the planned phase III trial of stem cell therapy candidate Nurown in amyotrophic lateral sclerosis, pending FDA and institutional review board approvals. Read More

Biondvax Pharmaceuticals Ltd., of Ness Ziona, Israel, signed an agreement to lease space in the Jerusalem Biopark, located in the Ein Kerem Hadassah campus, next to Hadassah University Hospitals and Hebrew University's Medical School. Read More

"The statute is silent" was the Health Resources and Services Administration's (HRSA) constant refrain Tuesday in a House subcommittee hearing on the growth and oversight of the 340B prescription drug discount program. Read More

Menlo Therapeutics Inc. added new faces to its stable of investors in a $50 million series C designed to move serlopitant, the company's NK-1 receptor antagonist, into a pivotal program as a once-daily oral treatment for the lead indication of chronic pruritus, or itch, associated with the skin disease prurigo nodularis. The company, aptly based in Menlo Park, Calif., also is advancing serlopitant to treat chronic pruritus associated with the broader indications of atopic dermatitis and psoriasis and to treat refractory chronic cough. Read More

FDA staffers gathered to hear advice on better balancing support for new drug development with efforts to speed access to lower-cost generics got an earful from generics companies, payers and their representatives about how loopholes, citizen petitions and market gaming have left the balance of power tilted toward innovators. Read More

HONG KONG – Cstone Pharmaceuticals Co. Ltd. has received the go-ahead from the CFDA to conduct clinical trials with its investigational agent, CS-1001, making it the first company in China to successfully have a fully human, full-length anti-PD-L1 monoclonal antibody enter clinical development. Read More

Despite some skepticism heading toward the July 21 PDUFA date, Puma Biotechnology Inc.'s breast cancer drug, Nerlynx (neratinib), won FDA approval a few days early, marking the first treatment designated as an extended adjuvant therapy in patients with early stage, HER2-positive disease. Read More

Cymabay Therapeutics Inc., of Newark, Calif., said it intends to offer and sell 10 million shares of its common stock, subject to market and other conditions, in an underwritten public offering. Read More