Fervent Pharmaceuticals LLC, of Greenville, S.C., submitted an IND application to the FDA for FP-101, its lead candidate to treat menopause symptoms, especially hot flashes. Read More
Biocancell Ltd., of Jerusalem, said that a full tender offer for its shares that was published by a group of investors led by its largest shareholder, Clal Biotechnology Industries Ltd. earlier this month, was not approved by shareholders, with the shareholder acceptance rate falling below the minimum required acceptance rate needed. Read More
Cellular Biomedicine Group Inc., of Shanghai, said it closed two private placement transactions selling an aggregate of 1.2 million shares to selected key executives and private investors at $12 each, for total gross proceeds of approximately $14.5 million. Read More
Luna DNA has raised $2 million in seed financing to launch the first genomic and medical research database undergirded by blockchain technology. It will incentivize individual participation via the distribution of cryptocurrency, the digital finance craze that's sweeping the globe which is often built on blockchain. Read More
PERTH, Australia – A Senate inquiry on research funding models for cancers with low survival rates has returned a report that outlines 25 recommendations to improve infrastructure, clinical trials and reimbursement processes for cancer drugs in Australia. Read More
LONDON – Newco Izana Biosciences Ltd. is driving namilumab out of the parking lot at Takeda Pharmaceuticals Co. Ltd. and has raised funding to take the antibody into a phase II proof-of-concept trial in the treatment of ankylosing spondylitis. Read More
HONG KONG – I-Mab Biopharma has entered a $548 million licensing agreement with Genexine Inc. for an immuno-oncology drug candidate. Shanghai-based I-Mab will receive exclusive development and commercialization rights to Genexine's Hyleukin in Mainland China, Taiwan, Hong Kong and Macau. Read More
The FDA said new draft guidance for formal meetings between sponsors and the agency is limited in scope to development and review of drugs and biologics, but excludes abbreviated new drug applications and applications for biosimilars. Read More