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Home » Newsletters » BioWorld

BioWorld

Dec. 29, 2017

View Archived Issues

In the clinic

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

Other news to note

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

Financings

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

Holiday notice

BioWorld's offices will be closed in observance of New Year's Day. Read More

Luna DNA formed to build genomic database powered by cryptocurrency

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

Australian Senate inquiry calls for overhaul of clinical trial infrastructure, more flexible reimbursement

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

Izana plucks namilumab from Takeda restructuring, set to move into phase II

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

I-Mab Biopharma licenses Genexine's IO asset Hyleukin for $548M

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

Regulatory front

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

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