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Home » Newsletters » BioWorld

BioWorld

July 5, 2018

View Archived Issues

Regulatory actions for July 3, 2018

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Clinical data for July 3, 2018

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Trigr licenses bispecific antibody portfolio from Korea's ABL Bio in $504M-plus deal

Trigr Therapeutics Inc., a private Irvine, Calif.-based cancer drug developer founded by industry veteran George Uy, is licensing global commercial rights to five early stage antibodies from South Korea's ABL Bio Corp. for $4.3 million up front and up to $500 million in milestones, plus potential royalties. Together, the companies expect to advance development of the immunomodulatory bispecific antibodies to investigational new drug filings in the U.S. beginning next year. Read More

Y-mabs picks up neuroblastoma vaccine as Mabvax doubles down on antibodies

A day after Mabvax Therapeutics Holdings Inc. opted to forgo submission of a plan to regain compliance with Nasdaq listing standards, the San Diego-based company inked an exclusive sublicense with New York-based Y-mabs Therapeutics Inc. covering its bivalent ganglioside-based vaccine, known as MV-NB-02, to treat the rare pediatric cancer neuroblastoma. Read More

A sign of the times in Japan: Astellas shutters two units, hands another to Eurofins

TOKYO – Japanese pharmaceutical companies are downsizing, bucking a longstanding practice in the country of providing lifetime employment, even as they try to prepare for the possibility of a shrinking industry. Read More

Cell death discovery paves way for new treatments

The discovery of how human cells are triggered to undergo cell death could have major implications for development of new drugs for treating cancer, stroke and tissue injury, and immune disorders, according to a study by Australian researchers. Read More

Holiday notice

BioWorld's offices were closed in observance of Independence Day in the U.S. No issue was published Wednesday, July 4. Read More

Other news to note

Menarini Asia-Pacific Holdings Pte. Ltd., of Singapore, a member of the Menarini Group, and Orion Corp., of Espoo, Finland, said they signed a multiyear licensing deal for Menarini Asia-Pacific to distribute and commercialize several of Orion's Easyhaler products in 10 countries in the Asia-Pacific region. Terms were not disclosed. Read More

Financings

Biocancell Ltd., of Cambridge, Mass., said it completed a $22.9 million PIPE financing round led by Shavit Capital together with investors from the U.S., Israel and existing shareholders.  Read More

Regulatory front

The FDA finalized a draft guidance it released in October advising on the submission of amendments to abbreviated new drug applications (ANDAs) under GDUFA. The guidance explains how the GDUFA II review goals apply to amendments to ANDAs and prior approval supplements.  Read More

Appointments and advancements

Neos Therapeutics Inc., of Grand Prairie, Texas, appointed Jerry McLaughlin CEO. Read More

Three out of four ain't bad? Neovacs phase IIb lupus trial misses its mark

DUBLIN – You could call it the Meatloaf interpretation of clinical trial data. Neovacs SA missed one of two co-primary endpoints on a phase IIb trial of interferon-alpha kinoid (IFNalpha kinoid) in systemic lupus erythematosus (SLE) but stressed that the study achieved "three out of four clinical objectives." The data are, it stated, sufficiently robust to justify moving the program into a phase III trial. Read More

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