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Home » Newsletters » BioWorld

BioWorld

April 3, 2018

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Clinical data for April 2, 2018

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Other news to note

Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., and Idera Pharmaceuticals Inc., of Exton, Pa., have each filed definitive proxy statements in connection with their pending merger.  Read More

Regulatory actions for April 2, 2018

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Bridge over troubled water for Alkermes, FDA to cross after MDD drug's RTF blow

Next steps with FDA-stalled ALKS-5461 in major depressive disorder (MDD) won't be known until Alkermes plc sits down with regulators, but maybe data from the ongoing phase IIIb study 217 with the oral, once-daily therapy can satisfy the demand for more data. Read More

Interim breast cancer data on Neuvax sends Sellas shares sailing higher

Shares of Sellas Life Sciences Group Inc. (Nasdaq:SLS) jumped 151 percent to close at $8.65 on Monday after the company said an interim analysis of an exploratory phase IIb study seeking the right patient population for its cancer immunotherapy, Neuvax (nelipepimut-S), showed it working synergistically with Herceptin (trastuzumab, Roche Holding AG), making a "clinically meaningful difference" in median disease-free survival for women with triple-negative breast cancer (TNBC). Read More

Compugen flexes dealmaking muscle in Medimmune I-O antibody pact

Compugen Ltd. moved toward the next iteration of its transition from discovery engine to integrated development organization and showed some dealmaking might by giving Astrazeneca plc's Medimmune unit an exclusive license to develop bispecific and multispecific immuno-oncology (I-O) antibody products. The deal provides the Holon, Israel-based company with $10 million up front and up to $200 million in development, regulatory and commercial milestones for a first product as well as tiered royalties on sales.  Read More

Days of telling a U.S. biosimilar by its suffix to come to an end

The time was when only biosimilars were laden with those clunky, four-letter, nonsensical suffixes the FDA insisted on attaching to their nonproprietary, or proper, names. Not anymore. Read More

Rabies virus vector gives immune system second chance at fighting West Nile

Short interfering RNAs that were directed against a conserved region of flaviviruses, when delivered to the brain, enabled mice to fight off West Nile virus (WNV) in both the brain and the body, and develop a durable immune response. Researchers from Yale University reported those findings in the March 29, 2018, issue of Cell Host & Microbe. Read More

Cullgen aims for UPS delivery, targeting protein degradation via uSMITE platform tech

HONG KONG – With a $15 million seed round closed last month, young biotech firm Cullgen Inc. is looking to build a new drug discovery platform based on advanced ubiquitin-mediated protein degradation technology. Read More

Financings

Macrolide Pharmaceuticals Inc., of Watertown, Mass., said it completed a $20 million financing led by current investors Advent Life Sciences, Gurnet Point Capital, Novartis Venture Fund, Roche Ventures and SR One.  Read More

Regulatory front

The NIH is issuing a final rule to exempt a subset of records covered under the NIH Electronic Research Administration Records, a new system that includes records used in managing NIH R&D applications and awards.  Read More

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