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Home » Newsletters » BioWorld

BioWorld

June 27, 2018

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Regulatory actions for June 26, 2018

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Clinical data for June 26, 2018

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Financings

Neogenomics Inc., of Fort Myers, Fla., redeemed 6.86 million shares of series A redeemable preferred stock held by an affiliate of General Electric Co. for approximately $50.1 million. The shares were redeemed at $7.30 per share.  Read More

Other news to note

Brainstorm Cell Therapeutics Inc., of New York, said it will not make Nurown available under the newly enacted Right to Try Act, at this time but will continue to focus efforts on completing the ongoing phase III study with the product as quickly as possible with the goal of bringing a treatment option to amyotrophic lateral sclerosis patients. Read More

First new influenza drug developed using viral genes

HONG KONG – A team of researchers from the University of Hong Kong (HKU) has developed a novel strategy for the prevention and treatment of influenza virus infection, which they then demonstrated to be effective in mice. Read More

Action, not hope, needed to bring down U.S. drug prices, Azar told

Noting that July 1 is when prescription drug companies typically raise their prices, U.S. Health and Human Services Secretary Alex Azar told the Senate Finance Committee Tuesday that he hoped the biopharma industry this year would get serious about the need to lower prices. Read More

Agios, Cstone join hands in potential $424M pact to advance ivosidenib across China

Agios Pharmaceuticals Inc. had the near-commercial asset and Cstone Pharmaceuticals Co. Ltd. had the market intel and rapidly maturing R&D engine. Together, the companies represent a formidable team to advance ivosidenib (Tibsovo, AG-120) in China, including Hong Kong, Macau and Taiwan, as monotherapy or in combination efforts. The oral isocitrate dehydrogenase 1 mutant, or IDH1m, inhibitor is under priority review by the FDA with an Aug. 21 PDUFA date for the treatment of individuals with relapsed or refractory acute myeloid leukemia (r/r AML). Read More

Taking aim at RNA: Skyhawk banks $100M in financing, Celgene deal

Barely a week after Wall Street hailed interim data from a RNA-targeting small-molecule candidate in spinal muscular atrophy (SMA) candidate, startup Skyhawk Therapeutics Inc., which also is taking a small-molecule approach to correct RNA mutations, disclosed a $40 million equity investment round and a neurology-focused option deal with Celgene Corp. that brings $60 million up front. Read More

Atom brings in $12.3M in series A to advance hyperuricemia, gout candidate

HONG KONG – Jiangsu, China-based Atom Bioscience and Pharmaceutical Co. Ltd. plans to advance its lead drug candidate – ABP-601 to treat hyperuricemia and gout – into clinical trials in the U.S. after completing a ¥80 million (US$12.3 million) series A round of financing from an undisclosed angel investor. Read More

Achaogen's Zemdri gains cUTI approval, but draws CRL for bloodstream infection

Despite winning FDA approval on Monday to market the antibiotic Zemdri (plazomicin) to treat adults with complicated urinary tract infections (cUTI) or pyelonephritis, Achaogen Inc. saw shares (NASDAQ:AKAO) sink 20.2 percent to $9.59 on Tuesday as the agency rebuffed its effort to secure approval to use the treatment of bloodstream infections (BSIs) with a complete response letter (CRL). Read More

Conference data: American Diabetes Association (Orlando, Fla.)

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