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Bio Roundup: Merger Drama, FDA Trauma, Big IPOs, CRISPR Fights & More

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prevalent form of the rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD).

—The FDA rejected the Acer Therapeutics (NASDAQ: ACER) drug celiprolol (Edsivo), telling the Newton, MA, company it needs to conduct a new clinical trial. The drug is an experimental treatment for vascular Ehlers-Danlos syndrome, an inherited connective tissue disorder.


—A “cabal” of scientists who supported the thesis that amyloid protein was at the root of Alzheimer’s disease stifled research into other approaches, according to a report from Stat. As Xconomy reported in 2017, some prominent researchers, pushing back against the amyloid hypothesis, have called for renewed focus on the part of the brain where Alzheimer’s starts.

—Without providing details, AstraZeneca (NYSE: AZN) reported that a combination of its immunotherapy durvalumab (Imfinzi) and chemotherapy beat chemo alone in a Phase 3 study in small-cell lung cancer (SCLC), an aggressive form of the disease linked to smoking. If approved, the Imfinzi regimen could challenge a rival combination from Roche that the FDA cleared in May. Merck is in the mix as well, with Phase 3 results expected in December. Here’s more from Vantage.

—The immunotherapy nivolumab (Opdivo) couldn’t beat sorafenib (Nexavar) in a Phase 3 trial in newly diagnosed patients with liver cancer. In 2017, Opdivo won accelerated approval as a second-line option for liver cancer patients who had failed Nexavar.

—Morphosys (NASDAQ: MOR) reported that tafasitamab, an experimental treatment for diffuse large B cell lymphoma, met the goals of a Phase 2 study.

—Aclaris Therapeutics (NASDAQ: ACRS) reported that ATI-502, its experimental topical drug for hair loss, failed a Phase 2 study.

—Conatus Pharmaceuticals (NASDAQ: CNAT) said it would lay off 40 percent of its staff following the mid-stage clinical trial failure of emricasan, an experimental treatment for the liver disorder nonalcoholic steatohepatitis.

—Shares of Krystal Bio (NASDAQ: KRYS) shot up 27 percent after positive Phase 2 data for its experimental treatment for epidermolysis bullosa, a rare inherited skin disorder. The Pittsburgh company then raised $100 million to finance Phase 3 studies expected to start by the end of this year.


—President Trump signed an executive order to make healthcare costs more transparent. Meanwhile, the Senate HELP committee voted 20-3 to advance legislation to end “surprise” medical bills and lower other costs. HELP chair Lamar Alexander (R-TN) hopes the full Senate will vote before the August recess.

—Maryland’s attorney general released the state’s unredacted complaint in a lawsuit alleging price-fixing among generic drug makers. Generics comprise about 90 percent of all US prescriptions.

—Boston’s Dana-Farber Cancer Center filed suit last Friday against Bristol-Myers and Ono Pharmaceuticals to recoup licensing revenues from a set of the company’s immunotherapy patents. A Massachusetts court ruled in May that Dana-Farber scientists should be named co-inventors on the patents.


—Former FDA commissioner Scott Gottlieb joined Pfizer’s (NYSE: PFE) board of directorsPatrick Yeramian was appointed chief medical officer of Amylyx Pharmaceuticals… Arcus Biosciences (NASDAQ: RCUS) tapped former AstraZeneca (NYSE: AZN) executive Eric Hoefer to become chief commercial officer… Bryan Irving left Five Prime Therapeutics (NASDAQ: FPRX) for the chief scientific officer post at Amunix PharmaceuticalsJosé Trevejo was appointed CEO of SmartPharm Therapeutics… recently departed Millendo Therapeutics (NASDAQ: MLND) executive Pharis Mohideen surfaced as the new chief medical officer of DBV Technologies (NASDAQ: DBVT).

Ben Fidler and Frank Vinluan contributed to this report.

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