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Home » Newsletters » BioWorld

BioWorld

Sep. 10, 2019

View Archived Issues

Neurotrope shares crushed on phase II bryostatin-1 fizzle in Alzheimer's

Shares of New York-based Neurotrope Inc. (NASDAQ:NTRP) fell 77.3% to close at a record low of $1 Monday after a phase II study of its lead candidate, bryostatin-1, failed to outperform a placebo in helping people with moderate to severe Alzheimer's disease (AD) achieve improvement on a standardized measure of cognition. Read More

Keeping the doctor away: Orchard gene therapy bid promising in MPS-I, more

As Wall Street ponders how pricing and reimbursement for gene therapies might shake out, companies in the field march intrepidly on, among them Orchard Therapeutics Inc., which early this month rolled out heartening results from an ongoing proof-of-concept trial evaluating the safety and efficacy of OTL-203 for mucopolysaccharidosis type I (MPS-I), a space that's heating up. Read More

Sandy beaches give way to rocky terrain for biotech investors

The pleasant memories of summer vacations are sure to fade quickly for biotech investors who are returning, post-Labor Day, to the harsh realities of markets that are not ready to embrace the sector anytime soon. As we head to the end of the third quarter, there is no momentum being built by blue-chip biopharmaceutical companies, as their share values languished once again last month.  Read More

Super cool study shows organ life can be extended

By preventing ice formation while cooling human livers below freezing, researchers have managed to extend the viable lifespan of donated livers threefold. Read More

China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions

BEIJING – China has finally written all its drug-related reforms into law, as it passed the amendment of its drug administration law in late August, the amendment to take effect on Dec. 1. Those moves carry one goal: to bring more and better drugs into the Chinese market as quickly as possible. Read More

Regulatory front

Mallinckrodt plc, of Staines-upon-Thames, U.K., reached a $24 million settlement with Ohio's Cuyahoga and Summit Counties in connection with opioid lawsuits pending in multidistrict litigation in the U.S. District Court for the Northern District of Ohio. Read More

Financings

Frequency Therapeutics Inc., of Woburn, Mass., filed to raise up to $100 million in an IPO. The number of shares and share price have not yet been disclosed. Read More

Other news to note

Acasti Pharma Inc., of Laval, Quebec, which is developing its prescription candidate Capre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, said it was awarded up to $750,000 in nondilutive and nonrepayable funding, as well as technical and business advisory services, from the National Research Council of Canada Industrial Research Assistance Program to expand and enhance its production capabilities for Capre. Read More

Clinical data for Sept. 9, 2019

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Regulatory actions for Sept. 9, 2019

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Hardly DRP in the bucket, Nuplazid's new indication rates Acadia blockbuster?

Good news from San Diego-based Acadia Pharmaceuticals Inc.'s phase III trial with Nuplazid (pimavanserin) in dementia-related psychosis (DRP) had analysts trotting out music metaphors in reports about the study called Harmony, while talking already about would-be sales of the drug, a selective serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor. Read More

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