Chinese biotech startup Affamed Therapeutics Ltd., funded by CBC Group, has merged with biopharmaceutical company Everinsight Therapeutics Inc., five days after it licensed in a dopamine agonist, KDT-3594, for Parkinson's disease from Japan’s Kissei Pharmaceutical Co. Ltd.
New York-based Avenue Therapeutics Inc. took receipt from the FDA of a surprise complete response letter (CRL) – characterized by Wainwright analyst Joseph Pantginis as “bizarre” – with regard to the NDA for intravenous (I.V.) tramadol in acute pain.
Opioid-related hazards with Alkermes plc’s combo drug ALKS-3831 – specifically, with the samidorphan element – and the significance of weight-gain reduction brought about by the tablet, which also includes olanzapine, became key topics in the joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Investigators at the University of Heidelberg have identified a previously unknown mechanism for excitotoxicity and used their insight to identify “unconventional neuroprotectant” compounds that could prevent cell death and reduce brain damage in a mouse model of stroke.
Dublin-based Jazz Pharmaceuticals plc’s phase III top-line win with Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adults with idiopathic hypersomnia (IH) provides the company with a needed foothold there as generics threaten its other sleep disorder drug, Xyrem (sodium oxybate).
As expected, weight mitigation and opioid-related risks turned up as the main concerns in briefing documents for the joint advisory panel meeting Oct. 9 to mull the approvability of Alkermes plc’s ALKS-3831.
HONG KONG – Shanghai-based Bioshin Ltd., the Asia-Pacific arm of New Haven, Conn.-based Biohaven Pharmaceutical Holding Co. Ltd., has added $60 million to its war chest via a series A investment.
In the past 10 years, the advances in understanding the etiology of neurodegenerative diseases have been dramatic. “The development of novel biomarkers and other tools as well are key in aiding diagnostic potential and the ability to track disease progression have been phenomenal,” Isaac Veinbergs, CEO of newly created Libra Therapeutics Inc., told BioWorld.
DUBLIN – Shares in AC Immune SA were off more than 40% Sept. 23 on news that its tau-directed antibody, semorinemab, which is partnered with Genentech, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease.
Shares of Vaccinex Inc. fell to an all-time low on Sept. 22 after top-line results of the phase II trial, Signal, found its SEMA4D inhibitor, pepinemab, failed to improve measures of cognition in people with early manifest Huntington's disease following 18 months of treatment.
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