Praxis Precision Medicines Inc. CEO Marcio Souza told BioWorld that the line figuratively walked by PRAX-114, a GABAA positive allosteric modulator in major depressive disorder (MDD), means upside relief without the downside of adverse effects.
LONDON – In a potent demonstration of how COVID-19 is transforming the U.K. clinical trial landscape, 47,000 patients have been recruited to studies investigating potential treatments for the infection in a little over two months.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Allakos, Antibe, Aridis, Athersys, Autifony, Cel-Sci, Diamyd, GSK, Krystal, Leo, Lupin, Marinus, Newron, Novartis, Novo Nordisk, Sound Pharma, Targovax, Viriom.
With regard to agitation in Alzheimer’s disease (AD), doctors “are in a very difficult position right now,” said Axsome Therapeutics Inc. CEO Herriot Tabuteau. That’s because the products currently used off-label are antipsychotics – all of which carry an FDA black box warning “specifically against their use in elderly patients with dementia, including AD,” since they double the risk of stroke and of mortality.
Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
Six of six critically ill COVID-19 patients survived after being treated as compassionate care cases with Capricor Therapeutics Inc.’s lead candidate, an off-the-shelf cardiac cell therapy. The success prompted the FDA to review the data and approve the company’s expanded access protocol for treating as many as 20 more COVID-19 patients.
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
HONG KONG – Israeli biopharma Redhill Biopharma Ltd. is looking to extend access to its new investigational drug, opaganib (Yeliva, ABC-294640), following the drug’s initial success from a compassionate-use study treating six patients in Israel hospitalized with moderate to severe COVID-19 symptoms.
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