WASHINGTON – After filing the patents a day earlier, Etienne Sibille was able to present new data at the 2019 American Association for the Advancement of Science (AAAS) meeting on small molecules that have shown remarkable and fast responses in reversing memory loss linked to depression and aging in mice. Read More
HONG KONG – China's Ascletis Pharma Inc. and California-based 3-V Biosciences Inc. have inked a licensing deal for 3-V Biosciences' fatty acid synthase (FASN) inhibitor TVB-2640. Read More
HONG KONG – Shenyang, China-based 3Sbio Inc. has signed a partnership agreement with Verseau Therapeutics Inc., of Lexington, Mass., to develop and commercialize monoclonal antibodies in the field of immuno-oncology for a broad range of cancers. The collaboration will be based on Verseau's drug discovery platform, which generates first-in-class macrophage checkpoint modulators (MCMs) to treat patients with cancer, immune and inflammatory diseases. Read More
After having donated the benzimidazole therapy to the World Health Organization (WHO) since 2005 as a way of helping to treat about 2 million patients in more than 30 countries, Novartis AG won approval by the FDA of Egaten (triclabendazole) for fascioliasis, or liver-fluke disease, in patients 6 years of age and older. Read More
DUBLIN – Motif Bio plc's stock collapsed during early trading in London Tuesday on news that the FDA issued a complete response letter (CRL) requesting more liver toxicity data in its NDA for iclaprim, an antibiotic in development to treat acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive pathogens. Shares in the company (LONDON:MTFB; NASDAQ:MTFB) fell by as much as 88 percent during early trading on AIM before ending the day at 10.8 pence (US$0.14), down 73 percent. The stock's ADRs took a similar tumble on Wall Street (NASDAQ:MTFB), where they closed at $2.72. Read More
Tim Dyer, CEO of Geneva-based Addex Therapeutics SA, told BioWorld that Indivior plc's decision to stop research with addiction candidate ADX-71441 and focus work on other GABAB positive allosteric modulator (PAM) therapies is "not the end of the world. The most important thing for us is that we've got a committed partner. Shifting from a lead asset to a backup – that's the business we're in," he said. Read More
H. Lundbeck A/S and Otsuka Pharmaceutical Co. Ltd., co-developers of the atypical antipsychotic brexpiprazole, said that during two global phase III trials the medicine failed to prove statistically better than a placebo in reducing symptoms of mania for adults with bipolar I disorder. The companies, which already sell brexpiprazole as Rexulti for the adjunctive treatment of major depressive disorder and as a maintenance treatment for schizophrenia, said they will conduct an analysis of the study results to determine next steps. Read More
With an agreement in hand to conduct research at the University of Pennsylvania's gene therapy center, as well as the expertise of scientist and company co-founder James Wilson, newly formed Passage Bio launched Thursday with a $115.5 million series A financing, money it will use toward rare monogenic central nervous system (CNS) diseases. Read More
As a Valentine's Day ode, FDA Commissioner Scott Gottlieb tweeted: "Some pills are red, Some pills are blue. All are safe and effective, If they undergo FDA review." But what happens, or doesn't happen, after that review is what had the leadership of the House Energy and Commerce Committee writing to Gottlieb this week to express concern about drug safety. Read More
Xeris Pharmaceuticals Inc., of Chicago, priced a public offering of 5.88 milion shares at $10 each for gross proceeds of $58.8 million. Underwriters, including Jefferies, SVB Leerink, RBC Capital Markets and Mizuho Securities, have an overallotment option for 882,000 shares. Xeris, a specialty pharmaceutical company, is leveraging its technology to develop and commercialize injectable and infusible drug formulations. Read More
With a deadline looming to prevent another shutdown, the U.S. Senate and House were expected to vote late Thursday on a spending package that would fully fund a number of federal departments and agencies, including the FDA, that have been limping along on a series of continuing resolutions. Read More
Abcellera Biologics Inc., of Vancouver, British Columbia, announced a multitarget and multiyear collaboration with Novartis AG, of Basel, Switzerland. Abcellera will apply its expertise in antibody discovery and its single-cell screening technology to advance programs on up to 10 targets elected by Novartis. Under terms of the agreement, Abcellera is eligible to receive technology access, research funding, downstream milestone payments, and royalties on net sales of products. Financial terms were not disclosed. Read More
Incyte Corp., of Wilmington, Del., reported fourth quarter 2018 product-related revenues of $468 million, including net revenues of $380 million for Jakafi (ruxolitinib), up 26 percent from the fourth quarter of 2017 and $19 million for Iclusig (ponatinib), down 2 percent from 2017. Read More
