Cerespir Inc. submitted a special protocol assessment (SPA) plan for the phase III trial with CSP-1103 to treat mild cognitive impairment (MCI) Alzheimer's disease (AD) – "the right drug at the right time," CEO Daniel Chain told BioWorld Today. Read More

In a bit of regulatory house cleaning, the FDA is tossing a few obsolete or duplicative rules for certain biologics-makers and reducing the need for animal testing. Read More

A phase IIb failure of sodium channel Nav1.7 inhibitor TV-45070 in osteoarthritis (OA) of the knee should have no readthrough to an ongoing phase IIb study of the topically applied small molecule in postherpetic neuralgia (PHN), executives of Xenon Pharmaceuticals Inc. assured investors Wednesday morning, citing distinct pain mechanisms between OA and neuropathic pain indications. Read More

As master switches for a number of processes that are important to cell growth, and, with mTOR and Akt, part of the network that integrates nutritional status information with growth decisions, PI3 kinase inhibitors have "enormous promise attached to them" as cancer treatments, Dario Altieri told BioWorld Today. Read More

It wasn't the perfect second quarter, but we'll take it. You'll recall, U.S. investments in private companies tracked by BioWorld in the first quarter of the year started off like gangbusters, more than doubling the funding in the year-ago quarter. IPOs, on the other hand, left something to be desired. Read More

Academic and non-profit research leaders intent on expanding the oft-constrained boundaries of clinical research sought to introduce clarity and caution ahead of the NIH's ambition plan to build a 1 million-participant cohort to support research into precision care approaches as part of the new Precision Medicine Initiative (PMI), launched in January. Read More

Cevec Pharmaceuticals GmbH, of Cologne, Germany, said it granted a license for its CAP Go technology to Biotest AG, of Dreieich, Germany, for the development, production and commercialization of candidate molecules to treat the symptoms of hemophilia patients. Under the terms, Cevec will receive service fees for ongoing development support, up-front and milestone payments as well as royalties on future product sales. Read More

Mabvax Therapeutics Holdings Inc., of San Diego, said that Opko Health Inc., of Miami, approved the release of $3.5 million in funds held in escrow from a $11.7 million financing that Mabvax completed in April. Mabvax agreed to give Opko the right, until June 30, 2016, to nominate and appoint up to two additional members to the company's board of directors, subject to satisfaction of standard corporate governance practices and other requirements. Read More

Vistagen Therapeutics Inc., of South San Francisco, received FDA clearance plus the go-ahead from the NIH to initiate an NIH-funded phase II clinical study of its orally active AV-101 in subjects with treatment-resistant major depressive disorder. Read More

DUBLIN – Sembragiline, the selective monoamine oxidase B (MAO-B) inhibitor Evotec AG licensed to Roche Holding AG, failed to demonstrate any effect on cognition in a phase IIb trial in Alzheimer's disease, adding yet another disappointment to a lengthening list of setbacks in what remains one of medicine's most intractable conditions. Read More