What the FDA's CRL for Mycapssa to treat adult patients with acromegaly might mean for the ongoing European study remained unclear, as Chiasma Inc. is "revisiting all priorities" and preparing for a post-review meeting with U.S. regulators, said CEO Mark Leuchtenberger. Read More

Tolero Pharmaceuticals Inc., of Salt Lake City, presented preclinical data on TP-0903, an AXL kinase inhibitor shown to sensitize cancer cells to various immuno-oncology agents, including an immune checkpoint inhibitor. Read More

Arix Bioscience Ltd., of London, formerly Perceptive Bioscience Investments, said it agreed to provide up to $25 million capital to accelerator Biomotiv LLC, a for-profit collaborator of the Harrington Project for Discovery & Development. Read More

Sage Therapeutics Inc., of Cambridge, Mass. reported data from the open-label phase I/II trial of SAGE-547 in super-refractory status epilepticus (SRSE), demonstrating that the 77 percent key efficacy endpoint response rate was not related to age, gender, ethnicity, co-morbid medical condition, or underlying anti-epileptic or third-line agents. Read More

LONDON – PTC Therapeutics Inc.'s muscular dystrophy therapy Translarna (ataluren; ID428) has survived intense scrutiny by the National Institute of Clinical and Care Excellence (NICE) to emerge with a recommendation that it is funded under a managed access agreement. Read More

NEW ORLEANS – Two tropomyosin receptor kinase (TRK) inhibitors presented at the annual meeting of the American Association for Cancer Research (AACR) had a high success rate in shrinking tumors with TRK fusions – and doing so for longer periods than inhibitors that target activating mutations are typically able to do. Read More

NEW ORLEANS – At the annual meeting of the American Association for Cancer Research (AACR), data from several new studies showed progress toward the wish of their developers, as expressed by Yervoy (ipilimumab, Bristol Myers Squibb Co.) developer James Allison at the 2012 annual meeting: "Get that tail up." Read More

DUBLIN – Even if the U.S. public markets are cooling on European biotech, a clutch of recent transactions suggests that companies' home markets still remain supportive. Financing activity has been sluggish this year, in contrast with last year, but a trickle of cash is still flowing into European biotech. Read More

Eli Lilly and Co. is returning rights for a phase II diabetes drug for which it paid $7 million to Toronto-based Transition Therapeutics Inc., after deciding against carrying the candidate into phase III development. The setback, which follows a disappointing phase II/III outcome for Transition's lead neuropsychiatric drug last year, sent the company's U.S. and Canadian-listed shares to 52-week lows as the company pondered its next step. Read More

SHANGHAI – Hutchison China Meditech Ltd., or Chi-Med, has begun human trials for HMPL-689, a PI3K delta blocker for the potential treatment of blood cancers that it hopes can be best in class by overcoming a rival's safety issues. The trial kicked off in Australia dosing 50 healthy volunteers. Read More

U.S. Sen. Dick Durbin (D-Ill.) and U.S. Rep. Tammy Duckworth (D-Ill.) called on the president and CEO of the Pharmaceutical Research and Manufacturers of America to take financial responsibility for the industry's role in curtailing the opioid overdose epidemic as other major companies have done. Durbin and Duckworth noted that other countries and some large counties in the U.S. have extended producer responsibility programs, which help ensure that pharmaceutical companies are legally held accountable for the environmental and social impacts of their drugs throughout the lifecycle – including drug take-back and responsible disposal. Read More

Kymab Ltd., of Cambridge, U.K., and Heptares Therapeutics, of Hertfordshire, U.K., part of the Sosei Group Corp., formed a collaboration to discover, develop and commercialize antibody therapeutics, which will target G protein-coupled receptors and focus on immuno-oncology. Under the terms, Heptares will use its Star platform and Kymab will utilize its Kymouse platform to combine antibodies with antigens. The two companies will share all costs involved. Financial details were not disclosed. Read More