Portola Pharmaceuticals Inc. chalked up a development and commercial deal for andexanet alfa in Japan with Bristol-Myers Squibb Co. (BMS) and Pfizer Inc., under which the compound will be explored further as an antidote for the latter pair’s therapy Eliquis (apixaban) and the “mega-blockbuster class” that includes other Factor Xa inhibitors as well. Read More

PARIS – With increasing reports of neurological disorders and neonatal malformations caused by the Zika virus from 22 countries, the World Health Organization (WHO) has declared an international emergency, calling it an “extraordinary event.” Read More

LONDON – The U.K. regulator has given researchers at the Crick Institute in London permission to use CRISPR/Cas9 gene editing on human embryos, with the aim of understanding which genes are involved in successful early development. Read More

LONDON – The life sciences arm of Index Ventures is splitting from its parent and launching a new $250 million fund dedicated to early stage European research. Read More

Exelixis Inc. added increased overall survival vs. Afinitor (everolimus, Novartis AG) to the list of benefits provided by cabozantinib for second-line renal cell carcinoma (RCC) patients, providing what president and CEO Michael Morrissey told BioWorld Today was “the missing piece of the puzzle in terms of the full cabozantinib second line RCC story.” Read More

Avalanche Biotechnologies Inc. plans to acquire privately held Annapurna Therapeutics SAS through an all-stock transaction that will combine pipelines, management teams and resources with the goal of creating a gene therapy company that’s bigger than the sum of its parts. What remains to be seen is whether the deal can reverse the slide that has plagued Avalanche since the Menlo Park, Calif.-based company disappointed investors last year with phase IIa results of AVA-101 in wet age-related macular degeneration (AMD), despite the fact that data met the study’s 12-month safety endpoint. Read More

HONG KONG – The Korean Ministry of Food and Drug Safety (MFDS) is shortening the biologics review process for rare and incurable diseases to speed up the approvals and overseas distribution of Korea-developed biopharmaceuticals. Although details of the policy are sketchy and yet to be disclosed, the announcement marks the country’s determination to make biopharmaceuticals a core industry. Read More

The FDA is welcoming congressional efforts to create a distinct review path for drug-device combination products. “It is a problem,” Janet Woodcock, head of the agency’s drug center, said at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing last week. “We need more clarity. We need a different path.” She added that the agency is eager to work with lawmakers on devising that path. Her comments coincided with the FDA reopening a 2009 comment period on how it reviews combination products. And next month, HELP will consider including the Combination Product Regulatory Fairness Act, introduced last June, in its trimmed-down response to the 21st Century Cures Act, which was passed by the House last year. (See BioWorld Today, Jan. 21, 2016.) Read More

Proteostasis Therapeutics Inc., of Cambridge, Mass., set terms for its IPO, filing with the SEC to raise $50 million by offering 3.9 million shares priced in a range of $12 to $14. The company said certain shareholders expressed interest in purchasing $30 million of shares in the offering. Proteostasis plans to list on the Nasdaq as PTI. Leerink Partners and RBC Capital Markets are joint bookrunners. Read More

Nordic Nanovector ASA, of Oslo, said it was awarded a grant of up to NOK15 million (US$1.7 million), payable over three years, from the Research Council of Norway’s user-driven research-based innovation program to support the research and development of targeted therapeutics for leukemia and non-Hodgkin lymphoma. The project is focused on development of antibody radionuclide conjugates (ARC) consisting of a chimeric anti-CD37 antibody and a radioactive nuclide as the cytotoxic agent. Nordic Nanovector will construct and investigate ARCs with different payloads that offer the potential to address multiple hematological malignancies. Successful candidates are expected to advance into clinical trials. Read More

Oryzon Genomics SA, of Barcelona, Spain, gained approval of its clinical trial application from the Spanish Drug Agency to initiate a phase I study with ORY-2001 for the treatment of Alzheimer’s disease. ORY-2001 is described as a highly selective dual LSD1-MAOB inhibitor. The trial will be conducted at a university hospital in Barcelona to evaluate the safety, tolerability and pharmacokinetics of ORY-2001 in healthy subjects as well as the elderly population. ORY-2001 also is in preclinical development to assess the potential effectiveness in other neurodegenerative diseases. Read More