Sosei Group Corp., of Tokyo, plans to develop an inhaled triple therapy called QVM149 for moderate to severe asthma uncontrolled by standard ICS/LABA medication. The product is a fixed dose, once daily combination of the long-acting beta2 agonist indacaterol, the long-acting muscarinic antagonist glycopyrronium bromide and the inhaled corticosteroid mometasone fuorate. First regulatory filings are planned for 2018. Read More

The FDA wouldn't get everything it wants in a House subcommittee's fiscal 2016 spending bill, but at least it wouldn't flat line or be put on the cutting board. The same can't be said for the agency's device center. Read More

An anti-infective response of the innate immune system slows down wound healing, and the effect is exacerbated in diabetic mice, according to studies published this week. Read More

Biomarin Pharmaceutical Inc. is considering the design to be sought for the pivotal phase III trial with BMN 111 (vosoritide), an analog of C-type natriuretic peptide (CNP), in children with achondroplasia, thanks to strong results with the highest of three doses – 15 µg/kg/daily – in a phase II experiment that enrolled 26 children with a mean age of 7.8 years. Read More

Teva Pharmaceutical Industries Ltd. is partnering with drug delivery specialist Microchips Biotech Inc. to develop a tiny implantable chip capable of storing and releasing hundreds of therapeutic doses of drug for periods ranging from months to years. If successful, the platform could potentially help the company win the favor of doctors, patients and payers, all of which stand to realize distinct advantages from the technology. Read More

PHILADELPHIA – Leroy Hood, president of the Institute for Systems Biology, is pushing to transform health care through the application P4 medicine that involves predictive, preventive, personalized and participatory approaches to improving wellness and intervening in diseases at the earliest stages before they can fully manifest. He presented his ideas in a session track on the closing day of the BIO International Convention. Read More

PHILADELPHIA – Kicking off the last panel of this year's BIO International Convention, radio and television host David Brancaccio referenced the scene from The Graduate, when a family friend tells Dustin Hoffman's character, "There's a great future in plastics." Brancaccio asked a group of panelists during the Scientific American Worldview session what word or phrase signifies to each of them a great future in today's world. Read More

Although the sprawling exhibit hall at the BIO International Convention sometimes seems like an indoor advertising showcase for big pharma, it also serves as an essential meeting point for smaller companies seeking to expand their networks or attract that critical initial partner. Pity the poor exhibitor stuck in a back corner who has to compete with floor to ceiling exhibits featuring gourmet delicacies, live entertainment, celebrities and visiting dignitaries. Read More

Batu Biologics Inc., of San Diego, completed a $1 million seed round of funding. Batu leveraged primarily private and angel funding to attain this fundraising goal. Batu Biologics recently filed an investigational new drug application with the FDA seeking to initiate a phase I dose-escalation study for Vallovax in patients with non-small cell lung cancer. Read More

TG Therapeutics Inc., of New York, reported updated results from its phase II study of TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, in an oral presentation during the 13th International Congress on Malignant Lymphoma in Lugano, Switzerland. Read More