WASHINGTON – Recognizing that regulatory science isn't keeping up with innovation in the U.S., the Biotechnology Industry Organization (BIO) donned its thinking cap to come up with some practical solutions. Read More
Jinzi Wu, CEO of biotech start-up Ascletis Inc., has flown so often between the company's China headquarters in Hangzhou and U.S. facility in Research Triangle Park, N.C., that he said he's not a "sea turtle" – the phrase for returning Chinese scientists – but rather a "sea gull." Read More
Genentech Inc. came out fighting during the second day of the FDA's public hearing on its proposal to withdraw accelerated approval of Avastin (bevacizumab) for metastatic breast cancer, putting members of the Oncologic Drugs Advisory Committee and representatives from the Center for Drug Evaluation and Research on notice that the company wouldn't go away quietly. Read More
While continuing to advance its internal pipeline, PTC Therapeutics Inc. signed yet another big pharma partnership for its Gene Expression Modulation by Small-molecules (GEMS) drug discovery platform. Read More
The combination of the words "dermatology start-up," "collagen" and "University of Southern California licensing agreement" leads somewhat naturally to visions of next-generation plumping injections for aging starlets – but Lotus Tissue Repair Inc., a Cambridge, Mass.-based start-up that today announced both an exclusive licensing deal with USC and a $26 million Series A financing from Third Rock Ventures, has more serious problems in its sights. Read More
Adopting the old adage that a bird in the hand is worth two in the bush, Medivir AB is forgoing a future revenue stream from North American sales of its cold sore product Xerese in return for an immediate payment of $45 million from its partner Meda AB. Read More
WASHINGTON – Here's a new mantra, and possibly a new discipline, for biotechs looking to do deals with pharma: Be tentacular. That is the advice of Shaun Grady, head of strategic partnering and business development at AstraZeneca plc, who described how the UK pharma company turned down the offer to license Nektar Inc.'s NKTR-118, a Phase III compound for treating opioid-induced constipation, on "two or three occasions." Read More
WASHINGTON – A finance panel Tuesday afternoon on the evolution of the venture capital model in biotech turned briefly toward the rise of corporate venturing, a trend that has helped keep money flowing into private firms even in the economic downturn, though traditional VCs warn that those investments might come with a different set of strings attached. Read More
WASHINGTON – The biotech industry has long appreciated the value of partnership, but biomarker development is taking collaboration to a new level. It is not possible to develop good and useful biomarkers without involving academics, having access to patients, expertise in sequencing, molecular diagnostics platforms, bioinformatics and the cooperation of clinicians and regulators. Read More
QRxPharma Ltd., of Sydney, Australia, said additional data from the Phase III trial of MoxDuo IR (morphine/oxycodone) showed the drug reduced the risk of severe oxygen desaturation compared to morphine or oxycodone alone. A new drug application filing is slated for later this year. Read More
Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said its therapeutic DNA vaccine INO-5150 for prostate cancer-generated T-cell immune responses in monkeys. The company plans to start a Phase I trial in 2012. Read More
