If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), it will not be approving Astrazeneca plc's olaparib anytime soon as a maintenance therapy for BRCA-mutated ovarian cancer. Read More
SAN DIEGO – In the early days of biotechnology, companies might have been thought arrogant, or downright foolish, for considering when and under what terms to partner their assets before even moving a candidate into human studies. But that zeitgeist has turned inside out, according to participants at the BIO International Convention. Read More
SAN DIEGO – Anne Wojcicki, CEO and co-founder of the direct-to-consumer genetic profiling company 23andme Inc., made no attempt to avoid the delicate topic of FDA scrutiny, opting instead to embrace the "exciting adventure" that she said her firm is undergoing with U.S. regulators. Read More
SAN DIEGO – Despite tantalizing overtures from pharmas and big biotechs, alternative menus for financing early innovation still exist, panelists from the U.S. and the European Union insisted during a session at the 2014 BIO International Convention. Read More
SAN DIEGO - The biotechnology industry continues to expand its global footprint, giving rise to an ever-increasing number of new biotech clusters, particularly in emerging countries. Cities around the world are latching onto the significant economic potential that a thriving biotech hub can bring. Read More
LONDON – Is it the tax break or the products? Abbvie Inc. launched its public campaign to acquire Shire plc for $47 billion, promising synergies in the pipelines and the opportunity to use its marketing heft to expand Shire's rare diseases and attention deficit hyperactivity disorder (ADHD) franchises. Read More
HONG KONG – A Chinese maker of novel oncology, cardiovascular and metabolic drugs is floating shares in Hong Kong next month and has developed a plan to set itself apart from the pack. Read More
SAN DIEGO – Researchers and executives gathered to discuss the future of regenerative medicine at the 2014 BIO International Convention said they saw value and hazard in the current intellectual property (IP) landscape for the field. Read More
Hedgepath Pharmaceuticals Inc. (HPPI), of Tampa, Fla., said it closed a $1.5 million interim private common stock financing. Funds were secured from Hedgepath LLC, the firm's majority stockholder, which, under the terms, will purchase 20 million shares of HPPI common stock. Read More
Basilea Pharmaceutica Ltd., of Basel, Switzerland, said, following further discussion with the FDA regarding antibiotic candidate ceftobiprole, the agency confirmed that potential regulatory approval for use in pneumonia in the U.S. would require additional phase III data, specifically prospective data in community-acquired and hospital-acquired pneumonia in accordance with the FDA's new guidelines. Read More
Quark Pharmaceuticals Inc., of Fremont, Calif., said the first patient was dosed in a double-masked, randomized sham-controlled phase IIa study to test safety, tolerability and pharmacokinetics of neuroprotective agent QPI-1007 when administered via a single intravitreal injection in patients suffering an acute attack of primary angle closure glaucoma (PACG). Read More
Valeant Pharmaceuticals International Inc., of Laval, Quebec, said it filed a preliminary proxy statement for a special shareholders meeting, at which Valeant shareholders will consider and vote upon, among other issues, a proposal to approve the issuance of Valeant common shares in connection with an acquisition of Allergan Inc., of Irvine, Calif. Read More
Bristol-Myers Squibb Co., of Princeton, said its randomized, blinded comparative phase III study testing PD-1 inhibitor nivolumab vs. dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the independent data monitoring committee showed evidence of superior overall survival in patients receiving the drug vs. those in the control arm. Read More
