On the heels of a handful of successful gene therapy IPOs and big pharma investments, analysts and investors were looking for the much-anticipated data from Celladon Corp.'s phase IIb CUPID2 trial testing heart failure candidate Mydicar to be a big win for the space. Read More
The critical tone of FDA briefing documents examining Amgen Inc.'s cancer immunotherapy drug, talimogene laherparepvec, or T-vec, in advance of Wednesday's joint meeting of the Cellular, Tissue and Gene Therapies and Oncologic Drugs Advisory Committee (adcom) wasn't especially surprising, given that T-vec showed a "strong trend" but missed statistical significance in overall survival (OS) in a phase III study in metastatic melanoma. Read More
HONG KONG – A new patent law could help China step up enforcement and improve protections for intellectual property while giving biotech companies, both multinational and domestic, greater assurances that their products will be protected. Read More
Resverlogix Corp. CEO Donald McCaffrey told BioWorld Today he is "very confident" about collecting the potential $400 million-plus from a licensing deal in China, Hong Kong, Taiwan, and Macau with Shenzhen Hepalink Pharmaceutical Co. Ltd., centered on RVX-208, a late-stage, first-in-class, small-molecule BET bromodomain inhibitor. "We downplayed the number," he said. Read More
Versant Ventures has achieved significant validation – potentially $485 million worth of it – for its build-to-sell investment model, as Celgene Corp. exercised an option to acquire portfolio company Quanticel Pharmaceuticals Inc. Read More
SHANGHAI – Uni-Bio Science Group Ltd. has submitted a new drug application (NDA) to the CFDA for Uni-PTH, a biosimilar of Forteo (teriparatide, Eli Lilly and Co.). Read More
HONG KONG – A study by researchers at the Duke-National University of Singapore Graduate Medical School (Duke-NUS) has identified a new means by which brown adipose tissue is regulated in the body, which offers an attractive new target for the development of new anti-obesity treatments. Read More
Drugmakers are lining up on both sides of the dance floor as the Federal Circuit prepares to hear arguments June 3 in Amgen Inc. v. Sandoz Inc. – the outcome of which could determine when Sandoz launches Zarxio as the first biosimilar in the U.S. Read More
The U.S. Patent and Trademark Office (PTO) is facing potential class action over its discontinued Sensitive Application Warning System (SAWS) that secretly delayed the patent review process for drugs, medical devices and other advanced technologies over the past 20 years. Read More
Atyr Pharma Inc., of San Diego, set terms for its IPO. It plans to generate $75 million by selling 5.36 million shares in the price range of $13 to $15. Read More
Ibio Inc., of Newark, Del., said it entered an agreement with Caliber Biotherapeutics LLC, of Bryan, Texas, for Caliber to scale up and produce materials for clinical development of Ibio's anti-fibrosis product, IBIO-CFB03. Read More
Neurovive Pharmaceutical AB, of Stockholm, said the first patient has been enrolled in a phase II study for acute kidney injury using the company's product Ciclomulsion. Read More
Mylan NV, of Potters Bar, UK, said its board unanimously rejected the unsolicited expression of interest from Teva Pharmaceutical Industries Ltd., of Jerusalem, having earlier said that combining the companies would be "without sound industrial logic or cultural fit." Read More
Synthetic Biologics Inc., of Rockville, Md., reported preclinical data showing that SYN-005, a monoclonal antibody combination comprising hu1B7 and hu11E6, demonstrated prophylactic effect in a murine model of pertussis, with the antibodies, both individually and in combination, completely blocking the rise in white blood cell count that is characteristic of the disease and reduced bacterial colonization in the lungs. Read More
strong>Bristol-Myers Squibb Co., of New York, reported that primary endpoints were met in ALLY-1, a phase III trial evaluating a 12-week regimen of daclatasvir and Sovaldi (sofosbuvir, Gilead Sciences Inc.) once daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) with either advanced cirrhosis or post-liver transplant recurrence of HCV. Read More
