Astrazeneca plc, of London, reported that a combination of Lynparza (olaparib) and paclitaxel, compared with paclitaxel chemotherapy alone, did not meet the primary endpoint of overall survival in either the overall population or patients whose tumor tested negative for Ataxia-Telangiectasia mutated protein during the phase III GOLD trial in advanced gastric cancer patients. Read More
Oryzon Genomics SA, of Barcelona, reported that its R&D collaboration with Roche AG, of Basel, Switzerland, around ORY-1001, licensed to Roche in 2014, has been extended until March 2017 with the goal of finalizing technology and knowledge transfer between the companies. Read More
Oncobiologics Inc., of Cranbury, N.J., said it closed its IPO of about 5.8 million units – each consisting of one share of common stock, one-half of a series A warrant and one-half of a series B warrant – priced at $6 per unit. Read More
SUZHOU, China – Two common themes ran throughout the first full day of the Chinabio Partnering Forum: an improving Chinese regulatory environment and an increasing number of innovators and multinational corporations looking for cross-border partnerships. Read More
BEIJING – China has been referencing FDA and EMA drug regulations along with developing its own versions. While it has a long way to go in terms of the number of regulations and the maturity of regulatory regime, the CFDA wants any new regulations to be tailored specifically for the country's market and to generate tangible benefits for the domestic industry. Read More
LONDON – Developers of new antibiotics should be given $1 billion market entry awards, to be paid on the condition that the drugs are available as and when required, but are not overmarketed so they become ineffective. Read More
Expanding its platform targeting dysregulating metabolism into the emerging field of metabolic immuno-oncology found Agios Pharmaceuticals Inc. linking up with a familiar ally in Celgene Corp., which plunked down a hefty $200 million in cash up front in a new collaboration. While they were at it, the partners retooled their existing collaboration, crafting what Agios CEO David Schenkein called a "win-win deal," that broadens Celgene's immuno-oncology shots on goal and positions Agios as a commercial player. Read More
With solid top-line phase IIb data for its oral insulin in hand, "everything is focused on taking this from where we are right now into a phase III trial," Chief Operating Officer Josh Hexter told BioWorld Today, adding that the company is still putting the results together and will schedule an end-of-phase-II meeting with the FDA when the package is ready. Read More
Macrogenics Inc. shares (NASDAQ:MGNX) climbed 16.7 percent to $21.06 on Wednesday as Janssen Biotech Inc. extended its collaboration with the company, agreeing to pay $75 million up front for a global license to MGD015, a preclinical bispecific antibody targeting CD3 and an undisclosed tumor target for the potential treatment of various hematological malignancies and solid tumors. Read More
Findings that precision medicine benefits patients even in phase I trials, and patients treated with Keytruda (pembrolizumab, Merck & Co. Inc.) had a three-year survival rate of about 40 percent, were among the highlights of the sprawling treasure trove that is the American Society of Clinical Oncology's (ASCO) annual meeting abstracts. Abstracts for the 2016 annual meeting, which will be held in Chicago June 3-7, were publicly released yesterday. Read More