Following a record-breaking year for deal-makers, 2016 isn't exactly off to the races. The drug pricing debate, magnified through the lens of a contentious Presidential campaign, and mounting pressure on the industry's blue chips to improve performance in the midst of a volatile stock market have placed heavy demands on partnering activity. In a super session on the final day of the BIO International Convention, a panel of veteran deal-makers debated whether big biopharmas will take a wait-and-see approach or throw caution to the wind and forge ahead with partnering and M&A. Read More
SHANGHAI – Shenyang Sunshine Pharmaceutical Co. Ltd. (3SBio), a revenue-generating biotech with products in China, has decided to try its hand at the hottest category in immuno-oncology. Read More
HONG KONG – Although the government has set its sights on advancing personalized medicine in China, most of the existing gene-related technologies are still of foreign origin, so are some of the leading companies operating here. The question at the moment is whether development of precision medicine in the country is a domestic or foreign affair? And where will the huge amount of government funding in the space go? Read More
SAN FRANCISCO – "Platforms are 'in' again," said Arthur Sands, CEO of Nurix Inc., which last September bagged an agreement with Celgene Corp. that brought $150 million up front plus an undisclosed equity investment to discover and develop drugs that target the ubiquitin proteasome system (UPS). Read More
HONG KONG – The findings of a new collaborative study by Chinese and German scientists suggest that activation in mice of a specific type of immune response, known as a Type 2 (Th2) response, using parasitic worm-derived stimuli, could clear the way to the development of new treatments for rheumatoid arthritis (RA). Read More
As part of the ninth annual International Internet Week of Action, the FDA, in partnership with international regulatory and law enforcement agencies, took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The annual global cooperative effort is led by INTERPOL and targets the online sale of illegal and counterfeit drugs. Read More
Selecta Biosciences Inc., of Watertown, Mass., has filed with the SEC to offer 4.25 million shares, priced between $14 and $16 each in an IPO. The company said it is using synthetic vaccine particle technology to discover and develop targeted therapies that are designed to modulate the immune system to effectively and safely treat rare and serious diseases. They have applied to list their common stock on the Nasdaq Global Market under the symbol SELB. Read More
Alkermes plc, of Dublin, said in a document filed with the SEC, that on June 3 the U.S. Patent and Trademark Office accepted two separate petitions for inter partes review (IPR) filed by Luye Pharma Group Ltd., challenging U.S. Patent number 6,667,061, which is an Orange Book-listed patent for each of Bydureon, Risperdal Consta and Vivitrol. The company has three months to respond, following which the U.S. PTO has a further three-month period to decide whether or not to institute a review of the challenged claims of the '061 patent. It said it will oppose Luye's requests to institute the challenge of the '061 patent, and, if the U.S. PTO institutes such challenge, the company will oppose the full proceedings and vigorously defend the '061 patent. Read More
Momenta Pharmaceuticals Inc., of Cambridge, Mass., dosed the first healthy volunteers in a phase I randomized, double-blind, placebo-controlled, ascending-dose cohort study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281, an anti-FcRn monoclonal antibody, for the treatment of autoimmune diseases. In preclinical models, M281 potently antagonizes FcRn binding of IgGs and rapidly diminishes circulating levels of IgG antibodies, the primary pathogenic agent in a number of autoimmune diseases. The study will enroll up to approximately 72 healthy volunteers. Read More