This year’s renewal of the FDA user fee agreements (UFAs) for drugs and devices is pitting industry hopes for a “clean” bill and timely action against some U.S. lawmakers’ pledges to put teeth to their sound bites on drug prices. Read More

DUBLIN – Pharmaleads SAS is like the comeback kid who never went away. The French drug developer has spent a decade quietly focused on a novel drug mechanism in pain that was long disregarded by others in the field. The accrual of preclinical and early clinical data on its two lead drug candidates, combined with findings from other labs, have now brought it to the point where the rubber hits the road. Read More

Privately held Synlogic Inc., a company leveraging synthetic biology to genetically reengineer microbes, is going public via a reverse merger with troubled microRNA mimic pioneer Mirna Therapeutics Inc. Read More

HONG KONG – China is on track to achieve some major milestones in biotechnology by 2020, further accelerating the growth of its drug development sector. Despite numerous challenges, the outlook for China’s pharmaceutical industry remains very positive as the country aggressively implements reforms, according to industry analysts. Read More

HONG KONG – Saudi Arabia is emerging as a powerhouse for drug production. Case in point is a newly built 75,000-square-meter drug manufacturing facility in the country’s King Abdulla Economic City. Read More

Mabvax Therapeutics Holdings Inc., of San Diego, said it priced a public offering of 1.34 million shares of common stock and an aggregate of 1 million shares of 0 percent series G convertible preferred stock at a public offering price of $1.75 each. Read More

Canbridge Life Sciences Ltd., of Beijing, and Amoy Diagnostics Co. Ltd., of Xiamen, China, said they inked an agreement to develop a companion diagnostic for CAN-008. The fully human Fc fusion protein is intended to treat glioblastoma multiforme (GBM), and the company aims to begin a phase II trial in China sometime next year. Read More

Antares Pharma Inc., of Ewing, N.J., said phase III data reported at the American Urological Association meeting in Boston demonstrated the pharmacokinetics and safety of subcutaneous testosterone enanthate delivered through the firm’s Quickshot autoinjector. Read More

The FDA released 37 draft product-specific guidances – 21 new and 16 revised – on how to develop generics that are therapeutically equivalent to specific drugs. Read More