The increase in the incidence of multidrug-resistant (MDR) bacteria has galvanized governments to stimulate industry efforts to develop new therapeutics to replace its current arsenal of antibiotics. It appears that this research and development stimuli in terms of economic incentives and market exclusivity is now gathering momentum, with a host of new companies formed, thanks to venture investments, and lucrative partnerships being inked. In this two-part article, the business and financial climate for developers of antibiotics will be examined along with the product pipeline progress that is being made. Read More
HONG KONG – Taiwan-U.S. biopharma company Foresee Pharmaceutical Co. Ltd. has out-licensed its core asset FP-001 (leuprorelin depot) for treating prostate cancer to U.K.-based Accord Healthcare in an $86 million deal. Read More
LONDON – Summit plc announced the opening of the phase III trial of ridinilazole in the treatment of Clostridium difficile infections, with the first patient being dosed in the U.S. on Tuesday. The orally administered drug becomes only the second antibiotic that currently is in phase III development to have a novel mechanism of action. Read More
CEO Shawn Singh of Vistagen Therapeutics Inc. called the favorable vote for ketamine derivative esketamine by a joint meeting of FDA advisory panels "the writing of a bright new chapter in the history of neuropsychiatry," telling BioWorld that the "next transformative step" will involve developing more convenient, at-home options. Esketamine is given under medical supervision. Read More
The FDA's decision to accept a new drug application (NDA) for pitolisant, a medicine Harmony Biosciences LLC is advancing following the drug's 2016 EMA approval, throws open the door that 2019 could bring U.S. narcolepsy patients two new medicines for excessive daytime sleepiness (EDS). An FDA decision on Jazz Pharmaceuticals plc's solriamfetol filing, the other NDA in review, is expected by March 20. Both drugs will face competition from wake-promoting agents, such as modafinil and armodafinil, and generic stimulants. Read More
HONG KONG – When it comes to innovation in China, the largest companies top the rankings. The annual Clarivate Analytics Top 100 Chinese Innovators list was dominated by big conglomerates such as Fosun International Ltd. and China Resources (Holdings) Co. Ltd. Travis Hu, general manager of Clarivate Life Sciences Business for greater China, said that big corporations have certain given advantages when it comes to drug discovery. Read More
Exelixis Inc., of Alameda, Calif., reported it generated total revenues of $228.6 million in the fourth quarter and $853.8 million for the full year. The revenues included the sale of Cabometyx (cabozantinib) for the treatment of advanced renal cell carcinoma (RCC) whose net product revenues were $176.2 million for the fourth quarter and $619.3 million for the full year. Read More
Xoma Corp., of Emeryville, Calif., said it received a $5.5 million payment from Rezolute Inc. (formerly Antriabio Inc.), of Louisville, Colo., in conjunction with the potential $240 million global license agreement between the companies in 2017 to develop and commercialize the insulin receptor antagonist XOMA-358 (now RZ-358) in all indications. Read More
Macrogenics Inc., of Rockville, Md., said it priced an underwritten public offering of 5.5 million shares at $20 per share. In addition, the company has granted the underwriters a 30-day option to purchase up to an additional 825,000 shares at the public offering price. It anticipates the gross proceeds will be approximately $110 million, and the net proceeds will be used for general corporate purposes and working capital needs. Read More
The FDA this week issued its first warning letter under the Drug Supply Chain Security Act to McKesson Corp., of San Francisco, for violations involving illegitimate drugs in its supply chain. Some of the violations stemmed from a tampering incident in which a customer notified McKesson that three of its pharmacy locations in Michigan had received bottles that were supposed to contain opioid pills. Read More
