Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide.
Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.
CEO Mark McKenna told BioWorld Asia that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs.
WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).
BEIJING – The ongoing trade war between the U.S. and China has helped put the biotechnology field on the U.S. foreign investment restriction list, causing a chilling effect on the market.
BEIJING – China's position as a global power in active pharmaceutical ingredients (API) could be jeopardized by the ongoing and worsening trade war with the U.S. Perhaps more worrisome for the pharma industry, any disruption to Chinese supply chains could have a serious impact on drug manufacturing and accessibility globally.
BEIJING – Despite tensions between the U.S. and China, especially in the tech sector, Oncologie Inc. maintains its plans to pursue drug development in both markets. The clinical-stage startup, led by U.S. scientists and funded with Chinese capital, has stationed itself in both Boston and Shanghai to focus on developing innovative cancer therapies simultaneously in China and the U.S.
Japan's Sumitomo Dainippon Pharma Co. Ltd. plans to pay $3 billion to acquire Roivant Sciences Ltd.'s ownership interests in five biopharma companies, plus options to acquire up to six more from the prolific company-builder. The deal, slated to close in October, would give Sumitomo Dainippon controlling interests in Myovant Sciences Inc., Urovant Sciences Inc., Enzyvant Therapeutics Inc. and Altavant Sciences Inc., as well as an equity stake of more than 10% in Roivant itself.
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