HONG KONG and BEIJING – Not just multinational players but domestic Chinese pharmaceutical companies are poised to benefit from China’s promise under a phase one trade deal with the U.S. to better protect intellectual property (IP), even if question marks remain around how the deal will be enforced. The move is in line with China's ambition to strengthen IP rights protection and upgrade the approach to innovation of its pharmaceutical and biotech industries.
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.
Dublin-based Medtronic plc reported Wednesday that the U.S. FDA has given the green light to its Stealth Autoguide system. The company said it is the first cranial robotic platform that integrates with its enabling technology portfolio to create an end-to-end procedural solution.
Heart failure is a leading cause of disability and death in the U.S., but many cases are diagnosed late due to limited access to echocardiography, the primary method of detecting the condition. To address that need, the U.S. FDA has granted breakthrough device designation to Eko Devices Inc., of Berkeley, Calif., for an electrocardiogram (ECG)-based algorithm that could serve as an easily accessible screening tool for heart failure during routine physical exams.
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. For all but one of the 13, the U.S. price is the highest.
In another marathon session Tuesday, the third U.S. House committee with jurisdiction over prescription drug pricing issues marked up H.R. 3, the Lower Drug Costs Now Act, clearing the way for a House vote on the partisan measure yet this month.
Days after going public, Viela Bio Inc. nailed down a deal with Mitsubishi Tanabe Pharma Corp. to develop and commercialize Viela’s humanized anti-CD19 monoclonal antibody, inebilizumab, in nine Asia regions for the rare disease called neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications.
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).