LONDON – The biotech industry has hit out at a proposal by the European Commission to make it legal for generics and biosimilars companies to manufacture and export products before EU intellectual property rights (IPR) expire. Read More
DUBLIN – DBV Technologies SA hopes to move its Viaskin Milk (VM) desensitization therapy for IgE-mediated cow's milk protein allergy (CMPA) into phase III trials next year, on the back of phase I/II efficacy data it unveiled Sunday at the European Academy of Allergy and Clinical Immunology (EACCI) congress in Munich. That depends on FDA agreement, however, and the Paris-based firm plans to meet with the regulator to discuss its next steps later this year. The treatment missed the primary endpoint of the trial but at the same time showed definite efficacy trends. Read More
The technologies underlying the switch to digital health are here and now, but alongside technical complexities of connecting silos of information spread around medical specialties and perfecting the interoperability of IT systems, a number of issues stand in the way of applying digital health at scale. Read More
Australian scientists have found a new way to make molecular isomers, opening up the possibility of a new area of chemistry and the development of countless new drugs and other useful new materials. Read More
PERTH, Australia – In response to industry comments, Australia's Therapeutic Goods Administration (TGA) is getting ready to implement a new fee structure for drug GMP inspections. Read More
A week after the U.S. Trade Representative released a joint statement with Chinese trade officials acknowledging "constructive" trade consultations between the two countries, the White House announced that President Donald Trump has signed a memorandum detailing steps the U.S. will take to protect its domestic technology and intellectual property from certain discriminatory and burdensome trade practices by China. Read More
Lion TCR Pte. Ltd., of Singapore, said it raised $20 million in a series A financing round. The proceeds will be primarily used to advance its ongoing clinical trials of lead candidate Liocyx (personalized HBV specific TCR T-cell therapy against HCC) in major hospitals in China and Singapore, as well as for broadening its products pipeline to fight viral-related solid tumors and clearance of chronic hepatitis B. Read More
