With a new drug application (NDA) filed at the FDA, SK Life Science Inc., part of one of South Korea's largest conglomerates, is taking a big step closer to gaining a foothold in the U.S. epilepsy treatment market. Now awaiting a Nov. 21 PDUFA date, the company's candidate cenobamate is poised to become its first-ever independent biopharma success in America. Read More
LONDON – After years in the planning, a pan-European medicines authentication system, tracking drugs from production line to point of dispensing, went live last weekend. Read More
PERTH, Australia – As pharma companies face global pricing pressures, value-based pricing mechanisms and health technology assessments more often than not determine which drugs get reimbursed and, ultimately, make it to the patient. Read More
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. Read More
Taiho Pharmaceutical Co. Ltd., of Tokyo, and Cullinan Oncology LLC, of Cambridge, Mass., inked a deal to develop TAS-6417, an EGFR tyrosine kinase inhibitor discovered by Taiho. Under the terms, Taiho will grant an exclusive global license, excluding Japan, for the development and commercialization of TAS-6417 to Cullinan Pearl, a newly formed U.S.-based company under the Cullinan Oncology umbrella. Read More
