A phase III trial testing Astellas Pharma Inc.'s acute myeloid leukemia (AML) candidate, gilteritinib, as a maintenance therapy after hematopoietic stem cell transplant (HCT) has dosed its first patient. It's the fourth late-stage trial testing the FLT3/Axl kinase inhibitor in an active landscape of increasingly tailored AML therapies. If successful, the study could help the Tokyo-based company establish a basis for a potentially broad label for the orphan-designated medicine. Read More
Dr. Reddy's Laboratories Ltd., of Hyderabad, India, said its wholly owned subsidiary Promius Pharma LLC, licensed the development, manufacturing, and commercialization rights to DFD-06, a topical steroid being developed for moderate to severe plaque psoriasis, to Encore Dermatology Inc., of Malvern, Pa. Promius is eligible to receive undisclosed pre- and post- commercialization milestone payments of up to $32.5 million and will receive fixed royalty payments on net sales. Read More
PERTH, Australia – A new technology spun out of Singapore's Agency for Science, Technology and Research (A*STAR) could change cancer treatment by building cell-based tumor avatars in the lab to test them against a multitude of drugs. Read More
HONG KONG – In the wake of the Indian patent office granting U.S. pharmaceutical giant Pfizer Inc. a patent for its pneumococcal conjugate vaccine (PCV), hopes have been dashed for better access to an affordable vaccine against pneumonia in the developing country of more than 1.3 billion people. Read More
HONG KONG – China's drug authority is upscaling the Marketing Authorization Holder (MAH) mechanism pilot, which is seen as a boon for drug innovation in the country. The CFDA released another notice regarding the pilot MAH mechanism in the country which clarified details on the responsibilities of the authorization holders and license transferring. Read More
HYDERABAD, India – India's drug authority has granted approval to Mylan Inc.'s Indian arm to market its anti-tuberculosis drug delamanid developed specifically for treating multidrug-resistant tuberculosis (MDR TB). Meanwhile, the country is also actively exploring new entities to tackle the TB problem via public-private partnership. Read More
