Savoring the big money that could be saved if biosimilars were to hit the U.S. market in significant numbers, lawmakers have scolded the FDA for its go-slow approach to shaping the biosimilar path, all the while ignoring other factors that could make or break the newborn market. Read More
UBS Wealth Management is getting into the cancer game. The financial services giant, which has joint headquarters in Basel and Zurich, Switzerland, raised $471 million to close the UBS Oncology Impact Fund, thought to be a first-of-its-kind initiative aimed at developing curative therapies for various types of cancer. Read More
Peptibodies targeting the B-cell receptor might provide a cancer therapy that is personalized to specific tumor cells but can be produced in a relatively automated fashion, making the production of such individualized therapy a realistic possibility. Read More
SHANGHAI – An unlikely union has been forged between San Francisco-based Unity Biotechnology Inc., a biopharma focused on developing anti-aging drugs to improve healthy life span, and Ascentage Pharma Group, of Shanghai, a clinical-stage firm focused on apoptosis-targeted oncology drug discovery and development. Read More
A joint bid to deploy Proteus Digital Health Inc.'s ingestible sensor with Tokyo-based Otsuka Pharmaceutical Co. Ltd.'s antipsychotic drug, Abilify, was met with a complete response letter from the FDA. Read More
Doctors Without Borders/Médecins Sans Frontières launched a global campaign calling on pharma firms Glaxosmithkline plc, of London, and Pfizer Inc., of New York, to cut the price of a pneumococcal vaccine in developing countries to $5 per child and to disclose what they currently charge countries for the vaccine. Read More
Oncobiologics Inc., of Cranbury, N.J., updated its plan for a proposed IPO, aiming to raise $60 million by offering 5 million shares priced in a range of $11 to $13. Read More
Opko Health Inc., of Miami, said the FDA accepted the resubmission of the new drug application (NDA) for Rayaldee (calcifediol) for the treatment of secondary hyperparathyroidism in patients with stage III or stage IV chronic kidney disease and vitamin D insufficiency. The company received a complete response letter in March, in which the agency indicated deficiencies during a facility inspection of Opko's third-party manufacturer. The resubmitted NDA has a six-month review period, with a PDUFA date of Oct. 22. Read More
Agenus Inc., of Lexington, Mass., said the first patient was dosed in a phase I trial of AGEN1884, an anti-CTLA-4 checkpoint antibody. The study in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. Read More
