Ascletis, Alphamab to collaborate for HBV antibody candidate in China | EU approves Opdivo plus Yervoy to treat kidney cancer | Dr. Reddy's to explore Chinese market
January 17, 2019
News on diagnostic and therapeutic innovations and regulatory science
Ascletis Pharma and Suzhou Alphamab have entered an exclusive licensing agreement to develop KN035, an anti-PD-L1 monoclonal antibody, as a treatment for hepatitis B virus and other viral infections in greater China. The deal grants Ascletis an exclusive license for the development and marketing of KN035 as a viral disease treatment in China, while Alphamab will receive an unspecified upfront payment in cash and will be eligible for development and commercial milestone payments and tiered royalties.
Saving Money, Saving Time in Pharma Operations A holistic data infrastructure removes the barriers of finding, capturing, converting and organizing operational data, enabling operators and engineers to model enterprise-wide operational intelligence while reducing complexity and cost. Be on your way to better data, higher quality and more efficient operations.
Opdivo and low-dose Yervoy received approval from the European Commission as a first-line treatment for intermediate- and poor-risk advanced renal cell carcinoma. The approval was based on studies that showed improved patient survival.
Dr. Reddy's Laboratories intends to expand its business in China by setting up new units and creating partnerships with local Chinese companies. The firm would supply generic and branded drugs to the Chinese market.
India launched a five-year program in 2017 called the National Strategic Plan for Malaria Elimination, and this year Abbott, in partnership with nonprofit Malaria No More and the government of the state of Odisha in eastern India, will collaborate toward that goal. Abbott will donate $750,000 over a three-year period, 1 million rapid diagnostic tests and technical expertise to boost the state's malaria surveillance and detection.
Eisai and Purdue Pharma have submitted to the FDA a new drug application for lemborexant, which is being developed for the treatment of patients with insomnia. The candidate met the primary endpoints in two late-stage studies.
The FDA has given orphan drug designations to Cerecor's D-galactose and D-mannose, which are indicated for phosphoglucomutase 1 deficiency and mannose phosphate isomerase deficiency, respectively. The company's L-fucose, being developed for congenital disorder glycosylation IIc, was also given orphan status.
FDA Commissioner Scott Gottlieb announced Tuesday plans related to the agency's push to improve oversight of cell and gene therapies considering the 800 active investigational new drug applications and the more than 200 expected each year by 2020. Initiatives include boosting administrative staff with the addition of 50 clinical reviewers and new guidance on regenerative medicine advanced therapy designations, development of products such as gene therapies for hematologic disorders, and development of chimeric antigen receptor T-cell therapies.
Sanofi and Biomunex Pharmaceuticals have entered into a licensing agreement to develop treatment options for disease areas including immuno-oncology from bi- and multispecific antibodies by using Biomunex's proprietary BiXAb platform. No information was disclosed on the deal's value.
Looking for opportunities to broaden your knowledge, enhance your skillset and advance your career? Check out our upcoming, can't-miss meetings for health care and life sciences professionals:
Are you aware of the latest and emerging changes in the regulatory environment and new technologies that are relevant to the promotion of FDA-regulated products? Join industry experts as they discuss the regulated industry's policy efforts in this rapidly evolving space, as well as ways companies may navigate these changes in order to maintain compliance and avoid enforcement, at DIA's Advertising and Promotion Regulatory Affairs Conference, Feb. 28-March 1. Nowhere else will you be able to discuss in-depth with representatives from industry, health authorities, and academia new guidances, letters, and issues regarding advertising and promotion coming down the pipeline from FDA. Advance Rates are in effect. Hurry to save your seat!
