Asia
Active Biotech, headquartered in Lund, Sweden, regained the global development and commercialization rights to laquinimod from Israel-based Teva Pharmaceutical Industries.
The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.
Cambridge, Mass.-based Biogen and Tokyo, Japan-based Eisai Co. announced results from an analysis of their ongoing long-term extension (LTE) Phase Ib trial of aducanumab for Alzheimer’s disease.
Pfizer and Astellas Pharma announced they have amended the protocols for two Phase III clinical trials, ARCHES and EMBARK, to evaluate Xtandi (enzalutamide) in hormone-sensitive prostate cancer (HSPC). Both trials will wrap sooner than planned as a result.
CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, today announced a new global leadership structure and the appointment of Yuling Li, PhD as Senior Vice President, Process Development and Manufacturing.
As the U.S. Food and Drug Administration begins to take aim at updating its 40-year-old draft guidance on drugs that treat major depressive disorder (MDD), three drugmakers with key business in that space are raising some concerns.
Vantage Pharma published a report that reviewed the biopharma and medical technology trends for the year-to-date. Broadly speaking, for biotech companies, venture capital investment is up and mergers and acquisitions is down, while for the medical device company it’s the reverse.
Swiss Pharma giant Roche expanded its presence in China with the approval of its lung cancer drug, Alecesna. Roche said the medication was approved by the China National Drug Administration under a priority review.
Harbour BioMed signed an exclusive strategic partnership deal with Sichuan Kelun-Biotech Biopharmaceutical Co. to develop and commercialize an anti-PD-L1 antibody, A167, currently in Phase II development.
As investigations into China’s major vaccine scandals continue, a number of top regulators and politicians have been fired as a result. Bi Jingquan, former head of China’s Drug Administration, resigned. Two deputy Chinese provincial governors and one mayor were also fired by the Community Party over the scandal.
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