Ongoing market access barriers for U.S. pharma and medical device companies landed India, Canada and Colombia on the U.S. Trade Representative's annual "Special 301" watch list again. The USTR's annual report reviews global developments on trade and intellectual property, identifying trading partners that USTR, part of the Executive Office of the President, deems to have harmful records on protection, enforcement or market access for U.S. innovators and creators. Read More
HONG KONG – Japanese researchers have determined for the first time the detailed atomic structure of a key molecule involved in intracellular transmission, which should contribute to development of better therapeutic approaches for neurodegenerative diseases such as Alzheimer's. Read More
Astellas Pharma US Inc., of Northbrook, Ill., part of Astellas Pharma Inc., of Tokyo, named Joseph Fleishaker senior vice president and head of clinical pharmacology and exploratory development; Susanne Gronen senior vice president and head of data sciences; and Andrew Krivoshik vice president of medical science, oncology. Read More
PERTH, Australia – The pharma industry largely supports the Therapeutic Goods Administration's (TGA) update to its orphan drug regulations, expected to become effective July 1, though industry stakeholders offered some suggestions for modifications, mostly regarding eligibility criteria for orphan designation and the time lapse for the validity period. Read More
The findings of a Chinese study showing that some health care workers exposed to high doses of the TB pathogen Mycobacterium tuberculosis (Mtb) made protective antibodies against future infection, despite having had no previous latent TB infection, may have important implications for rational development of new therapeutic and protective vaccines. Read More
HONG KONG – Aslan Pharmaceuticals Pte Ltd., an oncology-focused biotech company headquartered in Singapore, is set to commence a global pivotal study to treat biliary tract cancer with its lead product, varlitinib (ASLAN-001), after getting clearance from the FDA. Read More
HONG KONG – China's leading vaccine maker, Sinovac Biotech Ltd., has postponed its 2016 annual report while it investigates allegations made by U.S. investment management company Geoinvesting LLC that its CEO may have been involved in bribing a CFDA official to speed up drug approvals. Read More
Opthea Ltd., of Melbourne, Australia, said it completed its A$45 million (US$33.7 million) capital raising. Proceeds will enable the acceleration and diversification of the company's clinical development strategy for OPT-302, its VEGF-C/D Trap therapy for wet age-related macular degeneration and diabetic macular edema. Read More
