Scientists from Taiwan National University have shown that the reason that hepatitis B is typically cleared in adults, but becomes chronic when individuals are first infected as children, is related to the development of the gut microbiome. A string B-cell and T-cell immune response is necessary to clear hepatitis B infection, and the authors showed that in young mice, that immune response was dependent on the maturation of the gut microbiome.
HYDERABAD, India – India may have a proven track record developing generics, but it is limping far behind other countries in the discovery and development of new drugs, areas which call for entirely new skill sets and investments.
SHANGHAI – Glaxosmithkline plc, of London, has firmly denied rumors of sizable layoffs in its troubled China operation, reasserting its commitment to the country. While the company is sticking to its story that nobody will be let go, the firm also said in a statement it will continue to "realign resources to build a highly efficient and sustainable business."
HONG KONG — Japanese researchers have for the first time successfully induced human embryonic stem cells to self-organize into a functional three-dimensional structure similar to the cerebellum, providing clues on how to recreate neural structures in the laboratory and potentially leading to new drug discoveries.
TAIPEI, Taiwan – Biopharmaceutical companies, both in the novel drug and biosimilar spaces, are facing long waits for investigational new drug application (IND) approval in China from the CFDA, delays that are slowly stifling the industry. That's according to panelists at a discussion on Taiwan-China partnership issues that took place at the recently concluded Biologics World Taiwan 2015 conference.
HONG KONG – Novartis AG faces a new series of challenges in Japan that stem from a failure to notify authorities of serious side effects associated with two dozen of its drugs.
SHANGHAI – The all-important CFDA looks set to welcome a new commissioner into the fold. Bi Jingquan comes to the top spot with a long resume of government service, the bulk of which was spent at China's economic planning agency, the National Development Reform Commission (NDRC), where he specialized in pricing.
TOKYO – Thanks to a series of policy initiatives, Japan's Pharmaceutical and Medical Device Agency (PMDA) has morphed into a much more nimble regulator, one that processes approvals as fast as the FDA or the EMA.
HONG KONG – A Chinese clinical trial site management organization (SMO) is getting into monoclonal antibodies (mAbs) after acquiring the global development and licensing rights of drug candidates developed by Chinese academic researchers.
NEW DELHI, India – The EMA has recommended suspending the Hyderbad-based contract research organisation (CRO) GVK Biosciences on charges of data manipulation, a decision that once again shines a spotlight on the issue of Western drug firms outsourcing clinical trials to CROs to cut costs.
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