HONG KONG – The speed of approvals of biotechnology products in China remains a bone of contention for trade authorities in the U.S., even though "progress was made on some meaningful issues" in terms of market access within the second largest economy in the world in 2014.
TOKYO – In the nearly 12 years since the completion of the Human Genome Project, next-generation sequencing methods have made genome sequencing both faster and cheaper, leading to massive increases in the numbers of individuals who can be sequenced. Projects have gone from the Human Genome Project, to the 1,000 Genomes Project, to the announcement last week of a 100,000 Genomes Project that plans to start recruiting patients in February 2015. (See BioWorld Today, Dec. 23, 2014.)
HONG KONG – Chinese pharmaceutical regulators will begin 2015 by taking aim at improving supervision of shelf-life studies and storage of biological products in order to enhance consumer safety.
SHANGHAI – China's Phagelux Inc. has made a deal with Delaware-registered Iveria Technologies Inc. to acquire several biodegradable polymer delivery systems for its phage technologies being developed for both human and agricultural uses.
TOKYO – Even considering that much of the industry deals with life and death matters by the nature of the field, stem cells have long been a high drama part of biotechnology. And 2014 was no exception to that rule.
Mylan Inc., of Pittsburgh, said its subsidiary in India, Mylan Laboratories Ltd., a manufacturer of antiretroviral (ARV) drugs, has been selected, through its South African-based subsidiary Mylan Ltd., as one of the leading suppliers of ARV medications to the South African National Department of Health for the period April 1, 2015, to March 31, 2018.
To say that 2014 was a good year for the biopharma industry would be a radical understatement. The flourishing capital markets, the record-breaking number of companies successfully going public via initial public offerings and the validation of scientific breakthroughs that only a few years ago had been mere theories all made for a banner year for the sector. Yet as BioWorld compiled its annual list of the most impactful stories, the top story was one that dominated headlines worldwide: the Ebola virus outbreak in West Africa.
SHANGHAI – China's chief economic planning agency has proposed changes to the way medicine prices are set that will allow more room for market forces and do away with government set price caps. Released in a draft discussion document last month, the new policy is expected to come into force Jan. 1, 2015.
Tianyin Pharmaceutical Co. Inc., of Chengdu, China, said it achieved the public notice (Gong Shi) status for its good manufacturing practice (GMP) certificate of TPI's Qionglai Facility (QLF) from the CFDA. The public notice period lasts for approximately 10 business days which is to be followed by immediate issuance of the GMP certificate.
NEW DELHI – India's attempts to enter into a Regional Comprehensive Economic Partnership (RCEP) deal among 16 countries in Asia are likely to have a significant impact on the biopharma industry, but analysts are divided as to what that will be.