European regulators have joined the FDA in suggesting joint plant inspections and training with their Indian counterparts. The offers come as India's industry has lost status in recent years as the FDA and other countries have banned Indian plants from shipping to the U.S. and Europe over quality and data-integrity issues.
SINGAPORE-- Undeterred by its loss of a new patent bid for its Sovaldi (sofosbuvir) hepatitis C drug in India, Gilead Sciences put together package deals with 8 of the country's generics makers to add an experimental drug to a deal for low-cost copies in 91 poor countries around the world. Meanwhile, Gilead said Sovaldi won marketing approval this month in India and it's off and running in that country.
SINGAPORE-- Beginning next month, 26 international drugmakers will be earning less in the United Arab Emirates from many of their drugs. The companies negotiated a deal with the country's Ministry of Health in the latest reduction to drug prices, with one unfortunate product's price forced down by 55%.
The emerging pharmaceutical markets of Asia are expected, with a few exceptions, to grow this year and beyond, most providing attractive platforms for investments in the local industries, according to a series of analyses.
Boots on the ground underlies the expansion of Vygon, the specialist single-use medical devices group, into Singapore as Southeast Asia heads toward a regional economic pact and public and private hospitals mushroom in China and Indonesia.
AdvaMed's executive vice president of global strategy and analysis told FierceMedicalDevices that China has not implemented its much-ballyhooed policy of using more domestic devices at its hospitals at the expense of foreign imports.
China-based biotechnology company 3SBio bought the entire share capital of Italy-based pharmaceutical contract manufacturing company Sirton Pharmaceuticals from First Shanghai, the company said on Jan. 26.
Pharmaceuticals and biotechnology per se are not officially on the agenda, but both industries could be affected by the semi-annual meeting of the Cross-strait Economic Cooperation Committee set for Jan. 29 in Taipei. Taiwan biotechs meet a week later.
MerLion Pharmaceuticals said it is in sustained talks with potenial investors to take its successful Phase II trials of a urinary tract infection application for its finaloxacin antibiotic into Phase III as it moves into a competitive landscape for the fluoroquinolone class of antibiotics with approval for an ear infection treament by the U.S. FDA.
The Serum Institute of India, the world's fifth largest vaccinemaker by volume, is eyeing newer vaccines, including one for the human papillomavirus expected to be launched by late 2018 and sell at a third of the price of Merck & Co.'s blockbuster Gardasil, Bloomberg reported.