Sanofi bought control of Shantha Biotechnics in 2009 as a way to access low-cost vaccine manufacturing in India. Now the drugmaker will use the subsidiary to expand insulin production.
India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts.
The Chinese Pharmacopoeia Commission and Waters launched their Joint Open Laboratory on Jan. 28 in Beijing that aims to produce the first official compendium of drugs.
Don't look for any Trans-Pacific Partnership agreement on patent lengths for biologics this year. That was the message delivered at a congressional hearing on Tuesday.
Lupin is now allowed to sell off up to 49% of the company--if it decides it wants to--in a deal or deals that could be worth more than $1 billion. At Lupin's request, India's Cabinet decided to raise the cap on foreign investment in the company; previously, Lupin was allowed to sell up to a 33% stake.
Serum Institute of India, which has a history of undercutting its competition in the vaccine sphere, is expanding this undercutting game to HPV. Its low-cost competitor to Merck's Gardasil could hit the market in late 2018 at one-third the price.
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.