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.
In 2013, U.K. and European regulators banned most products from a Wockhardt plant in India that was found faking data, but the U.K. allowed it to continue shipping a few that were required for essential medicines. This week, the U.K. stiffened the action to include all active ingredients from Wockhardt's plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S.
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Last year Ranbaxy Laboratories persuaded the FDA to allow it to launch its exclusive of generic Diovan from its plant in New Jersey after the agency banned the Indian plant from which Ranbaxy would have made the drug. But with that workaround played out, and bans against four of its plants still in place, India's largest generic drugmaker saw earnings slip back into the red for the final quarter of the year.
GlaxoSmithKline is moving forward with an expansion of its active pharmaceutical ingredient manufacturing facility in Scotland that it announced more than a year ago.
Drug distributor AmerisourceBergen has again reported big quarterly increases in sales and profits as a relationship forged with Walgreens in 2013 continues to pay off big time. And without saying it directly, the company pointed to the phenomenal success of Gilead Sciences' hep C drugs, Sovaldi and Harvoni, as also playing a part in its earnings jump, saying its revenues were powered in part by sales of drugs for treating hepatitis C.
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.
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.
Biogen Idec has released a four-minute video via the Twitter sponsored feed that explains all of the manufacturing steps it goes through in making and purifying the treatment for hemophilia A.
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As the med tech industry homes in on next-generation devices for peripheral artery disease, medical experts are questioning the necessity of procedures to treat the disease, pointing to large Medicare payments made to physicians performing the operations.
Scientists in Florida have found a virus in ticks that is connected to hemorrhagic fever, which was thought to have disappeared globally more than 40 years ago.