Baxter International, which has been scrambling to get added supplies of saline to the market in the midst of a national shortage, is recalling one lot of large-volume bags in the U.S. because of contamination.
India's Central Drugs Standard Control Organization has issued new guidelines for state inspectors on how to prepare for and handle inspections of drug manufacturing facilities, Regulatory Focus points out.
Thanks to supply limitations in the U.S. that spurred a near-30% drop in adult booster vaccines, Sanofi reported Q2 vaccines sales down 0.4% overall. But its flu business posted big gains, ballooning 18.9% to €59 million ($78.9 million)--and CEO Chris Viehbacher says he expects that trend to continue.
GlaxoSmithKline and Johnson & Johnson, which control most of the needed supplies for the industry, want authorities to approve genetic engineering so opium farming can be both expanded and made less susceptible to pests and so they can assure their customers they can keep up with demand.
After its competitor UPS settled with U.S. authorities over accusations that it was a key link in the supply chain for Internet pharmacies, FedEx vowed to fight any charges that came its way. It will get the chance to do just that after the Justice Department filed charges against the international delivery service.
The polar vortex that caused low temperatures in towns and cities across the eastern U.S. is now long gone, but its effects are still being felt. Having closed schools, roads and businesses over the winter, the cold weather has now been blamed by Bausch + Lomb for a recall of 880,000 tubes of eye ointment.
Sanofi has a plant in Saudi Arabia but had decided to expand its production capacity and reach in the Middle East market with an investment in an established company there. The drugmaker is taking control of Globalpharma, a decade-old company that sells products in the Middle East and Gulf Coast markets.
Biosimilars are expected to be a big revenue generator for the companies with the expertise and the facilities capable to produce them. mAbxience, a Swiss-based subsidiary of a Spanish company, says it intends to be among those and has bought a competitor in Spain to move those ambitions down the road.
Last week, drugmaker Hikma struck a deal to buy some of the sterile injectable assets of a Boehringer Ingelheim unit to expand in that growing part of the industry. Now, U.S.-based Amneal Pharmaceuticals is looking to India for a chance to exploit that niche of the market.
AMRI said the Albuquerque, NM-based Oso will expand its capabilities in small-molecule and biologics manufacturing.