Consort Medical has placed a big bet on the convergence of drug and device production services, striking a £230 million ($374 million) deal to buy European contract manufacturer Aesica Pharmaceuticals.
When a shortage of BCG vaccine used to treat tuberculosis and bladder cancer developed two years ago because of serious problems at a Sanofi Pasteur plant, the FDA asked Merck to pick up the slack. But Merck has had supply issues that interrupted production that it is only now resolving.
New problems have developed at GlaxoSmithKline's vaccine plant in Canada, interrupting production and affecting supply. The bottom line for Canada is that it will shave 2 million doses of its FluLaval trivalent vaccine off what GSK can deliver for the upcoming flu season. The impact on the U.S. is still being evaluated.
Canada's Theratechnologies says it is again shipping its 1-mg dose of its Egrifta to U.S. wholesalers. Manufacturing problems had led it to halt production earlier this year of the human growth hormone which is used by some HIV patients.
Actavis' plan to discontinue production of the original version of its Alzheimer's treatment Namenda and move patients to the extended-release version depended on patient and payer buy-in and being able to produce adequate supplies. The company has achieved the first two goals but has run into a shortage because production has been unable to keep up with demand.
In an effort to contain the Ebola outbreak in Africa that has already killed more than 1,500 people, companies around the world, including GlaxoSmithKline, are fast-tracking treatments and vaccines to try to get ahead of the disease spread. And in an effort to do that, companies are manufacturing doses, even as they are testing drugs, so that they will have product ready to go ASAP.
French drugmaker Sanofi has released its first batches of a malaria treatment made from semisynthetic artemisinin using a new manufacturing process that will allow it to make tons of the ingredient and so help stabilize its volatile global market.
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.