Biogen said this week that it intends to build a $1 billion biologics plant in Switzerland. But the drugmaker expects the new EU facility to be just the first in a major manufacturing expansion that could result in two more new facilities as well as building up capacity at its existing sites.
Way back when, Actavis, which recently became Allergan ($AGN), started in Iceland. Now the drugmaker, which is known for its cost-control strategies, is taking the job ax to its roots there. It plans to shut down a manufacturing facility, cutting 300 jobs in the process.
The FDA has three classes of recalls it can request or order, with class I recalls being the most serious. Those are for situations when there is a "reasonable probability" that use of what the agency refers to a as a "violative product" will have serious consequences and could be fatal.
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The HIV-oriented joint venture of Pfizer, GlaxoSmithKline and Japan's Shionogi is turning to a Chinese manufacturer for a cheap supply of dolutegravir, the active ingredient in its Tivicay. The deal is seen as a way to cut the cost in China and some other developing countries of the JV's newest HIV fighter.
In April, Health Canada closed an active pharmaceutical ingredient repackager in Toronto and had it recall hundreds of bulk APIs that the regulators said could have been cross-contaminated by penicillin. Now the FDA has weighed in with a warning letter for the company.
On Wednesday, the FDA announced a federal permanent injunction against a company that continued to sell suppositories after being repeatedly warned they needed to be evaluated and approved by the FDA. Separately, it warned makers of unapproved children's eardrops they may face prosecution if they don't stop selling them.
While U.S. drugmaker Alexion is building up its manufacturing operations in Europe, French CMO Lonza will do the same for Alexion in the U.S.
Drugmakers have paid ever-increasing attention to the environmental impact their manufacturing operations have, looking for ways to lower their carbon footprint and to be improve energy efficiency. Toward that end, France's Sanofi said today that it has a three-year deal to have SUEZ environment improve the environmental and cost performance of its manufacturing sites globally.
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The U.S. Department of Agriculture has amended its rules to allow veterinarians to make vaccines in their offices for individual clients, so long as compounds aren't contracted out to unlicensed manufacturers.
A team of collaborators drawn from Harvard, Johnson & Johnson and other groups published results from a preclinical animal study Thursday afternoon that underscores the potential for developing the world's first HIV vaccine.