Denmark-based Novo Nordisk said on Friday that it had received a subpoena from a U.S. Attorney who wants some info about its manufacturing operations at a plant in Kalundborg. But the company said it really has no idea why.
Trying hard to fight off a hostile takeover by Canada's Valeant, Botox maker Allergan has sent out press releases every time it stumbles onto something that appears to besmirch its pursuer. New fodder is in this week's FDA Enforcement Report. Valeant is recalling a couple hundred thousand bottles and tubes of products.
Swiss drugmaker Roche has plans for a big overhaul of its corporate headquarters. The drugmaker will spend about 3 billion Swiss francs ($3.2 billion) on a renovation that will add new labs and offices, and upgrade existing buildings on its Basel, Switzerland-based site.
The U.S. biopharma industry has been battling a drug take-back law in Alameda County, CA, for several years, concerned that if it is approved, other jurisdictions would start asking them to pay for drug disposal. That law was upheld by a federal court, and now San Francisco is looking to the industry to pay the full cost of its drug-disposal law.
GlaxoSmithKline's manufacturing network will take a hit as the company cuts costs in the face of falling revenues. The U.K. drugmaker was shy on details but said in an earnings release Wednesday that it needed to "rescale" R&D and manufacturing, as well as other operations. It reported a 3% revenue decline for its third quarter.
According to an FDA Medwatch alert, drug repackager Contract Packaging Resources is voluntarily recalling 11,640 boxes of Assured brand naproxen sodium tablets in the 220-mg dose because some of the cartons actually contain bottles of 200-mg ibuprofen softgels instead.
Argos Therapeutics, which has a personalized immunotherapy drug to treat renal cell carcinoma in trials, has kicked off work on a $57 million manufacturing facility in North Carolina. The biotech will get nearly $10 million in public support for the project.
Another drugmaker is having to recall metoprolol succinate extended release tablets, a generic for AstraZeneca hypertension drug Toprol XL. This time it is Mylan and the recall is for nearly 16,000 bottles of the beta blocker.
Johnson & Johnson's Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination.
The Office of Pharmaceutical Quality will finally open Jan. 1, and the FDA's Janet Woodcock will serve as its first acting director.
The U.S. government invested $440 million in three vaccine plants in the U.S. in 2012 with the proviso that if something like a pandemic occurred, it could call on them to produce drugs that it required. With Ebola spreading, those calls have now been made.
More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.
Puerto Rico, which has seen a number of plant closings recently, is facing another. Eli Lilly said it will close a facility in Guayama next year and put it up for sale.
U.S. drugmakers are not the only ones building plants in Ireland to take advantage of the lower taxes and incentives afforded there. Italian specialty drugmaker Cosmo says that is what it intends to do.
The FDA, which has been corralling human drug compounders, is also keeping track of some focused on animal drugs.
In May, the FDA sent U.S. marshals into a warehouse to seize $11 million worth of drugs, everything from ear drops to urea cream, from an Indian company that the agency said were unapproved. Now the company is going to have to destroy them all while the FDA watches.
Abbott Laboratories, which has made a large bet on its global nutrition business, is in the final throw of a manufacturing triple play. The Chicago-area company this week opened a nutrition products plant in India after opening plants in the U.S. and China several months ago.
Hospira is recalling "certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage." But the description does not get to the depth and breadth of the recall, which is for 54 lots of nearly a dozen products. That includes two dozen lots of saline solution in the 1000-mL size, an essential hospital product that has been in short supply for months.
The FDA has taken steps against a Chinese heparin maker it says is using potentially tainted raw supplies and which refused to let inspectors get a good look at its plants or records so that it could find out for sure.
Some Indian companies that had put off production of HIV/AIDS meds while they waited for the government to sign contracts are now having to seriously ramp up because of shortages of some meds, Reuters reports.