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Regulatory

Latest Headlines

Latest Headlines

Emcure India plant banned by the FDA

Add Emcure to the significant list of Indian drugmakers with plants banned by the FDA. An import alert for all human and animal drugs from an Emcure Pharmaceuticals plant in Hinjawadi, with a few exceptions, was issued Monday, according to the FDA.

Almac's launch of Singapore APAC HQ also eyes regional growth of small biotechs

Multinational biologic trials in Asia are a "big driver" behind U.K.-based Almac Group's launch of a Singapore-based Asian headquarters, but business from emerging biotechs would be icing on the cake, company executives told FiercePharmaAsia in an interview.

Catalent says it has resolved issues FDA noted at North Carolina site

The Catalent Pharma Solutions facility in Morrisville, NC, where the company manufactures inhalation products, was written up with a half-dozen observations during a routine visit back in March, according to the Form 483 that the FDA posted publicly recently.

EMA to again place HPV vaccines under its safety lens

While the European Medicines Agency said it "does not question that the benefits of HPV vaccines outweigh their risks," on Monday it announced a safety review of the shots that have thus far failed to live up to expectations partly due to safety concerns and a sex-related stigma.

Novo Nordisk looks past blockbuster Victoza with PhIII success for weekly GLP-1 med

Novo Nordisk is humming along with its fast-growing GLP-1 drug Victoza. But it's also eyeing a follow-up to that once-daily med, touting the first Phase III success for its once-weekly GLP-1 therapy semaglutide.

U.S. House passes provision to keep tabs on medical devices used on patients

The U.S. House of Representatives passed a far-reaching medical research bill on Friday that includes an amendment to better monitor the use of medical devices for patient safety. The provision in the bill was a result of the controversy over use of laparoscopic power morcellators.

Otsuka, Lundbeck bag blockbuster FDA approval for antipsychotic Rexulti

Otsuka is facing plenty of bleeding, now that its blockbuster antipsychotic Abilify has generic competition. But the company is working hard to soften the blow, and a brand-new FDA approval for a long-acting antipsychotic could help.

As schizophrenia rivals rush in, Otsuka and Lundbeck gain FDA OK for Rexulti

Otsuka and its partner Lundbeck snagged an FDA approval for Rexulti (brexpiprazole) to treat schizophrenia and as an add-on therapy for major depression, leaving the two companies prepping for an August launch into an increasingly crowded field.

Fresenius Kabi, Calea fined $844,600 for lapses tied to patient death

Fresenius Kabi, which has faced any number of actions by the FDA over manufacturing issues, is now having to cough up a substantial amount of money in the U.K. Fresenius Kabi and a sister company have been penalized £550,000 after a court found that manufacturing lapses were tied to the death of a patient in a U.K. hospital.

FDA cracks down on Vegas firm selling unapproved kidney drug for dogs and cats

Three years after warning Bio Health Solutions of Las Vegas to stop marketing its unapproved compound, RenAvast, for veterinary use, the FDA has filed a consent decree against the company and its owner. The company had been marketing RenAvast to treat a variety of kidney conditions in cats and dogs, including chronic renal failure, the FDA alleges. The action, filed July 10 by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Nevada, prevents the company from marketing RenAvast or any other unapproved drug.