Washington Drug Letter

Johnson & Johnson (J&J) has agreed to pay $181 million and enter into a consent decree with 36 states and the District of Columbia to settle allegations that its Janssen subsidiary marketed prescription antipsychotic Risperdal off-label in violation of consumer protection laws, J&J says.

The country’s highest court is likely to mull Hatch-Waxman’s safe-harbor provision now that the U.S. Court of Appeals for the Federal Circuit has issued contradictory rulings on when the law allows drugmakers to use others’ patents without fear of infringement.

Teva has scored a victory on the road to biosimilar approvals with the FDA’s OK of its copycat version of Amgen’s Neupogen, a win that could halve Amgen’s U.S. market share by the end of 2016, analysts say.

The FDA has approved Gilead’s Stribild, previously called Quad, as a once-daily combo pill for treatment-naïve adults with HIV.

The FDA has placed a “precautionary” clinical hold on Idenix Pharmaceuticals’ next-generation nucleotide polymerase inhibitor, IDX19368, being developed to treat hepatitis C (HCV) infection.

The FDA has approved an sNDA for Janssen Pharmaceuticals’ Nucynta ER to manage severe pain in diabetic peripheral neuropathy (DPN).

The FDA has issued Genzyme a refuse-to-file letter on its sBLA for Lemtrada as a treatment for relapsing multiple sclerosis (MS).

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has urged Pacira Pharmaceuticals’ cancer drug DepoCyte be recalled in certain EU countries, citing “manufacturing deficiencies” found at the company’s San Diego, Calif., facility.

Merck is urging the Supreme Court to take up the issue of reverse patent settlements now that the Third Circuit Court of Appeals has created a split among the U.S. appeals courts.

Sun Pharmaceuticals’ Caraco unit may resume some of its Detroit and Wixom, Mich., operations after recent FDA inspections show it is in compliance with a 2009 consent decree.

Despite “fragile” trial data, the FDA should approve Abbott Laboratories’ proposed new indication for its blockbuster Humira to treat ulcerative colitis (UC) because new therapies for the chronic condition are needed and clinicians are comfortable with the drug’s safety profile, agency advisers say.