FDAnews Drug Daily Bulletin

A string of long-pending pay-for-delay cases against Cephalon are being placed on hold while the Supreme Court decides whether to grant Merck’s request and rule on the validity of reverse patent settlements — a hotly contested issue that has resulted in conflicting decisions throughout the nation’s lower courts.

The FDA has notified Indian generic-drug maker Claris Lifesciences that it can once again sell its products to the U.S. and will see its pending ANDAs addressed, the company says.

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.

A lung drug from Boehringer Ingelheim and Pfizer helped delay severe episodes in asthma patients, researchers said in two studies that may result in broader use of the medicine.

Abbott Laboratories’ AbbVie hit Amneal Pharmaceuticals with a patent suit in Delaware Federal Court, arguing that Amneal has infringed a patent covering its cholesterol medication, Niaspan.

Valeant Pharmaceuticals International has agreed to buy Medicis Pharmaceutical for $2.6 billion, the latest in a string of acquisitions that have transformed the Canadian drug maker into a multibillion-dollar global company.

U.S. antitrust officials have approved Spectrum Pharmaceuticals’ purchase of cancer drugmaker Allos Therapeutics, a $206 million deal aimed at giving Spectrum access to the Allos anti-cancer drug Folotyn.

Decades of campaigning by victims of thalidomide, a morning sickness drug, have taken a new turn, with the first apology in 50 years to the victims and their families by the drug’s German manufacturer — and an incensed rejection of the apology as too little and too late from many of those it was intended to placate.

Takeda Pharmaceutical and NPS Pharmaceuticals said the European Commission has granted European market authorization for the medicinal product teduglutide or Revestive as a once-daily treatment for adult patients with short bowel syndrome.