Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
Otsuka's patent cliff is coming, with the expiration date on best-seller Abilify's IP shield just around the corner. But now, the Japanese pharma has signed a $3.5 billion agreement to pick up Avanir Pharmaceuticals that could help soften the blow.
Did Bristol-Myers Squibb offer kickbacks and push Abilify for off-label uses? Some former sales reps-turned-whistleblowers claim it did. And given the fact that Bristol-Myers already paid $515 million to settle some off-label marketing claims related to Abilify, they say, the company violated its "we'll behave" promises to the feds.
Alkermes has taken another step toward the market with its long-acting version of the schizophrenia drug Abilify, filing for an approval with the FDA as it lays the foundation for a hoped-for launch in 2015.
Alkermes has crossed the finish line in a Phase III schizophrenia study of a long-acting version of Abilify, picking up the statistically significant results needed to back a new drug application later in the year.
It is the big sellers, the blockbusters--no, megablockbusters--that drug execs aspire to develop. And a look at the top 10 best-selling drugs globally can't help but impress with its big numbers.
Watchdogs worried about antipsychotic use in children now have more ammo. A new study links the drugs with Type 2 diabetes. Published in the journal JAMA Psychiatry, the study found a threefold increase in diabetes risk for kids who take antipsychotic drugs compared with those taking other psychotropic drugs.
The regulators have spoken on both sides of the Atlantic. And in both cases, we have winners--and we have losers.
A federal judge tossed out a lawsuit filed by health plans unhappy with Bristol-Myers Squibb's co-pay offers on Abilify. The insurers accused the drugmaker of racketeering and bribery for using coupons to combat generic versions of the antipsychotic drug.
Lundbeck has another chance to crow this week, now that its once-monthly version of Abilify has FDA approval. The agency nod comes fast on the heels of another, for the Danish drugmaker's alcohol addiction drug Selincro. This double victory opens the way for Lundbeck to transform turnaround promises into actual sales.