Specialty pharma OptiNose hopes to use up to $30 million in new financing to get its OPN-375 in combination with its novel breath-powered device through the FDA. But the agency already demonstrated some skepticism around the device last year--it issued a complete response letter to OptiNose partner Avanir because of device errors and required further testing.
Otsuka's antipsychotic franchise is facing more bad news, as Alkermes scored FDA approval for a long-acting injectable version of Abilify as it vies for a bigger spot in an increasingly crowded antipsychotic market.
Alkermes picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.
Japanese drugmaker Otsuka nabbed early FDA approval for a two-drug cocktail for colorectal cancer, planning to market the combination to treat advanced forms of the disease.
Japanese drugmaker Otsuka won FDA approval for a two-drug therapy for colorectal cancer, planning to market the combination as a treatment for advanced forms of the disease.
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.
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.
Otsuka has finally lost its battle with the FDA to prevent generics of its antipsychotic Abilify from hitting the market. A federal judge issued a final ruling against the Japanese drugmaker, a little more than a month after regulators opened the door for copycat versions of the meds.
A U.S. federal court ruled against Japan's Otsuka Pharmaceutical in an intricate court case involving an orphan drug, several patents and generics approvals. All of that was involved in a suit against the U.S. FDA.
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.