Latest Headlines

Latest Headlines

OptiNose raises up to $30M to get drug-device combo through FDA

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 stares down another rival with FDA approval for Alkermes' long-acting Abilify

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 wins an FDA nod for its monthly schizophrenia drug

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.

Otsuka prepares to roll out two-drug combo for colorectal cancer

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.

Otsuka wins early FDA approval for a colorectal cancer combo drug

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, 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.

Otsuka faces the music for generic Abilify, loses battle with FDA

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.

Teva a winner as U.S. Federal Court gives thumbs down to Japan's Otsuka on novel Abilify lawsuit

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 scrambles to persuade judge to block Abilify copycats

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.