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Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher will pay a $2.7 million fee in fiscal year 2016 — a $165,000 increase over this year, which ends Sept. 30. Read More
Amgen is seeking approval for its 420 mg monthly dosage form of Repatha just over two weeks after the FDA signed off on the PCSK9 inhibitor to control low-density lipoprotein cholesterol. Read More
Two FDA advisory committees voted 23 to 1 on Thursday not to recommend approval of Purdue Pharma’s NDA for Avridi, saying the public health benefits of the abuse-deterrent opioid don’t outweigh the risks to patients posed by the effect of food intake. Read More
Otsuka Pharmaceutical and Proteus Digital Health announced Thursday FDA acceptance of their first-of-its-kind digital medicine NDA combining Abilify with a digital tracking mechanism. Read More
Drug and biologics makers are urging the Centers for Medicare & Medicaid Services to reimburse each noninterchangeable biosimilar based on its own average sale price, saying that would avoid prescribing mix-ups and possible harm to patient care. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
The FDA on Friday approved Wellstat Therapeutics’s Xuriden to treat a rare metabolic disorder known as hereditary orotic aciduria, landing the company a rare pediatric disease priority review voucher. Read More
Acadia Pharmaceuticals Wednesday filed an NDA with the FDA for Nuplazid, a product that, if approved, would be a first-in-class drug and the first specific treatment for Parkinson’s disease psychosis. Read More