BioMarin, preparing for a make-or-break FDA panel vote next week, got a harsh review from agency staff over its treatment for Duchenne muscular dystrophy, taken to task for "contradictory" efficacy data and "life-threatening" safety risks.
AstraZeneca has been duking it out with Dr. Reddy's Laboratories over generic Nexium, winning a round last week after a Delaware district judge put the kibosh on sales of Dr. Reddy's generics and said that Nexium's distinctive purple hue protected it from copycat competitors. But Dr. Reddy's isn't going down without a fight.
A U.S. China-focused newspaper says multinational drugmakers are fighting an uphill battle to survive in China, citing three types of problems with government regulations. China Business News said international drug companies cite problems with the China Food and Drug Administration as the main source of their concerns, adding the agency needs to be reformed in the way it regulates drugs. Other major issues, the publication said, are reimbursement and market access.
As if Dr. Reddy's Laboratories didn't already have enough problems with U.S. regulators, a major American law firm has accused the India-based drugmaker of violating U.S. security laws involving misleading financial statements.
St. Jude Medical announced FDA approval of the Proclaim Elite Spinal Cord Stimulation System to treat chronic back pain.
The rising number of opioid-related deaths in the U.S. has translated into big opportunity for pharma companies making the antidote med naloxone, with drugmakers such as Amphastar Pharmaceuticals getting a sizable boost in revenue amid growing demand for its products. But Amphastar could soon face more competition, as the FDA has granted quick approval for a nasal spray opioid antidote that runs at a lower price than injectable treatments and promises increased benefits for caretakers.
A biosimilar copy of Amgen's Enbrel made by South Korea's Samsung Bioepis could be recommended for approval as soon as Friday (Nov. 20) for use in Europe, according to a report by Reuters. The move comes just days after the company said its Brenzys (SB4) biosimilar and others showed comparable safety and efficacy to the original products.
Amgen got a thumbs-down from the U.K.'s cost watchdog for its PCSK9 cholesterol-fighter Repatha (evolocumab), bad news for the drug as it contends with pricing pushback and competes head-to-head with Sanofi and Regeneron's Praluent for market share.
Amgen got a thumbs-down from U.K. cost watchdog the National Institute for Health and Care Excellence (NICE) for its PCSK9 cholesterol-fighter Repatha (evolocumab), bad news for the drug as it contends with pricing pushback and competes head-to-head with Sanofi and Regeneron's Praluent for market share.
Merck KGaA and Pfizer have bagged FDA breakthrough therapy designation for avelumab, the pair's anti-PD-L1 monoclonal antibody. And while the immunotherapy is lagging behind rivals' PD-1 and PD-L1 drugs in some indications, Merck KGaA and Pfizer think the breakthrough status could help them steal a lead in metastatic Merkel cell carcinoma.