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.
Novartis is moving toward the U.S. market with a biosimilar of Amgen's Neulasta, awaiting FDA approval for a long-acting treatment designed to boost white blood cell count.
India's generic drugs could face new price controls as early as next year, as the prime minister's office pushes for an investigation of what one official in press reports called "astronomical" markups by drugmakers, suppliers and retailers.
Suggesting that India's chief drug regulator may not be doing enough to protect certain volunteers in clinical trials, the Supreme Court ordered the agency to provide adequate oversight, particularly when drugs to treat the human papillomavirus are concerned.
The appointment of a new Controller-General for Patents, Designs and Trademarks in India has delayed the compulsory license application by Lee Pharma, which wants to produce the diabetes drug saxagliptin developed and patented by London-based AstraZeneca, according to a report by The Hindu.
Swiss drug giant Novartis says it has taken "remedical action" to correct problems at two of its plants in western India that were given a warning letter by the U.S. Food and Drug Administration, according to a report by NDTV.