Remove tag drug-regulation
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After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi

Fierce Pharma

regulators last month, Eisai and Biogen’s effort to deploy a more convenient version of their Alzheimer’s disease drug Leqembi appears to be back on track. After suffering a setback with U.S.

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STAT+: CMS will use outcomes-based agreements in bid to help Medicaid pay for sickle cell gene therapies

STAT

In response to concerns over multimillion-dollar price tags for new gene therapies for sickle cell disease, the U.S. Two therapies recently approved by health regulators cost $2.2 million and $3.1 million, respectively, and have raised alarms over the ability of financially strapped state Medicaid programs to absorb the expense.

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STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant

STAT

Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S.

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STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India

STAT

Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S.

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STAT+: Pharmalittle: We’re reading about Wegovy supplies, Biogen ditching Aduhelm, and more

STAT

… Novo Nordisk has begun to increase availability of its blockbuster obesity drug Wegovy for new patients in the U.S. Overall, Novo saw 154% growth in obesity drug revenue in 2023, driven by sales of its older obesity drug Saxenda and the launch of Wegovy in additional countries. million and $3.1

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Cannabinoids receptors: popular preclinical target but banned in 137 countries

Pharmaceutical Technology

Cannabinoid receptors are a popular therapeutic target for cannabinoid-based drugs in the treatment of pain, neurological disorders and inflammation, according to GlobalData’s Pharma Intelligence Centre Drugs database. Cannabinoid-based drugs are derived from compounds found in the cannabis plant.

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Axsome bounces back as FDA clears depression drug

pharmaphorum

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. However, it has a broader label as unlike J&J’s drug it is indicated for use in previously-untreated MDD. Photo by Sydney Sims on Unsplash.

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