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Less than a month after landing a positive opinion from the EMA's CHMP, Esperion Therapeutics Inc. has won FDA approval for bempedoic acid as an adjunct to diet and maximally tolerated statin therapy.
During a conference call with investors, Baudax Bio Inc. CEO Gerri Henwood let out an exuberant “woohoo!” to celebrate the FDA’s approval – after two turndowns and much haggling over data – of Anjeso (meloxicam) for moderate to severe pain. Echoing her sentiment was Piper Sandler analyst David Amsellem. “It’s nice to see the pain division finally get this one right,” he said.
HYDERABAD, India – To continue expanding their footprint and capabilities beyond simple generics to biosimilars and new chemical entities, Indian pharmaceutical companies will have to improve their quality controls, compliance capabilities and, just as importantly, adopt more effective digital strategies.
