Following a new FDA approval, Teva Pharmaceutical Industries Ltd. is set for an immediate launch in the US of the vesicular monoamine 2 transporter (VMAT2) inhibitor Austedo in tardive dyskinesia at the same list price as the drug's first indication in Huntington's disease – $60,000 per year.
Teva Set For Immediate US Launch Of Austedo In Tardive Dyskinesia
FDA-approved labeling includes boxed warning for depression and suicidality, though this is specific for Huntington's disease patients, who are prone to these conditions.
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The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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The German group is paying $3.9bn to get hold of the US firm and its two approved products.
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Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.