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Otsuka Pharmaceutical Co. Ltd.

www.otsuka.co.jp/en/

Latest From Otsuka Pharmaceutical Co. Ltd.

Generic Spiriva Delivers First Mover Advantage In US, Lupin Plans Europe Launch

Lupin’s Q2 margins jumped post launch of the first Spiriva generic in the US, encouraging launch plans for Europe and Canada. With four out of five plants clearing a regulatory overhang from earlier warning letters, the specialty engine is revving up though competition in first-to-file products launched earlier could dampen margins somewhat.

Strategy Generic Drugs

gSpiriva Delivers First Mover Advantage In US, Lupin Plans Europe Launch

Lupin’s Q2 margins jumped post launch of the first Spiriva generic in the US, encouraging launch plans for Europe and Canada. With four out of five plants clearing a regulatory overhang from earlier warning letters, the specialty engine is revving up though competition in first-to-file products launched earlier could dampen margins somewhat

Commercial Business Strategies

Efficacy Overstatements In Evofem’s Phexxi Brochure, Otsuka’s Rexulti TV Ad Draw Untitled Letters

US FDA releases two letters on the same day citing two different kinds of advisements for two different kinds of products, but both with a classic problem: overstatement of efficacy. And while sending multiple letters at once can be seen as bid to draw attention to its enforcement action, the move also underscores just how few letters the agency has been sending lately.

Ad Complaints Enforcement

Servier Continues Oncology Winning Streak With Tibsovo Approval For MDS

The targeted therapy won approval for myelodysplastic syndrome patients with IDH1 mutations, who have a higher propensity for progression to acute myeloid leukemia.

Approvals Business Strategies
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  • Industry
  • Medical Devices
  • Pharmaceuticals
    • Nutraceuticals
    • OTC, Consumer
  • In Vitro Diagnostics
    • Chemistry, Immunoassay
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