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Approvals

Set Alert for Approvals

JT Gains World-First Topical JAK Inhibitor Approval

Latest new drug approvals in Japan include the first anywhere for a topical JAK inhibitor and also a marketing clearance for a new contender in the large prostate cancer space.
Japan Approvals

Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications

Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.

Approvals Business Strategies

J&J's Stelara Gets Europe OK For Pediatric Psoriasis

The European Commission has backed J&J's blockbuster to treat children with psoriasis but the drug has fallen foul of NICE for ulcerative colitis.

Immune Disorders EU

Horizon Sees Blockbuster Future For Tepezza After US Approval

Once a pariah because of its price gouging, the new approval represents a change of tack from Horizon.

Approvals Commercial

Novartis MS Drug Mayzent Gets Europe OK

Mayzent is the first oral treatment specifically indicated for patients with secondary-progressive multiple sclerosis and while it is expected to be a blockbuster, the company tells Scrip that educational programs for physicians are a priority.

Neurology Approvals

Pipeline Watch: Phase III Starts With EB-101, Tavapadon, Ziresovir

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.

Pipeline Watch Approvals

Wockhardt Puts Up Superbug Fight With Punchy Broad Spectrum Antibiotic

Wockhardt has received approvals in India for two novel broad spectrum antibiotics with "advantageous" safety features over older MRSA drugs and the firm hopes to take them to other emerging markets as well, with China on the radar.

India Research & Development

Recordati's Isturisa Approved For Cushing's In EU

Acquired from Novartis last year, Isturisa is forecast to have peak sales of over $100m. Now all eyes will be on a PDUFA date in March.

Approvals Rare Diseases

Pipeline Watch: Phase III Starts For Tideglusib, Infigratinib, Galinpepimut-S

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.

 

Pipeline Watch Approvals
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