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Approvals & Launches

Set Alert for Approvals & Launches

Dermavant Prepares For First Launch, Looking To Build A Blockbuster Psoriasis Brand

The Roivant-owned company's Vtama topical cream was approved by the US FDA with a broad label permitting use for mild, moderate or severe psoriasis.

Approvals Launches

Sanofi Closes In On A Pair Of Approval Firsts

The French major has secured a fourth approval, in eosinophilic esophagitis, for Dupixent, while the EMA is set to make Sanofi's enzyme replacement therapy, Xenpozyme, the first drug approved in Europe for acid sphingomyelinase deficiency.

Approvals Rare Diseases

Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo

The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.

Approvals Renal

PTC Confident About Commercial Prospects For Gene Therapy Upstaza

PTC CEO Stuart Peltz tells Scrip that cost watchdogs are likely to look favorably on the firm’s transformational gene therapy for a distressing rare brain disorder in children who could not even lift their heads before treatment.

Gene Therapy Drug Review

Pipeline Watch: Seven Approvals And 10 Phase III Updates

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

Can Roche’s Phesgo Mirror UK Adoption Trend in India?

Roche debuts ‘responsibly priced’ Phesgo in India. Will the dramatic reduction in treatment time for women with HER2 positive breast cancer and other benefits, including insurance coverage, trigger sharp shifts towards the subcutaneous fixed-dose combination of Perjeta and Herceptin?

Commercial Pricing Strategies

Seagen CEO Search Under Way As Longtime Leader Siegall Resigns In Scandal

Chief medical officer Roger Dansey has stepped in as interim CEO until a new one is appointed.

Leadership Launches

Lilly’s Mounjaro Diabetes Approval Is First Challenge To Novo’s GLP-1 Franchise

The GLP-1/GIP agonist tirzepatide is a key addition to Lilly’s commercial portfolio as the company leans on new products to deliver on volume-driven growth through the current decade. 

Approvals Launches

Mitsubishi’s Oral Radicava Provides Convenience Option For ALS

Oral or feeding tube administration of the cerebral neuroprotectant should offer flexible dosing options for amyotrophic lateral sclerosis patients, the firm says.

Approvals Business Strategies

Pipeline Watch: Two Approvals And Four Phase III Trial Starts

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

UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

Complete Response Letters Immune Disorders

Pipeline Watch: 16 Approvals And Six Phase III Trial Starts

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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