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Approvals

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Merck KGaA Foresees Mid-2019 US Launch Of Oral MS Therapy Mavenclad

German Merck tells Scrip Mavenclad's long spell in the regulatory 'wilderness' allowed it to amass deep safety and efficacy data that should help the oral MS drug's commercial prospects.

Business Strategies Launches

Early Yutiq Approval Gives EyePoint Two Ophthalmic Drugs To Launch In 2019

Yutiq, for posterior uveitis, will compete with two existing steroid products and should launch during the first quarter of 2019. EyePoint’s Dexycu, although approved in February, is still in scale-up and probably will launch a bit later.

Approvals Ophthalmic

Pipeline Watch: Phase III Starts With STR001, Cabometyx And Brazikumab

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

INFOGRAPHIC: Winners In 2019 Launches

Highlighting key late-stage drugs that could reach their first markets during 2019, including first-in-class products, medicines likely to become standards of care, and products introduced for major new indications.

Policy & Regulation Approvals

Akcea Expects Convenience Edge For Tegsedi, Despite Monitoring Requirements

Approved two months after Alnylam’s Onpattro, Tegsedi is priced almost identically in the same hATTR indication. Ionis affiliate Akcea hopes weekly subcutaneous administration will provide convenience benefit compared to I.V. Onpattro.

Approvals Commercial

Pipeline Watch: Phase III Starts With Sintilimab, Lumasiran And Glepaglutide

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

Acacia Aghast As FDA Says No To Barhemsys

The UK company has been stunned by a complete response letter for its nausea and vomiting therapy which relates to problems at its contract manufacturer but is not linked to the data package. Despite the setback, Acacia is sticking to a first-half 2019 launch plan.

FDA Manufacturing

Roche's Hemlibra Wins Expanded FDA Approval, Opening The Door To Broad Hemophilia A Opportunity

Hemlibra was approved to prevent or reduce bleeding in adults and children with hemophilia A without factor VIII inhibitors, a significantly larger patient population than its current indication in patients with factor VIII inhibitors.

 

 

Approvals Launches

Paratek's Antibiotic Nuzyra Survived 20 Years – Now For The US Launch

Company still mulling pricing for broad-spectrum antibiotic Nuzyra (omadacycline), which is set to launch in the US in the first quarter, following FDA approval Oct. 2.

Approvals Infectious Diseases
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