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Approvals

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Astellas Stays Ahead of Daiichi Sankyo In AML With CHMP Nod For Xospata

A positive opinion for its FLT3 inhibitor for acute myeloid leukemia gives Astellas a further advantage over its Japanese competitor's same-class offering, quizartinib.

Drug Review Cancer

Novo Anticipates Q4 Soft Launch For Closely Watched Oral GLP-1 Agent Rybelsus In The US

US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.

Approvals Metabolic Disorders

Pipeline Watch: Phase II Starts In Hearing Loss, Type 1 Diabetes

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.

 

 

Approvals Pipeline Watch

Emmaus Fumes After EMA Rejects Sickle Cell Drug Again

The US firm has withdrawn its submission to get EU approval for Xyndari. After being turned down by the CHMP, Emmaus may try the decentralized approval procedure instead.

Drug Review Blood & Coagulation Disorders

J&J's Erleada Approved By FDA In New Prostate Cancer Indication

Erleada was approved for treatment of metastatic castration-sensitive prostate cancer (mCSPC), strengthening its position versus generic Zytiga and Pfizer/Astellas's Xtandi.

Cancer Approvals

Ardelyx Gets IBS-C Approval, But Focus Remains On Hyperphosphatemia

Tenapanor approved for IBS-C as Ibsrela, but Ardelyx is still seeking a commercial partner for that indication – and is maintaining focus on same molecule in hyperphosphatemia.

Approvals Business Strategies

Pipeline Watch: Phase III Starts With Evobrutinib, Gaboxadol

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.

 

Approvals Pipeline Watch

Xeris Joins Lilly On Market With Approval Of Easier-To-Use Glucagon

Xeris’s Gvoke gets FDA approval, joining Lilly’s Baqsimi as products to treat emergency episodes of hypoglycemia with an easier-to-use kit. Xeris will launch its prefilled syringe in Q4 and an auto-injector in 2020.

Approvals Business Strategies

Pipeline Watch: Phase III Readouts For Tenapanor, Ofatumumab

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
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