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Approvals

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Gelesis's Obesity Product FDA Acceptance Gives Boost To PureTech's Portfolio


PureTech's affiliate Gelesis has received FDA clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half. 
Approvals Metabolic Disorders

Pipeline Watch: Promising Clinical Trial Results In NASH

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

ViiV's Dovato: Treatment-Naive HIV Is Earmarked For The "Complete Regimen"

The first approval in the US of a once-daily single-tablet, two-drug regimen for treatment-naive HIV from the HIV/AIDS therapy specialist, ViiV Healthcare, suggests a shift away from three-drug regimens for HIV/AIDS could be gathering pace.

Approvals Infectious Diseases

Pipeline Watch: Phase III Starts With Patidegib, Reproxalap

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

Aveo's Tivozanib Under CHMP Spotlight If Negative OS Trend Continues In TIVO-3

An August 2019 analysis of overall survival in the TIVO-3 study of Aveo’s tivozanib in advanced renal cell carcinoma is now an interim rather than a final analysis, but EU regulators may take action if a negative overall survival trend is found to be continuing.

 

Cancer Clinical Trials

Merck KGaA Plays Down Mavenclad Label And $99,500 annual Price For 10 MS Pills

Merck KGaA's multiple sclerosis pill Mavenclad has finally won FDA approval, but some analysts think its US label, stipulating second-line use in relapsing MS but not in patients with clinically isolated syndrome, may hurt its uptake there.

Approvals Neurology

Pipeline Watch: Bumper Crop Of Product Approvals In Japan

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

Bluebird Bio's Zynteglo Flies Through Its CHMP Review

A nod in record time from the European Medicines Agency’s CHMP for its beta-thalassemia gene therapy Zynteglo pushes bluebird bio out of the nest and into commercial territory.

Approvals Gene Therapy

Clarus Keeping Commercial Options Open For Oral Testosterone Jatenzo

Jatenzo – the first oral testosterone cleared by US FDA – will compete against injectable and topical formulas in a field that has suffered safety worries in the past. Clarus has a jump on oral rival Lipocine.

Approvals Launches
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