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Research & Development

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Urovant’s Vibegron Flops In IBS Study

Another disappointment for irritable bowel syndrome therapies as Urovant Science’s vibegron fails in a Phase II trial, likely spelling the end for the investigational indication.

Clinical Trials Companies Gastrointestinal

Clinical Trials

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Latest From Clinical Trials

Jazz And PharmaMar’s Zepzelca Hits Buffers In ATLANTIS Study

Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.

Clinical Trials Companies

Ovid Shifts Focus After Angelman Syndrome Drug Disappoints In Phase III

The Phase III clinical trial showed a noticeable placebo effect compared with OV101.

BioPharmaceutical Neurology

Digital Scrip Awards Celebrate Biopharma After An Exceptional Year

The big winners of the night were AstraZeneca and Roche as pharma, biotech and allied industries came together online on 2 December to celebrate during a ceremony hosted by Ed Balls.

Companies Research & Development

Agios’ Phase III Data Move It Closer To First Therapy For Rare Anemia

Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.

Clinical Trials Drug Approval Standards

Novavax May Seek COVID-19 Vaccine Emergency Authorization In US Based On UK Data

With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.

Coronavirus COVID-19 Clinical Trials

Moderna Files COVID-19 Vaccine After Second Impressive Read-Out

Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.

Coronavirus COVID-19 Companies
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Approvals

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Latest From Approvals

UK Grants First Worldwide Authorization For Pfizer/BioNTech COVID-19 Vaccine

The UK's MHRA has granted an emergency authorization to the mRNA-based vaccine just nine days after receiving the final Phase III results from Pfizer.

Coronavirus COVID-19 Approvals

Sanofi's Dupixent Cleared For Children With Atopic Dermatitis In EU

The French major and Regeneron have racked up another indication for Dupixent with the blockbuster getting approval in Europe to treat children with severe eczema.

Approvals Immune Disorders

Y-mAbs Gives Thanks For First Approved Drug Danyelza

US regulators refused to accept the file for one of Y-mAbs's neuroblasoma drugs – omburtamab – in October but have given the green light to a second one, naxitamab.

Cancer Approvals

Pipeline Watch: Phase III Starts In RSV Prophlyaxis, Dry Eye Disease

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

Janssen's Tremfya Gains Psoriatic Arthritis Indication In EU

The European Commission has extended the indications for Janssen’s Tremfya to include psoriatic arthritis, and those for BMS’s Opdivo to include gastroesophageal cancer.

Cancer Approvals

Alnylam Turns To Value-Based Pricing Again For Oxlumo

As with its first two approved RNAi therapies, Alnylam will negotiate value-based agreements with payers, but for Oxlumo, approved in pediatric patients, it will offer a patient need adjustment.

Approvals Pricing Strategies
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