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
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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.
Ovid Shifts Focus After Angelman Syndrome Drug Disappoints In Phase III
The Phase III clinical trial showed a noticeable placebo effect compared with OV101.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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