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Oxford’s Vaccine Results Still Puzzle, AZ Expects Not To File With FDA

But UK, EU and India Decisions Anticipated

 
• By Andrew McConaghie

Partners hope non-US regulators will authorize early and then await later readouts to clarify vaccine's profile, but FDA is expected to hold out for US trial data.

Old Road Campus
Oxford University has led on the UK and Brazil trials, with AstraZeneca overseeing a US study which has yet to read-out.

Two weeks after first unveiling results, the full Oxford University and AstraZeneca’s Phase II/III COVID-19 vaccine studies have been published in The Lancet, but the paper has uncovered more shortcomings in the data to add to doubts raised two week ago when they were first presented.

Regulators in the UK, European Union and India are already reviewing the results, however, and may decide to grant emergency...

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Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By Joseph Haas

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

Novartis Chief Warns Of Fewer Launches And Drug Withdrawals In Europe

 
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Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?

Cipla CEO On Tariff Threat: ‘We Have One Of The Most Well Diversified Models’

 
• By Anju Ghangurde

Cipla's leadership fields shareholder queries on the specter of US tariffs and also outlines how the firm is nurturing the business for the future in areas like mRNA and point-of-care diagnostics, while building on its strength in the respiratory space.

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Novartis Chief Warns Of Fewer Launches And Drug Withdrawals In Europe

 
• By Kevin Grogan

Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.

Executives On The Move: Five New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?