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N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

 
• By Sue Sutter

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Makena-reflections
• Source: Shutterstock

The dispute between US FDA’s Center for Drug Evaluation and Research and Covis Pharma over the preterm birth prevention drug Makena marked the second-ever public hearing under the agency’s accelerated approval withdrawal regulations, coming more than 11 years after the proceeding involving the breast cancer indication for Genentech, Inc. ’s Avastin (bevacizumab).

The two hearings featured sponsors, drugs and circumstances that were very different.

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Big Three Lead From The Front With Medtech Back On Solid Growth Footing

 
• By Ashley Yeo

Abbott Laboratories and Johnson & Johnson joined Medtronic in putting a clear distance between themselves and other global medtechs in the Top 10 by revenues for 2021. Post-COVID-19 procedure growth, and, for Abbott, a strong rebound in non-COVID diagnostic demand, were key drivers.  

Infographic: Top 100 Pharma Companies

 
• By Lucie Ellis-Taitt

The Scrip 100 universe gathers FY2021 financial performance data and compares the activities of the top 100 biopharma businesses, ranked by pharma sales.    

Pfizer Leads An Unusual Year For The Scrip 100

 
• By Jessica Merrill

Pfizer catapulted back into the lead in the pharmaceutical rankings on the strength of COVID-19 revenues while BioNTech and Moderna both made the list for the first time.      

Outlook 2023: The Pharma Rollercoaster Shows No Signs Of Slowing Down

 
• By Jo Shorthouse

What will 2023 bring as the industry faces one of the toughest periods in the last decade? In Vivo asked three industry experts for their views.

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Investor Optimism Ahead As Big Medtech Proves ‘It’s All About Value’

 
• By Ashley Yeo

Pressure to exploit connected care functionality is accelerating the shift in care delivery away from the inpatient setting. Medtechs are reshaping to maximize faster-growth opportunities.

2024’s Busiest Dealmakers: Novartis Laps The Field, While Lilly, Sanofi Keep Busy

 
• By Joseph Haas

Nine biopharma companies made 12 or more deals, with Novartis inking 21 deals and leading M&A activity. Roche, meanwhile, spent little up front but maintained a hectic pace with 12 alliances.

Big Pharma Headcounts: Obesity Leaders Bulk Up As Others Go Lean

 
• By Andrew McConaghie

As Eli Lilly and Novo Nordisk reap the blockbuster rewards of their rival obesity therapies the companies are also bulking up their organizations to make the most of the phenomenal rise of the GLP-1 class.