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Celebrex Study Is Feel Good Story For Pfizer, But Are There Any Real Benefits?

 
• By Michael Cipriano

Companies with pipeline pain products may see a smoother path through FDA, but Celebrex already has generic competition in the US, limiting the benefits even if it could get the black box removed from labeling and Pfizer also recently settled a lawsuit for $468 million related to the drug's safety.

Pfizer Inc. has celebrated the results of its PRECISION clinical study, which found that the drug giant's erstwhile blockbuster Celebrex (celecoxib) poses no more of a cardiovascular risk than do Hoffmann-La Roche Inc.'s Naprosyn (naproxen) and Johnson & Johnson Consumer Inc.'s Motrin (ibuprofen).

In fact, subjects taking the COX-2 inhibitor Celebrex in the long-term non-inferiority 24,081-patient trial actually experienced fewer gastrointestinal events compared with those receiving prescription doses of the NSAIDs Naprosyn and Motrin

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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By Sue Sutter

Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.