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Another Testosterone Warning – This Time For Abuse

 
• By Brenda Sandburg

Action follows agency review of 81 adverse events reported with testosterone/anabolic androgenic steroid misuse, abuse, or dependence over 45 years; discussions continue on cardiovascular study.

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For the third time in three years, FDA has added new warnings to labeling of testosterone products. This time the warning is about the risks associated with the abuse and dependence of testosterone and other anabolic androgenic steroids.

In an Oct. 25 drug safety communication, FDA said that abuse of testosterone, usually at doses higher than those typically...

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US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

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ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
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The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

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Canada Unveils Draft List of Essential Drugs For Universal Pharmacare

 
• By Neena Brizmohun

The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.