CDC Advises Against Use Of Extended Release Opioids, Redefines High Dose

New clinical practice guideline recommends immediate-release opioids instead of extended-release and long-acting opioids when starting pain therapy. It specifies high dose is 50 mg morphine equivalent dose (MME) per day or higher. The 2016 guideline had set it at 90 MME/day.

Opioid prescription
CDC issues updated guideline for prescribing opioids for pain • Source: Shutterstock

The Centers for Disease Control and Prevention’s revised guideline for clinicians prescribing opioids directs them to prescribe immediate-release instead of extended-release and long-acting opioids when starting therapy for acute, subacute, or chronic pain.

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Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 

Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

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New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 

Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.

Global Pharma Guidance Tracker March 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
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US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth