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Opioid Labeling Instructions On Naloxone Are Compromise In Co-Prescribing Debate

 
• By Derrick Gingery

US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.

An ampoule Opioid next to it is a note written in English Opioid epidemic. All around, many tablets and syringes are scattered.
The FDA Drug Safety Communication also recommends prescribing naloxone to patients with children or other household members at risk of accidental ingestion or overdose. • Source: Shutterstock

US Food and Drug Administration has decided to recommend a discussion of naloxone when prescribing an opioid, stopping short of a potentially costly co-prescribing requirement that had been narrowly recommended by an advisory committee.

The agency will require opioid and opioid use disorder product labels to include language recommending “that as a routine part...

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MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

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Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.