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Medical Organizations Push For Mifeprex Miscarriage Indication, REMS Elimination

 
• By Brenda Sandburg

The American College of Obstetricians and Gynecologists and 48 other groups request the FDA ask Danco Laboratories to file a supplemental NDA for an expanded indication and eliminate requirements for provider and pharmacist certification. For now, Danco is focused on updating the REMS as modified in December.

Mifepristone
Groups advocate for expansion of the mifepristone indication and elimination of its REMS. • Source: Shutterstock

As the Biden administration has fallen short on pledges to increase access to medication abortion, medical organizations are advocating for the US Food and Drug Administration to eliminate restrictions on use of Mifeprex (mifepristone) and expand its indication.

The American College of Obstetricians and Gynecologists submitted a citizen petition to the FDA on behalf of itself and...

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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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Malaysia Clarifies Drug Shortage Reporting Rules And Penalties For Non-Compliance

 
• By Neena Brizmohun

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

Dutch HTA Calls For “Socially Acceptable” Price For Gene Editing Therapy Casgevy

 
• By Francesca Bruce

Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.