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Drug Safety

Set Alert for Drug Safety & Safety

Europe’s Proposed Chemical Ban Could Hit Many Thousands Of Global Marketing Authorizations

Drug manufacturing in the EU would grind to a halt in under three years if a proposal to restrict per- and polyfluoroalkyl substances in the European Economic Area is implemented in its current form, says industry group EFPIA.

Europe Drug Safety

Gene And Cell Therapy Clinical Holds Decline While Those For Drugs Hit 12-Year High

FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.

Gene Therapy Drug Safety

Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice

US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.

Advisory Committees Drug Safety

Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel On Nonapproval of Implantable GLP-1

CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for already approved GLP-1 agonists for type 2 diabetes – even other formulations of the same drug – potentially due to unique considerations associated with Intarcia’s delivery method.

United States Advisory Committees

Lack of Adequate Study Plan Prompts EMA Review Of Cardiovascular Risk With Mysimba

The European Medicines Agency is to recommend whether the marketing authorization for Currax’s weight management drug should be maintained, varied, suspended or revoked.

Europe Drug Safety

Don’t Use Topiramate In Pregnancy Unless No Other Drug Is Available, Says EU Drug Safety Committee

The European Medicines Agency’s pharmacovigilance committee said its safety review of topiramate took account of available data including three recent observational studies.

Neurology Regulation

South African Agency To Help National Regulators Build Up Their Capacities

RCORE designation means SAHPRA can support training and exchange programs as part of pan-African regulatory strengthening moves.

Middle East and Africa South Africa

A 3-Month Delay For A Better Label: US FDA User Fee Goal Extensions Are Usually Good News

Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

US FDA Performance Tracker Drug Review

Pakistan Sets Deadline For Companies To Submit Pharmacovigilance Officer Notifications

Pakistan’s medicines regulator is disappointed that so few drug companies have complied with a requirement notify to the National Pharmacovigilance Centre about their designated pharmacovigilance officers. 

Pakistan Drug Safety

Sun Pharma Seeks Recall Of Unapproved Phenobarbital Following Approval Of Its Product

Since FDA has approved Sezaby there is no reason for continued use of unapproved phenobarbital sodium products, firm tells FDA. Sun cites risks to neonates from three excipients in these products. The seizure drug has been marketed since 1940.

FDA Drug Safety

Keeping Track: Pfizer And J&J’s Dueling Myeloma Bispecifics; Regeneron And Ipsen Nab Priority Vouchers

Shared REMS, diverse confirmatory trials and manufacturing delays are among the highlights in the latest US FDA drug approval news from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

The Mifepristone Story So Far: Tracing The Origins Of The Legal Fight Over The Abortion Pill

Timeline depicts the 27-year history of mifepristone from new drug application submission through an advisory committee vote, REMS changes, and legal challenges. With the product headed back to the Supreme Court, FDA's approval authority in general is also on the docket.

FDA Drug Safety

EMA Probe Into Paternal Valproate Exposure Risk Continues After ‘Errors’ Found In Study

Initial results from a study indicate that children born to men taking valproate medicines are at an increased risk of having neurodevelopmental disorders, but “important limitations” and “errors” with the data highlight the need for further analysis.

Europe EU

Mifepristone REMS Modifications Likely Violated Administrative Procedure Act, Appeals Court Says

If ruling against US FDA by 5th Circuit is enacted, access to the medication abortion would revert to pre-2016 restrictions, meaning the product would be indicated for a maximum gestational age of forty-nine days and would need to be administered in person.

Legal Issues Politics

Breaking Down The Arguments In The Mifepristone Case

Chart encapsulates the fundamental questions in Alliance for Hippocratic Medicine v. FDA and the arguments of both parties on standing to sue, the agency’s approval standards, REMS changes, and the Comstock Act of 1873.

FDA Legal Issues

Manufacturers Of Albumin-Based Products Allowed To Use Plasma From UK Donors

Albumin medicinal products manufactured using plasma from UK donors pose minimal, if any, risk of infecting recipients with variant Creutzfeldt-Jakob disease, the UK regulator has determined.

Europe United Kingdom
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