Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Featured Stories



FDA Gene Therapy Office Chief Prefers Flexibility With Accelerated Approval Confirmatory Trials

Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.

Gene Therapy Clinical Trials Review Pathway

CDC Panel Backs Pfizer’s Maternal RSV Vaccine But Leaves Room For AstraZeneca/Sanofi’s Beyfortus

Abrysvo is recommended for use in pregnant people 32-36 weeks gestation if administered from September to January. For infants whose mothers were not vaccinated in this window, nirsevimab is recommended for prevention of respiratory syncytial virus infection.

Advisory Committees Vaccines Pediatrics

EU Could Soon Have Three XBB.1.5 COVID-19 Vaccines For Winter Season

The head of the European Medicines Agency says a group of international regulators got together to ensure “global alignment” on the approach to be taken on COVID-19 vaccination. 

Europe Coronavirus COVID-19 Vaccines

Lantidra Drug Review Profile

CellTrans’ Lantidra: Type 1 Diabetes Cell Therapy Overcame The Odds On Nontraditional Path To Approval

Despite a host of challenges with donislecel’s development and BLA, the US FDA approved based on clinical data from only 30 patients, using a clinically meaningful insulin independence endpoint and in a more carefully tailored population. Pink Sheet’s Drug Review Profile takes a deep dive into the FDA review of the first approved allogenic pancreas islet cell product.

Drug Review Profile Regenerative Medicine

Read all our drug review profiles...

Latest News

Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

More Podcasts

Performance Trackers

Keeping Track: Return & Renewal At US FDA

Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Review Drug Approval Standards

Global Pharma Guidance Tracker – August 2023

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.

Guidance Documents Regulation International


Multimedia

Lantidra Chronology: 19 Years From IND Submission To Approval For The Cellular Therapy

Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of CellTrans’ treatment for type 1 diabetes.

Lantidra’s First-Cycle Complete Response Letter Centered On Inspection And Product Quality Issues

Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.

IRA Litigation Landscape: Where The Cases Are And Where They Are Headed

Pink Sheet infographic details the district court judges and circuit courts that will be deciding the cases brought by industry against the IRA, breaking down the Democrat and Republican appointees as well as the arguments in each suit.

ANDA Submissions Lagging As FY 2023 Nears Its End

Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.

Regional Comparisons

Swiss New Drug Approval Times On A Par With EMA, But Longer Than US FDA

The median approval time for new drugs in Switzerland lengthened in 2022, mainly because of applications filed during the peak of the COVID-19 pandemic, says the country’s regulator.

How Do Japan’s Clinical Trial eConsent Rules Compare With The EU And US?

A newly-translated guidance document from Japan’s drug and device regulator outlines the points that clinical trial sponsors should consider when using electronic methods to collect informed consent from participants.

Rare Diseases: European Market Access ‘Better Organized’ Than US, Says Rhythm

Rhythm is working with country-level authorities and centers of excellence in Europe to gain reimbursement and access for its obesity treatment Imcivree.

Different, But Not Poles Apart: Running Decentralized Clinical Trials In EU & US

This second segment of a two-part article on a regional comparison of EU and US approaches to decentralized clinical trials highlights the differences between the two regions relating to the more practical aspects of setting up and running such studies.

See All
Recent Stories

Finding The Sweet Spot For Real-World Evidence: Aetion Stresses Early Feasibility Assessment

Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.

Korean Bioclusters Offer Tax, Other Incentives To Attract Global Firms, Talent

South Korea has formulated new detailed policy measures to support the formation of major bioclusters, which will offer tax and other incentives in a bid to lure foreign firms and talent.

EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns

The European Commission’s proposals to overhaul the EU pharma legislation, which will see some orphan drug incentives cut, would cause a “significant dip in innovation,” according to number crunching from pharma industry association EFPIA.

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.

NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval

However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.

US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus

After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

EU CHMP Opinions And MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access

Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.

EU Group Facilitates Switching Multinational Trials To CTR

Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”

As New Tech Emerges For Early Research, FDA Chief Scientist Says Diversity Must Start In Preclinical Development

In a Pink Sheet interview Chief Scientist Bumpus discusses need to move diversity conversation up further in the pipeline. Better ‘organs on a chip’ should help.

Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon

US FDA’s biologics center intends to ask for volunteers to help demonstrate the concept, modeled on the COVID vaccine effort, which includes speedier communication with sponsors to expedite development of products for rare diseases.

UsernamePublicRestriction

Register