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EU Health Chief Under Pressure To Explain Delay In Legislative Overhaul

The latest delay to the European Commission’s proposals for revising the EU medicines legislation has caused consternation among members of the European Parliament who do not believe that the hold-up is due simply to a “busy agenda” at the commission.

Europe Legislation Regulation

Medicare Rx Negotiation Horizon: The Key Dates Ahead Of 2026 Rollout Of The Pricing Program

Medicare Policy Reimbursement

Keytruda, Opdivo May Be Only Part B Drugs Chosen For Medicare Negotiation In First Applicable Year

In general, more Part D drugs will be eligible than Part B drugs in the early years of the program because Part D drugs have higher levels of spending and so will dominate the list of candidates. A new report sizes up the drugs that would qualify for Medicare Price negotiation in 2026-2028.

Reimbursement Medicare Policy

Bernie vs. Bancel

Moderna And The All-American Drug Pricing Hearing

Moderna’s time in the hot seat of the US drug pricing debate went about as well as it could for the company. The firm astutely set a tone of an All-American success story – but the hearing also showcased other ‘only in America’ themes.

Vaccines Pricing Debate

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Pink Sheet Podcast

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

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Performance Trackers

Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals Drug Review


Global Pharma Guidance Tracker – February 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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

Lilly’s Omvoh Among Nine New Drugs Securing EU Marketing Thumbs Up

A number of new drugs have taken a major step towards being approved for use in the EU after receiving the nod from the European Medicines Agency’s human medicines committee, the CHMP. Meanwhile, the marketing applications for three drugs have been withdrawn.

Europe Approvals

Bivalent COVID-19 Vaccine Bimervax Wins EU Marketing Approval

Bimervax is the first bivalent recombinant protein COVID-19 vaccine to be authorized in the EU, says Spanish company HIPRA.

Europe Approvals

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

Advisory Committees Drug Review

Pink Sheet Podcast: BrainStorm’s ALS Adcomm, Batch Testing Imported Drugs, US FDA’s First In-Person Meeting

Pink Sheet reporters and editors discuss the FDA’s upcoming advisory committee meeting for the controversial ALS cell therapy NurOwn, a proposal to batch test all drugs coming into the US amid problems conducting foreign inspections, and the FDA’s return to in-person meetings with industry.

Advisory Committees Manufacturing

The Power Of The Public: Isotretinoin iPLEDGE Advisory Cmte. Is Case Study In An Effective OPH

Open public hearings can include both emotional patient testimony and angry, anti-industry proclamations. During the isotretinoin REMS panel, the OPH was particularly effective in making a case for easing patient access despite the risks. Will it get FDA on board?

Advisory Committees Risk Management

iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data

Panel favors elimination of 19-day lockout after missed prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.

Advisory Committees Risk Management

Latest From Policy

Teva’s ‘Skinny Label’ Dispute Edges Toward Supreme Court With Government’s Backing

US Solicitor General urges the Supreme Court to grant Teva's petition, arguing that the Federal Circuit was wrong in ruling that Teva's carved-out labeling for generic carvedilol induced infringement of GlaxoSmithKine's brand product.

Generic Drugs Intellectual Property

Canadian Action On Rare Disease Is A ‘Step Forward,’ Says Industry

Canadian rare disease drugs strategy is expected to improve access to treatments and the collection and use of real-world evidence.

North America Canada

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Prescription To OTC Switch Approvals

Clinical / R&D Explore this Topic

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Latest From Research & Development

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Prescription To OTC Switch Approvals

Neonatal Drug Development Could Benefit From Rare Disease Experience

Early parent involvement in drug development and clinical trial design could improve recruitment and outcomes, stakeholders argue.

Pediatrics Research & Development

US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval

Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.

Cancer Research & Development

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Latest From Commercial

ACA Ruling Is Double Whammy For PrEP Coverage, With Contraception And Vaccines Still At Risk

 Obamacare’s affordable access to HIV pre-exposure prophylaxis is jeopardized by court order. Access to vaccines, contraception may also be at risk as the case continues to play out in higher courts. 

Legal Issues Reimbursement

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Prescription To OTC Switch Approvals

UK ABPI Suspends Novo Nordisk Over Code Breach

Novo Nordisk has been given a two-year suspension from membership of the Association of the British Pharmaceutical Industry for breaching the association’s code of practice.

Advertising, Marketing & Sales Ad Complaints

Manufacturing Explore this Topic

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Latest From Manufacturing

Pink Sheet Podcast: BrainStorm’s ALS Adcomm, Batch Testing Imported Drugs, US FDA’s First In-Person Meeting

Pink Sheet reporters and editors discuss the FDA’s upcoming advisory committee meeting for the controversial ALS cell therapy NurOwn, a proposal to batch test all drugs coming into the US amid problems conducting foreign inspections, and the FDA’s return to in-person meetings with industry.

Advisory Committees Manufacturing

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Prescription To OTC Switch Approvals

Batch Testing Of All Imported Drugs Floated At House Appropriations Hearing

While food oversight dominated lawmakers' attention, Republicans and Democrats were united on need to onshore more drug manufacturing to the US as FDA Commissioner Robert Califf testified about the agency’s fiscal year 2024 budget request.

FDA Supply Chain
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