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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.


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

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.
European Performance Tracker
Policy & Regulation Explore this Topic
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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 Meanwhile, the marketing applications for three drugs have been withdrawn.
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.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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.
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?
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.
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.
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.
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.
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.
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.
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.
Commercial Explore this Topic
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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.
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.
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.
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.
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.
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.
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