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US NIH Testing Strategy To Stretch Monkeypox Vaccine Supply Even Further

The National Institutes of Health is gearing up to launch a trial that would test a smaller intradermal dose of Jynneos than was recently given an emergency use authorization, which could double vaccine supplies relative to currently available intradermal dosing. The trial still will leave the efficacy question unanswered. 

Clinical Trials Vaccines Regulation

Cost Of Providing CAR-T Therapies Could Derail Reimbursement In England

Gilead claims that the mechanism used to work out the cost for the National Health Service in England of delivering CAR-T therapies to patients could threaten access to these medicines.

Europe United Kingdom Cost Effectiveness

‘I’m Still Here’: Janet Woodcock’s Swan Song At US FDA Looking Like A Longer-Term Job

Janet Woodcock’s imminent departure from the agency has been predicted often during her tenure. Her latest project may keep her there longer than even she thought possible.

FDA Leadership Regulation

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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: Axsome’s Auvelity Survives Long Review; Bluebird’s Zynteglo Cleared For Liftoff; Omeros Appeals CRL

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

US FDA Performance Tracker Approvals Gene Therapy


Global Pharma Guidance Tracker – July 2022

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

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Pink Sheet Podcast: Data Protection, Price Negotiation, Warning Letters, Amylyx At ICER

Pink Sheet reporter reviews recent stories on US FDA concerns about the EU data protection regulation, the US enacting the Medicare price negotiation law, warning letters sent to Emergent BioSolutions and ImprimisRx, and Amylyx’s ALS drug going in front of the Institute for Clinical and Economic Review.

Clinical Trials Pricing Debate

US Encouraging Monkeypox Vaccine Maker To Work With Large Pharma To Up Supply

The US FDA's Peter Marks also says the intradermal dose-sparing plan was motivated by concern over city and state one-dose strategies. 

Infectious Diseases Manufacturing

Overhyped? White House COVID Coordinator's Claims About New Boosters Go Beyond Data

Ashish Jha made promises about the upcoming bivalent COVID-19 boosters that neither he nor the companies are likely going to be able to keep when the rollout begins. 

Coronavirus COVID-19 Vaccines

Coming Up On US FDA’s User Fee Calendar: Zynteglo Approval Kicks Off Busy Season For Advanced Biologics, Pediatrics

At least 17 applications are pending with late August and September 2022 user fee goal dates, the Pink Sheet US FDA Performance Tracker shows.

US FDA Performance Tracker Biologics

COVID-19 Vaccine Skycovion Among Raft Of New EU Filings

EU marketing authorization applications for 12 products, including Skycovion, trastuzumab duocarmazine, alpelisib and sparsenta, are now being evaluated by the European Medicines Agency.

Drug Review Approvals

WHO Steps Up Drive To Build Local Drug & Vaccine Production In Lower-Income Countries

The COVID-19 pandemic has underlined the need for less well-resourced countries to improve access to medicines, vaccines, medical devices and other health products by building their own production capacities.

International Vaccines

Latest From Policy

Massive Zantac Product Liability Litigation Advances After Initial Settlements

GlaxoSmithKline will continue to defend itself against all claims alleging ranitidine increased the risk of cancer. Four generic firms reach settlements in the first case that had been scheduled for trial. GSK, Sanofi and Pfizer could pay $1bn-$2bn each in potential settlements, an analyst predicts.

Drug Safety Legal Issues

Amylyx ALS Drug: ICER Revised Evidence Report Casts Doubt On Firm’s New Data Analyses

ICER’s take on the Amylyx analyses raises questions about whether FDA will take a similar view and suggests payers may restrict coverage upon approval, at least initially, should it carry a very high price tag.

Health Technology Assessment Drug Review

Medicare Price ‘Negotiation’ Process Gets Broad Brush Treatment In New Law

With enactment of the drug pricing reform provisions in the Inflation Reduction Act, stakeholders now turn their attention to the implementing regulations that will be developed by the Centers for Medicare and Medicaid Services.

Pricing Debate Reimbursement

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Latest From Research & Development

US FDA Raises Problems With EU Data Protection Reg, But Are They Among Those Misunderstanding It?

An FDA blog post says some inspections have been hindered and application assessments soon could be delayed by the EU General Data Protection Regulation (GDPR), but experts argue the law includes directions to allow data sharing and remain compliant.

Clinical Trials Research & Development

Patient-Focused Drug Development Events May Be Giving Way To Small, Private Meetings With FDA

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

Research & Development Review Pathway

Pediatric Disincentive? Implications Of US Pricing Bill

The ripple effects from the pending drug price reform legislation in the US would include fundamentally changing the math on the incentive to encourage pediatric research on new products.

Pediatrics Policy

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‘A Forever Battle:’ Patent Reform, Launch Prices, And Where Lower Rx Price Advocates Will Go Next

Pharma’s opponents believe passage of the Inflation Reduction Act represents a momentum shift that will make it easier for politicians (even some Republicans) to take on the industry. They’ll need to count on that as they still have a long list of targets ahead on their lower-drug pricing agenda.

Pricing Debate Legislation

Patent Settlements and Medicare Negotiation: What Leverage Does Pharma Have To ‘Game’ Price Reform?

Brand drug companies might be able to use patent settlements with generic and biosimilar makers to get out of the drug price negotiations that will be created under the US legislation nearing enactment, but sponsors could run into regulatory and antitrust obstacles.

Legislation Pricing Debate

Lilly Needs Updated FDA Authorization To Sell COVID Antibody On Commercial Market

Biden administration will run out of supply of Lilly’s covid antibody bebtelovimab in August, forcing a shift to commercial market due to lack of funds. The transition will require changes to the emergency use authorization and involve a price hike.

United States Biologics

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Pink Sheet Podcast: Data Protection, Price Negotiation, Warning Letters, Amylyx At ICER

Pink Sheet reporter reviews recent stories on US FDA concerns about the EU data protection regulation, the US enacting the Medicare price negotiation law, warning letters sent to Emergent BioSolutions and ImprimisRx, and Amylyx’s ALS drug going in front of the Institute for Clinical and Economic Review.

Clinical Trials Pricing Debate

US Encouraging Monkeypox Vaccine Maker To Work With Large Pharma To Up Supply

The US FDA's Peter Marks also says the intradermal dose-sparing plan was motivated by concern over city and state one-dose strategies. 

Infectious Diseases Manufacturing

WHO Steps Up Drive To Build Local Drug & Vaccine Production In Lower-Income Countries

The COVID-19 pandemic has underlined the need for less well-resourced countries to improve access to medicines, vaccines, medical devices and other health products by building their own production capacities.

International Vaccines
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