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US Medicare Price Negotiation: Gaming FDA Approval Dates Could Delay Drug Selection

The early February date for publishing the list of products eligible for price negotiations could dictate approval strategies for drugs with potential for big sales in Medicare going forward.

Reimbursement Pricing Strategies Policy

Sponsors Split Over Benefits Of EU Clinical Trials Regulation

A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.

Europe Clinical Trials Regulation

Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials

Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.

Infectious Diseases Review Pathway 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: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA

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

Approvals Review Pathway Drug Review


Global Pharma Guidance Tracker – December 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

Policy & Regulation Explore this Topic

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Latest From Regulation

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos

The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.

Europe Approvals

More Execs Speak Out Over Risks Of UK Voluntary Pricing Scheme For Life Sciences

In 2022, a total of five companies chose to exit the UK’s voluntary scheme that manages branded medicines spending. The departure of two big firms – AbbVie and Lilly – is seen as a deliberate tactic to send a clear signal to government that the scheme is not working for industry and is jeopardizing investment and access to medicines in the UK.

Europe United Kingdom

Harmonizing COVID Vaccine Schedule Good Idea, But US FDA Should Remain Flexible, Advisors Say

Vaccines and Related Biological Products Advisory Committee also said that more data is needed to determine the groups that potentially could receive more than one periodic vaccine booster.

Coronavirus COVID-19 Vaccines

Sliding Scale: Bar For COVID Therapeutics EUAs ‘Can Be Somewhat Variable’ – FDA’s Peter Marks

Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.

Coronavirus COVID-19 FDA

US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests

Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.

Advisory Committees Coronavirus COVID-19

Latest From Policy

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Intellectual Property Legal Issues

Can US FDA Share Drug Sponsor’s Information With Patent & Trademark Office?

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.

Generic Drugs Biosimilars

Medicare Part D Redesign Could Expand Rebate-Driven Formulary Exclusions In Program

Increased application of utilization management controls expected as plans face higher costs under the redesign. However, the formulary advantages available to drugs in the protected classes may lead developers to sharpen their focus on those categories.

Reimbursement Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests

Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.

Advisory Committees Coronavirus COVID-19

Requests For EMA PRIME Designation Fall But Improvements Are On The Way

While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

Review Pathway Innovation

WHO Plans New Body To Boost Novel TB Vaccine Efforts

The WHO’s proposed “TB Vaccine Accelerator council” will focus on the need for firm political and funding commitments, drawing on the high-level coordination that helped in the rapid development of COVID-19 vaccines.

International Vaccines

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Latest From Commercial

In Medicare Drug Price Negotiations, Industry Sees Drawbacks And Silver Linings

Industry leaders are concerned about the outlook for small molecule drugs in particular, but execs at the J.P. Morgan Healthcare Conference were also optimistic there could be chances to shape the implementation of certain policies.

Pricing Debate Innovation

Novartis’ Kisqali Consumer Promos Inappropriately Convey Superiority, NAD Finds In Unusual Ruling

However, similar claim in materials directed at health care providers need not be discontinued, National Advertising Division says in challenge brought by Lilly; NAD decisions in Rx promotion disputes are rare, but voluntary resolution process could become more appealing to pharma firms.

Ad Complaints Advertising, Marketing & Sales

Medicare Drug Pricing Casts A Cloud Over J.P. Morgan’s Opening Day

Inflation Reduction Act means that industry ‘will have to adjust’ to new market realities, especially for small molecule drugs.

Reimbursement Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs

Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.

Compliance Manufacturing

Valisure’s Message To The FDA: It’s Part Of The Solution, Not Part Of The Problem

CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.

Manufacturing Quality

French Industry Chief On How To Encourage Innovation & Avoid Drug Shortages

Pricing challenges, high taxes and the growing problem of drug shortages have led the pharmaceutical industry body Leem to come forward with a set of proposals that it says should inform future government policy towards the sector.

Europe France
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