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Survey Or Shakedown? US Medicaid’s Audacious Negotiation Plan
The US Medicaid program is proposing what amounts to a price negotiation program by using a survey/audit authority as a 'stick' to encourage manufacturers to offer supplemental rebates or outcomes-based contracts. Is it an offer sponsors can’t refuse?

Pharma Industry On How To Tackle EU Regulatory & Reimbursement Barriers To Digital Therapeutics
When it comes to digital therapeutics in Europe, EFPIA says there is a lack of harmonization in the regulatory requirements, and only Belgium and Germany offer value assessment, reimbursement and funding pathways, with more intermittent offerings in countries like France and UK.

BIO Notebook: GSK’s Walmsley On M&A; Merck On How Falling Valuations Are Affecting Deals
On the first day of the BIO International Convention, our reporters hear from industry leaders about tough financing, when to go public, and why ‘there shouldn't be 700 listed biotechs in the US.’
Vaccine Policy: Progress and Pitfalls
GSK Makes New Adult Immunization Push, Seeks Reimbursement Changes Following RSV Approvals
From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.
International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine
UK Offers Fresh Funding For New Drugs & Vaccines Against AMR
EU’s Proposed Emergency Approval Route For Crisis-Related Products – Would It Work?
Pink Sheet Podcast: Alzheimer’s Drugs, US FDA’s New Patient Info Leaflet, COVID-19 Vaccine Harmonization
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Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.
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US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
US FDA Performance Tracker

Global Pharma Guidance Tracker – April 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
What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?
Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”
Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.
Diabetes Drugs: US FDA Proposes Hypoglycemia Efficacy Endpoints, With Limits
Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.
Pink Sheet Podcast: Alzheimer’s Drugs, US FDA’s New Patient Info Leaflet, COVID-19 Vaccine Harmonization
Pink Sheet reporters and editors discuss CMS’s latest coverage announcement for Alzheimer’s drugs and the VA’s approach to the issue, the FDA’s new one-page patient medication information document, international convergence on COVID-19 vaccine strain selection and Novavax’s place in the vaccine toolbox going forward.
European Parliament Wants EU-Wide Pull Incentive Scheme For New Antimicrobials
The three major EU institutions are all calling for urgent action to tackle antimicrobial resistance, with the emphasis very much on incentives for the development of novel medicines and a reduction in overall consumption of antibiotics.
The People Who Will Shape The UK’s New Drug Pricing Scheme
With talks on the next UK voluntary pricing scheme now well under way, the Pink Sheet looks at the industry and government negotiators who will be thrashing out the details in the coming months.
Latest From Policy
PBM Reform: Vertical Integration, Specialty Drug Tracking Among Differences In House v. Senate Bills
House Energy and Commerce Committee cleared a PBM bill that seems to contain more transparency loopholes and makes more limited policy tweaks to the drug supply chain middleman than the Senate HELP Committee’s bill, but the House-side legislation would pull back the curtain on specialty-drug reimbursement in a way the Senate version does not.
FDA, Medicare And The Future Of Coverage With Evidence Development For Accelerated Approvals
Health policy experts discuss ways Medicare coverage policy may evolve in the coming years and how efforts to smooth the transition between accelerated drug approvals and Medicare reimbursement decisions could play out.
BMS & Pfizer Win Funding ‘Firsts’ In England For Migraine & Heart Disease Drugs
Bristol Myers Squibb and Pfizer both asked the health technology assessment body NICE to evaluate their respective drugs, Camzyos and Vydura, for use in indications that are narrower than those for which they are – or will potentially be – approved.
Clinical / R&D Explore this Topic
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Latest From Research & Development
What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?
Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”
European Parliament Wants EU-Wide Pull Incentive Scheme For New Antimicrobials
The three major EU institutions are all calling for urgent action to tackle antimicrobial resistance, with the emphasis very much on incentives for the development of novel medicines and a reduction in overall consumption of antibiotics.
Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?
New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.
Commercial Explore this Topic
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Latest From Commercial
GSK Makes New Adult Immunization Push, Seeks Reimbursement Changes Following RSV Approvals
From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.
The US VA And Alzheimer’s: A Misunderstood Decision
US Department of Veterans Affairs' head for pharmacy benefits management says her agency’s coverage of Leqembi and Aduhelm is actually closely aligned with that provided by Medicare, in contrast to the initial characterization of the VA taking a different stance on the drugs.
Novo Nordisk’s Obesity Drug Activities Break UK Rules Again
The company has been found in breach of the UK code once again for its work with pharmacists, although this time Novo Nordisk has escaped the heaviest censure.
Manufacturing Explore this Topic
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Latest From Manufacturing
Why Generic Drug Manufacturing Is Faltering And Ways To Bolster It
Academic expert provides insight into the economic and quality challenges behind generic drug shortages, and what to do about it.
UK In Major Move To Boost Commercial Clinical Trials & Improve Life Sciences Environment
The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.
The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.
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