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Featured Stories



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?

Medicaid Reimbursement Pricing Debate

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.

Europe Digital Health Cost Effectiveness

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.’

M & A Leadership Financing

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.

Vaccines Policy

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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

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 Drug Approval Standards Drug Review


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.

Guidance Documents Regulation International

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.”

Europe Regulation

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.

FDA Review Pathway

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.

Drug Approval Standards Guidance Documents

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.

Reimbursement Drug Safety

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.

Europe Innovation

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.

Europe United Kingdom

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.

Pricing Debate Legislation

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.

Reimbursement Policy

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.

Europe United Kingdom

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.”

Europe Regulation

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.

Europe Innovation

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.

Generic Drugs Clinical Trials

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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.

Vaccines Policy

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.

Government Payers Medicare

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.

Companies Commercial

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.

Generic Drugs Supply Chain

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.

Europe United Kingdom

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.

Manufacturing Quality
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