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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 Policy

UK Beefs Up Health Security Body With New Vaccine Supply Role

The UK government says that the UKHSA will be able to “harness the strengths” of the Vaccines Taskforce, including its “excellent relationships with industry” and “expertise in innovation.”

Vaccines Europe United Kingdom

Trial Population Was One Reason For Pulling Surufatinib EU Filing

Hutchmed is in discussions with the European Medicines Agency on the path forward for its drug for advanced neuroendocrine tumors, whose marketing authorization application has now been withdrawn.

Europe Drug Review Clinical Trials

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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: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL

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

United States US FDA Performance Tracker Approvals


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

Policy & Regulation Explore this Topic

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Latest From Regulation

ImprimisRx's Approval And Superiority Claims For Compounded Drug Draw FDA Warning

The company known for compounding versions of Martin Shkreli’s Daraprim and Allergan’s Restasis is hit with a warning letter for promotions in professional periodicals about its compounded eye drop.

Warning Letters Ad Complaints

EU Allows Firms More Time To Make Nitrosamine-Related Manufacturing Changes

The European medicines regulatory network is giving sponsors of marketed medicines that contain chemically synthesised active substances an extra 12 months to apply for manufacturing changes to address nitrosamine-related risks.

Europe Drug Safety

UK Chooses mRNA Boosters For COVID-19 Vaccination Campaign

In making its recommendations for the autumn vaccination program against COVID-19, the UK’s JCVI says Novavax’s Nuvaxovid could be used in exceptional circumstances, but there is no room for AstraZeneca’s Vaxzevria.

Europe United Kingdom

Keeping Track: Enhertu Brings Anti-HER2 Therapy To Lung Cancer; Novaliq Platform Supports Two Dry Eye NDAs

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

US FDA Performance Tracker Approvals

New Zealand Extends Deadline For Opioid Risk Warning

Medsafe has taken on board industry’s request for more time to implement its new labeling requirement for medicines containing opioids.

New Zealand Drug Safety

UK First To Approve Moderna’s Bivalent COVID-19 Vaccine

The mRNA-1273.214 vaccine will add to the UK’s armory for protecting people against coronavirus over the coming winter season.

Europe United Kingdom

Latest From Policy

Medicare Drug Pricing Reform Is A Reality: Here Is What’s On The Agenda

Congressional Democrats achieved a long-sought goal in passing major legislation to control drug prices in Medicare. A complete lack of Republican support suggests the programs established by the bill will face the same kind of legislative and legal challenges that confronted the Affordable Care Act, which was enacted in a similar manner.     

Pricing Debate Reimbursement

Hepatitis C Treatment Restrictions In Spotlight After HHS Report

Study finds one-third of insured adults have access to hepatitis C treatment within 360 days of the first positive test. CDC suggests treating all eligible patients without restrictions and eliminating preauthorization requirements. For state Medicaid programs, 38 states require prior authorization and 12 states have substance use restrictions.

Government Payers Medicaid

Hepatitis C Treatment: Most Medicare Beneficiaries Are Not Getting Authorized Generics

The Office of the Inspector General finds that large rebates for higher-cost hepatitis C drugs and lack of formulary inclusion of authorized generics may be influencing the use of higher cost treatments in Medicare.

Generic Drugs Medicaid

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Latest From 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

Monkeypox: Siga Says FDA Hasn’t Indicated Emergency Use Authorization An Option for Tpoxx

Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.

United States Clinical Trials

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Latest From Commercial

‘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

Manufacturing Explore this Topic

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Latest From Manufacturing

EU Allows Firms More Time To Make Nitrosamine-Related Manufacturing Changes

The European medicines regulatory network is giving sponsors of marketed medicines that contain chemically synthesised active substances an extra 12 months to apply for manufacturing changes to address nitrosamine-related risks.

Europe Drug Safety

US FDA Training Up Inspectorate To Oversee Quality Of Novel Manufacturing Technologies

Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.

Innovation Quality

Advanced Therapies: Payment Revolution Must Accompany Industrial Revolution In Europe

The advanced therapies sector is undergoing something of an industrial revolution, but access issues for products coming to market remain, says Miguel Forte, CEO of Bone Therapeutics. However, there are opportunities to create a better environment for the sector, including regulatory change and more harmonization of HTA processes.

Europe Market Access
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