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Swiss Finally Beat EMA On New Drug Approval Times

More rolling reviews, a reduction in review rounds, and a rise in applications through two international regulatory collaboration initiatives were among the factors behind a reduction in new drug authorization times in Switzerland last year. However, “submission gaps” versus other regulators remain a problem.

BioPharmaceutical Approvals Regulation

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 Regulation

FDA Warning Letter Brings Another High-Flying Emergent CDMO Plant Down To Earth

Warning letter reveals agency found quality problems at Emergent BioSolutions’ Camden fill/finish plant during COVID-19 pandemic even as firm’s Bayview plant came under heightened scrutiny. Metal particulates appeared in vials as Camden plant and rest of Emergent’s CDMO network experienced sharp demand growth.

Manufacturing Quality Enforcement

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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

ICH Finalizes Guide To Cutting Down On Rat Carcinogenicity Studies

An ICH guideline describes the “weight of evidence” criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without the need for data from a two-year rat carcinogenicity study.

International Drug Safety

No OS Gain For 34 China-Approved Cancer Drug Indications

Sweeping regulatory reforms put China in catch-up mode for the approval of oncology drugs, some of which have been cleared for marketing only in the country. But how does the deluge of new products measure up in terms of actual overall survival benefits? A new study by Peking University scholars and specialists unveils some surprising results.

China Cancer

Updated: 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

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

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

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

Latest From Policy

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

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

Clinical / R&D Explore this Topic

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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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