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Sir Andrew Dillon Standing Down As Head Of England’s NICE After 20 Years

Sir Andrew Dillon is stepping down from what has been described as one of the most challenging and potentially controversial roles in British public life.

Health Technology Assessment United Kingdom Reimbursement

Enforcing A Belated Chemistry Lesson – The Nitrosamines In Sartans Saga

How authorities plan to root out the carcinogenic impurities and what it means for other classes of medicines.

Manufacturing Quality Enforcement

Topical Cocaine Provides US FDA With First Case Of ‘Dueling’ 505(b)(2) NDAs

Lannett and Genus’s battle parses the distinction between NMEs and NCEs and the meaning of US Hatch-Waxman exclusivity.

United States Drug Review Drug Approval Standards

Global Pharma Guidance Tracker – July 2019

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.
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Policy & Regulation Explore this Topic

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Latest From Regulation

UK’s No-Deal Brexit Plans For SPC Waiver Could Reduce IP Rights, Warns BIA

The UK’s plans to amend the supplementary protection certificate waiver legislation in the event of a no-deal Brexit could lead to the curtailment of IP protections, not only the terms of SPCs but regulatory data protection and orphan exclusivity too, the BIA claims.
United Kingdom Intellectual Property

Pink Sheet Podcast: Golodirsen CRL, Trump's Appeal Of DTC Ad Ruling, Pharmas' Statement Of Purpose'

Pink Sheet reporters discuss a Duchenne muscular dystrophy drug's denial by US FDA, the administration's attempt to revive the DTC price disclosure rule, and the Business Roundtable's new principles on corporate values.
Complete Response Letters Pricing Debate

Germany Remains In The Dark On UPC Implementation

With a constitutional challenge still pending in Germany, and lingering uncertainties over Brexit, Germany's federal government appears to have little idea when a planned European Unified Patent Court could come into effect.

Intellectual Property Europe

NICE Says Initial No To Epidyolex In England, But GW Pharma Remains Upbeat

Draft guidance from NICE has recommended against the use of GW Pharmaceuticals’ Epidyolex for refractory epilepsy, but the company believes it has the data needed to ensure a positive outcome to the appraisal.
United Kingdom Health Technology Assessment

Can’t Let Go: HHS Seeks To Overturn US Court Decision Striking Down DTC Ad Rule

The appeal is in keeping with the President Trump’s plan to stay active on drug pricing initiatives so he can claim victory on a key campaign promise.

Pricing Debate Legal Issues

New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development

Robert Temple, the FDA's voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules.

Drug Approval Standards Clinical Trials

Latest From Policy

£197m Payments Made Under New UK Pricing Scheme But Access Promises Still To Materialize

Payments have now been made under the UK’s 2019 pricing and access to branded medicines scheme, but industry will have to wait longer for promises on access to materialize.

Pricing Strategies Market Access

Zolgensma Fall-Out: Is Threat To Novartis – Or US FDA Climate Overall?

FDA’s disclosure of data “manipulation” in the application for the SMA gene therapy Zolgensma prompted two immediate inquiries from the US Senate – with very different focuses and potential outcomes.

Legislation Compliance

Patent “March-In” As Price Control Draw Little Support At US National Academies Meeting

The use of patent “march-in” rights as a tool to control the price of drugs developed with US federal funding support remains substantially less popular with the government-funded research community than with politicians.

Pricing Debate Pricing Strategies

Clinical / R&D Explore this Topic

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Latest From Research & Development

Cures 2.0: Can Congress Recapture The Legislative Magic?

Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?

Legislation Review Pathway

NHS England Tackles Barriers To Use Of Cannabis-Based Medicines in UK

A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns. 

United Kingdom Neurology

Outcomes-Based Pricing: Can It Facilitate The Study Of Precision Dosing?

Roche's Richard Peck says adoption of outcomes-based pricing in the US could be powerful incentive to study precision dosing, although he also calls on drugmakers to put out scientific examples.

Reimbursement Research & Development

Commercial Explore this Topic

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Latest From Commercial

Novartis’ “Living Drugs”: Kymriah, Zolgensma – And Diovan?

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

Commercial Manufacturing

Sunset Begins For Roche's Herceptin As Amgen/Allergan Biosimilar Launches

Amgen and Allergan launched the first US biosimilar for Roche's Herceptinand the Swiss pharma's Avastin – at a 15% discount to the brand-name products' list prices. Infographic reviews Herceptin's past and its future competitors.

Biosimilars Launches

When It Comes To FTC M&A Review, The Times May Be A Changin'

Spark signaled in an SEC filing that its merger with Roche could be delayed into 2020, fueling more speculation that FTC is increasing scrutiny over biopharma mergers.

M & A Pricing Debate

Manufacturing Explore this Topic

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Latest From Manufacturing

UK’s No-Deal Brexit Plans For SPC Waiver Could Reduce IP Rights, Warns BIA

The UK’s plans to amend the supplementary protection certificate waiver legislation in the event of a no-deal Brexit could lead to the curtailment of IP protections, not only the terms of SPCs but regulatory data protection and orphan exclusivity too, the BIA claims.
United Kingdom Intellectual Property

Zolgensma Fall-Out: Is Threat To Novartis – Or US FDA Climate Overall?

FDA’s disclosure of data “manipulation” in the application for the SMA gene therapy Zolgensma prompted two immediate inquiries from the US Senate – with very different focuses and potential outcomes.

Legislation Compliance

US FDA Warning Letter Draws Indian Solvent Recycler Into Valsartan Crisis

Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.

Manufacturing Quality
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