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EMA And FDA Claim 'High Concordance' In Approval Decisions

Divergences between the EU and US agencies in marketing application approval decisions in 2014-2016 were primarily due to differences in the regulators’ conclusions about efficacy based on review of the same data or to differing clinical data submitted to support the application, a study has revealed.

Approvals Europe United States

Advances On the Biosimilar Litigation Battlefield

A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump in settlements, new battles over manufacturing information and an expected petition to the Supreme Court.

Biosimilars Intellectual Property Legal Issues

Italy Unveils New Payment Model For Novartis’s CAR-T Kymriah

The Italian authorities have agreed a new kind of reimbursement model for Novartis's CAR-T therapy Kymriah that involves payment in instalments depending on the patient’s response to treatment.

Italy Reimbursement Cancer

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.
International Europe Australia

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Policy & Regulation Explore this Topic

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Latest From Regulation

Bladder Cancer: More Questions Than Answers With pCR Endpoint

Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.

Cancer Clinical Trials

Pfizer’s Ibrance And The Realities Of 'Real-World' Evidence

US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.

Drug Approval Standards Post Market Regulation & Studies

Keeping Track: A Quintet Of Novel Approvals

The latest drug development news and highlights from our US FDA Performance Tracker. 

US FDA Performance Tracker Approvals

Pink Sheet Podcast: Zolgensma Saga Continues, ICER Reviews DMD Drugs, FDA Issues Another LPAD Approval

Pink Sheet reporters review Novartis' latest response to Zolgensma data manipulation, discuss ICER reviews of Sarepta's Duchenne muscular dystrophy treatments, and recap the FDA's latest antibiotic approval.

Gene Therapy Rare Diseases

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

Industry Warns Of ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU

EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.

Clinical Trials Combination Products

Latest From Policy

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

GAO Report On Part D May Dampen Congressional Enthusiasm For POS Rebates

Legislation redirecting manufacturer rebates on prescription drugs to the point of sale could face an uphill battle following report’s description of the way rebates lower costs in Medicare Part D.

Pricing Debate Reimbursement

Korea’s Clinical Trial Road Map Eyes Faster Development, Patient Safety, Rare Diseases

Amid fierce jostling among Asian countries to attract clinical research, South Korea unveils a five-year road map to accelerate trial activities and improve global competitiveness, focusing on expansion of opportunities for rare and intractable diseases, protection of subjects' rights and enhancement of new drug development capabilities.

South Korea Clinical Trials

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

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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

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

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

Do Not Be So Quick To Blame Microbes On The Lab, The US FDA Warns Emcure

Emcure's Hinjwadi, India, plant should have investigated other more likely sources of contamination more thoroughly, the FDA says.
Manufacturing Quality
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