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Featured Stories


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 Europe

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 Medicare

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 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.
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Policy & Regulation Explore this Topic

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Latest From Regulation

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

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Frontiers In Real-World Evidence: US FDA Partners With Syapse To Explore Sources Beyond Electronic Records

Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine.

Clinical Trials Research and Development Strategies

Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions

US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.

Approvals Review Pathway

Latest From Policy

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

Canada Overhauls Drug Pricing, But Devil Will Be In The Detail

Long awaited changes to Canada’s Patented Medicines Regulations have been announced, but companies will have to wait for new guidelines from the pricing watchdog to better understand how they will be implemented.

North America Canada

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

Temple Wants US FDA To Consider Including PK/PD In Labels To Inform Dosing

CDER's Robert Temple said the US FDA has generally been nervous about using PK/PD analyses to support labeling changes, but that it might be time to rethink the subject. 

Research & Development Drug Approval Standards

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

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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