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Raine To Lead UK MHRA Ahead Of Permanent Head Announcement

June Raine has agreed to lead the Medicines and Healthcare products Regulatory Agency temporarily after the agency’s incumbent chief executive steps down in September.

Regulation United Kingdom Brexit

Golodirsen Rebuff: Did Exondys 51 Review Strife Influence US FDA's Decision?

Sarepta cited two safety issues when announcing a complete response letter for its exon 53 skipping DMD drug golodirsen, but the US FDA's decision may be a result of the Exondys 51 approval from 2016, analysts suggest.
Complete Response Letters Drug Review Regulation

Endo And Allergan Could Edge Out Of Opioid Bellwether Trial Spotlight With Proposed Settlements

Companies reach agreements in principal with plaintiffs in bellwether trial in the US multidistrict litigation as court date nears; plaintiffs narrow their claims from 11 to seven.
Legal Issues Advertising, Marketing & Sales Policy

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

UK Govt Asks: Are Trial Sponsors Ready For No-Deal Brexit?

Pharma firms are being asked to let the government know how prepared they are in terms of ensuring supplies of investigational medicines and other clinical trial supplies in the event of a no-deal Brexit at the end of October.

United Kingdom Brexit

Canadian Drug Pricing Reforms Could Lead To Medicine Shortages

Drug pricing reform in Canada could prompt companies to launch elsewhere or see drugs diverted to the US.

North America Canada

Will Pharma Firms Bear Cost Of UK Govt’s Latest No-Deal Brexit Supply Plans?

Life science companies are uneasy over the government’s latest proposals for emergency medical supplies to the UK if the country leaves the EU without a deal.

United Kingdom Trade

Graft Trail: Top Level Indian Regulatory Official Arrested

The arrest of India's deputy drugs controller creates shock waves and indicates an intent to clamp down on graft at any level, say industry experts.

Regulation Legal Issues

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

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

Latest From Policy

In Search Of Goodwill, Several Pharmas Commit To New Corporate ‘Statement Of Purpose’

The updated business principles may give pharma companies leverage, or at least talking points, as they continue to engage with the Trump administration on policies like the International Pricing Index and with US lawmakers on drug pricing legislation. J&J's Gorsky heads governing committee of multi-industry business group that revised its principles.

Pricing Debate Policy

Canadian Drug Pricing Reforms Could Lead To Medicine Shortages

Drug pricing reform in Canada could prompt companies to launch elsewhere or see drugs diverted to the US.

North America Canada

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

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

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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