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AZ Will Sideline ‘Lucky Mistake’ Data To Secure COVID-19 Vaccine Approval

A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.

Coronavirus COVID-19 Vaccines Clinical Trials

‘Legacy’ Drugs And Former US FDA Commissioner Gottlieb’s Legacy

A surprise move to unwind FDA’s efforts to end the marketing of unapproved drugs is in keeping with the overall sense of the top-down intervention in the agency’s policies at the end of the Trump Administration. It is also an unfortunate consequence of the embrace of drug pricing as part of FDA’s mission.

Pricing Debate FDA Leadership

Teva Slapped With €60m Fine Over Unlawful EU Provigil Delay

Teva received a “package of commercial side-deals” for agreeing to halt generic competition to Cephalon’s Provigil (modafinil) throughout the EU, which it “would not have achieved without committing to staying out of the market,” according to findings by the European Commission.

Europe Generic Drugs Legal Issues
Coronavirus 2019-nCov novel coronavirus concept resposible for asian flu outbreak and coronaviruses influenza as dangerous flu strain cases as a pandemic 3d rendering

COVID-19 Pipeline Tracker

Product candidates in development worldwide to address the 2019-nCoV pandemic, categorized by treatment and prevention. Subscription required.

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Performance Trackers

Keeping Track: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Drug Review Approvals

Global Pharma Guidance Tracker – October 2020

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

UK Warns Against Printing Out EHRs For Clinical Trial Monitors

New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.

United Kingdom Clinical Trials

Clinuvel’s Phototoxicity Drug Scenesse Approved In Third Market

Australian patients with phototoxicity due to the rare condition EPP will now have their first treatment option – provided the drug's developer, Clinuvel, secures reimbursement under the Pharmaceutical Benefits Scheme.

Australia Approvals

EU Plans IP Law Shake-Up

European Commission proposals for strengthening intellectual property protections in the EU, particularly the supplementary protection certificate (SPC) system, have been broadly welcomed by the European pharmaceutical industry federation EFPIA. But the medical NGO, MSF, says the SPC proposals run counter to the commission’s own efforts to improve access to medicines.

Europe Intellectual Property

Real World Data Failed To Impress Kaftrio’s European Reviewers

The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.

Europe Drug Review Profile

Swissmedic Clears Up Confusion Over Validity Of GMP Certificates

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.

Manufacturing Drug Safety

EU Pushes For Compulsory Licensing Of Drugs & Vaccines In Health Crises

The EU has published an action plan that is intended to upgrade the bloc’s intellectual property framework while ensuring that goods such as medicines and vaccines are made as widely available as possible. The initiative is part of wide-ranging plans to support member states’ recovery from the pandemic crisis and help ensure the EU’s resilience to future health threats.

Europe Intellectual Property

Latest From Policy

US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

Manufacturing Complete Response Letters

‘Most Favored Nation’ Pricing Data May Be Long-Term Impact Of Last-Minute Rule

Rushed final rule seeking to impose draconian cuts on drug reimbursement rates in the Medicare Part B program is certain to face legal and political obstacles. But the data included on international price benchmarks will still have an impact.

Medicare Pricing Debate

PMDA Eyes More Japan-First Approvals In Access Push

Highlighting progress it has made over the past few years, Japan’s regulatory agency says it wants to raise even further the number of “Japan-first” approvals, as part of its stated mission to get safe and effective new drugs to patients more quickly.

Japan Approvals

Clinical / R&D Explore this Topic

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Latest From Research & Development

Coronavirus Notebook: UK On Cusp Of First Vaccine Approval, Moderna To File mRNA-1273 in US & EU

Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.

United Kingdom Russian Federation

Trump’s Big Bet On COVID-19 Vaccines May Have Shortchanged Therapeutics. Should Biden Rectify The Difference?

Incoming US President may be wise to up government investment in COVID-19 therapeutics, including both research and manufacturing, experts say. Additional government funding should target a larger variety of treatment types and prioritize better study designs.

Coronavirus COVID-19 Elections

New EMA Head To Bolster Regulatory Collaboration In The EU & Beyond

Strengthening regulatory partnerships and being ready to support the translation of disruptive innovations into the treatments of tomorrow are on the to-do list of incoming European Medicines Agency chief Emer Cooke.

Europe Regulation

Commercial Explore this Topic

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Latest From Commercial

Catchup Capsule: Key APAC Insights You Need To Read

Given its ever-growing role as a critical component of the global biopharma industry, you can’t afford not to be up to speed on Asia. This biweekly selection of insights from our experienced on-the-ground team will help.

Asia Pacific Coronavirus COVID-19

Lilly's US Bamlanivimab Contract Raises Difficult Allocation Considerations

The price of the antibody monotherapy for COVID-19 will be $1,250 per vial for wealthy countries. CEO David Ricks outlined the company's guidelines for pricing and distributing a limited supply.

Coronavirus COVID-19 Pricing Debate

Gilead’s Immunomedics Buy: Five Things To Worry About

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

Clinical Trials Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

Manufacturing Complete Response Letters

Swissmedic Clears Up Confusion Over Validity Of GMP Certificates

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.

Manufacturing Drug Safety

Radical Shake-Up In Store For Entire EU Pharma Legislation

The EU pharmaceutical strategy published on 25 November will be the first step in a “complete overhaul” of the medicines legislative framework to be proposed in about two years’ time, says the European Commission.

Europe Innovation
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