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Pressure Mounts On EU To Follow US In Backing COVID-19 Vaccine IP Waiver

The pharmaceutical industry in Europe has attacked the US decision to come out in support of a relaxation of IP rights that is designed to boost global production of COVID-19 vaccines. But the move by the Biden administration could well cause other countries to rethink their opposition to the move.

Europe United States International

ChemoCentryx’s Avacopan May Need Another Trial After Tepid Advisory Committee Vote

Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.

Advisory Committees Rare Diseases Drug Review

CBER Will Staff Up With 100 More Reviewers ‘By Hook Or By Crook,’ Marks Says

US biologics center is getting back to regular business now that COVID-19 work is subsiding; director Marks credits acting commissioner Woodcock with using all available mechanisms to staff up.

Coronavirus COVID-19 FDA Regulation

Spotlight On Coronavirus

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Click to read Six Themes That Will Shape Biopharma In Transformational 2021

Key Predictions From Industry Leaders

 

 

 

Performance Trackers

Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase

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

US FDA Performance Tracker Drug Review Complete Response Letters

Global Pharma Guidance Tracker – March 2021

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 Pips EU To The Post With ‘Project Orbis’ Approval For Tagrisso

The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.

United Kingdom International

EU Reveals Plan To Speed Development Of New COVID-19 Therapies

Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.

Europe Coronavirus COVID-19

Pharma Industry Lists Multiple Failings Of EU Regulatory System

The European Commission’s plans for overhauling the EU medicines legislation have elicited a number of proposals from the pharmaceutical industry to improve the regulatory framework, including streamlining the committee system, improving the use of expedited evaluation pathways, and expanding the European Medicines Agency’s role in assessing drug/device combination products.

Europe Regulation

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

Piqray: German Withdrawal, European Reimbursement Deals & Broader Indication Plans

Novartis has failed to reach a reimbursement agreement to keep its first-in-class advanced breast cancer drug on the German market, but it is pressing on with plans to expand market access for the product across Europe. It is also working on securing regulatory approval to use Piqray in a broader patient population that would carve out a more meaningful place in the relevant treatment pathway.

Germany Health Technology Assessment

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Europe European Performance Tracker

Latest From Policy

After World-Leading Vaccine Roll-Out, UK Eyes Booster Phase But Faces Pressure To Help Globe

The UK’s purchase of 60 million extra Pfizer/BioNTech COVID vaccine doses, plus bets on Novavax and Valneva and others gives it a buffer against new variants – so when will it pledge to donate to more needy nations?

Coronavirus COVID-19 Vaccines

Is Aducanumab In Alzheimer’s A Candidate For Medicare ‘Coverage With Evidence Development’?

Medicare may look to bolster evidence on Biogen’s potential Alzheimer’s treatment, if approved, with a national coverage decision requiring the collection of clinical data in the postmarket setting.

Reimbursement Medicare

Piqray: German Withdrawal, European Reimbursement Deals & Broader Indication Plans

Novartis has failed to reach a reimbursement agreement to keep its first-in-class advanced breast cancer drug on the German market, but it is pressing on with plans to expand market access for the product across Europe. It is also working on securing regulatory approval to use Piqray in a broader patient population that would carve out a more meaningful place in the relevant treatment pathway.

Germany Health Technology Assessment

Clinical / R&D Explore this Topic

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Latest From Research & Development

Pfizer DMD Gene Therapy Phase III Trial Stalled In US After FDA Questions On Potency Assays

Pfizer disclosed that a Phase III trial for the gene therapy has been unable to start in the US because of questions from the FDA, even while enrollment in 15 sites outside the US is under way.

Gene Therapy Drug Approval Standards

New Scottish Agency Would Ensure Supply Of Cost-Effective Drugs

With elections taking place across the UK on 6 May, the Scottish National Party says it plans to take steps to ensure sustainable medicine supply chains and build up the manufacturing of generics and “specials” within the National Health Service in Scotland.

United Kingdom Europe

Failure to Heed FDA Warnings of Poor Trial Design Likely To Haunt ChemoCentryx At Advisory Cmte.

Phase III trial was statistically significant, but US FDA argues complex study design makes it unclear that ChemoCentryx’s avacopan offers a clinically meaningful benefit, including a safety advantage, for ANCA vasculitis. Agency had tried to direct company to better designed trials earlier in development program.

Advisory Committees Drug Approval Standards

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Latest From Commercial

Bladder Cancer Accelerated Approvals: Merck’s Keytruda and Genentech’s Tecentriq Each May Have One Last Lifeline

US FDA will ask advisory committee whether data from the trial supporting full approval of Merck’s Keytruda for second-line setting can be used to confirm clinical benefits for earlier setting of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy following a failed confirmatory study. Genentech’s Tecentriq is also at risk of losing its accelerated approval in that space but it could buy some time as its confirmatory study is not yet complete. New competitor entrant since accelerated approvals also lessens degree of unmet need.

Advisory Committees Cancer

With New Rare Blood Clot Warning, J&J COVID-19 Vaccine Rollout Resumes In EU

Similarities to AstraZeneca blood clots are clear, but more research needed before any ‘class effect’ conclusions can be drawn.

Commercial Companies

Lower Reimbursement For Accelerated Approval Drugs May Get Push From ICER

ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.

Pricing Debate Cost Effectiveness

Manufacturing Explore this Topic

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Latest From Manufacturing

EU Reveals Plan To Speed Development Of New COVID-19 Therapies

Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.

Europe Coronavirus COVID-19

US COVID Vaccine Patent Waiver Is Big, Symbolic Blow For Pharma, But The Fight Is Just Beginning

Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.

Intellectual Property Coronavirus COVID-19

Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections

US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up. 

Manufacturing Quality
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