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Biosimilar Litigation: Battles Continue Over Launch Notification, Access To FDA Info

A look at the status of suits involving Remicade, Neulasta, Epogen and Enbrel proposed biosimilars; Humira patents are being challenged in inter partes review proceedings rather than district court.

Legal Issues Patent Litigation Biosimilars

Large Employer Drug Contracting Block Could Challenge Manufacturers, PBMs

Express Scripts has been talking to members of the Health Transformation Alliance about negotiating pricing on behalf of the group, which includes 20 large employers providing health benefits for four million individuals.

Commercial Pricing Reimbursement United States

ANDA User Fees Offer Sponsor Relief, But More Facility Pain

Final GDUFA I application fees decrease amid expected boost in submissions, while facility fees will increase for the fourth time in five years.

Regulation Analysis Drug Review

Japan Builds Asia Links Through New AMED Programs

In line with similar initiatives by Japan on other regulatory fronts, the country's Agency for Medical Research and Development is building up its partnerships and presence in Asia.

Asia Pacific Japan BioPharmaceutical
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FDA Performance Tracker
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Policy & Regulation

Set Alert for Policy & Regulation

2020 Vision For FDA's Sentinel: 'Systemic' Integration Of Surveillance Looms

PDUFA reauthorization agreement sets up fiscal 2020 as milestone for weaving active surveillance into drug review – and for keeping sponsors informed of activities that affect their products.

Regulation Drug Safety Post-Marketing

Latest From Regulation

People In the News: Amicus, Catabasis, Astellas Add Reg/Policy Execs

Andrew Mulberg leaves US FDA for Amicus Therapeutics. Ipsen, Iroko, TapImmune make topside changes.

People Europe

ICH Takes Flexible Approach On Presenting Benefit-Risk Assessment In Drug Submissions

The International Council for Harmonisation's final guidance on standardizing benefit-risk information in drug submissions is expected to support regulatory decision-making through a more consistent description of information.

BioPharmaceutical Application Process

FDA Postmarketing Study Oversight To Benefit From Informatics Upgrades

Changes in legacy DARRTS system, transition to new platform and standardized format for annual report submission should improve FDA's tracking of postmarketing requirements, agency tells Office of the Inspector General.

Regulation Drug Safety

Latest From Policy

People In the News: Amicus, Catabasis, Astellas Add Reg/Policy Execs

Andrew Mulberg leaves US FDA for Amicus Therapeutics. Ipsen, Iroko, TapImmune make topside changes.

People Europe

Will PDUFA VI Fee Structure Changes Slow Revenue Growth?

User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.

Policy Drug Review

Clinton Vs. Trump: Three Scenarios For Biopharma

The presidential campaign is about to begin in earnest, and for biopharma companies, the biggest question is what the outcome will mean for the pricing climate in the US. It isn’t an easy question to answer.

Policy Pricing & Regulation

Clinical / R&D

Set Alert for Clinical / R&D

Latest From Research & Development

Tobira Says Secondary Endpoint In NASH Will Carry CVC Into Pivotal Study

The biotech argues that success in reducing fibrosis is more important than the failed primary endpoint measuring NAFLD activity score improvement – and also meets FDA's expectations – but the firm is taking a beating nonetheless.

Research & Development Drug Approval Standards

Better Risk Assessment And Dose Determination Key To EMA's Plans For Updated Phase I Trial Guideline

Proposed revisions to the European Medicines Agency's guideline on first-in-human studies are intended to help identify and reduce the risks to study participants by making better use of non-clinical data in areas like the choice of the therapeutic dose, the dose escalation strategy, and the criteria for stopping a trial.

Europe Regulation

ICH Consults On Supporting Multi-Regional Trials, Non-Clinical Evaluation Of Anticancer Drugs

The International Council on Harmonisation has endorsed draft versions of two new guidelines – one on conducting multi-regional clinical trials and the other on supporting the non-clinical evaluation of anticancer medicines. The ICH is now seeking stakeholder feedback on both documents.

Clinical Trials Regulation

Commercial

Set Alert for Commercial

Latest From Commercial

People In the News: Amicus, Catabasis, Astellas Add Reg/Policy Execs

Andrew Mulberg leaves US FDA for Amicus Therapeutics. Ipsen, Iroko, TapImmune make topside changes.

People Europe

Tobira Says Secondary Endpoint In NASH Will Carry CVC Into Pivotal Study

The biotech argues that success in reducing fibrosis is more important than the failed primary endpoint measuring NAFLD activity score improvement – and also meets FDA's expectations – but the firm is taking a beating nonetheless.

Research & Development Drug Approval Standards

Bundled Contracts To Defend Against Biosimilars May Face Payer Skepticism

J&J plans to rely on its broad portfolio to contract favorably in a 'post-biosimilar world,' but cross-category bundling is generally discouraged by payers.

Commercial Policy

Manufacturing

Set Alert for Manufacturing

Latest From Manufacturing

GSK Faces 'Profoundly Difficult' Penicillin Challenge, FDA Warning Letter Says

Aging plant in Worthing, UK, must either dedicate building solely to penicillin or undergo wrenching decontamination before US distribution of non-penicillin products could resume.

Manufacturing BioPharmaceutical

WHO Pilots Pre-Submission GMP Inspections To Facilitate Prequalification Of Medicines

The WHO pilot will allow drug makers seeking prequalification for their medicinal products to work simultaneously on addressing GMP issues and preparing their dossiers for submission.

Regulation Africa

FDA Says Preapproval Inspections Will Not Trigger Surveillance Audits

Decisions to conduct GMP surveillance audits for currently marketed products are not triggered by pending NDAs subject to preapproval inspections, FDA official confirms. The two types of inspections are “delinked” from each other.

BioPharmaceutical Manufacturing

Consumer / OTC Drugs

Set Alert for Consumer / OTC Drugs

Latest From Consumer

Perrigo Shareholder Lawsuits Claim Joining Mylan Was A Better Idea

Two complaints seeking compensation for Perrigo shareholders and four motions seeking lead plaintiff designations in the litigation have been filed in US district court. Both target Perrigo's fundamental argument against Mylan's takeover bid in 2015, that the company would be stronger continuing on its own.

United States Ireland

Weekly Trademark Review July 19, 2016

OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Africa Asia

OTC Drug Industry News Roundup

Merck expands US life sciences facility; Ei moves R&D lab; AZO offers UTI defense; and more news in brief.

Consumer Consumer
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