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Brazil: The Next Hot Spot For Biosimilar Substitution?

Biosimilars manufacturers could reach a wider patient population in Brazil if they can demonstrate interchangeably, as they do not face the potential barrier of discretion from states.

Biosimilars Drug Approval Standards Regulation

Q&A: Pfizer On Unlocking The Promise Of Real World Evidence

Real world evidence offers big potential to get medicines to the market, but exploiting the data is not always easy for companies. Pfizer's James Harnett explains the firm's RWE strategy and some of the challenges, like unstructured data and the need for incentives and standards for gathering the data.

Review Pathway Market Access Post Marketing Studies

Medicare Risk-Sharing Contracts: A More Feasible Drug Cost Solution?

Duke’s Mark McClellan made a strong pitch for such contracting during a Capitol Hill debate on cost control with Johns Hopkins’ Gerard Anderson.

Pricing Debate Market Access Medicare

Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

Policy Generic Drugs Drug Review

FDA Performance Tracker
For more on the FDA Performance Tracker, click here.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Putting The Pieces Together For Combo Products Oversight

Bradley Thompson has been shepherding the Combination Products Coalition for more than a decade. In a recent interview, he said the recent policy spotlight on the combo-products space, including in a recent user-fee deal, is a welcome development after a period of neglect. He also spoke about the numerous reforms in the works and the state of the sector.

Combination Products Regulation United States

Latest From Regulation

Global Pharma Guidance Tracker – Sept-Oct 2016

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.

Regulation Post Marketing

WHO To Pilot ‘Biological Qualifier’ Scheme Despite Protests From Biosimilars Industry

The World Health Organization has decided to pursue its “Biological Qualifier” scheme despite concerns that it may conflict with other traceability systems. Calls by the European biosimilars industry to put the scheme on ice appear to have fallen on deaf ears.

Biosimilars Keeping Track

FDA's ANDA Approvals

Generic drug approvals and tentative approvals in late October.

Generic Drugs Approvals

Latest From Policy

India Plans New TB Strategy Amid Sharp Rise In Cases

India is planning to mount a new, expanded strategy to combat the country’s worsening tuberculosis epidemic, amid rising concerns that the actual number of patients afflicted by the disease may be even higher than a new WHO estimate.

India Policy

Japan Drug Cost Concerns Rise To The Top

Sharply rising medical spending in Japan, driven in part by expensive new drugs, is now attracting attention at the highest political levels, with a key prime ministerial council set to debate potential cost-cutting measures.

Japan Policy

NIH Funding Component of 21st Century Cures May Get White House Boost

Vice President’s Cancer Moonshot project could provide final thrust for '21st Century Cures' bill in the lame duck Congressional session after election.

Legislation Policy

Clinical / R&D Explore this Topic

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Latest From Research and Development

Uncertainty Hinders Compliance With EU Rules On R&D On Biological Resources

Bart Van Vooren explains why pharmaceutical and medical device companies are finding it difficult to comply with the Nagoya Protocol and why they must get involved with the drafting of coming guidance.

Europe Research and Development

NIH Funding Component of 21st Century Cures May Get White House Boost

Vice President’s Cancer Moonshot project could provide final thrust for '21st Century Cures' bill in the lame duck Congressional session after election.

Legislation Policy

It’s Started: EMA Proactively Publishes Clinical Data On New Drugs

The European Medicines Agency has delivered on its promise to grant public access to clinical reports that form the basis of its recommendations to the European Commission on whether or not a medicine should be authorized for use in the EU.

Regulation Clinical Trials

Commercial Explore this Topic

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Latest From Commercial

340B Impact: Roche Starts Educating Investors About Discount

The 340B hospital discount program has a much higher profile in the Rx policy world than it did before the Affordable Care Act was signed into law; now, Roche is starting to highlight the impact of the program to a different audience: its investors.

Pricing Debate Medicare

Theravance’s Revefenacin On Track For 2017 Filing With Success In Two Pivotal Trials

Partnered with Mylan to bring the first once-daily nebulized LAMA bronchodilator to market for COPD, Theravance reports statistical significant in two Phase III studies and now awaits data expected next year from an open-label safety study.

Respiratory Clinical Trials

Anthem Denies Coverage For Eteplirsen, Citing Lack Of Clinical Efficacy

The move to deny coverage for an approved orphan drug is ‘highly unusual,' NORD VP says. 'We certainly hope this isn’t going to set a precedent.'

Market Access Pricing Reimbursement

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA’s Teva Warning Letter Sets Agenda For Investigating, Remedying Sterility Failures

FDA has published a warning letter that not only provides detailed guidance for Teva’s ongoing remediation of sterility assurance failures at a plant in Godollo, Hungary, but also suggests a game plan for any manufacturer of sterile drug products that’s seeing signs of issues with aseptic operations.

Enforcement Manufacturing

EMA Maps Global Drug Supply Chain Regulatory Gaps For ICMRA

Gaps and overlaps in global and regional efforts to protect pharmaceutical supplies from intrusion of fake drugs, manufacturing quality problems and natural disasters are among the issues the European Medicines Agency has identified by mapping international initiatives for the International Coalition of Medicines Regulatory Authorities.

Distribution Manufacturing

FDA Enforcement And Compliance In Brief

FDA traces B. cepacia to PharmaTech, Nippon Workers blocked FDA investigator, Yangzhou Hengyuan used wrong API, FDA bans two Chinese firms, and Kaley to provide FDA data integrity training.

Manufacturing Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Colgate Builds On Oral Care, Counts E-commerce As Emerging Sector

Colgate's oral care business gains market share in the third quarter on new product sales, including Colgate Total Daily Repair and Colgate Optic White High Impact. President and CEO Ian Cook says the firm is not underrepresented in e-commerce and it will build its online sales “thoughtfully.”

Consumer Dental Oral

Manufacturers Argue FDA Sunscreen Reviews Keep Outside Science In Shade

FDA officials and the Public Access to Sunscreen Coalition will meet Nov. 1 in effort to find common ground between FDA and outside scientists on standards for testing requirements of new sunscreens under one of four draft guidances the agency is scheduled to finalize by the end of the year.

Consumer Dermatology

Bayer Consumer Health Journey Still Short Of Destination

Bayer says issues encountered after acquiring Merck & Co.’s consumer brands two years ago have meant slower growth than expected. But it suggests that’s not a precedent for its planned mega-merger with Monsanto.

Consumer Deals