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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

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

Another Testosterone Warning – This Time For Abuse

Action follows agency review of 81 adverse events reported with testosterone/anabolic androgenic steroid misuse, abuse, or dependence over 45 years; discussions continue on cardiovascular study.

Product Safety Post Marketing

FDA Adds New Co-Primary Endpoint For Female Sexual Desire Drugs

Draft guidance says 'associated distress' may replace number of satisfying sexual events as a co-primary efficacy endpoint.

Clinical Trials Drug Approval Standards

Iressa Reviewers

FDA staff who participated in the review of AstraZeneca’s EGFR tyrosine kinase inhibitor gefitinib; a feature of the Pink Sheet’s Drug Review Profile series.

Drug Review Profile BioPharmaceutical

Latest From 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

10 Questions For Bayer's UK CEO On Market Access Reforms In England

Bayer AG's CEO for the UK and Ireland, Dr. Alexander Moscho, outlines his concerns about the reformed cancer drugs reimbursement system in England and Wales, which in October 2016 saw the first new drug introduced since an overhaul and relaunch earlier this year. Moscho also highlights his worries around proposals from NICE to introduce fees for appraisals of new medicines for use on the National Health Service, which he believes could taint the health technology appraisal committee's reputation and generate skepticism around its independence from industry.

Pricing Reimbursement Market Access

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

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

Inflectra Launch Prep Continues Post-Deadline, Pfizer Says

The 180-day notification period has passed for biosimilar of Celltrion's Remicade, but Pfizer seems to be aiming for an at-risk launch sometime this year.

Biosimilars Product Launch

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

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

P&G Keeps Direct-to-Consumer In Perspective, Retail Distribution Primary

Procter & Gamble remains focused on conventional retail sales, though it will continue to leverage the DTC distribution channel for several categories, CFO Jon Moeller says. Health care sales in the firm's latest quarter jumped 7%, outperforming other sectors.

Consumer Dental Oral