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Political Appointees Shouldn't Influence Approval Decisions, Califf Says

FDA commissioner offers new details about why he left final decision on Sarepta's controversial Duchenne muscular dystrophy drug to FDA's expert bureaucrats.

Approvals Drug Review Policy

Accelerated Approval Should Be Less 'Wide Open,' Califf Says

FDA should write more about its interpretation of regs and apply it more consistently across divisions, commissioner says.

Drug Approval Standards Review Pathway Clinical Trials

No More Sarepta-Like Development, FDA Officials Say

OND Director Jenkins says Sarepta's Exondys 51 shouldn't be a model, gets an earful from patient advocates.

Approvals Clinical Development and Trials Drug Approval Standards

Biopharma Goes 3 For 3 In Presidential Debates

The Presidential debates are over, and the biopharmaceutical industry has to be counted among the winners, simply because there was no substantive discussion of high drug prices as an issue. That may not mean much come 2017 – but at least the industry’s reputation hasn’t been further damaged during the highest profile phase of the national campaign.

US Election 2016 Pricing Debate Policy

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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Q&A: Janssen on where it is heading with real world evidence

Getting to grips with real world evidence can help companies get their medicines to patients, but there are multiple challenges too, such as “messy” data and building trust, says Nigel Hughes of Janssen Pharmaceutical.

Regulation Clinical R and D Comparative Effectiveness

Latest From Regulation

ANDA Holder Fee Will Start With Industry-Driven Database 'Clean-Up'

FDA is again relying on sponsor self-reporting as it launches GDUFA II.

Drug Review FDA

GDUFA II: Industry Shares Stage With FDA

Public meeting departs from usual format, allowing industry representatives to sit next to FDA and answer audience questions as generic during user fee agreement outlined.

Drug Review FDA

AstraZeneca's Cediranib Withdrawal: CHMP Had Two Major Issues

European filing for ovarian cancer candidate cediranib was undone by difference in opinion between AstraZeneca and EMA's advisory committee in two key areas – the clinical benefit, and compliance with GCPs.

Clinical Trial Regulation Drug Review

Latest From Policy

Biosimilar Guidance Development Timelines Criticized By Docs And Patients

FDA's user fee deal with sponsors sets target dates for documents on interchangeability, naming and labeling, but non-industry stakeholders urge agency to accelerate their release; guidance development efforts will get boost in BsUFA II with funding for new dedicated biosimilars unit starting in fiscal year 2018.

Policy Biosimilars

Biosimilars Switching Debate Escalates After Remicade and Remsima Match In Landmark Study

Biosimilar drug makers say that the NOR-SWITCH study on switching from Johnson & Johnson’s infliximab to the Celltrion product supports the concept of biosimilarity and proves that they are subject to the same regulatory standards as originators. Originators, meanwhile, want more evidence that switching works.

Biosimilars Prescribing

EFPIA Urges Japan To Consider New Funding Models

Amid intensifying official scrutiny of rising drug costs, the European industry federation EFPIA would like Japan to focus more on the measuring the actual benefits and health outcomes of new therapies, helped by new approaches and technology.

Japan Policy

Clinical / R&D Explore this Topic

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Latest From Research and Development

GSK's David Leather On Transitioning from GP And Radio Doctor To Real World-Evidence Czar

Leather – the man behind GlaxoSmithKline's ground-breaking real-world evidence initiative, the Salford Lung Study – is GSK’s in-house RWE expert. He spoke with the Pink Sheet about a range of topics, including how Salford might influence the development of RWE.

Clinical Trials Comparative Effectiveness

Biomarkers For Pancreatic Cancer To Be Tested In Multi-drug Collaborative Study

Patient advocacy group is spearheading the genomics-driven trial, which will assess if stratification may finally be possible in pancreatic cancer.

Clinical Trials Combination Products

Zika Vaccine Trials Could Test Multiple Candidates Vs. Common Control Group

FDA and NIH officials propose three strategies for clinical trials, saying it will be challenging to identify the most promising candidates; Sanofi and Walter Reed researchers note challenges in vaccine development, including manufacturing scale up.

BioPharmaceutical 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

WHO Issues Best Practice Guide For Counterfeit Drug Detection

WHO heeds the call of member states and issues guide on standard operating procedures for labs to follow in testing suspected counterfeit drug products. A majority of survey respondents had told WHO that drug counterfeiting is a major problem within their territories and that such a guidance is needed.

Manufacturing Manufacturing Quality

ICH Sets Three-Year Goal To Harmonize Criteria For Biowaivers

ICH outlines an ambitious work plan to harmonize the disparate requirements for biowaivers among regulators worldwide; New concept paper and business plan highlight areas of disagreement.

Manufacturing Manufacturing Quality

Does India's Perpetual Licensing Plan Risk Backfiring?

India's wide-ranging drug regulation overhaul plan, including a perpetual licensing system aimed at simplifying processes and potentially delinking licensing and enforcement responsibilities may well emerge as a double-edged sword.

Manufacturing India

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

With OTC Lidocaine, Salonpas Takes Path Of Less Resistance To Market

Hisamitsu America looked to the OTC lidocaine market after deciding it would have to wait too long for an ANDA approval for an Rx generic. "We really saw the opportunity in the OTC space with a 4% OTC patch," says President and CEO John Incledon.

Japan Asia Pacific

Sinex Says 'Clear Your Head' To Launch Oral Dosage, Mist Sprays

P&G will promote its re-launched Vicks Sinex nasal decongestant brand with an ad campaign that will feature the tagline, “The Clear Your Head Medicine.”

Consumer Advertising and Marketing

Benefit From OTC Switches Supported In Study Of PPIs' Outpatient Impact

Proton pump inhibitor OTC switches since 2003 had a profound and sustained impact on outpatient health care visits – illustrating the potential for other switches to benefit US health care, a recent study suggests.

Prescription To Otc Switch Consumer