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Will Alkermes Data Package Support ALKS 5461 Approval?

Alkermes revealed successful completion of its third Phase III trial for the depression drug ALKS 5461 as well as a risky plan to seek FDA approval based on two negative and one positive late-stage study.

Clinical R and D Review Pathway Neurology

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 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 Regulation

'Upheavals' In Store As India Set To Mandate Marketing Code

India's uniform code for pharmaceuticals marketing practices, so far voluntary in nature, appears to be on course to becoming "statutory" and "mandatory", signaling some potential short-term turbulence in the growing domestic market.

Marketing and Sales India Regulation

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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

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 Regulation

Latest From Regulation

UK MPs On Brexit: EMA And MHRA Are ‘Completely Intermingled’

Perhaps appealing to the wider European audience, UK legislators debating Brexit’s impact warn of damage to EU and as well as UK regulatory systems.

Brexit Regulation

DTC Animation Study Moving Forward After FDA Rejects Merck Critique

Merck contends FDA's study of animation in drug ads may be ‘unnecessary for the proper performance of FDA’s functions’ but agency says it could influence policy.

BioPharmaceutical Regulation

Complex ANDAs To Be Allowed Pre-Submission Product Meetings

FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.

Combination Products Clinical Development and Trials

Latest From Policy

Biosimilar Prescribing Decisions May Depend Upon Disease State

Express Scripts’ Eichholz says clinicians may be less inclined to use a biosimilar in ‘life or death’ oncology indications compared to inflammatory diseases.

Policy Biosimilars

Korea Plans Breakthrough System To Encourage Innovation

Following up on its May announcement of a conditional approval scheme to shorten R&D and approval periods, and aiming to ensure the prompt and stable supply of life-saving drugs, South Korea is planning a new law on breakthrough therapies and for drugs for public health crises.

South Korea Review Pathway

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

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

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

Set Alert for Consumer OTC Drugs

Latest From Consumer

Pharma Firm ISO OTC Switch Partner; NDA Experience, Resources Needed

Success in OTC switches can hinge on finding the right partner, say switch consultants during a CHPA webinar. Due diligence in negotiations can help determine if a potential partner is the right fit for the time- and labor-intensive processes.

Prescription To Otc Switch Consumer

J&J Consumer Sales Flat: Consumer Health News Roundup

Catalyst Principal continues east Africa health care investing; Salonpas adds lidocaine patch; and more news in brief.

Asia Pacific Germany

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