Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.

Digital Health Advertising, Marketing & Sales Regulation

Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later

CBER Director Peter Marks says the "half-life" for the existing six gene therapy guidances likely is two to three years due to the fast pace of scientific discovery.
Regenerative Medicine Regulation Biologics

Health Must Be At Center Of Post-Brexit Relationship, Say Industry & NHS Bodies

UK industry and National Health Service bodies say that the “political declaration” on the future UK-EU relationship fails to address key public health issues such as regulatory cooperation, collaboration in science and innovation, and tackling counterfeit medicines.
Brexit Regulation Europe

US FDA Launches Study Of Prescriber Perceptions About Abuse-Deterrent Opioids

The agency is assessing whether to use different language to describe addiction and abuse deterrence.
Drug Safety Neurology Post Market Regulation & Studies

Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid

Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
Complete Response Letters Neurology Drug Review
Advertisement

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – October 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

International Australia Hong Kong

Pharma Report Store

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop Now

Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

Read Now

Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

Read the eBook and discover more

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

FDA Reports Growing Use Of Process Modeling Tools To Support Continuous Manufacturing

FDA reports “growing traction” of continuous manufacturing and a corresponding uptick in the use of models to support this mode of manufacturing. Officials explain how they assess these models during inspections.
Manufacturing Quality BioPharmaceutical

Latest From Regulation

UK Agency Boss Hudson Leaves Brexit Challenge To Successor

A new leader is needed for MHRA as UK agency CEO Ian Hudson announces he'll leave next September. Someone else will have to reshape and guide the agency after Brexit.
Europe Brexit

European CHMP Opinions And MAA Updates

This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

French Launch Fast-Track Clinical Trial Approval Scheme

Sponsors are being invited to trial a new fast-track system for authorizing clinical trials as part of French preparations for the new EU trial rules that are set to come into force in 2020.

Clinical Trials France

Latest From Policy

Medicare's Part B Reform Proposal May Be Gaining Momentum; Congress Not Hearing Strong Protests

Muted stakeholder reactions may reflect Trump Administration efforts to address physician concerns in its Medicare Part B drug payment reform.

Pricing Debate Medicare

Outcomes-Based Funding Deals On The Up In EU But Are They The Right Tool?

Outcomes-based reimbursement agreement are becoming increasingly popular in Europe. They’re complicated, there’s no “one size fits all” and it’s important companies and payers alike know what’s involved, says a forthcoming report.

Europe Government Payers

Outcomes-Based Contracts May Be Negotiated By Michigan Medicaid

Michigan follows Oklahoma in gaining approval to negotiate supplemental rebates in the context of value-based contracts for drugs. Oklahoma now has four novel contracts in place.

Pricing Strategies Reimbursement

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

The Meta-Physics Of Meta-Analysis: US FDA’s Curious Framing Of New Safety Guidance

Long delayed guidance on meta-analysis “will assist sponsors of drug and biological products in designing safety meta-analyses of randomized controlled trials using best practices,” FDA Commissioner says. True – but is that really the point? 
Clinical Trials Drug Safety

US FDA Drug Development Tool Qualification Takes Center Stage At December Meeting

Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.

Research & Development Animal Testing

Expanded Access: US FDA Told To Increase Regulatory Clarity, Early Interactions With Sponsors

Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.

Research & Development Clinical Trials

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Bayer Consumer Health Yet To Turn Corner Due To Supply, Innovation Detours

Company needs to get beyond a supply problem for products including iconic Bayer Aspirin brand and heat up Coppertone sun care and sunscreen product sales with line extensions to help drive the consumer health business to heights envisioned as part of an expansion a few years ago.

Consumer Commercial

Prestige Consumer's First Quarter Exclusively In OTCs Is Prelude To Growth

Prestige Consumer's sales in its latest quarter were lifted by gas relief and ear wax products, but the gains were offset "revenue recognition" accounting changes and slower sales of BC and Goody's as supplies of the analgesics transitioned to new packaging.

Consumer Commercial

Potassium Lowering Therapies Hit NICE Hurdle In UK

AstraZeneca’s Lokelma and Vifor’s Veltassa will be subject to a final review by the England and Wales health technology appraisal body in December following draft guidance not recommending their use in the National Health Service to treat hyperkalemia.

Health Technology Assessment Reimbursement

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

NIIMBL Issues Roadmaps For Advancing Gene Therapy, Vaccine And Antibody Drug Conjugate Manufacturing

A public/private manufacturing technology partnership has produced three roadmaps to help the biopharmaceutical industry navigate some of the regulatory and analytical hurdles in developing and manufacturing gene therapies, vaccines and antibody-drug conjugates. All three roadmaps cite a knowledge gap in the industry and the need for an adequately trained workforce.

United States Manufacturing

Firms Should Characterize Their Cell And Gene Therapies Early, FDA Says

US FDA official advises that to avoid the “brick wall” of BLA rejection, manufacturers should characterize their cell and gene therapy products and develop potency assays as early as possible.

United States Manufacturing

FDA Launches Protocol For Inspections Of Sterile Drug Manufacturing Facilities

US FDA expects the New Inspection Protocol Project (NIPP) it launched Nov. 9 to increase the consistency of its sterile manufacturing inspections – and the ability of those inspections to catch quality problems before they could lead to drug shortages.

Quality Compliance

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Bayer Consumer Health Yet To Turn Corner Due To Supply, Innovation Detours

Company needs to get beyond a supply problem for products including iconic Bayer Aspirin brand and heat up Coppertone sun care and sunscreen product sales with line extensions to help drive the consumer health business to heights envisioned as part of an expansion a few years ago.

Consumer Commercial

OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History

Amphastar has initial inventory on hand of epinephrine inhalation aerosol reformulated with hydrofluoroalkane as a propellant, and expects "almost no costs" for sales of first several hundred thousand units. After two NDAs and two CRLs, firm convinces US FDA consumers can use the product without doctor or pharmacist guidance and understand it is not for ongoing asthma treatment.

Consumer Approvals

Perrigo Moves From Health Care To 'Self Care'

Providing self-care products "opens this organization up to massive opportunity" which Perrigo will identify in early 2019, says new CEO Murray Kessler. It remains committed to selling or spinning off its Rx unit, though it's "just a few FDA approvals away from significantly" growing, he says as firm reports $68m net loss in its latest quarter.

Consumer Sales & Earnings
UsernamePublicRestriction

Register

Advertisement