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


Opioid Prescribing Guidelines Will Be More Template Than Commandment

Commissioner Gottlieb says US FDA does not intend to force physicians to adhere to opioid prescribing guidelines being developed by National Academies of Sciences, Engineering, and Medicine.
Drug Safety Neurology Regulation

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 Medicaid

Brexit: EU Countries Dragging Feet On At-Risk Medicines

The EU regulatory network is finding it difficult to identify non-centrally authorized medicines that are at risk of Brexit-related shortages, a workshop on medicines availability has heard. 
Brexit Regulation Europe

No Quick End To Brexit Activity Hold At EMA

As the European Medicines Agency gears up to implement its carefully crafted Brexit business continuity plan, it hopes to be in a position to reintroduce some of its currently suspended/reduced activities in the second half of next year.
Europe United Kingdom Brexit

Mallinckrodt's Abuse Deterrent Oxycodone IR Narrowly Wins US FDA Panel Backing

"Incremental" step forward is sufficient for product to be labeled as deterring abuse by nasal, but not intravenous route, advisory committee members conclude.
Advisory Committees 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

Reliance On ‘Digitized Paper’ Is Slowing Drug Development – US FDA’s Woodcock

Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.

Clinical Trials Drug Review FDA

Latest From Regulation

CAR-T Label Update Could Address Medicare Coverage Challenges, FDA’s Gottlieb Suggests

Medicare’s current approach to inpatient CAR-T reimbursement in 2019 would lead to an $186,500 shortfall for providers per patient, stakeholders estimate.

Regulation Medicare

US FDA Allows Waiver Of Informed Consent For Clinical Investigations With Minimal Risk

Agency seeks input on types of investigations that would involve minimal risk, exclusion of waiver to research involving identifiable private information.

BioPharmaceutical Regulation

Opioid Sparing Outcomes, Non-Opioid Alternatives To Get Spotlight From US FDA Advisory Cmte.

The advisory committee will discuss a broad range of questions on a facet of FDA's opioid strategy that has received less attention than the others.
Advisory Committees Neurology

Latest From Policy

Express Scripts New Flex Formulary Will Prefer Lower-Priced Brand Alternatives

Gilead’s authorized generics for Epclusa and Harvoni will be first alternatives to benefit from preferred coverage on the pharmacy benefit manager's National Preferred Flex Formulary.

Pricing Strategies Market Access

Scottish HTA Okays Neuroblastoma Ultra Orphan Qarziba

The Scottish Medicines Consortium has recommended EUSA’s ultra-orphan neuroblastoma treatment Qarziba.

Health Technology Assessment Government Payers

Triangulation Or The Bermuda Triangle: Can Trump Work With House Dems On Drug Prices?

President Trump is highlighting drug pricing as an area where he may be able to work with the new Democratic majority in the House. The political wisdom of building common ground on the topic is hard to ignore – but the tempestuous personality of the President is still the overriding factor. Instead, focus on whether HHS can win some breathing room to keep going with administrative changes.
Elections Pricing Debate

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

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

Good News For Australian Sponsors Sourcing APIs From Canada

Australian and Canadian drug regulators have extended their mutual recognition agreement on good manufacturing practice inspection and certification to include active pharmaceutical ingredients.

Australia Canada

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