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Featured Stories


UK Pharma Takes Hope From Draft Brexit Deal But Uncertainty Reigns

The Brexit deal agreed by UK ministers brings little certainty for the life sciences sector.  Moreover, the related and unprecedented political instability means that its final approval is far from guaranteed. 
Brexit Legislation Regulation

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 Legislation

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 Market Access

PMRS Continues Campaign Against Other Abuse Deterrent Opioid Products

Latest citizen petition seeks to halt US FDA approval of Mallinckrodt's immediate release oxycodone abuse deterrent formulation; user fee action date is Nov. 16.

Drug Review Neurology FDA

Opioid-Sparing Regimens Face High Hurdles After US FDA Advisory Cmte.

Panelists felt the phrase "opioid sparing" was too broad, and contended that it is difficult to develop a non-opioid alternative without an opioid as an active comparator. 
Advisory Committees Neurology Clinical Trials
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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.

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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.

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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

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
Drug Review Europe Approvals

Latest From Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

UK Court Ruling A Blow For Pfizer And A Warning For Patentees

A UK Supreme Court decision to invalidate Pfizer's pregabalin patent is not only bad news for Pfizer and good news for the generics firms involved – it could also mean that companies have to produce more evidence to substantiate their patent claims in future.
Intellectual Property Regulation

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

Latest From Policy

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

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

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

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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

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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
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