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Featured Stories


Big Share Of EU Decentralized Procedures Still Seeking Post-Brexit Home

Progress is being made with redistributing UK rapporteurships for non-centrally approved medicines, but companies need to keep up the momentum if all procedures are to be reallocated to other EU countries by the Brexit date of March 29, 2019.

Brexit Life Cycle Management Regulation

'Teva Has Earned Nothing,' US FDA Tells Court In Battle Over Generic Restasis 180-Day Exclusivity

Court orders agency to provide 48 hours' notice before issuing decision that would allow any manufacturer other than Teva to launch a generic.

Generic Drugs Legal Issues Intellectual Property

Is Bloom Gone From Rosy ANDA Approvals Figures?

US FDA sets a new monthly record for full approvals, but industry group argues that approvals alone aren't creating more generic competition in the market.
Generic Drugs Pricing Debate Regulation

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 Research and Development Strategies

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 Review Pathway
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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

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 Drug Approval Standards

Latest From Regulation

Merck's View On The Challenges Of Ebola Vaccination In The DRC

With the latest Ebola outbreak threatening to spread across the Democratic Republic of Congo and beyond, efforts are being stepped up to vaccinate the at-risk population and health workers with Merck Sharp & Dohme’s experimental vaccine, V920. MSD’s Mel Kohn spoke to the Pink Sheet about the development of the vaccine, the experience gained from its use to date, and the difficulties involved in getting the vaccine to those who need it.
Vaccines Infectious Diseases

Novartis And Stemline Try For Fast-Track EU Review

The European Medicines Agency is this week deciding whether it will fast track its review of orphan drugs that Novartis is developing for the treatment of Cushing's syndrome and Stemline Therapeutics is developing for the hematologic malignancy, BPDCN.
Drug Review Regulation

EMA Outlines Regulatory Expectations On Use Of Patient Registries

Building on its ongoing patient registry initiative, the European Medicines Agency has issued recommendations on the methodological and operational aspects of the use of patient disease registries and registry studies for regulatory purposes.
Europe Clinical Trials

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

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Latest From Research & Development

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

Regulatory Lessons For Advanced Therapy Makers: A Case Study

Developing advanced therapy medicinal products is not easy, but the head of regulatory affairs at Swedish cell therapy company Immunicum has some useful tips for SMEs that could help them navigate their development more easily.

Research & Development Clinical Trials

ICER Is Weighing Early Research Consulting Work With Pharma

The drug value assessment organization said it is considering whether or not to move forward with a program to consult pharmaceutical manufacturers on early research, a move that could raise questions about the group's independence.

Clinical Trials Health Technology Assessment

Commercial Explore this Topic

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Latest From 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

Amgen Drops Repatha List Price 60% To Cut Medicare Co-Pays And Boost Use

Company says 75% of Medicare Part D patients who aren't eligible for low income subsidies abandon the PCSK9 inhibitor at the pharmacy counter due to $370 co-pay, which may now range from $25-$150 per dose.

Pricing Strategies Market Access

Manufacturing Explore this Topic

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Latest From Manufacturing

Firms Should Characterize Their Cell And Gene Therapies Early

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

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

Glaxo, Sanofi Look Far Afield For Consumer Health Growth

Big pharmas' recent third-quarter results and commentaries point to sales drivers for consumer health divisions coming from markets outside their established primary markets of US and Europe. Consumer unit lines include oral care and topicals as well as nutritional products.

Consumer Sales & Earnings

Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.
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