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Featured Stories


Medicare Part D ‘Modernization’ Policies Still Priority Reforms – OMB’s Grogan

Office of Management and Budget health programs official highlights the Administration’s plan for updating and lowering costs in Medicare Part D, including point-of-sale rebates.

Pricing Debate Regulation Medicare

US FDA Threatens Fines For ClinicalTrials.gov Noncompliance

Draft guidance states that "responsible parties" could be fined $10,000 for not submitting trial information to the federal data repository as required by law.
United States Clinical Trials FDA

UK Court Opens Way To Generic Versions Of Gilead’s Truvada

The High Court has ruled that Gilead’s supplementary protection certificate on Truvada is invalid, opening the way to generic versions of the combination drug for preventing HIV infection.

 

Intellectual Property United Kingdom Generic Drugs

The Economics Of Drug Shortages: US FDA Seeks Broad Input

FDA is planning series of stakeholder meetings to identify new approaches to drug shortages, with particular interest in defining “essential” drugs. Agency is also looking outside for expertise, with Boston University’s Rena Conti tapped as advisor.
Manufacturing Regulation Pricing Strategies

Korea Lowers Medical Cost For Rare Disease Patients, Eases Off-Label Use Rules

In an ongoing effort to improve access to drugs and provide more treatment options for rare disease patients, South Korea unveils new steps to lower their treatment costs and expand the scope of what are considered rare diseases.

South Korea Regulation BioPharmaceutical
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Global Pharma Guidance Tracker – August 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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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.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Non-Traditional Antimicrobials Can Follow Regulatory Path Laid By Small Molecule Antibiotics, US FDA Says

Live biotherapeutics, fecal microbiota transplants and bacteriophages may be novel when it comes to fighting hard-to-treat infections, but their development and route to approval may not be all that different than traditional antibiotics, officials from FDA’s drugs and biologics center say.


Drug Approval Standards Clinical Trials Infectious Diseases

Latest From Regulation

Not The End For Exondys In EU, Says Sarepta

Sarepta Therapeutics’ hopes of marketing its controversial Duchenne muscular dystrophy drug in the EU have again been dashed, but the company says it hopes to learn from EU regulators next year what it can do to get the drug to patients in Europe. Meanwhile, sales of the product are going well in the US.

Drug Review Approvals

Dutch Insurer Seeks €4m from AZ Over ‘High’ Seroquel Price

AstraZeneca is being pursued in court for compensation over what a health insurer calls the “unnecessarily high price” that the company charged for Seroquel.

Pricing Debate Reimbursement

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
European Performance Tracker Drug Review

Latest From Policy

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues

Cigna Acquisition Of Express Scripts 'Unlikely' To Harm Competition, DOJ Concludes

Department of Justice clears insurer Cigna to acquire PBM Express Scripts with no divestitures or other actions required by the two giants; American Antitrust Institute says it will "trigger a fundamental restructuring of the US healthcare system."

Pharmacy Benefit Management Private Payers

Northern Ireland Improves Access To Cancer Drugs Fund Treatments

Measures announced by the Northern Ireland department of health to bring access to cancer treatments in line with other parts of the UK are expected to make the region more attractive for clinical research.
BioPharmaceutical Europe

Clinical / R&D Explore this Topic

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Latest From Research & Development

Repeated Questions Prompt EMA To Reconsider Guidance On Neonates

The European Medicines Agency wants to update its guidance on the investigation of drugs in term and preterm neonates to reflect the “considerable experience” it has gained in assessing pediatric investigation plans.
Clinical Trials Research & Development

Making Real World Evidence Less 'Messy' To Help With Drug Pricing

The Medicines Company's inclisirin CV trial is 100-fold cheaper with digitized records, while Lilly is still hunting for a good HBA1C dataset, and Merck worries about "idiosyncratic" data.

Pricing Strategies Research & Development

Biosimilars: Is Small Dip In Development Indicative Of Sustained Downward Trend?

As US FDA sees dip in application development, experts offer contrasting assessments about future of biosimilars at AAM's GRx Biosims conference. 
Biosimilars Research & Development

Commercial Explore this Topic

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Latest From Commercial

Novo Nordisk CEO Says Group Doubling Medical Supplies in UK Ahead Of Brexit

Novo Nordisk's chief says the Danish company is stockpiling medicines in case of "no deal" hard Brexit

Brexit Business Strategies

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues

Cigna Acquisition Of Express Scripts 'Unlikely' To Harm Competition, DOJ Concludes

Department of Justice clears insurer Cigna to acquire PBM Express Scripts with no divestitures or other actions required by the two giants; American Antitrust Institute says it will "trigger a fundamental restructuring of the US healthcare system."

Pharmacy Benefit Management Private Payers

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates

Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.
United States Manufacturing

Some Double Bar-Coding Required After November DSCSA Deadline, US FDA Says

As agency offers further guidance on how and when to begin complying with Drug Supply Chain Security Act requirements, one twist is that some packages will need two barcodes, depending on the circumstances.

Distribution Manufacturing

Contract Manufacturers Cautioned On Allure of Novel Cell and Gene Therapies

Contract development and manufacturing organizations are fielding requests from sponsors to ramp up for emerging novel treatment modalities like CAR-T cells and gene therapies but shouldn't "over-invest," consultant advises. Meanwhile, MAb production capacity, already huge, is growing 50% over the next five years to meet surging demand.

Business Strategies Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Freshkote Buy Narrows Eyevance's Focus

Agreement with Focus Laboratories includes all Freshkote formulations in multi-dose bottles and single-unit vials to market and commercialize the line worldwide.

Deals Ophthalmic

GSK Invests In OTC Production, Prepares To Divest Horlicks Nutritional Business

Latest consumer health investment was $36m upgrade to a Canadian facility, which by mid-2019 will begin making Voltaren OTC topical gel products. GSK's next move in consumer health divestment is its pending sale of its Horlicks business.

Consumer M & A

FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says

In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow.  CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.

Prescription To Otc Switch Drug Approval Standards
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