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Featured Stories


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 Immune Disorders

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 M & A

Opioid Bills Could Enhance US FDA Approval, Withdrawal Authority

House opioid package includes ability to deny or withdraw products because of abuse potential, but new Senate package does not, setting up potential conference battle.

Review Pathway Neurology Regulation

Opioid REMS Increases Nearly Six-Fold As US FDA Adds Immediate-Release Products

Basically every doctor prescribing any opioid is now covered by the REMS, but training remains voluntary. 
Risk Management Neurology Regulation

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 United Kingdom
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European Performance Tracker

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.

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 Urges Development Of Generic Alternatives To Bring Down Prices Of Complex Drugs

Given the pressing need for more affordable versions of complex drug products like peptides, liposomes, transdermals and metered dose inhalers, FDA is encouraging generic drug companies to submit more applications for generic alternatives. FDA encourages industry to leverage agency-sponsored research for more advice on how to submit applications that will get approved.
Generic Drugs Quality Manufacturing

Latest From Regulation

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

Ukraine To Start Disclosing Clinical Trial Results

A newly-approved law in Ukraine will give the public access to clinical trial results for drugs marketed in the country.

Clinical Trials Ukraine

Biosimilar Sponsors: We Need To Do A Better Job Educating Physicians And Patients

Mylan's Chrys Kokino says failure of sponsors to educate "really is a huge miss on our part."
Biosimilars Regulation

Latest From Policy

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

Medicare's CAR-T Panel Underscores Hurdles For PROs – And FDA/CMS Collaboration

MEDCAC meeting demonstrates complexity of patient-reported outcomes and place for PROs in regulatory decision-making compared to coverage.
Medicare Clinical Trials

Sofosbuvir Patent Challenge Could Highlight Weaknesses In IP Systems

NGOs from across Europe are challenging a patent protecting Gilead’s Sovaldi in an effort to expand patient access to hepatitis C treatments. They say the case will also expose failings in the intellectual property rights system that hinder access to innovation.

Europe Generic Drugs

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

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

Bayer Fortifies Branding In OTC Naproxen Market With Win In Trademark Litigation

Bayer convinces federal court to affirm USPTO appeal board decision to cancel competitor Belmora’s Flanax US naproxen product trademark because the firm used packaging that resembled a Bayer product with the same name sold in Mexico. The ruling could provide standing for owners of foreign marks to assert priority rights over similar US marks, according to a patent attorney.

International Mexico

HHS Secretary Alex Azar Talks Rebate Changes, But Not Eliminating Discounts Altogether

Details on anticipated changes to rebate practices are in demand. HHS Secretary Azar talked about changes that would still allow negotiated discounts at the point of sale during a presentation at the FT Pharma Pricing and Value Summit.

Market Access Pricing Debate

Bayer’s Consumer Health Sales Stay Cool During Summer Months

Bayer reported consumer health sales globally fell 1.4% to $1.64bn after a late start to the allergy season drove down Claritin sales. Aleve analgesics sales grew 3.3% to $112.5m on US line extensions while Alka Seltzer line sales were flat at $47.5m.

Consumer Sales & Earnings

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

The Quality Lowdown: A Contagion Of Dubious Sterility Assurance?

The constant battle of assuring the sterility of purportedly sterile products is underscored by recent warning letters, consumer alerts and other notices from US FDA. It’s clear at least that some firms are serious about microbial contamination risks – others, not so much.

Compliance Manufacturing

FDA Guidance On Post-Approval Changes for Drug Substances Closes Regulatory Gap

FDA’s guidance on post-approval changes for drug substances fills in some of the missing pieces of the regulatory puzzle on how these changes are to be reported and documented. And it arrives just as FDA and other regulatory authorities are talking with industry about major upgrades to post-approval changes processes proposed in the International Council on Harmonization’s draft Q12 guideline.
Manufacturing Quality

Another Nitrosamine Impurity Found In Valsartan; ‘Low’ Cancer Risk Seen

Zhejiang Huahai has detected a second probable carcinogen in valsartan API it manufactured. Meanwhile risk analysis suggests cancer risk from the first probable carcinogen is low, at least so far.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Bayer Fortifies Branding In OTC Naproxen Market With Win In Trademark Litigation

Bayer convinces federal court to affirm USPTO appeal board decision to cancel competitor Belmora’s Flanax US naproxen product trademark because the firm used packaging that resembled a Bayer product with the same name sold in Mexico. The ruling could provide standing for owners of foreign marks to assert priority rights over similar US marks, according to a patent attorney.

International Mexico

GSK Sees Excedrin Sales Growth As Consumers Visualize Headache Pain

Excedrin Extra Strength US sales for the 12 months ending Aug. 12 were up 4.07% to $77.2m, but those figures don't include the 12,000 free packages of Excedrin gel tablets consumers ordered during GSK's the Limited Edition promotion. The firm offered Excedrin in packages marked with causes consumers commonly link with headaches: commuting, bad dating and "adulting."

Consumer Advertising, Marketing & Sales

OTC Drug Irradiation Rule Exposed As Unnecessary In FDA Regulatory Review

US FDA proposes to repeal regulation that, since 1955, has required an NDA or ANDA for any drug product sterilized by irradiation, including drugs that otherwise would be marketed under an OTC monograph. It notes the Trump administration's order that federal agencies identify and potentially eliminate any unnecessary rules and regulations.

Consumer Manufacturing
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