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Featured Stories


BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process

Janssen and Amgen suggest user fee agreement changes aimed at speeding review process for some biosimilar applications and supplements in comments to US FDA on biologic product competition and innovation, while Merck presses agency to clarify its current view on cross-product labeling.

Biosimilars Legislation Pricing Debate

Common Combo Product Designation Mistakes To Be Outlined In Upcoming Guidance

US FDA's Office of Combination Products hopes Q&A guidance will help lower high refusal rate on requests for designation.
Combination Products FDA Regulation

US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments

Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.


Advisory Committees Drug Approval Standards Metabolic Disorders

QIDP Program Heads Into Uncomplicated Territory: Iterum, Paratek Eye uUTI Indications

Iterum’ssulopenem is first QIDP candidate to enter Phase III for uncomplicated urinary tract infection; Paratek’sNuzyra could be next.

Review Pathway Clinical Trials Infectious Diseases

US FDA Preparing For New 'Combination Product Agreement Meetings'

Cures legislation offers more development certainty for sponsors by allowing informal agreements with the agency on pre- and postmarket issues.
Combination Products Research and Development Strategies Regulation
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US FDA Performance Tracker

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.

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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

European CHMP Opinions And MAA Updates

This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Europe Approvals Drug Review

Latest From Regulation

CAR-T Therapies Should Impress EU Reimbursement Bodies

Health authorities in Europe have different approaches to evaluating the cost-effectiveness of new drugs, but in the case of the CAR-T therapies, they are likely to look favorably on factors such as their innovative nature, the small patient populations, and the dearth of effective treatments.

Health Technology Assessment Reimbursement

Keeping Track: Pfizer’s Talzenna Ensures Record Year For Novel US Approvals; Novartis Submits SMA Gene Therapy

The latest drug development news and highlights from our FDA Performance Tracker.

US FDA Performance Tracker Drug Review

Opioid Blister-Pack Mandate Tops Gottlieb's Agenda With New Authority

US FDA Commissioner says mandate for unit-of-dose packaging for opioids coming soon, but also acknowledges that move may make the drugs more expensive.
Neurology FDA

Latest From Policy

Drug Pricing Reform In Medicare And Medicaid: Upcoming Regulatory Actions

Two highly anticipated proposed rules in Medicare Part D are scheduled for near-term release.

Pricing Debate Medicare

How Brazilian Patients Might Access Sickle Cell Disease Drug Faster

Masters Speciality Pharma is in the process of registering sickle cell disease drug Siklos in Brazil. The company revealed how it would ensure the product gets to patients sooner rather than later.

South America Brazil

J&J Supports ‘Spirit’ Of DTC Pricing Transparency, But Prefers PhRMA’s Voluntary Approach

Leading off the third quarter earnings calls for biopharma, J&J offered mild support of a proposed HHS policy to require pricing information in direct-to-consumer advertising, but more enthusiastically backed a voluntary approach suggested by PhRMA.

Pricing Debate Commercial

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

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

Ovarian Cancer Risk Cut 23% With Aspirin Use – Harvard Study

Study analyzed follow-up data on 205,498 women from the Nurses’ Health Study started in 1976 and Nurses’ Health Study II opened in 1989; 1,054 of the women developed ovarian cancer.

Drug Safety Consumer

ASPREE Results Support FDA Aspirin Label Guidance On Cardiovascular Disease

Data from ASPREE trial with more than 19,000 subjects show five-year-use of low-dose aspirin did not prolong disability-free survival and is associated with a significantly higher rate of hemorrhage and somewhat higher rate of all-cause mortality. Findings in three reports in NEJM track with US FDA's guidance that OTC aspirin marketers include a statement referring to doctors when aspirin package labels include a heart or other image suggesting a CV indication.

Drug Safety Consumer

Commercial Explore this Topic

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Latest From Commercial

With TheraFlu PowerPods, GSK Brews Market For OTCs From Coffee Makers

GSK takes Theraflu brand from medicine cabinet to kitchen with launch of PowerPods of OTC ingredients delivered through single-serve coffee makers. Introduction of non-coffee pods also is growing, including lemonade, hot ciders, teas and Campbell's Soup pods.

Consumer Drug Delivery

Anatomy Of A Biotech Company: Acorda Gets Dressed For A Second Act

Acorda's rise, fall, and attempt to rise again is a snapshot of the life of a biotech. The company reached the commercial-stage pinnacle with Ampyra, only to eventually see it fall away to patent challenges. Now, after big staff cuts, the company is hoping to prevail in the commercial market again, this time with Inbrija.

Commercial Companies

J&J Supports ‘Spirit’ Of DTC Pricing Transparency, But Prefers PhRMA’s Voluntary Approach

Leading off the third quarter earnings calls for biopharma, J&J offered mild support of a proposed HHS policy to require pricing information in direct-to-consumer advertising, but more enthusiastically backed a voluntary approach suggested by PhRMA.

Pricing Debate Commercial

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Survey Shows Drug Makers Don't Expect To Begin Serializing All Packages By November Deadline

Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA product package serialization requirement appear to be bearing fruit, according to a recent survey.

United States Manufacturing

Seqirus Completes Long Journey To Restore Afluria's Pediatric Indication

The key to pediatric approval for a flu vaccine: a manufacturing root cause investigation and subsequent process improvements.

 

Manufacturing Vaccines

EU GMP Annex 1 Would Give Microbiologists A Greater Role In Sterility Assurance, Rapporteur Says

A proposed revision of the EU GMP Guide’s Annex 1 calls for microbiologists to get out of the lab and more involved in risk assessments to ensure that sterile products are free from contamination, according to the annex’s rapporteur.

Europe International

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

With TheraFlu PowerPods, GSK Brews Market For OTCs From Coffee Makers

GSK takes Theraflu brand from medicine cabinet to kitchen with launch of PowerPods of OTC ingredients delivered through single-serve coffee makers. Introduction of non-coffee pods also is growing, including lemonade, hot ciders, teas and Campbell's Soup pods.

Consumer Drug Delivery

Acne Claims For Cosmetics Leave Blemish On UK Advertising Regs

Advertising Standards Authority issued decisions Oct. 17 on complaints against three cosmetics brands and an online beauty retailer for statements the independent regulator reads as acne-treatment claims, or the “spots” equivalent, calling them medicinal claims for unlicensed products.
Consumer United Kingdom

J&J's Supplement Step With Zarbees Helps Drive A Leap For Consumer Health Growth

Supplement brand being marketed to compete with OTC drugs, including J&J's own brands, in cough and cold and other categories helped J&J overall consumer health sales grow 9.7% to $440m in Q3. Oral care brands showed 3.2% worldwide growth to $384m, benefiting from recent launch of chewable Listerine Ready! Tabs.

Consumer Advertising, Marketing & Sales
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