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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

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

Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets' Utility And Limitations

A European pharmacoepidemiology study helped reassure advisory committee members about the constipation drug’s cardiovascular safety, but confounding factors limited interpretability of the results and information about the study population’s racial makeup was lacking; nevertheless, panelists urged a similar study be conducted to assess potential carcinogenic and psychiatric risks.

Advisory Committees Drug Review

Former US FDA Chief Counsels Offer Advice For Navigating Thorny First Amendment Conundrum

Daniel Troy suggests FDA increase its investment in science of consumer understanding, while Richard Cooper recommends bully pulpit approach to get attention of industry; panel of former chief counsels stresses that agency cannot continue to ignore First Amendment issues.
Advertising, Marketing & Sales Legal Issues

The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety

Zelnorm’s revival is self-conscious effort to revisit a decision made in “Safety First” era a decade ago. Is dropping CV outcomes standard for diabetes drugs next?
Drug Safety Drug Review

Latest From Policy

Part B Payment Model Indexing Commercial Discounts Proposed By Genentech

Approach offered as alternative to more disruptive changes to Part B's existing buy-and-bill system; more aggressive proposals include new iteration of  competitive acquisition program and moving Part B drug coverage to Part D.

Pricing Debate Medicare

Jitters Over Innovative Drug Pricing System Intensify In Korea As FTA Revision Deadline Nears

Concerns are brewing in South Korea as a deadline to revise the global innovative drug pricing system nears as part of the revised FTA with the US. One lawmaker has asked the government to cautiously negotiate with the US over any revisions to protect the domestic pharma industry and financial status of the national health insurance scheme.
South Korea United States

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

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

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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

Naloxone Model OTC Label Expected From US FDA As Part Of Opioids Strategy

US FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees meet in December to discuss proposed routes to make the opioid overdose reversal agent naloxone more available: both as an OTC product and one co-prescribed with opioids.

Prescription To Otc Switch Advisory Committees

Crackdown On Illegal Online Pharmacies Like Playing Internet 'Whack-A-Mole'

US FDA sends warning letters to online businesses operating a total of 465 websites selling unapproved Rx drugs for indications including breast cancer, chicken pox and pain relief. Warning letters were part of Interpol's annual Operation Pangea against online sales of illegal medical products; this year, US and 115 other countries made 859 arrests worldwide and seized $14m in potentially dangerous pharmaceuticals.


Consumer Enforcement

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