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Featured Stories


It’s Time For The Feds To Get Into Drug Manufacturing, Senator Warren Says

Warren's proposed legislation aims to bring down prices and stabilize supplies by establishing government competition to generic drug monopolies.

Generic Drugs Biosimilars Manufacturing

GDP Failings A Public Health Risk, Says UK Inspector

Despite a succession of steps to improve the API supply chain, the UK regulator still finds may instances of non-compliance with good distribution practice.

Distribution Manufacturing Europe

Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected

In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.
Drug Approval Standards Neurology Drug Safety

Naloxone Mandate In Opioid Labels Divides US FDA Panel, Even As It Wants Patient Conversations

Advisory committee members vote narrowly in favor of labeling opioids with a recommendation to co-prescribe naloxone, but more agree that the goal is to facilitate patient-provider dialogue about overdose risks.
Neurology Advisory Committees Drug Safety

DTC Price Disclosure Should Include Cost Sharing Context, Patient Groups Tell CMS

Some patient groups, payers support CMS proposal to require disclosure of list prices in TV ads but want to expand the requirement to other media and beef up enforcement. Others are skeptical the proposal would lower prices.

Pricing Debate Regulation Medicare
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – November 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.
International Europe Belgium

Global Generics & Biosimilars Awards 2018

Generics bulletin was able to celebrate the outstanding progress that both teams and individuals achieved in providing greater healthcare access through generic, biosimilar and value-added medicines. Many of these achievements have been documented in Generics bulletin. Click below and enjoy the selection of articles that reflect the wide array of industry activities.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

MAH Responsibilities Clarified In Revised EU Guide On Active Substance Master File

The European Medicines Agency's updated ASMF procedure guideline says the marketing authorization holder is responsible for ensuring access to all relevant information needed to take full responsibility of the quality of the active substance in a medicinal product.
Europe Quality Safety

Latest From 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.

 

Drug Review Approvals

Pharma May See Brighter Enforcement Environment After US Justice Department Policy Changes

Policy revisions on individual liability for corporate misconduct, noncompliance with agency guidance documents and dismissal of False Claims Act cases suggest a greater willingness by DoJ leadership to reconsider arguments often raised by life sciences companies, attorneys say at a Food and Drug Law Institute conference.


Enforcement Compliance

Biomarker Qualification Can Focus On Risks, Benefits, And Expansions – US FDA

Draft guidance describes evidence needed to support qualification of a biomarker for use in drug development programs.

Clinical Trials Drug Approval Standards

Latest From Policy

HHS Senior Advisor O’Brien Emerges As Azar’s Lead On Drug Pricing In 2019

O’Brien assumes role from his late colleague and friend Dan Best as HHS closes out administrative items in the blueprint.
Pricing Debate Policy

Arnold Foundation Will Retain Drug Pricing Focus As Health Care Agenda Grows

In an interview with the Pink Sheet, Laura and John Arnold Foundation VP Health Care Mark Miller discusses the foundation’s ongoing drug pricing priorities.

Pricing Debate Medicare

Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Biomarker Qualification Can Focus On Risks, Benefits, And Expansions – US FDA

Draft guidance describes evidence needed to support qualification of a biomarker for use in drug development programs.

Clinical Trials Drug Approval Standards

Drug Development Tool Qualification: US FDA Offers Three-Step Review Process

FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle. 

Clinical Trials Research & Development

Major Depressive Disorder Patients Emphasize Long-Term Nature Of Disease In Feedback Meeting

Externally hosted patient focused drug development meeting in MDD brings timely messages to US FDA during period of active regulatory review of new applications. Patients stress need for fewer side effects to encourage long-term medication use, and also want fast-acting meds that can “jump start” lifestyle changes. 
Neurology Research & Development

Commercial Explore this Topic

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Latest From Commercial

HRA Pharma Reveals Big Growth Ambition: Become Top 10 OTC Player

Consumer OTC Drugs

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA’s Revised Draft For Compounding Pharmacies Opens Door To Compounding For Office Use

FDA’s revised draft guidance on GMPs for outsourcing pharmacy compounding operations responds to calls to allow the compounding of small quantities of drugs presumably for office use. The IACP applauds the move.
United States Manufacturing

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

New Russian Quality Assurance Rules Could Push Up Costs & Delay Product Launches

New rules aimed at tightening quality control on medicines that are to be introduced in Russia next year are expected to help prevent low-quality drugs getting to the market. However, they will bring some additional costs for pharmaceutical companies. It is also being suggested they could lead to delays in product launches.

Regulation Russian Federation

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

HRA Pharma Reveals Big Growth Ambition: Become Top 10 OTC Player

Consumer OTC Drugs

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

Crown Labs Spreads Out, GSK Narrows Focus In OTC Skin Care Brand Deal

GSK further narrows consumer health focus with sale to Crown Labs of North American distribution rights for PanOxyl acne wash, Sarna anti-itch lotion, Zeasorb anti-fungal product, Desenex athlete’s foot treatment and Mineral Ice pain-relieving gel. Deals also helps UK pharma pay for its $5.1bn acquisition of oncology drug firm Tesaro.

Dermatology M & A
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