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Opioid-Sparing Claims Should Meet High Bar, US FDA Panel Says

At meeting on Pacira's Exparel, advisory committee members warn against rushing to adopt products purported to reduce opioid consumption absent long-term longitudinal data showing beneficial public health impacts and clinical data linking reduced opioid use to functional outcomes or other clinical benefit.

Advisory Committees Drug Approval Standards Neurology

EFPIA Picks Holes In EMA's Pediatric Extrapolation Proposals

Pharmaceutical companies are worried about new requirements the European Medicines Agency has proposed on using extrapolation to support the development of pediatric medicines.

Pediatrics Clinical Trials Regulation

Seeking A Meeting? CDER Wants Patient Advocacy Groups To Go Online

Web portal makes it easier for non-industry stakeholders to request meetings on development and safety matters but might sow confusion for some patient groups, particularly when it comes to externally led patient-focused drug development meetings.

FDA Drug Approval Standards Drug Safety

US FDA Chief Gottlieb Envisions Tiered Mandates For Opioid Training System

Mandatory training could be reserved for physicians who want to prescribe opioids for longer-term use, as opposed to those who would prescribe recommended amounts in blister packs; evidence that blister packs would affect prescribing still is needed, however.
Neurology Risk Management Regulation

FDA Performance Tracker

Keeping Track: Vitaros Reenters The Wilderness, Remoxy Gives It A Fourth Try, And Two Novel Approvals

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

Drug Review Regulation United States

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

OTC Oral Contraceptive Interest Could Be Price Sensitive, Study Suggests

A survey with 2,026 women and 513 teens showed they are willing to pay out-of-pocket for the convenience of OTC access to an oral contraceptive but not to pay as much as they were four years earlier, according to a study led by Daniel Grossman, University of California-San Francisco, and Kate Grindlay, Ibis Reproductive Health.

United States Consumer Prescription To Otc Switch

Latest From Regulation

Two Hopefuls And A ‘No’: EMA Decisions On Accelerated Access

Regeneron and Shire should find out this week whether the European Medicines Agency will agree to fast-track its review of their products.

Drug Review Europe

Supreme Court Ruling on ‘Plausibility’ In Landmark UK Lyrica Case Expected Early Summer

Companies looking forward to a ruling from the Supreme Court on “plausibility” in the UK case involving second medical use patents may have to wait until May or June.

Intellectual Property United Kingdom

EU Advocate General Sides With Pfizer Over Orifarm’s Parallel Importing Of Enbrel

An advocate general of the Court of Justice of the EU has given an opinion in the case of Pfizer v Orifarm that, if followed by the full court, will clarify the scope of the “specific mechanism” that was introduced to give patent holders protection against parallel imports from the acceding member states between 2004 and 2013.

Intellectual Property Europe

Latest From Policy

In Case You Missed It … News On Brexit, DTC In Mexico, ICH, And More

We clean out your President's Day inbox so you don't have to.

Policy Regulation

Fight Brewing In Congress Over Part D Coverage Gap Discounts

Pricing Debate Legislation

An Image To Maintain: GAO Profit Picture Of Drug Industry Is Good To Store Away For Future Debates

Big pharma has been highly successful at changing the debate from the level of drug company profitability to who shares what part of dollars generated by drug sales, but there are still lingering efforts to define and describe overall drug industry profitability and put it in the overall context of the broader economy. These efforts are backburner for now but will come back at some point in the future. Some of the portrayals are friendlier to pharma than others.

Pricing Debate Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Disease-Specific Guidances Reflect US FDA's 'Nimble, Collaborative, Patient-Focused' Approach

Patient groups helped with draft guidance on ALS drug development and revision of Alzheimer's draft guidance; agency also issues draft guidance on pediatric seizure, final guidances on DMD and migraine.

Drug Approval Standards Clinical Trials

Alzheimer's Biomarkers Gain Prominence In Drug Development Guidance

US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple advances,' Alzheimer's Association says.

Neurology Drug Approval Standards

New Resolution Could Drive Advanced Therapy Investment And Research In Brazil

Brazilian medicines regulator ANVISA is poised to publish a new resolution that sets out good practices for using human cells in therapeutic and clinical research.

Research & Development Brazil

Commercial Explore this Topic

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Latest From Commercial

Bristol's Opdivo/Yervoy Bid Will Show Whether Tumor Mutation Burden Is Ready For Prime Time

US FDA officials have supported tumor mutation burden as a biomarker, but analysts question whether a subset analysis of CheckMate 227 will be enough to support approval of Bristol's Opdivo/Yervoy combination in first-line lung cancer.

ImmunoOncology Sales & Earnings

Providers, Payors and Prior Authorization: A Second Front In Pricing Fight

A below-the-radar effort to streamline prior authorization policies could have important implications for easing access to high-priced medicines. A new consensus statement aligns large provider groups with payors on some first principles.

Reimbursement Business Strategies

Just Do It: Lilly CEO Ricks On Rebates At The Pharmacy Counter

Lilly's chief exec came out strongly in favor of passing rebates onto patients at the point of sale, a big issue of debate in the industry. While it's not surprising that Lilly would be in favor of such a move, Ricks was more outspoken than some of his peers have been.

Pricing Debate Medicare

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA And Industry Officials Tout Benefits Of Performance-Based Established Conditions In ICH Q12

ICH given “two thumbs up" for performance-based established conditions concept in draft Q12 guideline. This approach gives industry much needed flexibility in managing post-approval changes as well as requesting fewer changes from regulators.ICH plans to adopt the guideline as a Step 4 document in 2019.


Manufacturing Quality

Eggs May Be Culprit In Poor Flu Vaccine Performance This Year

US health authorities, manufacturers investigating why egg-based product appears to have lower effect in adults compared to cell-based flu vaccine.

Vaccines Manufacturing

EMA Drops 130 US Manufacturing Site Inspections Under Landmark MRA

The European Medicines Agency says it is too early to speculate on when the EU will recognize the first US Food and Drug Administration inspection under the mutual recognition agreement signed last year.
Manufacturing Europe

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

More GRASE Time For 6 OTC Antiseptic Ingredients But 24 Flushed In Final Rule

An FDA final rule rejects generally regarded as safe and effective status for 24 OTC monograph antiseptic ingredients regarding products intended for use by health care professionals in hospitals or similar venues. However, six ingredients on which FDA deferred its decision also are used in consumer antiseptic washes, which GRASE decisions pending in separate rulemakings.

Consumer Drug Approval Standards

FDA Broadens Nicotine Therapy Indication Review With Steering Committee Docket

FDA seeks broader guidance than comments and information submitted at a January public hearing on standards testing and evaluations that could expand the variety of products approved as NRTs The docket is open to "recommend specific topics for direct, collective engagement and consideration by the" steering committee.

United States Consumer

Mucinex Fast-Max Advertising Claim Exceeds Indications In NAD Review

Review was second in two years by the Council of Better Business Bureaus' National Advertising Division of a challenge to Reckitt Benckiser ad claims for its Mucinex cough/cold line made by Procter & Gamble, which markets competing products including Vicks NyQuil and DayQuil brands.

Europe United Kingdom