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Agree A Brexit Transition By March Or See Pharma Waste Money On Contingency Plans, Says UK Cttee

UK health secretary Jeremy Hunt has been told by the Commons health committee that the government must agree a Brexit transition period that preserves the “regulatory status quo,” otherwise companies will be forced to start spending money on contingency planning that may prove unnecessary.

Brexit Regulation Distribution

Mexico Allows DTC Advertising, But Firms Likely To Move Hesitantly

Confusion may be strongest message delivered since Mexico's General Health Law still only allows for advertisement of over-the-counter products even as new guidelines permit promotion of prescription drug products in Mexican mass media. 

Advertising, Marketing & Sales Regulation 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 Legislation

Updated EU Guide On Unique Identifiers May Impact Drug Distribution Strategies Post Brexit

The European Commission's updated guidance on the unique identifiers that are required under the Falsified Medicines Directive contains new information on several areas. It clarifies that the “decommissioned status” of an exported medicine that is brought back into the EU from a third country cannot be reversed and that such medicines should be fitted with a fresh identifier.

Brexit Distribution Regulation
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FDA Performance Tracker

Keeping Track: DMD, RMAT, HIV, BTDs, Tc-99m – FTW

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

Drug Review Regulation United States

Policy & Regulation Explore this Topic

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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 Regulation

Latest From Regulation

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

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Advisory Committees Drug Review

New EU Submissions For Pfizer’s Lorlatinib, Teva’s Fremanezumab - And A CV Filing For Canakinumab

Four new products are being evaluated by the European Medicines Agency, including Pfizer’s lorlatinib for lung cancer, Teva’s fremanezumab for migraine, and Shionogi’s lusutrombopag for thrombocytopenia. An already authorized drug, Novartis’s canakinumab, has been filed for a new use: reduction of cardiovascular risk.

Drug Review Approvals

Latest From Policy

Fight Brewing In Congress Over Part D Coverage Gap Discounts

Pricing Debate Legislation

Impact Of Rebates On Drug Pricing Will Diminish -- CMS Experts

Actuaries with the US Centers for Medicare and Medicaid Services predict the share of retail prescription drug costs represented by manufacturer rebates will level off in the coming years, resulting in higher drug pricing trends across government and commercial insurance.
Pricing Strategies Reimbursement

Drug Pricing Alliances Expand In Europe

Slovenia has joined the Valletta group, with Croatia set to follow. Meanwhile, Ireland has formally signaled its interest in joining the BeNeLuxA collaboration.
Government Payers Health Technology Assessment

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

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

Lacking Backup Plan, WHO Allows Continued Use Of Contraceptives Barred From US

Disappointed by firm's follow-up to FDA inspection that barred its US market access, WHO nevertheless lets contraceptives API maker with data integrity issues continue to supply rest-of-the-world markets with contraceptives of uncertain quality, in part for lack of a backup emergency contraceptives API supplier.
Compliance Manufacturing

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.

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