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Latest News & Analysis

A Big Week For FDA’s Top Eye Drug Reviewer

Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.

Advisory Committees Drug Review

New ICH Guide To Eliminate ‘Discordant Advice’ On Juvenile Animal Studies

Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline that explains in which situations nonclinical juvenile animal testing is considered informative and necessary to support pediatric drug development. The guideline is expected to address the "discordant advice" that different regulatory agencies currently offer companies in relation to such studies.

Safety Clinical Trials

Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say

US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.

Review Pathway FDA

FDA Search For CDER Deputy Emphasizes 'Executive Direction'

An M.D. is preferred for position that would run CDER in director's absence and oversee 'major programs' at the Center.

FDA Leadership

Moscicki's Move From FDA To PhRMA About 'Best' Use Of Leadership Skills

At inconveniently timed NORD conference, the former CDER deputy center director finds himself unable to speak for either FDA or the Pharmaceutical Research and Manufacturers of America.

FDA Leadership

Anthem In-House PBM Will Draw On CVS But Retain Formulary Control

Hybrid approach to pharmacy benefit management expected to save insurer $4bn annually after Anthem ends its relationship with Express Scripts in 2020. Integration of medical and Rx benefit data could lead to more value-based contracting.

Pharmacy Benefit Management Pricing Strategies

Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.

Advisory Committees Drug Review

Nicorette, Tylenol Ease J&J's Consumer Pain From Slow Oral Care Sales

J&J’s worldwide OTC drug division sales rose 4.4% to $1bn, driven by the Tylenol and Nicorette brands, the firm reports Oct. 17. Those revenues helped offset softness in the firm’s Listerine and other oral care products due to more competition online from start-ups selling straight to consumers.

Consumer Sales & Earnings

Consultation To Help Determine Whether EU SPC Framework Fit For Purpose

The European Commission has launched a consultation on proposals to “recalibrate” supplementary protection certificates and patent research exemptions.

Europe Biosimilars

Pharma’s ‘No-Show’ At Regulatory Meetings In India: Who Loses?

Regulators in India routinely face flak over lengthy approval timelines, but drug firms failing to show up at pre-scheduled regulatory meetings does little to improve the situation. The reason for the no-shows is open to speculation. Absenteeism appears to be significant in areas such as oncology and hematology.

Regulation Review Pathway

Chronic Fatigue Syndrome Research Takes Leap Forward With NIH Funding

Research centers are collaborating on projects to find causes of disease; Ampligen, Rituxan and KPAX-002 are only drugs in clinical trials.

Research and Development Strategies Neurology

Drug Pricing Legislation Appears Nowhere In Sight Following Senate Hearing

Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.

Pricing Debate Reimbursement
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