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Medicare May Require Part D Plans To Provide Point-of-Sale Rebates

CMS outlines possible approach to point-of-sale rebates in Medicare Part D, recognizing that using rebates to lower cost sharing for 'many' would increase premiums for all.

Pricing Debate Pharmacy Benefit Management Medicare

Ibrance v Kisqali: Quicker Novartis Discount Helps Cut UK NICE’s Timeline

It took NICE, England’s health technology appraisal body, 84 days to say yes to Novartis’ Kisqali and almost a year to recommend Pfizer’s Ibrance. Willingness to sacrifice on price could have had a big impact on timelines.

Reimbursement Market Access United Kingdom

Lawsuit, Warning Letter Mark Return Of B. Cepacia As GMP Issue

Lawsuit over infant's death and warning letter over recurring contamination underscore the importance of screening for Burkholderia cepacia and when found, removing the microorganism from pharmaceutical manufacturing processes.

Quality Compliance Manufacturing

Will Inter Partes Review Go Away? Supreme Court Weighs Fate

Biopharma and generic industries stand on opposing sides in case that could eliminate the patent challenge proceeding. Interactive timeline covers IPR's five-year history leading to oral arguments Nov. 27.

Legal Issues Intellectual Property Policy
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Policy & Regulation Explore this Topic

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EFPIA Welcomes EMA’s Electronic Format Plan For Package Leaflets But Not ‘Key Info’ Idea

The EMA has published an action plan on improving the product information companies provide in package leaflets and the SmPC.

Europe Regulation BioPharmaceutical

Latest From Regulation

Keeping Track: A Second Straight Burst Of FDA Approvals

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

Performance Tracker Drug Review

US FDA's Patient Affairs Office Is An Office … In Spirit

Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.

FDA Drug Review

French Regulator Wants More Trial Sponsors To Take Part In Pilot Of Future EU Procedures

A French pilot project testing out the future EU clinical trial authorization procedures has borne fruit after the first two years, but the regulator wants many more sponsors to use the pilot so that the country is ready for the new rules in 2019.

Clinical Trials France

Latest From Policy

What Is Inter Partes Review?

A description of the patent challenge proceeding and how it differs from district court litigation.

Intellectual Property Legal Issues

How Comprehensive Do IPR Decisions Have To Be?

Supreme Court to consider whether Patent Trial and Appeal Board must address all patent claims challenged in an inter partes review petition.

BioPharmaceutical Policy

AstraZeneca On Bridging The Gap Between Accelerated Approval And HTA Requirements

Health technology assessment agencies are struggling to evaluate drugs on the basis of evidence generated for early approvals, says AstraZeneca.

BioPharmaceutical Approvals

Clinical / R&D Explore this Topic

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Latest From Research & Development

KemPharm Taking Ritalin Prodrug Into Phase III For ADHD

Months after reaching agreement with FDA to refile the NDA for its abuse-deterrent opioid Apadaz, KemPharm has gotten the okay to take its prodrug of Ritalin into Phase III for ADHD.

Clinical Trials Drug Review

No Sweat – Hyperhidrosis Patients Seek Broader Approvals; Botox Access An Issue

US FDA not looking to reduce attendance at third-party patient meetings, which deliver 'bang for the buck.' Excessive sweating is first externally led PFDD meeting for a more common condition.

Drug Approval Standards Dermatology

US FDA Gives Sponsors Some Leeway In Studying Drug Effects On Driving

Final guidance on evaluating drug effects on ability to operate a motor vehicle has been slightly modified in response to suggestions by Eisai, Pfizer and Merck.

Drug Safety Neurology

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Latest From Commercial

Merck KGaA Says Outcomes-Based Pact With NHS England 'Precedent-Setting'

Merck KGaA Healthcare CEO Belén Garijo tells the Pink Sheet that outcomes-based reimbursement deals like the one it has done with NHS England “are the way of the future”.

Approvals Commercial

Generic Price-Fixing Lawsuit Grows As More Companies, Two Executives Named Defendants

US state attorneys general name executives from Mylan and Emcure as defendants, and list may further expand as investigation continues into additional companies and drugs.

Generic Drugs Legal Issues

CAR-T Indication-Based Pricing May Be Evaluated In Medicare Demo

Novartis exec discusses details around its agreements with CMS for outcomes based payments and indication-based pricing for Kymriah.

Pricing Strategies Cancer

Manufacturing Explore this Topic

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Latest From Manufacturing

Risk Assessments Of New Drug Elemental Impurities Get Mixed Reviews From Regulators

ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.

Manufacturing Quality

Why Industry Wants ICH To Harmonize Process Validation Guidance

After a proposal for harmonized process validation guidance didn't make the cut at ICH, PhRMA and US FDA proponents are making the case to a broader audience. Current ICH guidance is unclear, and regional guidance is conflicting, they told the ISPE annual meeting.

Manufacturing Quality

Promotional Lip Balm, Sanitizer Imports Blocked On Drug GMP Problems

In addition to AZX Sport lip balms and hand sanitizers, other topical consumer drugs often considered personal care or cosmetic products outside the US were added in the latest update to FDA's list of import alerts for "detention without physical examination of drugs from firms which have not met drug GMPs."

Consumer Distribution

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Clearblue Connects Peak Fertility Data To Smartphone App

P&G's connected Clearblue tracks a user’s personal hormone profile and sends data to a smartphone, typically alerting on the four or more best days to get pregnant, providing a window into fertility two days longer than other ovulation testing brands, the firm says.

International United States

Pricing Pressures 'Manageable' To P&G, But Threatening To Analysts

Procter & Gamble says retailer pressure for the firm to lower product pricing to compete with e-commerce and private label is a “real but manageable” problem, while an industry consultant says four megatrends are dictating product prices and changing the way consumers think about consumer health products.

International United States

P&G Board Seat Swings To Peltz In Ongoing Vote Tally

P&G says results from an independent tabulator indicate Trian Fund head Nelson Peltz is leading the firm's candidate, Ernesto Zedillo, in a board proxy vote by around 42,780 shares, or 0.0016% of total outstanding shares. But P&G says the vote count isn't completed.

Consumer Business Strategies
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