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EMA Reviewing Guide To Support New Genome Editing Technologies, CAR-T Cell Therapies

The European Medicines Agency is updating its five-year old guideline on drugs containing genetically modified cells to factor in rapid scientific developments in relation to gene editing technologies, and the development of promising new cancer immunotherapies, such as CAR-T cells.

Regenerative Medicine Regulation Europe

India’s Stem Cell Guidelines Mandate Additional Checks

Draft update to national guidelines factors in additional safeguards and makes it mandatory to establish institutional panels to review stem cell research. Gene editing would be an area of "restrictive" research.

Policy Review Pathway BioPharmaceutical

Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline

Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.

Regulation Drug Safety Generic Drugs

FDA Gives Congress Reprieve On Deadline For Passing User Fee Bill

Commissioner Gottlieb says agency won't issue layoff notices 'unless and until Sept. 30 passes without reauthorization.'

FDA Legislation Regulation
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Policy & Regulation Explore this Topic

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CMC Regulatory Updates In Brief: CSL's Haegarda Specs; CMC Data Elements; ICH Q3C Maintenance

US FDA explains why it requested CSL Behring to reinstate non-critical manufacturing process controls and tighten container specs in line with process capability. FDA also proposes CMC data elements and posts ICH Q3C updates.

Manufacturing Quality United States

Latest From Regulation

China Cybersecurity Law Catches Pharma Firms Unawares

China’s first cyber security law came into effect in June, but some pharma companies do not realize they need to comply.

China BioPharmaceutical

Revised EMA Guideline On First-In-Human Trials Addresses Dosing And Complex Protocols

The European Medicines Agency has updated its 2007 guideline on the strategies drug sponsors should apply to identify and mitigate risks in first-in-human trials to provide additional advice on dosing issues and the use of integrated protocols, among other things. The revised guideline will apply from February 2018.

Clinical Trials Regulation

Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles

First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.

Drug Review Profile Biosimilars

Latest From Policy

UK’s NICE Updates Policy For Preventing Bias In Advisors

Health technology assessment body NICE wants feedback on its revised policy on declaring and managing any conflicts of interest of its advisory committees.

United Kingdom Health Technology Assessment

Dems' 'Better Deal' Would Create Drug Price Gouging 'Enforcer'

Plan would empower new agency to investigate and potentially fine drug manufacturers that make unjustified price increases.

Pricing Debate Legislation

AbbVie AndroGel Jury Verdict Targets 'Low T' Promotion

In first bellwether trial in testosterone replacement therapy litigation, jury issues $150m verdict against AbbVie for fraudulent misrepresentation of AndroGel.

BioPharmaceutical Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Keeping Track Of Novel Agents: US FDA Approves Nerlynx And Vosevi, Turns Down Evenity; Macrilen Returns

News and highlights about novel agents from our FDA Performance Tracker.

Approvals Complete Response Letters

Keeping Track: Tremfya Clears FDA; Dextenza Amendment Is Too Late; Emicizumab, Abemaciclib Filed

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

Regulation Research & Development

Master Protocols Are Both Welcome And Inevitable – US FDA's Woodcock

Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine.

Clinical Trials Personalized Medicine

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Latest From Commercial

Activist Investor 'Buzz' Annoys Colgate CEO As Earnings Sting Shareholders

Colgate CEO Ian Cook says speculation that recent organic sales misses and competitive pressure make company an activist investor target is “noise” and the firm will combat competitive pressure through increasing advertising, growing e-commerce and expanding its natural product lines.

Consumer Advertising, Marketing & Sales

Emerging Dialysis Drugs Will Face Medicare Reimbursement Challenges

Navigating Medicare's complicated bundled payment system could be tricky for new class of anemia drugs, the HIF prolyl hydroxylase inhibitors, which may start to reach the market for dialysis patients in 2019.

Medicare Reimbursement

Trump Lauds Big Pharma Collaboration On Super Strong Glass Packaging

President announces Merck, Pfizer and Corning collaboration on new glass packaging for injectable drugs as part of "Made In America Week;" says FDA is streamlining regulations.

BioPharmaceutical Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Guidance Addresses Self-Identification, Facility Payments Under GDUFA

An FDA guidance addresses which types of facilities must self-report under GDUFA and pay the facility fee and which facilities must just self-report. Guide also covers whether two separate locations of the same company have to pay a user fee.

Compliance Manufacturing

FDA's Kopcha Says New Inspection Protocols May Never Be Disclosed

Head of US FDA's Office of Pharmaceutical Quality says agency doesn't want pharmaceutical companies to know just how they will be inspected under the emerging standardized 'NIPP' approach, lest they use that knowledge to game the process.

Compliance Manufacturing

Trump Lauds Big Pharma Collaboration On Super Strong Glass Packaging

President announces Merck, Pfizer and Corning collaboration on new glass packaging for injectable drugs as part of "Made In America Week;" says FDA is streamlining regulations.

BioPharmaceutical Commercial

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Latest From Consumer

Consumer Health Weekly Trademark Review July 18, 2017

Compiled from the Official Gazette of the U.S. Patent and Trademark Office] for [Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) trademarks registered and published for opposition.

Consumer Trademarks

Activist Investor 'Buzz' Annoys Colgate CEO As Earnings Sting Shareholders

Colgate CEO Ian Cook says speculation that recent organic sales misses and competitive pressure make company an activist investor target is “noise” and the firm will combat competitive pressure through increasing advertising, growing e-commerce and expanding its natural product lines.

Consumer Advertising, Marketing & Sales

International Headwinds Counter J&J's Consumer Growth Confidence

"Some much weaker markets and some macroeconomic conditions, particularly in China and India" prompt J&J to adjusts its overall and consumer business expectations, CFO Dominic Caruso says. Its consumer product revenues climbed 1.7% to $3.5bn in is latest quarter.

Consumer Advertising, Marketing & Sales
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