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Featured Stories


‘Keep Planning For No-Deal Brexit,’ UK Govt Tells Pharma As Chaos Grows

Amid the growing mayhem in parliament over the Brexit process, life science companies have been advised to continue preparing for the possibility that the UK might leave the EU without a deal at the end of next week. 
United Kingdom Brexit Trade

Gottlieb Touts US FDA's Organizational Structure For Advancing Policies During His Tenure

Outgoing FDA commissioner said his direct contact with center directors helped agency advance policies and helped centers solve their problems.

Leadership FDA Regulation

Price ‘Anchoring’? Zolgensma And The Art Of Managing Gene Therapy Sticker Shock

Public statements by Novartis and AveXis suggest Zolgensma could be cost effective at a price up to $5m. Analysts expect $2m. The lower estimate is still stunning, but could it be considered reasonable by comparison?
Pricing Strategies Reimbursement Policy

Clinical Trials: US FDA Should Frame Risk-Based Monitoring As Best Practice, ACRO Says

Recent Q&A draft guidance is aimed at assisting sponsors in planning and conducting risk-based approaches to monitoring, but ACRO’s Doug Peddicord says agency needs to take a more straightforward, proactive approach to encouraging the move away from 100% source data verification.

Clinical Trials Digital Health Quality

FDA Inspectors Focusing Attention On Traditional Manual Aseptic Filling Lines

Firms that manufacture sterile drugs on traditional filling lines instead of using restricted access barriers or isolators risk tighter scrutiny from FDA inspectors, agency official says. Yet it remains unclear how much of a difference the increased oversight will make.

 

Manufacturing Quality Compliance
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US FDA Performance Tracker

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Global Pharma Guidance Tracker – February 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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Policy & Regulation Explore this Topic

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US FDA “Enriches” Trial Guidance With Recent Examples

Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
Clinical Trials Drug Approval Standards Research & Development

Latest From Regulation

Opioids, Old Initiatives Dominate FY 2020 US FDA Funding Increase

The agency requested a funding increase in part to implement 2018 legislation intended to combat the opioid crisis, but also to support many initiatives in last year's budget request.
FDA Legislation

Latin America Notebook: Advancing Adaptive Trial Designs, Translating ICH Guidelines, Sharing Confidential Information

Brazil's drug regulator ANVISA will require more experience in dealing with adaptive trial designs before issuing guidance; translating older ICH guidelines remains a barrier to their implementation; and industry is asked to be more transparent in sharing their confidential information among drug regulators to facilitate convergence.

South America Clinical Trials

Italy Moves To Raise Biosimilar Use And Awareness

The use of biosimilars is growing in Italy, but the authorities want their market share to rise further and so the regulator has set up a dedicated webpage to explain the biosimilar concept more clearly to doctors and the general public and to help dispel any remaining doubts about their safety and efficacy. The aim is to increase awareness and use of biosimilars and rationalize state spending on biologic medicines.

Italy Biosimilars

Latest From Policy

AbbVie's 'Unjustified' Humira Settlements Divide Market, Class Action Claims

First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.

BioPharmaceutical Biosimilars

Measles Hearings Offer Counterpoint To Pricing Spotlight: Vaccines Touted As Cost-Effective Solution To Outbreaks

Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.

Legislation Drug Safety

Generics Firms Improved Chances Of Winning Pre-ANDA Meetings For Complex Drugs Last Year

FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.

Manufacturing Quality

Clinical / R&D Explore this Topic

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Latest From Research & Development

Achilles On Getting ‘New Wave’ Immunotherapy From Concept To Clinic In Three Years

Clonal neoantigen immunotherapy developer Achilles Therapeutics tells the Pink Sheet how the regulatory landscape for advanced therapies might not be as tricky as it used to be.

Research & Development Clinical Trials

Cancer Trials: US FDA Guidances Aim To Expand Eligibility Criteria And Better Inform Labeling

Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.

Clinical Trials Regulation

Historic Output Of Disease-Specific Guidances Is Among Gottlieb's Legacies At US FDA

A Pink Sheet analysis illustrates how the outgoing commissioner enhanced FDA's ability to facilitate the further development of innovative drugs. 
Research & Development Drug Approval Standards

Commercial Explore this Topic

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Latest From Commercial

Making The Case For Rebates: UnitedHealth Pushing Expansion Of POS Program

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Pharmacy Benefit Management Pricing Debate

Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.


Generic Drugs Launches

Australian Competition Watchdog Probes GSK/Pfizer Consumer Health JV Proposal

Assessing how closely GSK's OTC brands including Panadol compete with Pfizer's Robitussin and other OTC brands is the aim of investigation by Australia's Competition and Consumer Commission into the pharma giants' proposed consumer health joint venture. ACCC states particular interest in importance of Panadol, Voltaren and Advil brands, and whether GSK and Pfizer compete closely in supply of pain relief, gastrointestinal and cold and flu relief products.

M & A Regulation

Manufacturing Explore this Topic

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Latest From Manufacturing

Proponents Of Quality Control Multi-Attribute Methods Tackle Adoption Challenges

Challenges ranging from fear of QC job loss to training requirements and discovery of surprise impurities confront effort to expand the use of powerful test methods for release of biopharmaceuticals.

Quality Manufacturing

The Quality Lowdown: Valsartan Options, Supply Chain Warnings, Button Cameras

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

Manufacturing Quality

Generics Firms Improved Chances Of Winning Pre-ANDA Meetings For Complex Drugs Last Year

FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.

Manufacturing Quality
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