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Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality

In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.
Biologics Biosimilars Drug Safety

Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Approvals Neurology Regulation

Running The Gauntlet: Takeaways From The First Round Of HHS Hearings In 2019

Release of the White House budget proposal kicked off the first round of hearings on HHS with a new Democratic majority in the House and a new HHS budget czar in the Senate. HHS Secretary Azar did his best to set a constructive tone for advancing drug pricing policies – and maintaining his own position – in the year to come.  
Legislation Leadership Pricing Debate

Canada Plans New Agency To Negotiate Drug Prices & Tackle Soaring Costs

A proposed new drugs agency with the power to evaluate the effectiveness of medicines and negotiate prices with manufacturers is seen as the first step towards a national pharmacare program offering universal drug coverage in Canada.
Pricing Debate Reimbursement Canada

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells the Pink Sheet how Denmark is setting up a unique data analytics center for drugs and devices without reinventing the wheel.
Denmark Europe Artificial Intelligence
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European Performance Tracker

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.
International Europe Australia
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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Saudi FDA Consults On Compassionate Use Program Requirements

The Saudi drug authority has clarified the roles and responsibilities of the various players involved with giving patients access to drugs under development on compassionate grounds.
Saudi Arabia Regulation BioPharmaceutical

Latest From Regulation

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

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

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

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

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

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

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

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

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

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

Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

FDA Legal Issues

FDA Aims For Greater Role In Pharma Business Continuity Planning

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Manufacturing 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
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