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Featured Stories


Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs

US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.

Review Pathway Regulation Rare Diseases

US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

Drug Approval Standards Post Market Regulation & Studies Regulation

Daiichi Sankyo’s AML Drug Among Nine CHMP Hopefuls

Will regulators in the EU follow their US counterparts in requiring more efficacy data for Daiichi Sankyo’s acute myeloid leukemia drug quizartinib, which is already approved in Japan?

Drug Review Approvals Europe

Spotlight On Drug Pricing

House Price 'Negotiation' Plan: It Is Even Worse Than It Sounds

The House Democratic leadership is pushing an international benchmark price for its 'negotiation' plan in the US. The summaries have focused on the maximum price, but the one-sided “negotiation” process suggests that the minimum is the more relevant number – and it is likely to be quite low.

Pricing Debate Reimbursement

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Performance Trackers

Keeping Track: Scenesse, Reyvow, and Beovu Make Trio Of Novel Approvals

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

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – September 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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

US FDA's GDUFA-Related FTEs Increase … Except In CBER

Employees performing generic drug user fee program and related work increased nearly 68% between FY 2014 and FY 2018; Costs, as well as dependence on fees to pay for them, also increased during the period.

Review Pathway Generic Drugs

Possible Mortality Imbalance For Shionogi's Cefiderocol On US FDA Panel Agenda

Although cefiderocol demonstrated safety and efficacy in a pivotal trial for complicated urinary tract infections, there was a mortality imbalance between the study drug and comparator arms in a separate descriptive trial; the US FDA is unsure whether the imbalance was a "chance finding."
Advisory Committees Infectious Diseases

RWE: Comparators, Therapeutic Area May Be Key For Trial Replication

It may be easier to use observational study data to replicate randomized controlled trial results in certain therapeutic areas or where drugs were studied against each other instead of placebo, the US FDA’s David Martin says; the agency-funded DUPLICATE real-world evidence demonstration project has completed replication work on the first five trials, all of which are diabetes drug cardiovascular outcomes studies.

Clinical Trials Regulation

UK Signs First No-Deal Brexit Ferry Contracts

If the UK leaves the EU without a deal at the end of this month, pharmaceutical companies will be able to book space for medicine deliveries on ferries run by four operators between UK and EU ports. 

Europe United Kingdom

Yet Another Myeloma CAR-T Therapy Makes It Onto EMA’s PRIME

Only two of seven applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical need to patients faster were successful last month.

Research and Development Strategies Europe

UK Tackles GCP Concerns Over Electronic Health Records

As NHS Trusts switch from paper-based to electronic health records, concerns have arisen about the compatibility of EHR systems with the clinical trials legislation in some cases.

Clinical Trials Regulation

Latest From Policy

NIH Eyes Expansion Of US FDA Partnerships To Gene Therapy

NIH Director Francis Collins describes evolution of existing collaborations and how the two agencies might facilitate development of gene therapy, such as by having a common template for regulatory review.

FDA Gene Therapy

For Biopharma, There May Be Only One Race To Watch In 2020

Senate Majority Leader McConnell is the one constant keeping drug price controls from gaining any legislative traction.

Pricing Debate Legislation

New Tool To Help Evaluate Quality of RWD

A new tool from the European Network For Health Technology Assessment to evaluate the quality of registries is now being piloted.

Europe Health Technology Assessment

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

New Tool To Help Evaluate Quality of RWD

A new tool from the European Network For Health Technology Assessment to evaluate the quality of registries is now being piloted.

Europe Health Technology Assessment

Yet Another Myeloma CAR-T Therapy Makes It Onto EMA’s PRIME

Only two of seven applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical need to patients faster were successful last month.

Research and Development Strategies Europe

US FDA Fulfills Annual Antibiotic Guidance Goal With Three Women’s Health Guidances

Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.

Drug Approval Standards Infectious Diseases

Commercial Explore this Topic

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Latest From Commercial

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Legal Issues Policy

Novartis’ “Living Drugs”: Kymriah, Zolgensma – And Diovan?

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

Commercial Manufacturing

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Quality Advice On How To Surf The Approaching Wave of Cell And Gene Therapies

Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.

Quality Manufacturing

Nitrosamine Episode Could Lead To Paradigm Shift In Quality

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

Manufacturing Regulation

PDA, ISPE Launch Quality Culture Effort With Root Cause Analysis Guide

Industry groups PDA and ISPE have banded together to produce a guide to help pharmaceutical manufacturers get a better handle on their deviations through choosing the right root cause analysis method and human factors studies.

United States Manufacturing
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