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Featured Stories


Opioid Trial Preview: The Claims, Defenses, And Last-Minute Maneuvers

Trial opens after settlement proposals by three distributors, Teva and J&J fail to gain support of cities and counties. Distributors want to call former FDA Commissioner Kessler to testify over plaintiffs' objections. Judge rules plaintiffs cannot seek future damages.

Legal Issues Advertising, Marketing & Sales Neurology

New Italian Pricing Decree To Drive R&D Transparency

Following on from moves to push price transparency on to the global agenda, Italy is poised to pass a decree that would oblige companies to disclose public R&D funding.

Europe Italy Government Payers

Real-World Evidence Study Registration May Help Drive FDA Acceptance

US FDA’s David Martin encourages sponsors to register observational studies on drug effectiveness to enhance transparency and agency confidence in the data.

Regulation Real-World Evidence FDA

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: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta

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

First Ebola Vaccine Among Seven Products To Get EMA Nod

Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.

Approvals Europe

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

UK Signs Three More No-Deal Brexit Drug Transport Contracts

Efforts to ensure that supplies of medicines continue to flow if the UK leaves the EU without a deal have been stepped up with the announcement of three contracts to provide an express delivery service for urgently needed products.

United Kingdom Brexit

ANDA Reviews Sometimes Miss GDUFA Goal Dates To Get Quicker Approval, But How Often?

Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.

Generic Drugs Review Pathway

Top US FDA Officials Continue To Lament Advisory Cmte. Recruitment Difficulties

Strict conflict of interest rules have hampered the agency's ability to fill advisory committee vacancies.

Advisory Committees FDA

Rx Patent Reform Gets Renewed Interest From GOP As Alternative To Price Negotiation

A Republican congressman and witness discuss shortened IP protections while criticizing Nancy Pelosi's drug price negotiation plan.

Legislation Pricing Debate

Latest From Policy

Infographic: A Decade Of Opioid Lawsuits And Settlements

A timeline of the history of opioid litigation from Purdue Pharma's 2007 settlement to the bellwether trial in Ohio.

Legal Issues Enforcement

Medicare Part D Redesign Backed By House Republicans Retools Manufacturer Discount

Offered as a failed amendment by House Energy & Commerce Committee’s ranking Republican during markup of Speaker Nancy Pelosi’s drug pricing bill, the proposal is in line with biopharma’s position on manufacturer price concessions in Part D and suggests a road map for the kind of bill that might pass the Senate.

Legislation Medicare

Italy: Added Benefit Will Be Key To Reimbursement

A draft decree in Italy aims to put added therapeutic value at the centre of reimbursement decisions.

Europe Italy

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

Set Alert for Commercial

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

Risk-Based Approach To Protecting Data Integrity Outlined In Forthcoming PDA Report

An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.

Manufacturing Quality

US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

Quality Enforcement

Early GMP Compliance Seen As A Key To Avoiding Complete Responses

Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.

Manufacturing Quality
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