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Featured Stories


Pelosi Rx Pricing Bill Offers Big Savings, Big Drop In Drug Development – CBO

Overall effect on health of US families stemming from increased use of drugs but decreased availability of new drugs is 'unclear,' the Congressional Budget Office concludes in its preliminary analysis of HR 3.

Pricing Debate Legislation Reimbursement

Disappointing End For MolMed’s Zalmoxis Cell Therapy In EU

MolMed decided to the withdraw the drug's conditional marketing authorization after Phase III clinical trial results showed that the drug offered no benefit on disease-free survival.

Europe Regulation Clinical Trials

Austria Works On Method To Improve Price Transparency

Austria’s health technology appraisal institute aims to further discussion on public investments in R&D and medicines pricing transparency.

Europe Austria Health Technology Assessment

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 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

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Europe Drug Review

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

Biosimilars: US FDA Ends FY 2019 With Record Number Of Approvals, One Complete Response Letter

Agency approved 11 biosimilars from six sponsors with only one publicly disclosed complete response letter (Tanvex’s filgrastim). Pink Sheet infographic shows 351(k) application submission, approval and CRL rates over the life of the user fee program.

 

Biosimilars Review Pathway

One Patient, Many Questions: Milasen ‘N of 1’ Trial Provides Early Template For Individualized Genomic Medicine

Rapid development of patient-customized oligonucleotide at Boston Children’s Hospital suggests promise and hazards of new drug development model.

Drug Approval Standards Rare Diseases

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

Latest From Policy

New Price Helps Secure Funding For Rubraca In England

Clovis Oncology’s ovarian cancer treatment Rubraca is the latest PARP inhibitor to get the all-clear from the health technology assessment body, NICE.

Health Technology Assessment United Kingdom

PhRMA Willing To Contribute To Drug ‘Affordability’ – But Mum On How Much

PhRMA CEO Steven Ubl offers list of policy alternatives to drug pricing bills pending in the US Congress that he argues would stifle innovation; industry's plans, on the other hand, could produce "meaningful" legislation.

Pricing Debate Pricing Strategies

Beyond ICER: Arnold Foundation Wants To Dig Deeper On R&D And Pricing

Arnold Foundation VP Mark Miller explains how research into “what it costs to bring a drug to market” could supplement existing efforts to determine how prescription drug prices line up with value.

Cost Effectiveness Pricing Debate

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

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

One Patient, Many Questions: Milasen ‘N of 1’ Trial Provides Early Template For Individualized Genomic Medicine

Rapid development of patient-customized oligonucleotide at Boston Children’s Hospital suggests promise and hazards of new drug development model.

Drug Approval Standards Rare Diseases

BeyondSpring’s Pivotal NSCLC Trial For Plinabulin Designed To Avoid Bavencio’s JAVELIN 200 Failure

Lessons learned about blinding and stratification from Pfizer and Merck KGaA’s earlier Phase III disappointment shaped the design of BeyondSpring's ongoing Phase III trial of plinabulin in second- and third-line non-small cell lung cancer.

Clinical Trials Cancer

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

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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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