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EU Ruling Raises New Questions For Orphan Designation

An EU court has upheld a decision to revoke the orphan designation awarded to GMP-Orphan's trientine product for Wilson's disease, saying that the product no longer met the “significant benefit” criterion on the grounds of lack of availability of another drug. The case has raised questions about the level of evidence needed to justify a significant benefit. 

Rare Diseases Europe Regulation

Drug Pricing Policy Show Moves Into Next Act With Biopharmas' Suit Against DTC Ad Rule

Merck, Lilly, Amgen join advertisers in suit against HHS; rule helped Trump administration spotlight industry pricing practices but potential impact has always been unclear.

Pricing Debate Legal Issues Advertising, Marketing & Sales

USP Standards For Biological Drugs Would Restrict Innovation, US FDA Says

Top officials at the US FDA explain why the agency opposes USP monographs for biological products as a Senate committee proposes to disallow them and the USP launches an advertising campaign in their favor.

Biologics Manufacturing Quality

Messy Rules For Non‐Biological Complex Drugs Under Fire

Calls are mounting for the EU to make the centralized procedure mandatory for follow-on versions of non‐biological complex drugs and for better regulatory alignment with the US and other countries.
Drug Review Europe US States

Argentina, Israel, Jordan And Saudi Arabia Join ICH As Observers

The International Council for Harmonisation appointed more observers at its latest meeting in Amsterdam and identified several new topics on which it plans to issue harmonized guidelines.
International Regulation Clinical Trials
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – May 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

NEW from CMIC: Tailoring Bioanalytical Testing In A New Era Of Drug Development

With unrelenting pressure to enhance the speed, efficiency and cost-effectiveness of drug discovery and development, companies need to be confident their Bioanalytical testing is not only tailored to these translational goals, but delivers added value in an environment in which scientific innovation, commercial imperatives and unmet patient needs are rapidly transforming the drug-development paradigm.

Read the Whitepaper

Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

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Policy & Regulation Explore this Topic

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Pink Sheet Podcast: Insys Divests Opioids, Pretomanid's Advisory Committee Meeting, And Biosimilar User Fee Collections

Our discussion of the Insys corporate integrity agreement and bankruptcy filling, US FDA's advisory committee meeting on the TB treatment pretomanid, and new data showing lower US biosimilar user fee collections than expected.
Biosimilars Advisory Committees Neurology

Latest From Regulation

Keeping Track: Approvals For Polivy, Keytruda, FDA Applause For Biosimilars

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

US FDA Performance Tracker Approvals

US Medicare Oncology Demo Should Test Value-Based Drug Pricing – Providers

Community Oncology Alliance proposes updates to the Oncology Care Model demonstration project, including a sharper focus on lowering prescription drug costs.

Reimbursement Pricing Strategies

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

Latest From Policy

Medicare Part B International Price Index Could Result In 25% R&D Cuts – Study

Reductions in research and development spending will be much greater than the 1% average often quoted by HHS, consultant tells the Biotechnology Innovation Organization annual convention.

Medicare Reimbursement

The Future Of US Biosimilars Litigation: Method-Of-Use Patents And ‘Dance’ Obligations

Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’

Biosimilars Intellectual Property

Antibiotic Incentives: Advocates Sounding The Alarm For DISARM

Antibiotic developers have a blunt message for Congress: the time for action is now or never. They see a targeted reimbursement change (The DISARM Act) as vital to send a signal to investors that the sector can be saved – and don’t want to delay to debate other ideas like “subscription” models.

Infectious Diseases Legislation

Clinical / R&D Explore this Topic

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Latest From Research & Development

Now It Really Is Personal: US FDA 'Rushing' To Develop Policy For 'Bespoke Therapies'

Recent cases of individual designed treatments have FDA playing a bit of catch up. The concept has been on the horizon, but now “bespoke therapies” are here.

Drug Approval Standards Gene Therapy

Roche Outlines Use Of Real-World Evidence In Entrectinib NDA

Roche used its Flatiron Health oncology EHR database to generate an external control arm for pivotal single-arm data supporting the personalized medicine candidate, which has an 18 August user fee goal.
ASCO Innovation

EMA Enlists GPs’ Help To Generate More Real-World Evidence

The generation of more real world evidence on medicines is one of the aims of a newly announced collaboration that will see family doctors playing a bigger role in providing data for the European Medicines Agency to use in its drug evaluation activities.

Europe Drug Review

Commercial Explore this Topic

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Latest From Commercial

BIO 2019 Notebook: Lartruvo Lookback, M&A Soars, BIO Vs. ASCO

News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.

Drug Review Review Pathway

A New Drug Price Milestone

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

Pricing Debate Rare Diseases

BIO 2019 Notebook: Merck; RMAT; Out-Licensing Deals

News and views from day one of the BIO International Convention: Merck reaffirms commitment to antibiotic space the same day Zerbaxa picks up a new indication; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018.

Regenerative Medicine Financing

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Puts Compounding Office Under CDER Compliance To 'Institutionalize' Maturing Program

The US FDA plans to give its young drug compounding oversight program new leadership and move it from the drug center director's office down to the center's compliance office. Whether this move translates into heightened enforcement of drug compounders remains to be seen.

Manufacturing Quality

More Countries Join US-EU Inspections Deal

There are now just two European countries left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.

Manufacturing Compliance

FDA Signals Willingness To Grant Regulatory Flexibility For Cell and Gene Therapy Products In CMC Reviews

US FDA official says that the complexities involved in producing cell and gene therapies necessitate a “new manufacturing paradigm” in evaluating biologics license applications. For such therapies, the agency is willing to grant regulatory flexibility in certain areas of its chemistry, manufacturing and controls review.

 

Manufacturing Quality
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