Pink Sheet is part of the Informa Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


‘Impossible' To Prepare UK Supply Chain For October No-Deal Brexit

The UK parliament's Exiting the EU Committee has heard strong words from industry representatives who say that the sector will not be ready for a no-deal Brexit in in October and that such a scenario would result in stockpiling problems, drug shortages and safety issues.  
Brexit United Kingdom Manufacturing

Amgen's Elliott Levy On Adaptive Design And Real-World Evidence Strategies

Levy, SVP of global development, notes that two years after launching an in-house Center for Design and Analysis, Amgen considers adaptive designs for most new studies and more than half include adaptive elements.

Clinical Trials Research and Development Strategies Drug Approval Standards

US FDA's New Paragraph IV Data Further Illustrates Generic Competition Problems

Data on the number of ANDAs submitted with valid paragraph IV certifications shows some products with strong generic interest and others with almost none.

Generic Drugs Legal Issues Regulation

Iran Joins Global Drug Regulators Group

Members of the International Pharmaceutical Regulators Programme have met in Amsterdam, where they discussed new topics including potential opportunities for reliance and use of real-world data in pharmacovigilance. Iran has joined the group.
International Regulation BioPharmaceutical

Oncology, Orphans Dominate Japan Fiscal 2018 Approvals

Oncology again dominated new drug approvals in Japan last fiscal year, when expedited and special review pathways also played a major role in ensuring early access to new therapies.

Japan Approvals Regulation
Advertisement

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.

Download Whitepaper
Advertisement

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Data Standards: Technical ‘Postmortem’ Could Clarify US FDA Preferences, Industry Says

Feedback on application-specific data submission issues that vexed the agency but were not onerous enough to warrant a refuse-to-file letter would help inform future filings and reduce variation across sponsors, industry representatives say at meeting on analytical data standards.

 

Drug Approval Standards FDA Regulation

Latest From Regulation

Cures Act Hiring Authority Expansion Could Help Recruitment Woes, US FDA's Sharpless Says

Acting commissioner says greater flexibility in hiring has 'a real potential to solve some of our problems,' although only about 40-50 people have been added to date; recruitment and retention were very much on the minds of the FDA’s leadership at the recent BIO annual meeting, where center directors spoke of the long-term damage caused by the five-week partial government shutdown.

FDA Gene Therapy

Postmarketing Commitments: Sponsors Often Do Not Publish Results Of New Clinical Trials

Only 15% of postmarketing commitments for drugs approved in 2009-2012 were for clinical trials and only half of these were published, study finds; authors call for US FDA to provide more trial information.

Post Market Regulation & Studies Clinical Trials

Sharpless Wonders Why Cancer Success Doesn't Translate To Other Diseases

Acting US FDA commissioner also said he wants to be nominated to the permanent position.

Cancer Research & Development

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

Set Alert for Clinical R&D

Latest From Research & Development

Sharpless Wonders Why Cancer Success Doesn't Translate To Other Diseases

Acting US FDA commissioner also said he wants to be nominated to the permanent position.

Cancer 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

Commercial Explore this Topic

Set Alert for Commercial

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

Set Alert for Manufacturing

Latest From Manufacturing

Cell/Gene Therapy Manufacturing Readiness Urged As A Condition For US Expedited Designation

Requiring that certain chemistry, manufacturing and controls conditions be satisfied before awarding breakthrough or regenerative medicine advanced therapy status would help ensure that the quality side of product development keeps pace with the clinical side, says Parexel's Mo Heidaran, a former CMC reviewer in the FDA’s biologics center.

Regenerative Medicine Gene Therapy

The US Zolgensma Review: Full Speed Ahead Despite Dose, Stability, Method Uncertainties

Normally, toddlers with infantile-onset spinal muscular atrophy would be in bed on ventilators. But most of these were sitting up on their own. Two were even standing and walking. The question was how to get the manufacturing process for the gene therapy that worked this magic ready for prime time.

 

Gene Therapy Quality

US FDA Pressing Industry To Use Standards For Cell and Gene Therapies

A US FDA official is exhorting the biopharmaceutical industry to adopt standards to help in developing new cell and gene therapy products, yet this may pose difficulties as there is a lack of standards in this space, particularly in areas such as cell viability, chain of identity and viral vector gene quantification.

Manufacturing Quality
UsernamePublicRestriction

Register

Advertisement