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Only One In Seven PRIME Applications Meet EMA Test

Of the 14 applications for entry onto the European Medicines Agency’s priority medicines scheme during the first two months of 2019, only two – from AstraZeneca and Freeline – made the grade.
Europe Market Access Research and Development Strategies

Part D Rebates: Policy Tweak Would Retain Manufacturer ‘Contributions’

Peter Bach’s new approach to calculating TrOOP cost in Medicare would prevent big savings to manufacturers from point-of-sale rebates.
Pricing Debate Reimbursement Pharmacy Benefit Management

US FDA Reorg Emphasizes Office of Therapeutic Biologics and Biosimilars

Final reorganization structure includes new office within OND to coordinate review of biologics and biosimilars applications, as well as new oncology and hematology divisions.

FDA Biosimilars Regulation

Health Technology Assessments And the Trouble With Rare Disease Treatments

To get their gene or cell therapies through health technology appraisals, companies need to agree to gather longer-term evidence, be upfront about what treatments can really deliver and remember to ask for patient input.

Europe Health Technology Assessment Innovation

Compounding Chief Departing US FDA After Leading Office Through 'Tumultuous Times'

Julie Dohm, who led a wide range of initiatives to bolster FDA's oversight of compounding pharmacies, will be joining Covington & Burling after leaving the agency March 29. A replacement has not yet been announced.

Manufacturing Quality United States
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – February 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
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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

ICH Consults On Guideline To Improve Bioanalytical Data Consistency

The finalization of a new international guideline that proposes a harmonized approach on bioanalytical method validation is expected to reduce the need for additional validation experiments and support streamlined global drug development.
International Regulation BioPharmaceutical

Latest From Regulation

US FDA Reorg: Defining The “Central” Purpose Of A Commissioner

Scott Gottlieb will formally implement a new structure for the Office of the Commissioner just days before he departs from the job. That may be odd timing, but the new structure is in many ways a perfect capstone for Gottlieb’s tenure.
FDA Leadership

UK MHRA Clarifies No Deal Brexit Plans For PIPs

The Medicines and Healthcare products Regulatory Agency explains how it would deal with pediatric investigation plans if the UK leaves the EU with no deal.

Brexit Pediatrics

WHO's Human Genome Editing Standards Must Not Impact Somatic Cell Research

Concerns have been expressed that efforts by the World Health Organization to establish global standards for the whole spectrum of human genome editing research may inadvertently have a negative impact on companies developing somatic cell therapy medicinal products.
International Regulation

Latest From Policy

Running The Gauntlet: Takeaways From The First Round Of HHS Hearings In 2019

Release of the White House budget proposal kicked off the first round of hearings on HHS with a new Democratic majority in the House and a new HHS budget czar in the Senate. HHS Secretary Azar did his best to set a constructive tone for advancing drug pricing policies – and maintaining his own position – in the year to come.  
Legislation Leadership

AbbVie's 'Unjustified' Humira Settlements Divide Market, Class Action Claims

First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.

BioPharmaceutical Biosimilars

Price ‘Anchoring’? Zolgensma And The Art Of Managing Gene Therapy Sticker Shock

Public statements by Novartis and AveXis suggest Zolgensma could be cost effective at a price up to $5m. Analysts expect $2m. The lower estimate is still stunning, but could it be considered reasonable by comparison?
Pricing Strategies Reimbursement

Clinical / R&D Explore this Topic

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Latest From Research & Development

US FDA “Enriches” Trial Guidance With Recent Examples

Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
Clinical Trials Drug Approval Standards

Achilles On Getting ‘New Wave’ Immunotherapy From Concept To Clinic In Three Years

Clonal neoantigen immunotherapy developer Achilles Therapeutics tells the Pink Sheet how the regulatory landscape for advanced therapies might not be as tricky as it used to be.

Research & Development Clinical Trials

Cancer Trials: US FDA Guidances Aim To Expand Eligibility Criteria And Better Inform Labeling

Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.

Clinical Trials Regulation

Commercial Explore this Topic

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Latest From Commercial

Making The Case For Rebates: UnitedHealth Pushing Expansion Of POS Program

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Pharmacy Benefit Management Pricing Debate

Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.


Generic Drugs Launches

Australian Competition Watchdog Probes GSK/Pfizer Consumer Health JV Proposal

Assessing how closely GSK's OTC brands including Panadol compete with Pfizer's Robitussin and other OTC brands is the aim of investigation by Australia's Competition and Consumer Commission into the pharma giants' proposed consumer health joint venture. ACCC states particular interest in importance of Panadol, Voltaren and Advil brands, and whether GSK and Pfizer compete closely in supply of pain relief, gastrointestinal and cold and flu relief products.

M & A Regulation

Manufacturing Explore this Topic

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Latest From Manufacturing

Gottlieb: Valsartan API Crisis Spurs Drug GMP Revision

FDA commissioner discloses effort underway to tighten oversight of changes to active pharmaceutical ingredient manufacturing processes by rewriting parts of its drug GMP regulation.

Manufacturing Quality

Gene Therapy Manufacturing Make-Or-Buy Options Weighed

Once a gene therapy product begins to show promise in clinical trials, the next step is deciding how the product is to be manufactured. Options are to make the product in house, contract out the manufacturing, or to combine the two approaches. An industry representative discussed some of the advantages and disadvantages of each approach and what to look for in the site selection process if the company decides to build out.

United States Manufacturing

Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

FDA Legal Issues
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