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Featured Stories

Brand-Generic Pay-For-Delay Deals May Become Extinct, FTC Finds

Only one of 232 brand-generic patent suit settlements in the US during FY 2016 contained a side deal or commitment not to market an authorized generic.

Generic Drugs Intellectual Property Legal Issues

UK Competition Watchdog Targets Four Firms Over Seven-Fold Prochlorperazine Price Hike

The UK CMA alleges that four companies were involved in a non-compete agreement that resulted in a 700% increase in the cost to the NHS of a generic medicine for nausea and dizziness.

Legal Issues Pricing Strategies Business Strategies

New Payment Models For Curative Treatments Have CMS’ Attention, Verma Says

US Centers for Medicare and Medicaid Services administrator Seema Verma discusses solutions for handling the high cost of gene therapy and the Trump administration’s drug pricing agenda in briefing with reporters.

Medicare Reimbursement Regenerative Medicine

Biosimilars: US FDA Favors Quality Range Testing For Comparative Analytical Assessments

New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving biosimilar sponsors more flexibility.

Biosimilars Drug Approval Standards Regulation

Calls For Pharma To Come Clean On R&D Spending Grow Louder

Pharmaceutical companies must heed growing international calls to be more transparent on how R&D is funded, say NGOs.

Europe International BioPharmaceutical

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – April 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.
Europe Australia India

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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Cell Therapies: US FDA Asked To Clarify Development Standards For Early-Phase Trials

Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry.

Regenerative Medicine Clinical Trials Manufacturing

Latest From Regulation

Pink Sheet Podcast: US Appropriations, More Drug Pricing Legislation To Review

Our discussion of the new FY 2020 US FDA appropriations bill, a new Senate drug pricing package, and updated list of planned federal regulations
Legislation FDA

NHS England Offers ‘Improved’ Orkambi Deal, But Vertex Lukewarm

The NHS in England says it has made a “revised and improved” offer to Vertex to make Orkambi available, but the company is not impressed and says its attitude to the negotiations has been mischaracterized.
Health Technology Assessment Pricing Debate

WHO Consults On Good Practices For Medical Product Supply

The World Health Organization's draft guideline is applicable to all persons and outlets involved in any aspect of storing and distributing medical products.
International Distribution

Latest From Policy

Korea Pledges Broad Innovation, Policy Support As It Eyes Global Stage

After selecting the bio-health sector as one of three major industries to nurture, South Korea unveils new strategy to triple the industry’s global market share and improve regulations in line with global standards, with a focus on the pharma and medical device sectors. While industry supports the move, some uncertainties could slow the government’s efforts.

South Korea Policy

Pricing And R&D Transparency Proposals Face Pushback At WHA

A draft resolution on the transparency of medicine prices and R&D costs is being discussed this week by World Health Organization members, but the pharmaceutical industry says some measures will be damaging for medicines access.

Government Payers Market Access

Publicly Funded R&D In EU Should Come With Conditions, Says Report

Conditions should be attached to the public funding of biomedical R&D in response to escalating prices of drugs developed with public money, a new report says.

Europe Netherlands

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

QIDP Roundup: Familiar Names Dominate 2019 Designations

US FDA's Qualified Infectious Disease Product program is growing slowly, but still growing.

Review Pathway Infectious Diseases

Publicly Funded R&D In EU Should Come With Conditions, Says Report

Conditions should be attached to the public funding of biomedical R&D in response to escalating prices of drugs developed with public money, a new report says.

Europe Netherlands

ImmunoGen Regroups After FORWARD Setback, Looks To New Ovarian Cancer Phase III

US FDA dashes hopes for accelerated approval of mirvetuximab soravtansine based on subgroup data, but will work with ImmunoGen to design a new trial focused on highly FRα-positive patients.

Cancer Drug Approval Standards

Commercial Explore this Topic

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Latest From Commercial

Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

Biosimilars Metabolic Disorders

Pfizer, Express Scripts Clash Over Biosimilar Formulary Placement

Pfizer VP blames rebate strategies of innovators for difficulty in getting biosimilars on formularies while Express Scripts official says it is all about net cost during House hearing on lowering Rx drug prices.

Market Access Biosimilars

Amgen Resolves Repatha Access Kerfuffle With Express Scripts

On eve of congressional hearing, the pharmacy benefit manager assures Amgen that Repatha is available to its employees.

Market Access Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

No Means No, US FDA Advises 503A Compounding Pharmacies

The US FDA has issued question-and-answer guidance to help pharmacies better understand and comply with its final rule establishing its 503A bulks list. The guidance addresses how the agency developed the list of approved bulk drug substances and how to appeal decisions to get substances placed on the list.

Manufacturing Quality

WHO Proposes Expanding Inspectorates' Guide To Cover All Good Practice Inspections

Recent changes in the field of quality management systems has prompted the World Health Organization to propose updates to its 2002 guideline on QMS requirements for inspection services within national regulatory authorities.
International Quality

Samsung Bioepis Data Suggest Clinical Impact From Herceptin Product Quality Drift

Post hoc data from a long-term safety study of Samsung’s trastuzumab biosimilar and Genentech’s reference product suggest event-free survival rates differ based on a shift in one of Herceptin’s key quality attributes; Genentech said it proactively alerted health authorities when the shift was detected and the evidence does not indicate a clinical impact on patient outcomes.

Biologics Biosimilars