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Featured Stories


Medicare Part D Redesign Will Lead To Bigger Rebate Demands – MedPAC Panelist

DeRoyal’s DeBusk urges a focus on rebates, while Brookings' Ginsburg wants a focus on design, not savings per se, as MedPAC discusses restructuring the Part D design to better accommodate current market dynamics. Formal recommendations to Congress may be approved in the spring.

Medicare Reimbursement Pricing Strategies

Six-Month Delay For Russia’s Track And Trace System

Russia’s new drug traceability system won’t now be implemented until July, but companies that are ready and able are being encouraged to put the system through its paces in order to flush out any glitches.

Russian Federation Business Strategies Compliance

Decade In Review: Biopharma's Shifting Legal Landscape

Emergence of the inter partes review process dramatically changed the patent dispute arena.  The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.

Legal Issues Biosimilars Intellectual Property

Spotlight On Drug Pricing

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Performance Trackers

Keeping Track: Ayvakit Approval, Keytruda Supplement, NME Submissions

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

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – December 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.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

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Latest From Regulation

Countries Urged To Open Up On Managed Entry Deals

Performance-based managed entry agreements need to be made more effective, but this can only happen if countries relax their stance on confidentiality and share information on MEAs amongst themselves, says a working paper from the OECD.

International Comparative Effectiveness

Switzerland Fast Tracks Registration Of EU/US-Approved Anti-Infectives

Swissmedic will scale back its review procedure for certain anti-infectives if the indications for which approval is being sought are identical to those approved in the EU or the US.

Switzerland Drug Approval Standards

New EU Patent System On Course For End Of 2020, Says EPO

Progress is being made towards the implementation of the EU’s new patent system, but the UK’s insistence on severing all ties with the European Court could spell the end for its participation.

Europe Intellectual Property

EMA On Track To Install New Chief In November

The recruitment process for the new executive director of the European Medicines Agency seems to be running to schedule.

Europe Regulation

Opioid-Sparing Hopes, Efficacy Worries Drive Inconclusive Advisory Cmte. On Durect's Posimir

US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.

Advisory Committees Drug Review

December ANDA Rush Is Largest Monthly Haul In Two Years

However, the month may be losing its influence over the US FDA's annual submission total.

Generic Drugs Review Pathway

Latest From Policy

US FDA's Decade In Review: From Biosimilars To Real-World Evidence

A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.

FDA Biosimilars

A Visual Guide To US FDA's Evolutionary Decade In Review

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

FDA Regulation

Supreme Court Takes Pass on Clarifying Patent Eligibility, Disappointing BioPharma

Industry now needs to wait for a more appealing appeal or a revived legislative effort after the high court declines review of Athena Diagnostics v. Mayo Collaborative Services, which created a sharp divide in the Federal Circuit, and Hikma v. Vanda; biopharma and others contend eligibility issue is biggest problem in patent system.

Legal Issues Intellectual Property

Clinical / R&D Explore this Topic

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Latest From Research & Development

EU Looks At New Ways To Tackle Antibiotic Market Failure

A novel Swedish payment scheme and transferable exclusivity vouchers for new antimicrobials are among mechanisms being examined by the European Commission for encouraging the development of new drugs to tackle the growing problem of antibiotic resistance. 

Europe Innovation

US FDA Approval Of Lynparza For Pancreatic Cancer Opens Door For PFS Endpoint In Disease

AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.

Approvals Cancer

New Gene Therapies For Pediatric Diseases Win EMA PRIME Designations

Just two of six applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster were successful last month.

Research and Development Strategies Europe

Commercial Explore this Topic

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Latest From Commercial

J.P. Morgan Notebook Day 4: Novartis CEO Weighs In On AI, Sangamo’s Next Steps And More

Additional highlights from the J.P. Morgan Healthcare Conference, including Takeda’s partnering outlook, Sage’s guidance on Zulresso sales, Frequency’s next steps for its hearing loss drug and Revance’s preparations to take on the aesthetics market. 

Business Strategies Artificial Intelligence

J.P. Morgan Day 3: Skyrizi Momentum Builds, What's Next For Amarin, Viatris Debuts And More

Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: AbbVie's Skyrizi takes psoriasis lead, Amarin goes it alone, Viatris debuts, BeiGene on US drug pricing and Roche think neuroscience is the new oncology.

Business Strategies Launches

J.P. Morgan Notebook Day 2: Bourla Feels Pfizer's Underappreciated, GSK Prepares For Myeloma First And More

Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: GSK's first-in-class oncology opportunity, Pfizer's Bourla on underappreciated pipeline, AstraZeneca's Enhertu pricing, Amgen's genomics push, Lilly filters through deals and Medicxi's de Rubertis teases big pharma CEOs about M&A. 

Business Strategies Launches

Manufacturing Explore this Topic

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Latest From Manufacturing

New AMR Report Is ‘A Wake-Up Call’, Says Industry Body

Another day, another report on how to tackle the ever-present problem of antimicrobial resistance and the dearth of new treatment. In its latest assessment of the state of play, the AMR Industry Alliance has come up with some alarming facts and figures – and some ideas for the next steps.

International Manufacturing

New Jersey OTC Firm Lacked GMP Basics, FDA Warning Letter Says

US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.

Manufacturing Quality

India 2019 – R&D Highs, Compliance Woes And Other Lows

2019 saw Indian companies advance innovation efforts and build and expand their specialty portfolios and biosimilars businesses. But manufacturing compliance issues weighed down several firms while on another front charges against the Singh brothers of Ranbaxy escalated.

India Regulation
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