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Featured Stories


Fast Track Pathway May Be ‘Poor Man’s Breakthrough’ But It Works

Most requests for the FDA’s less-heralded expedited review designation are based on Phase II or earlier data, and have a greater chance of success than requests for breakthrough designation.

Review Pathway United States Regulation

EU Call For Coronavirus Projects Sparks Big Pharma Interest

Europe’s Innovative Medicines Initiative is calling for R&D projects aimed at tackling the spread of COVID-19, saying that collaborative ventures have the potential to accelerate the development of therapeutics and diagnostics to tackle this and future coronavirus outbreaks.

Europe Infectious Diseases Research and Development Strategies

Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov

Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.

FDA Clinical Trials Legal Issues

Spotlight On Drug Pricing

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Performance Trackers

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Review Approvals

Global Pharma Guidance Tracker – January 2020

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 Europe

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

Novartis Payments For Kymriah Treatment Logistics Avoid Kickback Concerns

US HHS Office of Inspector General clears company program to provide travel expenses and lodging to needy patients located far from designated treatment centers.

Compliance Legal Issues

New Indications For Diabetes Drugs Under The Spotlight At EMA

Janssen and AstraZeneca are among a raft of companies that might this week find out whether the European Medicines Agency will recommend approval of their products for expanded therapeutic indications.

Drug Review Europe

EU Funding For COVID-19 Drug & Diagnostic Research

Europe’s Innovative Medicines Initiative is to get €90m in funding for programs targeting the coronavirus outbreak.

Europe Infectious Diseases

Brazilian Regulator Approves New Advanced Therapy Regulations

Brazil’s medicines regulator, ANVISA, finally has a new set of rules for the evaluation and marketing authorization of advanced therapy medicines.

South America Brazil

Market For COVID-19 Therapeutics Will Exceed Government Demand, US Believes

HHS Secretary Azar says $1bn of the $2.5bn emergency supplemental funding request is for vaccine development.
Vaccines Infectious Diseases

Expanded Lung Cancer Claim For Lilly’s Cyramza Faces US FDA Scrutiny

Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.

Advisory Committees Drug Review

Latest From Policy

Mallinckrodt's Opioid Resolution Through Generic Unit Bankruptcy May Be 'Test Case'

Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.

Legal Issues Advertising, Marketing & Sales

Continuous Manufacturing: Cost, Lack Of Know-How Have Deterred Generic Firms, Prof Says

Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.

Manufacturing Legislation

ICER’s Biopharma Members: Why They Joined And What They Get

Biopharma’s funding support for the Institute for Clinical and Economic Review has been slightly above that of payers and providers for the past three to four years.

Health Technology Assessment Reimbursement

Clinical / R&D Explore this Topic

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Latest From Research & Development

EU Funding For COVID-19 Drug & Diagnostic Research

Europe’s Innovative Medicines Initiative is to get €90m in funding for programs targeting the coronavirus outbreak.

Europe Infectious Diseases

Market For COVID-19 Therapeutics Will Exceed Government Demand, US Believes

HHS Secretary Azar says $1bn of the $2.5bn emergency supplemental funding request is for vaccine development.
Vaccines Infectious Diseases

Two Companies, Two BARDA Contracts, Two Approaches To Coronavirus

Sanofi follows Janssen in teaming up with HHS' BARDA to develop a COVID-19 vaccine; using technology platform of its Flublok vaccine, Sanofi expects to enter clinical trials in 1 to 1 ½ years.

Vaccines Infectious Diseases

Commercial Explore this Topic

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Latest From Commercial

Japan 2010s In Review: Specialize, Focus, Innovate

Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.

Japan Reimbursement

At Muted J.P. Morgan, Focus Is Execution, But US Pricing Is Persistent Overhang

Political worries aside, industry is confidently executing on focused strategies as it welcomes a new decade, even if a lack of deal news at the J.P. Morgan Healthcare Conference didn't excite investors.

Pricing Debate Business Strategies

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

Manufacturing Explore this Topic

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Latest From Manufacturing

The Quality Lowdown: On Redeploying Inspectors, API Suppliers Thanks To Coronavirus

US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.

Enforcement Manufacturing

Continuous Manufacturing: Cost, Lack Of Know-How Have Deterred Generic Firms, Prof Says

Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.

Manufacturing Legislation

‘Highly Questionable’ GMP Compliance In Pakistan Prompts New Licensing System

Increased fines and penalties are on the cards for manufacturing facilities that fail to comply with proposed new requirements.

Pakistan Manufacturing
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