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Featured Stories


Novartis, D&A Pharma Prepare For High-Stake EMA Meetings

Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.

Europe Drug Review Approvals

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 Policy

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 Regulation

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

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

Hunt On For New Chair Of UK Regulator

Whoever takes over as chair of the Medicines and Healthcare products Regulatory Agency will play a key role in its plans to deliver a program of “ambitious business change.”

United Kingdom Brexit

EMA Crunch Time For Shionogi’s Novel Antibiotic Cefiderocol

The EU marketing application for cefiderocol that lost fast track status last July is now up for an opinion by the European Medicines Agency.

Drug Review Europe

ICH Syncs Reproductive Toxicity Guidance With Current Science

The International Council for Harmonisation has replaced its 1993 guideline on reproductive toxicity studies with an updated version.

International Safety

Could Revisiting US Approval Decisions Become Less Rare?

While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available. 
Rare Diseases FDA

Steba’s Tookad: US FDA Panel To Weigh Novel Endpoints, Missing Data And Toxicities

Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.

Advisory Committees Drug Review

Latest From Policy

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

Joint Tendering Creates ‘Attractive Nordic Market’

Joint tendering among Nordic countries can help reduce shortages of older, off-patent medicines. 
Europe Denmark

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

US Researchers Working Toward Universal Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Vaccines Manufacturing

Novel Ticagrelor Reversal Agent Wins Place On EMA’s PRIME

Only two of seven recent applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster made the grade.

Europe Regulation

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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