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Featured Stories


EU Countries Test Offering Simultaneous Scientific Advice

An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.

Innovation Regulation Europe

US FDA Drug Risk Management Board To Be Lead By CDER Deputy Cavazzoni

CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.

Drug Safety FDA Leadership

China Coronavirus Outbreak Response Critical As First US Case Confirmed

A quickly spreading coronavirus outbreak in China could upend the country’s healthcare priorities as the health regulators and reimbursement agency officials gear up to “control and prevent” the worst public health emergency since the deadly SARS outbreak in 2003.

China Infectious Diseases Policy

Spotlight On Drug Pricing

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Performance Trackers

Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues

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

US FDA Performance Tracker Drug Review Regulation

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

Complex Generic Approval Delays Getting Congressional Attention

US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.

Generic Drugs Legislation

EMA Suspends Leo’s Actinic Keratosis Drug Picato

The latest drug safety actions by the European Medicines Agency affect products for dermatological use and vaginal atrophy.

Europe Drug Safety

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Approvals Europe

EU Panel Outlines Practical Way Forward With Big Data

An ambitious action plan drawn by an EU task force, if implemented on a priority basis by the European Commission, could increase the EU’s capacity to advise on, assess and analyze big data.

Real-World Evidence Drug Approval Standards

ViiV Wins Fast-Track Review At EMA For HIV Therapy

A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.

Europe Approvals

Australian Fees To Rise As Drug Registrations Decline

The Therapeutic Goods Administration says that its cost-recovery fees need to go up, mainly because of a fall in the number of medicines on the therapeutic products register. It is also seeing a rise in the cost of the fee-free services it provides.

Australia Regulation

Latest From Policy

India Rare Disease Policy Proposes Crowdfunding But Patients Feel Let Down

Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.

India Policy

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

Power Of Proprietary Drug Names To Be Studied By US FDA

FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.

Advertising, Marketing & Sales FDA

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

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

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

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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