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Featured Stories


New US FDA Commissioner Stephen Hahn Heads to White Oak Under Vaping Cloud

Bipartisan Senate confirmation vote comes despite concerns about Stephen Hahn's non-answers to e-cigarette regulation questions.

FDA Leadership Regulation

Sarepta Scores Another Remarkable Approval With Vyondys 53 For Duchenne

Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.

Drug Approval Standards Neurology FDA

Real-World Evidence Fails Another Test At US FDA

Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.

Real-World Evidence Cardiovascular Drug Approval Standards

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Performance Trackers

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

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

US FDA Performance Tracker Cancer Drug Review

Global Pharma Guidance Tracker – November 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.

International Europe Australia

Policy & Regulation Explore this Topic

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Latest From Regulation

Expert Panel Affirms ‘Continued Marketing’ Of Ambrisentan, Everolimus In India

Years after a scathing Indian parliamentary report flagged concerns around regulatory lapses for drug approvals, an expert panel has endorsed the continued marketing of ambrisentan and everolimus in the country. But dronedarone, also featured in the report, is no longer sold by Sanofi in India.

India Regulation

EU Preserves Status Quo On Drugs Under Additional Monitoring

The European Commission has set aside, for now, concerns expressed by member states regarding the scope of medicines subjected to additional monitoring requirements.

Europe Safety

USCMA Revision Worsens Innovator Woes In Canada

Stripping the revised USMCA deal of provisions to strengthen IP rights for biologics will worsen market difficulties in Canada caused by changes to the drug pricing regime, says industry.
North America Canada

EU Ministers Want Decisive Action On Medicines Access & Shortages

Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.

Europe Distribution

Regulatory Blessings Helping China CAR-Ts March Closer To Global Cancer Patients?

A regulatory framework that encourages physicians to conduct experimental cell and gene therapies have propelled China to become a major developer of such promising cancer-treating tools, but insiders say three are a plethora issues at stake.

China Clinical Trials

Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions

FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.

Advisory Committees Ophthalmic

Latest From Policy

USCMA Revision Worsens Innovator Woes In Canada

Stripping the revised USMCA deal of provisions to strengthen IP rights for biologics will worsen market difficulties in Canada caused by changes to the drug pricing regime, says industry.
North America Canada

Biologic Exclusivity Provision In USMCA Is Boon To Generics Industry; BIO Is 'Tremendously Worried'

Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.

Trade Intellectual Property

US Supreme Court Seems Poised To Allow Patent Holders More Judicial Review Options

In case that could impact challenges of biopharma patents, Supreme Court questioned the consequences of not allowing courts to review PTAB institution decisions when petition may be time barred.

Intellectual Property Legal Issues

Clinical / R&D Explore this Topic

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Latest From Research & Development

Novartis And The Medicines Company: Five Things To Worry About

The $9.7bn acquisition hinges on the small interfering RNA inclisiran, but an ongoing cardiovascular outcomes trial, manufacturing hurdles, and reimbursement challenges provide subjects for concern.

M & A Reimbursement

Introducing The Citeline Awards 2020; Nominations Open

The 2020 Citeline Awards, Informa’s premier event recognizing excellence in R&D, recognize the myriad achievements across the industry and are open for nominations through 17 January.
Research & Development BioPharmaceutical

The Absurd Innovation Debate: Dueling Views Of HR 3 Miss The Point

White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.

Pricing Debate Research & Development

Commercial Explore this Topic

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Latest From Commercial

Novartis And The Medicines Company: Five Things To Worry About

The $9.7bn acquisition hinges on the small interfering RNA inclisiran, but an ongoing cardiovascular outcomes trial, manufacturing hurdles, and reimbursement challenges provide subjects for concern.

M & A Reimbursement

Galectin’s NASH Phase III Trial Will Use Surrogate Measures Of Esophageal Varices

Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.

Liver & Hepatic Drug Approval Standards

Vaccine Development Challenges Include Extensive Quality Control, Sanofi's Loew Notes

Sanofi spends 70% of vaccine production on quality control, Sanofi Pasteur exec VP David Loew tells the Pink Sheet; company is working on next generation flu vaccines that may provide greater efficacy.

Vaccines Research & Development

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Slams Teligent For Lax Approach To Complaint Handling And Stability Testing

Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.


Manufacturing Quality

EU Ministers Want Decisive Action On Medicines Access & Shortages

Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.

Europe Distribution

The FDA Builds On Lessons Learned In Rebuilding Quality Metrics Program

US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.

Manufacturing Quality
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