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Featured Stories


UK Set For January Brexit After Conservatives Win Election

The Conservative Party's victory in the UK general election means the Brexit withdrawal deal will be able to pass. The UK will leave the EU by 31 January and enter a transition period during which medicines regulation will remain broadly unchanged.

United Kingdom Brexit 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

Set Alert for Policy & Regulation

Latest From Regulation

Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Compliance Regulation

Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning

Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.

Drug Review Approvals

Horizon's Teprotumumab Breezes Through US FDA Adcom, But Safety Questions Remain

Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.

Advisory Committees Ophthalmic

Keeping Track: Vascepa Adds CV Risk Reduction Claim, Vyondys 53 Get A Stunning Approval, And Submissions Pour Into FDA

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

US FDA Performance Tracker Approvals

Beovu & Recarbrio Among Five Drugs On Track For EU-Wide Approval

Five new drugs have been recommended for EU approval at the latest meeting of European Medicines Agency’s drug evaluation committee.

Europe Approvals

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

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

Set Alert for Manufacturing

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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