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Featured Stories


Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.
Generic Drugs Legal Issues Pricing Strategies

Concerns Emerge Over England’s Desire For Even Lower Drug Prices

With the emphasis on getting lower prices even for cost-effective drugs, England’s proposed commercial framework may be sending a negative signal to global companies.

Pricing Strategies United Kingdom Market Access

ANDA Approval Records Will End As US FDA Mops Up Backlog

CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.

Generic Drugs Review Pathway Regulation

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Performance Trackers

Keeping Track: Oxbryta Approval Headlines Pre-Thanksgiving Week Of News

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

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – October 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

Drug Shortages, AMR & Cancer High On New EU Commissioner’s Agenda

The new EU commissioner for health has been given a number of high-priority tasks, including medicines supply and tackling antimicrobial resistance. These topics will be taken up by the European Commission’s advisory body, the Pharmaceutical Committee, in its new work plan.

Europe Distribution

Future Unclear For EU Mandatory Joint Clinical Assessment Plans

Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.

Europe Health Technology Assessment

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. 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

Commissioner Nominee's Required Divestitures Illustrate US FDA's Broader Recruitment Challenge

Stephen Hahn will have over 100 stocks to divest upon becoming FDA commissioner.

FDA Leadership

US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January

The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate ­– Hylton Joffe – will be serving as acting OND deputy director.

FDA Leadership

HHS Will Take Anti-Kickback Safe Harbor Proposals For Drug Contracting ‘Seriously,’ US Official Promises

Health and Human Services Department Deputy Secretary Eric Hargan invites biopharma companies to submit proposals on how to modify or create safe harbors that would be suitable for innovative reimbursement contracts involving prescription drugs.

Reimbursement Medicare

Latest From Policy

Future Unclear For EU Mandatory Joint Clinical Assessment Plans

Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.

Europe Health Technology Assessment

Glumetza Patent Settlement Without An Authorized Generic Plus Price Hike Spawns Litigation

Walgreen and other retailers allege no-authorized generic patent settlement for extended-release metformin allowed Santarus (Valeant) to block generic entry for four years while raising the price more than 750%.

Legal Issues Intellectual Property

Europe's Off-Patent Industry Seeks Action On Shortages

Medicines For Europe has called on EU leaders to take action on the issue of medicine shortages, urging the new European Commission to prioritize prevention measures in its first 100 days.

Europe Market Access

Clinical / R&D Explore this Topic

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Latest From Research & Development

Adaptive Clinical Trials: US FDA Offers More Advice On Bayesian Designs

Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.

Guidance Documents Clinical Trials

Real-World Database Studies: Prepare For A Long Journey, IQVIA Advises

Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.

Real-World Evidence Research & Development

EMA Heeds Ombudsman’s Advice On Avoiding Perception Of Bias In Drug Evaluations

An inquiry by the EU Ombudsman has prompted the European Medicines Agency to introduce changes to ensure that its experts, who advise companies in the premarket phase, are not appointed to evaluate marketing applications for the same drugs.

Approvals Research & Development

Commercial Explore this Topic

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Latest From Commercial

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

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Drug Shortages, AMR & Cancer High On New EU Commissioner’s Agenda

The new EU commissioner for health has been given a number of high-priority tasks, including medicines supply and tackling antimicrobial resistance. These topics will be taken up by the European Commission’s advisory body, the Pharmaceutical Committee, in its new work plan.

Europe Distribution

US FDA Mulls Pilot To Examine Separate Review Pathway For Novel Excipients

Proposal could yield a bounty of new options for innovative drug delivery systems.

Manufacturing Quality

Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges

Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?

Drug Review Manufacturing
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