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A Successful Failure? Lartruvo’s Speedy Withdrawal Sets New Bar For Accelerated Approval Drugs

Lilly withdraws soft tissue sarcoma drug for failure to confirm clinical benefit two and a half years after US FDA awarded accelerated approval, becoming the fastest withdrawal yet under the regulatory pathway.

Review Pathway Drug Approval Standards Cancer

EU Regulators Asked To Define 'Drug Shortages' Before Finalizing Notification Framework

The EU pharmaceutical industry has highlighted key aspects that it wants regulators to address when it comes to defining the term "drug shortages."

How SmPCs Can Affect Pricing Talks And Market Access

Companies should be aware of how wording in the summary of product characteristics for their medicine can impact pricing talks and market access.

Europe Market Access Policy

FTC Slams Surescripts' E-Prescribing Networks, Says 'Web Of Loyalty Contracts' Blocks Competition

Surescripts maintained a monopoly on electronic prescription routing and eligibility markets through exclusive contracts with pharmacies and PBMs, complaint alleges.

Legal Issues Enforcement Pharmacy Benefit Management

Rabies Monoclonal Antibody Development Plan Gets US FDA Panel Backing

A second-line indication for rabies post-exposure prophylaxis is the best a monoclonal antibody can initially expect, but postmarketing studies could get the product upgraded to first-line status, the Antimicrobial Drugs Advisory Committee suggests as it endorses the US FDA's proposed development plan in two separate 16-0 votes.

Advisory Committees Infectious Diseases Regulation

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – March 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

Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

Download Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Amgen, Astellas Bring Tally Of US Charity Co-Pay Kickback Settlements To Eight

Astellas to pay $100m and Amgen to pay $24.75m to resolve allegations they paid Medicare copays for their products through copay assistance foundations.

Legal Issues Enforcement Advertising, Marketing & Sales

Latest From Regulation

Accelerated Approval Withdrawals Through The Years

Lartruvo’s brief time on the market is especially quick compared with other drugs and indications that received accelerated approval from the US FDA and were subsequently withdrawn, our infographic shows.
Drug Approval Standards Review Pathway

New EU Market Hopefuls Await Their Fate; EMA Re-Adopting Zynteglo Opinion

Sponsors of a raft of new products will find out this week if the European Medicines Agency’s medicines evaluation committee, the CHMP, is convinced the therapies are ready for marketing.

Europe Approvals

Widespread Off-Label Use Could Ensure Injectable Bacitracin's Future

US FDA advisory committee will weigh fate of the injectable antibiotic, which can cause renal failure and is only approved for treatment of pediatric pneumonia. However, its real-world use is almost entirely in the surgical setting for irrigation and prophylaxis. Xellia, one of five companies that markets the generic drug, said the risk/benefit profile for on-label use remains positive and evidence on off-label use warrants further exploration.

Advisory Committees Drug Review

Latest From Policy

End Of The 'March-In' Pricing Petitions?

KEI vows to continue battle over Bayh-Doyle restrictions after US Commerce Department suggests it may issue regulations to exclude pricing as a basis for requiring companies to license their patents.

Intellectual Property NGO Action

Medicare Weighing Higher Add-On Payments For New Drugs, Including CAR-T

Change would increase maximum new technology add-on payments from 50% to 65% of costs.

Cancer Reimbursement

AZ, Pfizer, Lilly Novel Anticancers Head For India Debut

AstraZeneca’s Calquence, Pfizer’s Lorbrena and Lilly’s Verzenio, which all address unmet medical needs, have been endorsed by an expert panel in India, paving the way for their potential introduction on the market. But all eyes will be on pricing to ensure access in this largely self-pay market.
India Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

First US FDA RMAT Designation Of 2019 Goes To ExCellThera’s ECT-001

Five-month drought broken by ExCellThera’s "optimized culture system" designation for treatment of hematologic malignancies. The Pink Sheet details each of the 27 announced Regenerative Medicine Advanced Therapy designations in a table.
Cancer Review Pathway

Building A Wall? The Plan To End “March In” Threat To US Drug Patents

Calls to exercise “march in” rights on federal patents licensed to pharmaceutical companies are a recurring theme in the US drug pricing debate. Now the Department of Commerce is proposing to make those threats even emptier than they already are.
Pricing Debate Innovation

Life After FDA: Rachel Sherman To Tackle Real World Evidence, Clinical Trial Efficiency

Sherman, who left the No. 2 post at FDA in January, is working part-time at Duke-Margolis and serving as a consultant to Medidata Solutions.

FDA Appointments

Commercial Explore this Topic

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Latest From Commercial

US FDA Squashes Sprout's Attempt To Remove Boxed Warning From Addyi Label

In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.

Drug Safety Post Market Regulation & Studies

Rebate Reshuffle: Could Pharma Foot The Bill To Offset Higher Premiums?

Bernstein Research analysts said CMS could charge pharmaceutical manufactures a fee to offset increases in insurance premiums anticipated from the elimination of rebates in a "win-win" move.

Pricing Debate Reimbursement

Making The Case For Rebates: UnitedHealth Pushing Expansion Of POS Program

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Pharmacy Benefit Management Pricing Debate

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA: Despite Improvement, Particulate-Related Injectables Recalls Remain A Concern

The US FDA reports that particulate contamination was the second leading cause of recalls for injectable drugs over a 10-year period. Yet the good news is that the recalls attributed to visible particle contamination has actually gone down. FDA official says it may be premature to celebrate, more work is needed to bring these recalls down and improve the quality of injectable products.

Manufacturing Quality

EMA Guides Industry On How To Demonstrate Adequate Sterilization of New Drugs

Final guidance recently issued by the European Medicines Agency explains how to show assessors that new drugs, along with the drug substances, excipients and final containers, have been adequately sterilized.

Manufacturing Quality

The Quality Lowdown: What Happens When The Wrong Ingredients Are Used

Some ingredient risks to consider: IV castor oil hypersensitivity; oral liquid bioburden; elm in the coconut.

Quality Enforcement