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Trump Slams FDA Regulations In Joint Session Of Congress

President hit on his sentiments of faster drug approval times and deregulation, signaling agency could be in for period of sustained criticism.

Drug Review Approvals Regulation

First Generic Approvals Decline For Fourth Straight Year At US FDA

Blemish in otherwise record-setting performance could simply be a result of coalescing variables, but it robs the agency of an easy pricing message.

Approvals Generic Drugs Regulation

More Checks And Balances For Orphan Drugs Needed, Says Germany’s G-BA

The German pricing and reimbursement authority wants better scrutiny of orphan drug designations and incentives for orphan drug development to help address the access problem.

Policy Rare Diseases BioPharmaceutical

Data Integrity Failures Undermine Trust That Can’t Easily Be Won Back, EMA Official Says

A forum on quality excellence in India saw global regulators highlight regulatory requirements and expectations in critical areas such as data integrity and the investigation of compliance-related complaints. The fostering of a quality culture was another key theme at the event, with one EMA speaker noting there are no easy fixes when trust in data is broken.

Regulation Drug Safety Quality Control
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Policy & Regulation Explore this Topic

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Pfizer Suffered 'Significant Loss Of Control' At McPherson Plant, US FDA Warning Letter Says

Infractions that have delayed Copaxone generic in plant Pfizer acquired when it bought Hospira suggest that pattern of quality issues may be continuing. Warning letter assigns eight tasks related to particulate contamination.

Manufacturing Quality Compliance

Latest From Regulation

First Approvals Under EMA’s Adaptive Pathways May Be Just A Few Years Away

The first marketing authorizations under the European Medicines Agency’s hotly debated adaptive pathways concept for getting drugs to patients faster could be granted in just a few years’ time.

Drug Review Market Access

Pharma Firms In Russia Must Adhere To New Good Distribution Practices

Pharmaceutical companies in Russia now have an obligation to ensure they meet new medicine distribution and storage rules, with penalties for those that don’t. They are also responsible for ensuring any warehouses they contract services to meet the same requirements.

Distribution Russian Federation

CHMP’s Positive Opinions In February Include Lokelma, Natpar and Varuby

EMA committee's marketing approval recommendations from their February meeting.

Approvals Regulation

Latest From Policy

Exonics Using CRISPR To Develop One-Time Treatment for Duchenne

Newly formed biotech company hopes to avoid patent melee and use gene editing technology to develop therapy for up to 80% of boys with DMD; trial outcomes to drive terms of future licensing deals.

Intellectual Property Legal Issues

Rival For Opdivo As Keytruda Launches For NSCLC In Japan At Same Daily Price

Opdivo has a new rival in the lung cancer setting in Japan following the reimbursement and launch of Keytruda at the same daily price.

Japan Policy

Abuse-Deterrent Opioids: US FDA Follows The ‘Route Of Abuse’ To Exclusivity

Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.

Policy Approvals

Clinical / R&D Explore this Topic

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Latest From Research & Development

Exonics Using CRISPR To Develop One-Time Treatment for Duchenne

Newly formed biotech company hopes to avoid patent melee and use gene editing technology to develop therapy for up to 80% of boys with DMD; trial outcomes to drive terms of future licensing deals.

Intellectual Property Legal Issues

Adverse Event Assessment In India Gets Harvard-Built Tool; Will Increased Trial Activity Follow?

Against backdrop of subdued trial activity in the country and concerns about injury compensation, Indian Society for Clinical Research and Harvard's MRCT Centre offer a portal to facilitate a more objective assessment of causality of serious adverse events.

Drug Safety Clinical Trials

Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Regulation Clinical Trials

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Latest From Commercial

Janssen's Drug Pricing Report Emphasizes Value Of Rebates

As political pressure on pricing continues to build, Janssen's first-ever transparency report notes average list price increase was 8.5% in 2016; annual pricing parties are no longer 'raves,' Raymond James & Associates says.

Pricing Debate Legislation

Cost Versus Value: Earnings Calls Spotlight US Pricing Reforms

Pink Sheet has scoured big pharma annual results presentations to gauge the industry's reactions and concerns around the increasingly tough US drug pricing environment and proposed changes to the Affordable Care Act under the new Trump administration.

Pricing Debate Pricing Strategies

J&J Outlines Pricing Transparency Plan, Will Others Follow?

CEO Gorsky describes J&J’s approach to drug pricing and pledges to provide more detail in an annual transparency report. Investor pressure regarding the pricing debate continued during the Novartis earnings call. Value arguments expected to dominate pharma’s message.

Pricing Debate Sales & Earnings

Manufacturing Explore this Topic

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Latest From Manufacturing

WHO Reviews Eight-Year Old Stability Testing Guide For APIs, Finished Products

The World Health Organization has proposed changes to its 2009 guideline that seeks to exemplify the core stability data package required for the registration of active pharmaceutical ingredients and finished pharmaceutical products.

Regulation Quality

FDA Urges Full Participation In Quality Metrics Program

Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.

Manufacturing Quality

Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch

Sandoz/Momenta’s generic of Teva’s 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer’s McPherson, Kan., plant put review on hold.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Perrigo Trims Workforce, Ships Tysabri License, Stays European Course

The firm is reducing its non-production workforce by 750, a decision made after three representatives of disgruntled investor Starboard Value joined its board. Perrigo charts a course of recovery for its struggling international consumer health business, but some analysts are convinced it took a wrong turn with its 2015 investment in European OTC drug and nutritional product businesses and brands.

Europe United States

Consumer Health Weekly Trademark Review Feb. 21, 2017

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Australia China

Direct OTC Purchases With Pre-Tax Accounts Swing On ACA Change, Not Repeal

Sens. Pat Roberts, R-KS, and Heidi Heitkamp, D-ND, and Reps. Lynn Jenkins, R-KS and Ron Kind, D-WI, once again introduce the Restoring Access to Medications Act, proposing amending rather than repealing ACA.

United States Dietary Supplements
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