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EMA’s Post-Brexit Home ‘Could Be Decided This Year’

The leader of Denmark’s bid to host the European Medicines Agency after the UK leaves the EU says that a rapid decision-making process on the agency’s new location is needed in order to avoid entanglements with the wider Brexit negotiations, and that a decision could be taken sometime in the second half of this year.

Brexit Regulation Denmark

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 Reimbursement

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 Research & Development

Off-Label Promotion Decisions Likely Made Case-by-Case, US FDA Official Says

OPDP chief Abrams did not give many general tips for complying with guidance on off-label promotion 'consistent with' FDA-approved labeling, leaving sponsors to make own interpretations.

Advertising, Marketing & Sales FDA Regulation
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Policy & Regulation Explore this Topic

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Survival Benefit For Hypotension Shock Drug Nice But Not Needed By FDA, La Jolla Says

La Jolla Pharmaceutical's angiotensin II drug LJPC-501 is on track for NDA via SPA this year, after meeting blood pressure increase primary endpoint in ATHOS-3, but also showing a trend toward an overall survival benefit.

Cardiovascular Clinical Trials Drug Approval Standards

Latest From Regulation

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

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

Mexico's COFEPRIS: A Friend Or Foe To Industry?

'We have a lot of red tape, but we have a clear red tape,' attorney José Alberto Campos-Vargas says in an interview.

Drug Review Regulation

Latest From Policy

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

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

FluMist May Not Get CDC Seal Of Approval For Several Years

CDC advisory committee wants vaccine effectiveness data for H1N1 component but that is not the predominant strain this season; AstraZeneca is not giving up.

Vaccines Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

Intercept's Revised NASH Trial Improves Prospects

The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.

Clinical Trials Research & Development

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Latest From Commercial

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

New Policy Fund Reflects Korea’s Commitment To Health Biotech

South Korea's plan to create a policy fund to support new growth engine industries seems to reaffirm the government's unwavering commitment to nurture the biotech and health care sectors despite the ongoing political chaos in the country.

South Korea Financing

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

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

Bayer Plans 19 Consumer Product Launches To Revive Sluggish Sales

Bayer consumer readies 19-product pipeline for 2017 as it works to increase sales of brands including Coppertone and Dr. Scholl’s brands that have been sluggish since being acquired from Merck & Co.

Consumer Advertising, Marketing & Sales
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