Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Latest News & Analysis

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

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

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

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

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

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

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

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

Keeping Track: US FDA Files Another Pfizer Cancer Biologic And TMC's New Antibiotic

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

Performance Tracker Approvals

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

ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources

The International Council for Harmonisation has proposed major changes to its good clinical practice requirements in a bid to allay concerns about the problems they pose in conducting well-designed randomized trials. The revised GCP framework would also address the increasing diversity of clinical trial designs and data sources.

Regulation Clinical Trials

Bayer CEO On Europe's 'Identity Crisis'

The UK's decision to leave the European Union and a change in global politics that has prompted emotions to get in the way of facts are the catalysts for Europe's current identity crisis, says Bayer chief Werner Baumann. During the company's annual financial results presentation in Leverkusen, Germany, the CEO also called on European regulators to better protect innovation during times of political uncertainty.

Brexit Policy
See All
UsernamePublicRestriction

Register