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Latest News & Analysis

Par Alleges 'Shocking' Trade Secret Theft By QuVa Pharma

Par says former employees who founded QuVa used Par's trade secrets to develop a vasopressin product, which FDA has added to its list of ingredients for drug compounding.

Intellectual Property Policy

Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication

Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 13.

Advisory Committees Pediatrics

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

Pharma Requests Pilot To Test Public Value Of EU Guide On Plain Language Summaries

The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”

Clinical Trials Regulation

EU Member States Taking New Steps To Tackle Drug Shortages

The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.

Distribution Manufacturing

Updated EU Guideline On Manufacturing Finished Dosage Forms Addresses Supply Chain Complexities

New EU guidance will help companies preparing marketing authorization applications understand what to include in Module 3 of their common technical document.

Europe Manufacturing

Consumer Health Weekly Trademark Review Aug. 8, 2017

Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Trademarks

Zero Compliance With Indian GMP/GLP Self-Inspection Rule Prompts New DCGI Notice

The Drug Controller General of India has reissued its demand for manufacturers to comply with a new self-inspection and reporting rule and has set a deadline for them to do so.

India Manufacturing

White House Advisor Philipson Brings Industry-Aligned Views On Drug Value

Tomas Philipson, a University of Chicago professor and consultant to the pharmaceutical industry, is named to the White House Council of Economic Advisors.

Appointments Pricing Debate

GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.

Consumer Manufacturing

Pharma Calls For Practical Advice On Using Risk-Based Approach To Trials in EU

The pharmaceutical industry and other stakeholders are calling for practical advice on how the new EU guideline on using a risk-proportionate approach to clinical trials will be implemented in practice. Clarity has been sought on several topics, especially on new requirements such as preparing a risk assessment and mitigation plan as part of a trial protocol.

Clinical Trials Safety

Latest China Cybersecurity Proposal Could Impose Heightened Scrutiny On Biopharma

Drugmaking is among key information infrastructure industries likely subject to additional security and reporting obligations under draft legislation, adding costs and even potentially causing business disruptions, legal experts say.

Cybersecurity Legislation
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