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

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


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 Europe

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 Legal Issues

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Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical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 Review Pathway

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 Europe
Advertisement

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

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 BioPharmaceutical

Latest From Regulation

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

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

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

Latest From Policy

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

Korea's Reimbursement Steps Spark Drug Price Cut Concerns

In its first announcement of major health care measures since the Moon Jae-in administration took charge, South Korea unveils steps to hike its national health insurance coverage ratio to levels in advanced countries, raising concerns that this might lead to sharp drug price cuts.

Policy Reimbursement

Pooled Purchasing Is Poor Answer To Latin American Drug Pricing Worries, Says Industry

Pooled procurement will not fix problems relating to affordability and access to medicines in South America, says the US pharma industry association, PhRMA, in response to news that Mercosur trade bloc members will join forces to negotiate better prices for medicines.

BioPharmaceutical Emerging Markets

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Medically Senseless: Why EU Pediatric Investigation Plans Should be Abandoned

Most clinical trials required under EU pediatric investigation plans are medically senseless, and many cause harm to patients, argues consultant Klaus Rose. This is a challenge not only for the pharmaceutical industry but for regulators and wider society as well.

Pediatrics Europe

Keeping Track Of CRLs: US FDA Again Faults Bausch + Lomb Manufacturing

A look at recent developments tracked by the Complete Response Letters chart on the Pink Sheet's US FDA Performance Tracker.

Complete Response Letters Regulation

English PrEP Study To Use Mylan’s Generic Version Of Gilead’s Truvada

A study of tenofovir plus emtricitabine in HIV pre-exposure prophylaxis is to begin in England in September, using Mylan’s generic version of Gilead’s originator drug Truvada. Wales is running a similar trial with Truvada, while Scotland has decided to fund the drug for PrEP under the National Health Service.

Clinical Trials Cost Effectiveness

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Commercial Capsules: Autoimmune Positioning; Sanofi In China; Migraine Race; BMS Deal; Clinical Advances

AbbVie outlines how it will stay top dog in autoimmune therapy; Dermira licenses lebrikizumab, threatening pressure on Sanofi/Regeneron's Dupixent; Sanofi has driven up vaccine sales in China after responding to new government distribution rules; Lilly plans a migraine filing; FibroGen, Myokardia and Hansa Medical advance in the clinic and Bristol-Myers shells out up to $2.3bn to turn cold tumors hot. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Clinical Trials Deals

Commercial Capsules: Pfizer's Tax Reform M&A Pause; PARP Deals; PD-1 Sales; Antimicrobial Financing

Pfizer's CEO says uncertainty over US tax reform was staying his hand in M&A; following AstraZeneca's MYSTIC miss, Bristol-Myers Squibb and Merck & Co. were duly grilled over their own PD-1/CTLA-4 combination programs; recent deals highlight gathering enthusiasm for combining PARP and PD-1/PD-L1 inhibition. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Deals Commercial

Number One With A Bullet: Eylea Takes Top Spot In Medicare Part B Drugs

Regeneron’s Eylea is the new holder of the number one spot in Medicare Part B prescription drug payments. It is also the fastest growing entrant on the top-ten list tracked by MedPAC. That is a sign of great commercial success – but could be an uncomfortable spotlight.

Medicare Ophthalmic

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From 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

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

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

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

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

NHS England Tackles Use Of ‘Ineffective And Dangerous’ Medicines

The National Health Service in England has drawn up a proposed list of “ineffective and dangerous” medicines that should not be routinely used in primary care, in a move to conserve resources and improve patient outcomes. They include products containing substances like fentanyl, tadalafil and trimipramine, as well as homeopathics and traditional herbal medicines.

Cost Effectiveness Drug Safety
UsernamePublicRestriction

Register

Advertisement