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Featured Stories


Humira Under Pressure As NHS England Invites 'Competitive Prices' For Biosimilars

Companies wanting to compete in the newly off-patent adalimumab market in England have until Oct. 22 to submit their bids. They will need to offer “competitive prices” if they are to secure the highest share of sales to the national health service. At the same time, NHS trusts and clinical commissioning groups have been warned not to accept discounted interim offers from suppliers keen to get a foot in the door.
Biosimilars United Kingdom Government Payers

DTC Advertising: The 'Kick Me' Sign On Big Pharma’s Backs

Treating mandatory wholesale acquisition cost disclosure in TV ads as a major drug pricing reform is close to ludicrous. But the broad approval of the action is an important sign of the continued public image cost of the ads to the drug companies.

 

Pricing Debate Reimbursement United States

Anatomy Of A Biotech Company: Acorda Gets Dressed For A Second Act

Acorda's rise, fall, and attempt to rise again is a snapshot of the life of a biotech. The company reached the commercial-stage pinnacle with Ampyra, only to eventually see it fall away to patent challenges. Now, after big staff cuts, the company is hoping to prevail in the commercial market again, this time with Inbrija.

Commercial Companies Intellectual Property

Brexit Hits Third Countries – CPPs Delayed

The European Medicines Agency is struggling to meet its 10-day turnaround for issuing certificates of pharmaceutical products (CPPs), documents that many countries outside Europe rely on to make their own regulatory decisions.

Brexit International Regulation

Next Step After 'Right To Try'? Senate Hearing Includes Call To Reopen Orphan Drug Act

Trump Administration’s successful campaign to pass “Right to Try” legislation may be emboldening advocates to push for other policies that will loosen FDA regulatory requirements on rare disease drug development.
Rare Diseases Legislation Intellectual Property
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – August 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
International Australia Singapore

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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

Read the eBook and discover more

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Data Integrity And The Iceberg Concern

US FDA official outlines a number of issues around data integrity lapses, including how they trigger concern around all records of a non-compliant firm and that certain factors, including the limited oversight of sponsors over CMOs, could potentially be linked with data integrity problems.
Manufacturing India Drug Safety

Latest From Regulation

US FDA's Ostroff, Twice An Acting Commissioner, Retiring Next Year

A former Walmart executive will replace the deputy commissioner for foods and veterinary medicine, who spent nearly 15 months total as acting commissioner.

FDA Leadership

New EU Approvals

Six new products, including Eli Lilly's breast cancer drug Verzenios, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of new active substances. The list includes brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Approvals Europe

Zelnorm's Return: US FDA Panel Hands Down Split Decision On Constipation Drug's Target Population

Seven advisory committee members said the treatment for irritable bowel syndrome with constipation should be labeled for females at low cardiovascular risk; three panelists, including two cardiologists, supported a narrower indication limited to low CV risk patients who also suffer from severe symptoms.

Advisory Committees Drug Review

Latest From Policy

Drug Pricing Reform In Medicare And Medicaid: Upcoming Regulatory Action

Two highly anticipated proposed rules in Medicare Part D are scheduled for near-term release.

Pricing Debate Medicare

How Brazilian Patients Might Access Sickle Cell Disease Drug Faster

Masters Speciality Pharma is in the process of registering sickle cell disease drug Siklos in Brazil. The company revealed how it would ensure the product gets to patients sooner rather than later.

South America Brazil

J&J Supports ‘Spirit’ Of DTC Pricing Transparency, But Prefers PhRMA’s Voluntary Approach

Leading off the third quarter earnings calls for biopharma, J&J offered mild support of a proposed HHS policy to require pricing information in direct-to-consumer advertising, but more enthusiastically backed a voluntary approach suggested by PhRMA.

Pricing Debate Commercial

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

ICER Is Weighing Early Research Consulting Work With Pharma

The drug value assessment organization said it is considering whether or not to move forward with a program to consult pharmaceutical manufacturers on early research, a move that could raise questions about the group's independence.

Clinical Trials Health Technology Assessment

Ovarian Cancer Risk Cut 23% With Aspirin Use – Harvard Study

Study analyzed follow-up data on 205,498 women from the Nurses’ Health Study started in 1976 and Nurses’ Health Study II opened in 1989; 1,054 of the women developed ovarian cancer.

Drug Safety Consumer

ASPREE Results Support FDA Aspirin Label Guidance On Cardiovascular Disease

Data from ASPREE trial with more than 19,000 subjects show five-year-use of low-dose aspirin did not prolong disability-free survival and is associated with a significantly higher rate of hemorrhage and somewhat higher rate of all-cause mortality. Findings in three reports in NEJM track with US FDA's guidance that OTC aspirin marketers include a statement referring to doctors when aspirin package labels include a heart or other image suggesting a CV indication.

Drug Safety Consumer

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

J&J Supports ‘Spirit’ Of DTC Pricing Transparency, But Prefers PhRMA’s Voluntary Approach

Leading off the third quarter earnings calls for biopharma, J&J offered mild support of a proposed HHS policy to require pricing information in direct-to-consumer advertising, but more enthusiastically backed a voluntary approach suggested by PhRMA.

Pricing Debate Commercial

10 Things For Pfizer's New CEO To Worry About

Albert Bourla will face opportunities and potential pitfalls.
Strategy Companies

PhRMA’s Defensive Move On DTC Ads: Putting Drug List Prices ‘In Context’

Member companies’ direct-to-consumer TV ads will direct patients to information about drug costs – including list price, estimated out-of-pocket costs for the drug, and availability of financial assistance – under a voluntary program that takes effect in April 2019; initiative falls short of mandatory list price disclosures proposed by Trump Administration.

Pricing Debate Advertising, Marketing & Sales

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Seqirus Completes Long Journey To Restore Afluria's Pediatric Indication

The key to pediatric approval for a flu vaccine: a manufacturing root cause investigation and subsequent process improvements.

 

Manufacturing Vaccines

EU GMP Annex 1 Would Give Microbiologists A Greater Role In Sterility Assurance, Rapporteur Says

A proposed revision of the EU GMP Guide’s Annex 1 calls for microbiologists to get out of the lab and more involved in risk assessments to ensure that sterile products are free from contamination, according to the annex’s rapporteur.

Europe International

EMA Aims To Carry On With EU GMP Annex 1 Revision Despite Brexit-Related Staff Departures

The European Medicines Agency is continuing to work on revising Annex 1 of the EU GMP guideline even as the agency focuses more on core tasks like responding to urgent public health threats amid greater-than-expected staff departures in advance of its Brexit-driven move from London to Amsterdam.

Europe Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Acne Claims For Cosmetics Leave Blemish On UK Advertising Regs

Advertising Standards Authority issued decisions Oct. 17 on complaints against three cosmetics brands and an online beauty retailer for statements the independent regulator reads as acne-treatment claims, or the “spots” equivalent, calling them medicinal claims for unlicensed products.
Consumer United Kingdom

J&J's Supplement Step With Zarbees Helps Drive A Leap For Consumer Health Growth

Supplement brand being marketed to compete with OTC drugs, including J&J's own brands, in cough and cold and other categories helped J&J overall consumer health sales grow 9.7% to $440m in Q3. Oral care brands showed 3.2% worldwide growth to $384m, benefiting from recent launch of chewable Listerine Ready! Tabs.

Consumer Advertising, Marketing & Sales

Ovarian Cancer Risk Cut 23% With Aspirin Use – Harvard Study

Study analyzed follow-up data on 205,498 women from the Nurses’ Health Study started in 1976 and Nurses’ Health Study II opened in 1989; 1,054 of the women developed ovarian cancer.

Drug Safety Consumer
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