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Featured Stories


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 Emerging Markets

Shire’s Motegrity: US FDA Panel Nod On CV Safety Comes With Concern About Neuropsych Events

In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.


Advisory Committees Drug Review Gastrointestinal

Drug Pricing Reform In Medicare And Medicaid: Upcoming Regulatory Actions

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

Pricing Debate Medicare Medicaid

Unbearable Lightness? China Levies Record $1.3bn Fine Amid Vaccine Scandal

Record-breaking fine slapped on scandal-hit domestic vaccine maker in China has some wondering if the tide of opinion may be turning against private companies.

China Vaccines Regulation

Teva Sues US FDA To Obtain 180-Day Exclusivity For Its Generic Restasis

Complaint challenges agency's revised definition of "first applicant," which does not require notice of Paragraph IV certification to obtain exclusivity.

Generic Drugs Legal Issues Regulation
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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

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 Regulation

Latest From Regulation

Controversial Dengue Drug Among Six Products To Get EMA Thumbs Up

Dengvaxia, the dengue vaccine from Sanofi that was suspended in the Philippines last year, is among six new products to get a recommendation for marketing authorization from the European Medicines Agency this week.

Approvals Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

EU Launches Joint Assessment Of Pediatric & Orphan Drugs Legislation

A new European Commission consultation marks the launch of an evaluation exercise to assess the joint impact of the EU pediatric and orphan drugs legislation in supporting the development of pediatric medicines for rare diseases.
Europe Pediatrics

Latest From Policy

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

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

Trump Administration's Rx-Price-Disclosure Reg Sets Up Legal Fight With PhRMA

From kinds of ads targeted to agency that's issuing the reg, policy seems designed to withstand a court challenge.
Advertising, Marketing & Sales Pricing Debate

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

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

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

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

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

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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