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Featured Stories


Government Action/Industry Reaction: HHS Sees Success In Approach To Drug Pricing Solutions

US HHS officials Azar and O’Brien tell a National Academy of Medicine forum that an important element of the Trump Administration’s approach to lowering drug prices is eliciting voluntary change from market players.

Pricing Debate Advertising, Marketing & Sales Regulation

Submit Your Brexit-Related Changes Before We Move: EMA Plea To Industry

A continuous two-way dialogue on Brexit between the European Medicines Agency and industry is a must. The EMA is tentatively planning three Brexit-related events for stakeholders and, in the meantime, it wants companies to keep it abreast of their plans for products affected by the UK’s departure from the EU

Brexit Market Access Europe

Shire’s Prucalopride Brings Real-World CV Safety Data To US FDA Panel, But Will It Be Enough?

European postmarketing epidemiological study results ‘reasonably exclude’ a greater than three-fold increased risk of major adverse cardiovascular events with the constipation drug but, due to potential bias, cannot definitively exclude a possibly unacceptable level of risk, agency says.

 


Advisory Committees Drug Review Regulation

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 Policy

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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Global Pharma Guidance Tracker – August 2018

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

10 Things For Pfizer's New CEO To Worry About

Albert Bourla will face opportunities and potential pitfalls.
Strategy Companies Drug Review

Latest From Regulation

US FDA Seems Ready For Return Of Zelnorm, But Seeks Advice On Best Subpopulation

Whether Sloan Pharma's irritable bowel constipation drug tegaserod should be indicated only for women at low cardiovascular risk, women who are severely symptomatic, or women who fall into both categories is a question for FDA's Gastrointestinal Drugs Advisory Committee; panel also is asked to discuss risk of psychiatric adverse events with the 5-HT4 receptor agonist.

Advisory Committees Drug Review

EU Policymakers Under Industry Pressure To 'Neuter' SPC Waiver Plan

“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.

Biosimilars Generic Drugs

Takhzyro Among Hopefuls For EU Approval Recommendation

A handful of companies are expected to find out this week whether their products will be recommended for EU approval. The EMA's drug evaluation committee, the CHMP, is due to give its opinion on marketing authorization on two orphan drugs for use in HAE and myotonia respectively, another biosimilar trastuzumab, a generic tobramycin product, and a flu vaccine.
Europe BioPharmaceutical

Latest From Policy

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

Step Therapy For Anti-Inflammatories, ESAs Coming To UnitedHealthcare Medicare Plans

Remicade, Procrit, Aranesp and biosimilars will be subject to step therapy in limited number of Medicare Advantage plans in 2019.

Pricing Debate Medicare

Pfizer Forks Over $700,000 For Copayment Coupon Claims

Agreement with New York attorney general resolves allegations Pfizer deceptively advertised that consumers would "pay no more" than $15 or $20 for drugs even though they were often far more expensive.

Legal Issues Pricing Strategies

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

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Latest From Commercial

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

AbbVie's Fourth Humira Patent Settlement Allows Sandoz Biosimilar US Entry Eight Months After Amgen

Sandoz joins list of companies that opt to settle rather than challenge AbbVie's hefty patent portfolio; staggered launches offer model for future deals.

Biosimilars Intellectual Property

Cough/Cold, Analgesic Patch Sales Ease Pain Of Private Label Growth In OTCs

Topical analgesic sales grew double digits in 2017 on innovation and adhesive patch launches, helping drive 2.1% growth of US manufacturers' OTC drug sales in 2017 to $21.2bn, Kline & Co. independent consultant Laura Mahecha says. But private label continues to outpace branded product sales growth.

Consumer Prescription To Otc Switch

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

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

EU Policymakers Under Industry Pressure To 'Neuter' SPC Waiver Plan

“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.

Biosimilars Generic Drugs

US FDA’s Pre-ANDA Advice On Correspondence, Meetings And Product-Specific Guidance

OGD's Lionberger offers advice on when to request a pre-ANDA meeting instead of controlled correspondence – and on the pros and cons of waiting for the agency to update product-specific guidance with the latest approaches.

Generic Drugs Drug Review

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

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

Sales of Drug-Spiked Nicotine Could Sink E-Cigarettes' Smoking Cessation Chances

Since Commissioner Gottlieb's appointment, US FDA has challenged END industry more aggressively to eliminate products and advertising targeting children and has said sales to minors could be a focal point of an FDA action to ban all e-cigarette sales. Finding pharmaceutical ingredients in liquid nicotine could make a general ban on e-cigarette sales more likely in addition to imperiling approval for a smoking cessation indication.

Consumer Enforcement
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