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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 Reimbursement

EMA To Discuss Reactivating Landmark Clinical Trials Transparency Policy

The European Medicines Agency will be looking at reviving its policy on proactive publishing of clinical study reports, which is currently suspended as the agency copes with huge staff losses on account of Brexit.
 
Europe Brexit Clinical Trials

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 Market Access

UK Appeal Panel Tells NICE To Revisit Scenesse Rejection

An appeals panel has upheld some of the objections to NICE’s decision not to recommend Clinuvel’s Scenesse for NHS funding in England. The HTA body’s Highly Specialized Technologies committee will now have to reconsider its guidance in light of the panel’s conclusions. 
Health Technology Assessment United Kingdom Regulation

US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating

FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.
Generic Drugs Pricing Debate Regulation
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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.

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Policy & Regulation Explore this Topic

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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 Commercial

Latest From Regulation

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

US FDA Appoints Another Orphan Products Development Office Head Amid Growth Expectations

Janet Maynard will become acting Office of Orphan Products Development director at the end of October, the fourth head of the office in the last 10 months; staff is expected to grow and may begin to provide development advice.
FDA Rare Diseases

Study On Patient Support Program Impact Piques EMA's Interest

The pharmaceutical industry's renewed effort to find a pragmatic solution to managing adverse events from patient support programs has drawn the European Medicines Agency's attention.

 
Europe Drug Safety

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

Nordic Procurement Deal Signals New Weapons In Fight For Lower Prices

A new joint procurement agreement between Norway and Denmark is a signal to drug companies that they will have to increasingly negotiate with more than one country in a new age of collaboration, says Amgros, the Danish medicines procurement agency.

Europe Denmark

PTO Final Rule Dropping BRI Patent Claim Standard Offers No Deference To District Courts

Patent office may issue guidance on how PTAB will consider prior claim constructions; actions on other procedures may be coming in the 'near future.'
Intellectual Property Legal Issues

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

Want An RMAT Designation? Please Include At Least Some Data, US FDA Tells Sponsors

CBER's Rachael Anatol says such a situation has happened "more than a few times"; instances appear to have been largely concentrated in earlier days of the RMAT program.

Research & Development FDA

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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

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

REDUCE-IT Will Test Risks Of Weakening Protection Of FDA-Labeled Claims

Amarin spent five years and lots of money to show Vascepa reduced the risk of cardiovascular events. REDUCE-IT trial results will test what Amarin will get for conducting the trial and whether the company’s off-label argument could work against them. 
Advertising, Marketing & Sales Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

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

FDA And EU Regulators Find Data Integrity Lapses Are Still A Major GMP Problem

The large number of US FDA warning letters going to firms for data integrity failings is mirroring trends with EU regulatory authorities, who are flagging data integrity failings in almost half of their GMP non-compliance reports. The issue strikes close to home for one FDA official.

United States Europe

No-Deal Brexit Means ‘Re-Planning A Whole Industry,’ Says ABPI Chief

Mike Thompson, head of the Association of the British Pharmaceutical Industry, outlined his industry’s concerns over medicines stockpiling, batch testing, tariffs, regulatory collaboration and other issues at a parliamentary committee hearing on the implications of a no-deal Brexit.

Brexit Europe

Consumer / OTC Drugs Explore this Topic

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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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