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UK Industry Raises Conflict of Interest Concerns Over NICE’s PRIMA Service

PRIMA, the new service the National Institute for Health and Care Excellence offers to review economic models, must not be affected by confidentiality and conflict of interest issues, warns UK the pharmaceutical industry group, ABPI.

Europe United Kingdom Health Technology Assessment

Sarepta Should Gain Clean Slate With CBER Review of DMD Gene Therapy

Sarepta will face a US FDA staff with which it does not have a controversial history, the Center for Biologics Evaluation and Research, likely avoiding the reviewers that evaluated its Duchenne muscular dystrophy treatment Exondys 51.

Rare Diseases Review Pathway Regulation

Increase In Antibacterial R&D Prompts EMA Proposal For Improved Guidance

Following a resurgence of activity in the field of antibacterial products, the European Medicines Agency has proposed merging and updating its two existing guidelines on this topic into a single, clearer, core document.

Europe Clinical Trials Regulation

BARDA Official Worries About How Non-Traditional Antibiotics Will Get To Market

Promising non-traditional antibiotic therapies need a clear path to market to entice investment, US Biomedical Advanced Research and Development Authority official says.

Infectious Diseases Clinical Trials Policy

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – May 2018

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

Clinical and Research Excellence Awards 2018 eBook

The Clinical and Research Excellence (CARE) Awards provides an opportunity for the pharma industry to celebrate all its achievements, and pay tribute to the people and teams behind these feats. 2017 was a successful year for the industry, which was evident by the volume and quality of the entries received for this year’s CARE Awards.

Read the eBook and discover more

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

Does AbbVie Have 'Unclean Hands' From Building Humira Patent Thicket? Judge Allows Discovery

Magistrate judge says Boehringer's theory 'may or may not be viable' as an infringement defense; permits third party subpoenas for information on clinical trials.

Biosimilars Intellectual Property BioPharmaceutical

Latest From Regulation

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

European Performance Tracker Europe

Ireland Clarifies Requirements For Generic Interchangeability

Ireland has amended its guideline on generics interchangeability to clarify that a demonstration of bioequivalence is not a requirement for inclusion on the list of interchangeable medicines.
Generic Drugs Ireland

Approval For Access? Decoding The Significance Of China’s Opdivo Opening

First comes the approval, then market access. A rapid regulatory clearance for BMS’s Opdivo in China not only pioneers a new and potentially huge market for immuno-oncology treatments, but may potentially set an example in how to expand market access for many new therapies waiting to get into the country, amid multiple recent regulatory and policy changes.

China Approvals

Latest From Policy

Ireland Clarifies Requirements For Generic Interchangeability

Ireland has amended its guideline on generics interchangeability to clarify that a demonstration of bioequivalence is not a requirement for inclusion on the list of interchangeable medicines.
Generic Drugs Ireland

340B Legislative Reforms: Where Do We Go From Here?

Third US Senate committee hearing on 340B reforms focuses on the need for legislation requiring that providers report the drug discounts received and how they use the savings, but prospects for achieving change are unclear.

Legislation Pricing Strategies

US FDA’s Patient Input Guidance Opens Door Wider To Social Media Data Collection

Following stakeholder criticism of an earlier discussion paper, draft guidance does not automatically foreclose use of social media data as the primary source of qualitative research; however, agency says entities submitting such data for regulatory review must ensure rigor in methodology and data integrity.

Clinical Trials Drug Approval Standards

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.

Clinical Trials Digital Health

Kite’s CAR-T Therapy Makes It Back Onto EMA’s PRIME, Along With Three New Products

The four latest products to be accepted onto the European Medicines Agency’s popular priority medicines scheme target mantle cell lymphoma, chikungunya, hematopoietic stem cell transplant patients, and the rare monogenic disease, X-linked myotubular myopathy.

Regulation Market Access

Toxicology Initiative From US FDA Aims To Replace Animal Safety Models, But Slowly

Predictive Toxicology Roadmap will help make drug development more efficient by promoting new technologies for safety testing, Commissioner Gottlieb says.

Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

AbbVie's Elagolix May Be Cost Effective, But Will Test Health Budgets – ICER

Third-party value assessment organization says AbbVie/Neurocrine's elagolix would be cost effective for endometriosis and associated pain, using a placeholder price of $7,000 per year. But the cost would be substantial for health budgets given the broad prevalence of the condition. 

Gynecology & Urology Cost Effectiveness

Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.

Biosimilars State News

Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

Generic Drugs Respiratory

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Lauds St. Gallen's Findings On 10 Metrics For Ensuring Drug Quality

US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.

United States Manufacturing

ANDA Amendments Cannot Get Mid-Review Communications Like Full Applications - FDA

Generic industry officials ask that information requests and discipline review letters be issued during ANDA amendment assessments, but the US agency says they are not allowed in GDUFA II.

FDA Generic Drugs

How Manufacturers Need To Shore Up Fragile Supply Chains To Prevent Antibiotics Shortages

The potential of an impending “apocalypse” of antibiotic drug shortages means that the pharmaceutical industry should pay careful attention to managing fragile supply chains for these drugs. A report details how manufacturers can manage these supply chains to avert potential shortages.

Manufacturing Infectious Diseases

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

For Kamedis, Botanicals Plus OTC Topical Equals Acne Remedy Claim

"We can say we are OTC but the botanicals are doing a lot of the heavy lifting," says Kelli Rodriquez, the firm's sales and marketing chief. Salicylic acid supports the acne treatment claim under an OTC monograph; leaving out benzoyl peroxide, an allergen for some consumers, also allows labeled use more frequently with a claim of faster symptom reduction.

Consumer Dermatology

US House Committee Requests Proof Of FDA Progress Seizing Opioids In International Mail

Energy & Commerce's Republican and Democrat leadership ask FDA Commissioner Scott Gottlieb about work by the agency's Office of Criminal Investigations focused on opioid drugs, the office's staffing and its priorities. They note FDA's FY2018 appropriation included $94m for its work in international mail facilities.

Policy & Regulation Safety

Rulemaking For OTC Switch Process Changes Pushed To 2019

Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.

Consumer Drug Approval Standards