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Featured Stories


US FDA Fine-Tunes Tecentriq, Keytruda First-Line Bladder Cancer Accelerated Approval Indications

FDA’s decision to restrict use based on the level of PD-L1 expression shows how confirmatory trials for accelerated approval can help to inform and adapt labeling. 

Approvals Post Market Regulation & Studies ImmunoOncology

Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study

HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.

Consumer Prescription To Otc Switch FDA

UK Regulator Promises Reasonable and Pragmatic Approach For EudraVigilance Inspections

Aware that marketing authorization holders are still finding their way around the EU’s revamped pharmacovigilance database – a UK inspector explains what procedures and processes companies should have in place to show compliance with new requirements to monitor and report safety signals.
Europe United Kingdom Regulation

Fixing Part D Coverage Gap ‘Cliff’ Is Right Way To Lower Costs, PhRMA Says

PhRMA pushing for legislation to address upcoming surge in Medicare Part D out-of-pocket spending requirements and reverse the recently-enacted increase in the discount on branded drugs in the coverage gap.

Medicare Legislation United States
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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

US Orphan Fee Waiver Requests Must Include Much More Extensive Documentation

In update of 2011 draft guidance, FDA gives more detail on documentation needed for orphan sponsors to receive a program fee waiver; Guidance also suggests the agency is no longer working with SBA to make small business determinations.

Rare Diseases Review Pathway

Keytruda's Broad Confirmatory Trials Suggest Evolution Of US FDA’s Accelerated Approval Model

FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.

Approvals Post Market Regulation & Studies

PIC/S Adopts New Guide On Cross-Contamination, Transposes EU GMP Requirements

The group representing international pharmaceutical inspectorates, PIC/S, has issued new guidance on controlling cross-contamination in shared facilities. It has also transposed several EU guidelines on good manufacturing practice that non-EEA participating authorities can adopt on a voluntary basis. 
International Europe

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

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

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

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

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

Set Alert for Manufacturing

Latest From Manufacturing

PIC/S Adopts New Guide On Cross-Contamination, Transposes EU GMP Requirements

The group representing international pharmaceutical inspectorates, PIC/S, has issued new guidance on controlling cross-contamination in shared facilities. It has also transposed several EU guidelines on good manufacturing practice that non-EEA participating authorities can adopt on a voluntary basis. 
International Europe

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

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

AMA Encourages Oral Contraceptive OTC Options In Policy Update

AMA members agree to strengthen association's policy language supporting approval and reimbursement of OTC contraceptives.
Consumer Prescription To Otc Switch

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
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