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Featured Stories


Obamacare Is Dead – Long Live The ACA

Making sense of the 'Repeal And Replace' effort in 2017, and thinking through the implications for 2018 and beyond.

Legislation Pricing Debate Policy

EMA Boosts Transparency On Maintaining Orphan Status At Time Of Approval

New orphan maintenance assessment reports are expected to increase transparency around the European Medicines Agency's decision-making process on whether an orphan-designated drug continues to qualify as an orphan once it gets on to the market.

Rare Diseases Regulation Europe

R&D Model Needs ‘Radical Reshaping,’ Says UK Report

A new report has identified a number of ways to boost the productivity of drug research and development at small and medium-sized companies, including new R&D tools and models, more collaborative approaches and better use of the huge amounts of data being generated.

Research & Development United Kingdom Biologics

Rebate Pass-Through Would Lower, Not Raise, Medicare Spending – PhRMA

Biopharma manufacturers dispute predictions that passing through rebates at the point-of-sale in Medicare Part D would increase government spending. Pharmacy benefit managers argue the policy would violate the Part D statute and the Trade Secrets Act.

Pharmacy Benefit Management Medicare Pricing Debate
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Policy & Regulation Explore this Topic

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Allergan Loses Another Battle, But War To Block Restasis Generics Continues

US FDA rejects Allergan's third citizen petition seeking to require comparative clinical trials of generic versions of its dry eye medicine; company appeals patent invalidity ruling and PTAB admonishes Mohawk Tribe for its actions in IPR proceeding.

Generic Drugs Ophthalmic Intellectual Property

Latest From Regulation

Off-Label Communications Bill Allowing Discussion Of Unapproved Drugs Advances

Safe harbor for off label discussions between manufacturers and payers clears US House Energy & Commerce Health Subcommittee. Bill covers unapproved drugs as well as off label uses for approved agents.

Regulation Legislation

PhRMA Wades In Over Colombian Hep C Declaration Of Public Interest

Declaring hepatitis C drugs to be of public interest would establish a dangerous precedent, PhRMA, the US pharma industry association has warned the Colombian health ministry.

Market Access Intellectual Property

Planning Ahead In The EU: The Impact Of The GDPR On Clinical Trials And Research

When it becomes effective in the EU in May, the new General Data Protection Regulation will have major implications for the planning and conduct of clinical trials and research. Lawyers David Pountney and Richard Binns discuss how pharmaceutical companies and CROs should plan to ensure they remain compliant.

Clinical Trials Legal Issues

Latest From Policy

Joint HTA And Pricing: How To Make Specialized Treatments like Strimvelis Affordable

Joint negotiations and outcome based deals could be key in securing access to advanced therapies like Strimvelis that are available only from specialized centers.

Market Access Rare Diseases

Clinical Study Disclosures Will Make Drug Reviews More Efficient – Gottlieb

US FDA pilot program linking drug approval documents to sponsors' clinical study reports will improve review efficiency and access to information by medical researchers and drug developers, commissioner says; move also could aid sponsors when it comes to reimbursement decision-making, Foley and Lardner's Rosen predicts.

Drug Review Clinical Trials

Complete Response Letters: US FDA Trying To Identify Subsets For Public Release

Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'

Complete Response Letters Drug Review

Clinical / R&D Explore this Topic

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Latest From Research & Development

Putting Innovation In The Spotlight

The Clinical and Research Excellence (CARE) Awards are Informa Pharma Intelligence's way of honoring the R&D accomplishments across the biopharmaceutical industry. Nominations are free and open through Jan. 19.

Commercial Research & Development

Target's NASH Study Captures Real World Data, Helps Partners With Trial Design

Longitudinal observational study of NASH patients provides data to companies to help them better understand disease; Target PharmaSolutions conducting similar efforts in primary biliary cholangitis, hepatocellular carcinoma, and inflammatory bowel disease.

Clinical Trials Liver & Hepatic

J.P. Morgan Notebook Day 3: Lilly's CGRP Prospects, Juno On Track, Color From Alnylam's Greene, Shire's New CMO

Daily round-up of news and notes from the 2018 J.P. Morgan Healthcare Conference in San Francisco: Lilly CEO on CGRP reimbursement jitters, Alnylam president on Sanofi deal terms, Juno stakes BCMA myeloma claim, Shire's new CMO.

Commercial Companies

Commercial Explore this Topic

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Latest From Commercial

Putting Innovation In The Spotlight

The Clinical and Research Excellence (CARE) Awards are Informa Pharma Intelligence's way of honoring the R&D accomplishments across the biopharmaceutical industry. Nominations are free and open through Jan. 19.

Commercial Research & Development

Reflections From J.P. Morgan: Challenges As Always And Reasons For Optimism

Biopharma investors were underwhelmed by the deal-making news, but innovation, corporate tax reform and a relatively positive outlook on drug pricing left attendees at the J.P. Morgan Healthcare Conference with the sense that good things are in store for pharma in 2018.

Pricing Debate Business Strategies

J.P. Morgan Notebook Day 4: CRISPR's Not Worried; Theratechnologies' HIV Niche; And Is Moderna's IPO Coming Soon?

Daily round-up of news and notes from the 2018 J.P. Morgan Healthcare Conference: Alder's Options for CGRP drug; CRISPR's not worried about Cas9 controversy; Theratechnologies seeks more HIV niche products; Moderna is shaping up to have a big 2018; TG Therapeutics and Immunomedics milestones ahead.

Commercial Companies

Manufacturing Explore this Topic

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Latest From Manufacturing

Complex Generics Guidance: US FDA Aims To Alert Firms, As GAO Requested

The US FDA says it's working to provide the type of notice generic drug firms told the General Accountability Office they want to receive whenever the agency plans to issue or revise product-specific guidance on complex generics. Surprise issuance causes setbacks for generic drug sponsors who must scramble to revise their applications accordingly, if they can.

Manufacturing Quality

French To Import Czech Version Of Sandoz’ Penicillin For Syphilis Amid Global Shortage

The French regulator has announced that it is importing supplies of Sandoz’ penicillin product benzathine benzylpenicillin as a result of shortages of the product. The French situation reflects a wider problem with supply of the product at the global level due to GMP issues and the shrinking number of API manufacturers.

Manufacturing Quality

Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote

An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.

United States Consumer

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Power Toothbrushes Engage Kids, Collect Data With Digital Apps

Colgate Smart Electronic Toothbrush E1 is available exclusively on Apple.com and in select Apple stores for $99.95. The product is similar to a device sold in Europe by French firm Kolibree, which also introduced a children’s smart toothbrush featuring augmented reality to encourage brushing.

Consumer Innovation

OTC Monograph Reform Momentum Carries Potential Exclusivity Snag

Support was unanimous during House Health Subcommittee markup for draft legislation on streamlining FDA's monograph system by eliminating public rulemakings from the process and allowing the agency to make decisions with administrative orders. Two-year exclusivity for some products didn't go over so well.

United States Consumer

Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote

An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.

United States Consumer
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