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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

ANDA Complete Responses Spike In FY 2018, But Why?

In the first quarter of FY 2018, the agency issued over 800 CRs for generic drug applications, more than half the total it issued in all of FY 2017.

Generic Drugs Review Pathway

Viewpoints Cover The Waterfront At FDA Nicotine Replacement Therapy Policy Hearing

FDA added to the docket for its initiative evaluating nicotine replacement therapies reference materials including a meta-analysis on efficacy of NRTs in smoking cessation and a report on quitting smoking among adults in the US, 2000-2015.

United States Consumer

Keeping Track: We're Back!

The latest drug development news and highlights from our US FDA Performance Tracker.

Performance Tracker Drug Review

Latest From Policy

French Govt Must Act To Stop ‘Inexorable Decline’ Of Pharmaceutical Industry

The president of France’s industry association Leem says the authorities need to look at new ways of handling the health technology evaluation and pricing of innovative drugs, and to implement more predictable, long-term health policies, if the country is to reverse the “inexorable decline” of the pharmaceutical sector.

Reimbursement Pricing Debate

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

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

FDA Commissioner Outlines Priorities For Tightening Oversight Of Drug Compounding Facilities

To encourage drug compounding pharmacies to register as 503B drug outsourcing facilities, FDA plans to propose assigning these pharmacies a lower risk category, thus subjecting them to less stringent GMP controls if they make limited volumes of drugs as part of a “2018 Compounding Policy Priorities Plan” announced by FDA Commissioner Scott Gottlieb.

Manufacturing Quality

Speed Recall: Firms Get Just 24 Hours To Issue Requested Public Warnings

If US FDA asks firms to warn the public about recalls of dangerous drug or other FDA-regulated products, they must issue the warning within 24 hours or the agency may issue its own warning, draft guidance says.

Compliance Distribution

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

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Viewpoints Cover The Waterfront At FDA Nicotine Replacement Therapy Policy Hearing

FDA added to the docket for its initiative evaluating nicotine replacement therapies reference materials including a meta-analysis on efficacy of NRTs in smoking cessation and a report on quitting smoking among adults in the US, 2000-2015.

United States Consumer

Entrepreneur Davies Enters Consumer Health With Indian Research Support

UK generics firm Neolab founder and serial entrepreneur John Davies outlines his latest product development efforts, targeting the consumer health space for the first time, in an interview. Three Indian research groups have significant roles in the plans.

International Europe

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
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