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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or other FDA-regulated products, they must issue the warning within 24 hours or the agency may issue its own warning, draft guidance says.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 Manufacturing

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 France

EMA Working On New Guidance For Infectious And Respiratory Diseases, Biosimilars

Companies can expect to see a number of finalized and draft EU guidelines published throughout 2018 and into 2019, according to newly published work plans for the European Medicines Agency’s Infectious Disease Working Party, Biosimilar Medicinal Products Working Party and the Respiratory Drafting Group.

Standards Regulation BioPharmaceutical

US FDA Enters Shutdown Mode: Reviews Will Continue, But Will Morale?

User fee funding will allow many functions to continue, but only 58% of staff will be retained until funding deal is reached.

FDA Legislation Leadership
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Policy & Regulation Explore this Topic

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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 United States

Latest From Regulation

CNS Treatments Highlight US FDA's Busy Pipeline Of Novel Agents For 2018

Rare disease and infectious disease candidates also are among the most common treatments in agency's review queue.

Drug Review Neurology

Shutdown Winds Down: Short 'Lapse Period' Likely Means Few Disruptions At US FDA

FDA lost one work day to the shutdown, but staff may require more time to catch up again.

FDA Legislation

UK MHRA ‘Pushback’ Against Efforts To Sideline It From EU Processes

The EMA says the UK is continuing to bid for EU regulatory work as the Brexit date of March 29, 2019 draws nearer. The head of the BioIndustry Association says this is something of a “pushback” against efforts to squeeze the UK out of its EU regulatory role in preparation for Brexit.

Brexit United Kingdom

Latest From Policy

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

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

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 / R&D Explore this Topic

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Latest From Research & Development

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

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

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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

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Latest From Consumer

Pharmacists Stall Turkey's Launch Of Regulated Consumer Health Market

Turkish regulators published a list of 241 products, based on 62 ingredients, selected to become available nonprescription but withdrew it after pharmacists argued that consumers in the country typically are not knowledgeable about health care issues and might buy the wrong drug product without a doctor’s advice.

Consumer Regulation

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.

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