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Brexit Could Rob Industry Of Access To Markets Covered By 35 EU Free Trade Deals

A coalition of life sciences industry bodies has written a position paper outlining its concerns about Brexit in areas such as EU free trade deals, customs declarations and tariff barriers.

Brexit Trade Europe

Tagrisso Reimbursed In Korea, After Difficult Price Negotiations

Korea's National Health Insurance Service and AstraZeneca reach an agreement on reimbursement of Tagrisso, sharply reducing financial burdens of NSCLC patients in the country. Tough price negotiations between the two sides underlines the difficulties pricey innovative drugs face to get reimbursed in the country.

Reimbursement Market Access South Korea

FDA Investigators Want Top Management Involved In Manufacturing Inspections

FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.

US States Manufacturing Compliance

Generic Labeling Rule Dies In Latest Reg Agenda, But Electronic Labeling Is Reborn

US FDA also indicated plans to update definition of biologic product and propose a one-page Patient Medication Information in the latest Unified Agenda.

Regulation FDA Generic Drugs
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Policy & Regulation Explore this Topic

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EMA To Establish Minimum Requirements For CAR-T Cell Registries

The European Medicines Agency is exploring the possibility of establishing minimum requirements for all CAR-T Cell registries in the EU to facilitate efficient data collection on such products in the post-authorization phase.

Post Market Regulation & Studies Regulation Europe

Latest From Regulation

340B Penny Pricing, Civil Monetary Penalty Revisions On Deck In Proposed Rule

Proposed rule will revisit controversial provisions in the January 340B final rule to address manufacturer concerns about the US discount program.

Pricing Strategies Market Access

EU Approval In Sight For New ATMP, Products For XLH And Diabetes, And 2nd Biosimilar Herceptin

A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a multiple myeloma product, and a sea squirt-based MS drug was withdrawn from the review process.

Europe Approvals

FDA Blocks Chinese Contract Manufacturer's OTC Topical Imports

FDA says in a warning letter that Hangzhou Facecare Cosmetics's response to inspectors' findings following a June inspection was inadequate and the firm's imports in September were ordered detained without physical examination at all US ports.

Dermatology Consumer

Latest From Policy

Biosimilar Sponsors Are Not Liable Under State Law For Declining Patent Dance

US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'

BioPharmaceutical Policy

Sanofi's Dengue Vaccine Gets WHO Backing In People Previously Infected

Label restriction, discussions with regulators should keep vaccine in use, Sanofi suggests; Philippines suspended its vaccination program after data showed product can worsen disease in those not previously exposed to infection.

BioPharmaceutical Policy

Mandatory Provider Training For Opioids Embraced By PhRMA

Trade association members also commit tens of millions of dollars to set up addiction prevention programs and create new health care tools.

Neurology Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Gene Therapy Guidances Will Focus On Specific Diseases, Gottlieb Says

US FDA's first such guidance will focus on hemophilia, commissioner tells Congress.

FDA Research & Development

Will ‘Transformative’ UK Life Sciences Sector Deal Help Offset The Brexit Effect?

The UK government has published its life sciences sector deal, which it says will allow the UK to respond to the challenges and opportunities of demographic change and pioneering research and development – although there is no mention of the “Brexit effect.”

Innovation Research & Development

EMA Points Out Shortfalls To Avoid When Seeking Novel Methodology Qualification

A new EMA checklist of “essential considerations” for the successful qualification of novel methodologies covers common issues that have compromised applications for qualification in the past.

Research & Development Research and Development Strategies

Commercial Explore this Topic

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Latest From Commercial

Pharma Faces More Probes On Generic Price Hikes in UK

As Concordia finds itself in the dock again, this time over its pricing of the essential thyroid treatment liothyronine, the UK's Competition and Markets Authority has recently opened four new investigations into "suspected abuse of dominance" concerning generics.

Legal Issues Pricing Strategies

Merck KGaA Says Outcomes-Based Pact With NHS England 'Precedent-Setting'

Merck KGaA Healthcare CEO Belén Garijo tells the Pink Sheet that outcomes-based reimbursement deals like the one it has done with NHS England “are the way of the future”.

Approvals Commercial

Generic Price-Fixing Lawsuit Grows As More Companies, Two Executives Named Defendants

US state attorneys general name executives from Mylan and Emcure as defendants, and list may further expand as investigation continues into additional companies and drugs.

Generic Drugs Legal Issues

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Blocks Chinese Contract Manufacturer's OTC Topical Imports

FDA says in a warning letter that Hangzhou Facecare Cosmetics's response to inspectors' findings following a June inspection was inadequate and the firm's imports in September were ordered detained without physical examination at all US ports.

Dermatology Consumer

FDA Pilot Finds That Advance Records Yield More Inspection Findings

When FDA piloted the use of Section 706 authority to obtain records in advance of inspection, the US agency found the results included more inspection findings but not quicker inspections.

Compliance Manufacturing

FDA Mulls Which EU Inspections To Skip Under EU MRA

As US FDA sets its FY 2018 inspection priorities, it is considering whether there are recent or upcoming inspections by inspectorates in eight European countries recognized under a US/EU mutual recognition agreement that it could rely on instead, agency official says. Over time, FDA could rely more on EU inspection priorities.

Compliance Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

FDA Blocks Chinese Contract Manufacturer's OTC Topical Imports

FDA says in a warning letter that Hangzhou Facecare Cosmetics's response to inspectors' findings following a June inspection was inadequate and the firm's imports in September were ordered detained without physical examination at all US ports.

Dermatology Consumer

Nonprofit Pharma Targets Making Naloxone Available OTC, Trimming Price

Nonprofit Harm Reduction Therapeutics targets an OTC switch of naloxone, an opioid antagonist used to reverse an opioid overdose. It aims to make the product available at low cost in 110,000 retail locations nationwide.

Consumer Prescription To Otc Switch

Consumer Health Weekly Trademark Review Dec. 5, 2017

Compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

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