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US FDA Outlines Streamlined Development Path For Targeted Therapies

But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic cancer therapies are not always equally effective.

Research and Development Strategies Cancer Drug Approval Standards

Argentina Rejects Key Sofosbuvir Patent Application

Argentina’s patent office, INPI, has rejected an application for a key patent relating to Gilead’s hepatitis C drug Sovaldi (sofosbuvir).

South America Argentina BioPharmaceutical

A Bad Day For DTC

US Senate Health Committee’s final 2017 hearing on drug pricing focused on a National Academies report with almost three dozen recommendations. But one in particular – eliminating the tax deductibility of DTC advertising – attracted the most attention.

Advertising, Marketing & Sales Pricing Debate Legislation

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for a pediatric use authorization, But it turned down a multiple myeloma product, and a sea squirt-based MS drug was withdrawn from the review process.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 Regulation
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Policy & Regulation Explore this Topic

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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 Pricing Debate

Latest From Regulation

Keeping Track: Approvals, A Burst Of Submissions, And Some Priority Reviews

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

Performance Tracker Drug Review

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's NDA And BLA Approvals: Xepi, Admelog, Ixifi

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

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 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

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

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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