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Featured Stories


Express Scripts Pushing Manufacturers To Lower List Prices By Offering Cheaper Brand Alternatives

Companies should introduce same drug under new NDC at lower list price to overcome difficulties of reducing list prices on existing brands, PBM says.

Pricing Debate Pricing Strategies Policy

Long-Awaited Brexit White Paper Lays Out UK’s Plans For Medicines Regulation

The UK government has finally published its white paper on the UK’s future relationship with the EU following Brexit, to the relief of the pharmaceutical industry.
Brexit Regulation Europe

UK NICE Knock Back For Janssen’s ‘Game-Changing’ Darzalex Combo

Draft guidance from the health technology assessment body, NICE, says that while Darzalex in combination with two other drugs is an innovative therapy for previously treated multiple myeloma, there is not enough long-term data to support its use on NHS England.

Health Technology Assessment Reimbursement United Kingdom

GSK's Tafenoquine Faces Questions Over Review Pathways At US FDA Panel

Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.

Advisory Committees Drug Review Review Pathway
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – June 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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Clinical and Research Excellence Awards 2018 eBook

The Clinical and Research Excellence (CARE) Awards provides an opportunity for the pharma industry to celebrate all its achievements, and pay tribute to the people and teams behind these feats. 2017 was a successful year for the industry, which was evident by the volume and quality of the entries received for this year’s CARE Awards.

Read the eBook and discover more

Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

Read the eBook and discover more

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Hemophilia Gene Therapy Studies Could Use Non-Inferiority Design, US FDA Suggests

Development guidance from CBER recommends comparing investigational gene therapy products to existing prophylaxis treatment.

Biologics Blood & Coagulation Disorders Regulation

Latest From Regulation

Celgene, Agios Drug Enasidenib Among New Filings At EMA

Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.

Drug Review Review Pathway

Canada Makes It Mandatory For Pharma To Report Overseas Safety Actions

Canada claims to be the first country to issue formal regulations that make it mandatory for drug companies to report within strict timelines safety issues related to their products in certain foreign jurisdictions.
Canada Drug Safety

Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi

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

Latest From Policy

Vertex Refuses To Back Down On England Orkambi Deal

Vertex is staunchly defending its cystic fibrosis portfolio-based reimbursement deal rejected by NHS England and has called on the UK’s prime minister to intervene. The company says similar deals have worked well in Ireland and Sweden.

Europe United Kingdom

340B Reform: US House Bills Mark The End Of The Beginning

Energy & Commerce Health Subcommittee releases several discussion drafts at hearing on 340B drug discount program reform as the debate seems poised to move into the next phase.

Pricing Debate Legislation

Penny For Your Thoughts? HHS Secretary Azar’s Blunt Words For 340B Providers

Azar didn’t bring much comforting news to attendees at the annual 340B Coalition conference, with a strong defense of cuts in reimbursement for providers who use the drug discount program. But he did suggest that the 'penny pricing' policy will be finalized soon.
Pricing Debate Pricing Strategies

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

French Industry Welcomes Moves To Speed Up Access To Innovative Drugs

A French government/industry discussion forum has come up with concrete plans for accelerating access to innovative medicines by streamlining clinical trial approval and price negotiations.

France Innovation

Ex-US FDA Director John Jenkins Sketches Regulatory Path For Esperion's Bempedoic Acid

Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.

Clinical Trials FDA

Breakthrough, Priority Review Designations Could Set High-Water Marks In 2018

Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018. 
Drug Review Review Pathway

Commercial Explore this Topic

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Latest From Commercial

Amazon OTC Line's Impact On Pricing Grows Along With Its SKUs

Amazon's Basic Care OTC brand SKUs have doubled units since last year's launch and is putting great pricing pressure on private label competitors, says a Jefferies analyst. But a private label consultant says the e-commerce giant's threat to competitors in the consumer health market is over-hyped.

Advertising, Marketing & Sales Business Strategies

Pfizer Agrees To Roll Back Prices On 40 Drugs, Yielding To Pressure From Trump

After a conversation with President Trump, CEO Ian Read agreed to cancel price increases on 40 drugs that took effect July 1, to give the administration time to work on its blueprint for improving the health care system.

Pricing Debate Pricing Strategies

Trump Tries To Shame A Defiant Pfizer On Drug Pricing

President Trump called out Pfizer’s recent price increases on Twitter July 9. Pfizer was one of only four companies that took a second round of price increases in 2018, according to analysts at Morgan Stanley. CEO Read has long defended the industry's pricing practices, even as public criticism of the high drug prices has grown. 

Pricing Debate Pricing Strategies

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution

New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.

Manufacturing Regenerative Medicine

Illegal Emissions Force Sanofi Production Stoppage

Sanofi is working on technical improvements after its Mourenx site in southwest France was found to be emitting illegally high levels of solvents. Production at the site is on hold.

Manufacturing Compliance

‘Unacceptable’ Medicine Shortages Lead French Senate To Set Up Task Force

Medicine shortages are under scrutiny at national and EU level. In France, a newly established Senate task force is hearing evidence from a range of stakeholders including industry and regulators.

Distribution Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Amazon OTC Line's Impact On Pricing Grows Along With Its SKUs

Amazon's Basic Care OTC brand SKUs have doubled units since last year's launch and is putting great pricing pressure on private label competitors, says a Jefferies analyst. But a private label consultant says the e-commerce giant's threat to competitors in the consumer health market is over-hyped.

Advertising, Marketing & Sales Business Strategies

Pfizer Deals Consumer Health Its Own Hand, Plays Waiting Game For Bids

By setting up Pfizer Consumer Healthcare to have sales and earnings results reported separately, pharma giant could be making the division's assets more visible to potential buyers. Its sales pitch: "With a strong portfolio of global brands that span health and wellness, the company believes this business is well positioned to continue its growth."

Consumer Deals

European OTC Shifts: BMS Eyes Selling French Business, Private Equity Controls Italy's Recordati

Bristol-Myers Squibb weighs selling its UPSA French OTC business, conducting a strategic review to assess its growth potential. Milan-based Recordati, says it plans to grow its OTC business; the firm sold a 51.8% stake owned by the Recordati family to a consortium of private equity funds for $3.56bn.

Consumer M & A
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