Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework

Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.


Drug Approval Standards Post Market Regulation & Studies Regulation

Retail Drug Spending In US Flat For 2017 Due Mainly To 'Non-Price' Factors

Drop in number of prescriptions dispensed for opioids contributed to minimal spending growth for retail prescription drugs in 2017, according to latest CMS National Health Expenditures Report.

Reimbursement Medicare Policy

US FDA To Rely On Inspections From More European Countries

The US Food and Drug Administration can now rely on the results of GMP inspections from 20 EU member states after confirming that five more countries have been deemed suitable for inclusion in its mutual recognition agreement with the EU.

Europe US States Compliance

Beefed-Up SPC Manufacturing Waiver Gains Traction In European Parliament

A proposal to allow generics firms to manufacture versions of supplementary protection certificate-protected medicines in preparation for EU launch immediately on SPC expiry is making progress through the European parliamentary process, to the delight of the generics industry – and the dismay of originator companies.
Europe Intellectual Property Manufacturing

Actelion Is Third Company To Settle Charity Co-Pay Kickback Claims With DOJ

Company agrees to pay $360m to resolve allegations it used a charity as a conduit to pay Medicare patient copays for its drugs; several other companies are under investigation.

Policy Enforcement Legal Issues
Advertisement

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – November 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International Europe Belgium

Pharma Report Store

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop Now

Biosimilars Review: Impact of Increasing Global Competition on Biosimilars

The biosimilars market has been gaining momentum over the past few years, as a result not just of the growing number of products available, but of gradual changes in attitudes. Download this new report, “Biosimilars Review: Impact of Increasing Global Competition on Biosimilars,” which showcases Informa Pharma Intelligence’s coverage of the expanding biosimilars market.

Download Report

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

NGOs Continue Fight To Remove Key Patent On Gilead’s Sovaldi

NGOs are continuing their efforts to pave the way for lower-cost generic versions of Gilead’s breakthrough hepatitis C treatment Sovaldi and have appealed a decision by the European Patent Office to uphold a key patent relating to the drug.

Intellectual Property Market Access Pricing Debate

Latest From Regulation

Keeping Track: Some Calm Before The Storm

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

Drug Review Approvals

Real-World Evidence: US FDA Framework Emphasizes Data Fitness And Study Quality

Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.

Drug Approval Standards Regulation

French Gene & Cell Therapy Trials To Get Own Fast-Track Approval Process

Experimental gene and cell therapy products are to get a boost from the French regulator in the form of a new fast-track clinical trial approval process. This is the third accelerated pathway to be introduced as part of efforts to speed up patient access to new medicines.
France Clinical Trials

Latest From Policy

Biosimilar Litigation Settlement Score Card: Genentech-Pfizer Herceptin Agreement Is 10th Deal

Genentech inks second settlement of trastuzumab biosimilar litigation; suits ongoing against Amgen, Celltrion/Teva, and Samsung with joint claim construction proceedings.

United States BioPharmaceutical

CVS ‘Guaranteed Net Cost’ Program Is Alternative To High Price/High Rebate Model

Program likely to generate fewer rebates so it remains to be seen whether payers will embrace the new model in a big way.

Pharmacy Benefit Management Reimbursement

Japan R&D Industry Presents United Front On Policy Reforms

Following pricing reforms earlier this year that industry saw as generally unfavorable, major pharma associations in Japan present a united front in calling for a broad range of policy revisions to promote an ecosystem that better fosters and rewards innovation.

Japan Policy

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

A Call To Action On Antibiotic Development

Recent comments by US FDA’s top infectious disease review manager about the need for new ideas to incentive development of antibiotics should be a call to action for biopharma companies and patient advocates who do not normally consider infectious disease as part of the portfolio.
Research & Development Reimbursement

NASH Drug Development Guidance Encourages Sponsors To Adopt Innovative Trial Designs

Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.
Clinical Trials Liver & Hepatic

Global Blood Therapeutics Leaves ASH With Momentum Behind Voxelotor In Sickle Cell Disease

Company revealed that US FDA agreed to accelerated approval pathway for voxelotor in sickle cell disease, with focus on stroke prevention. Updated data from a key trial was also released at ASH.

Clinical Trials Regenerative Medicine

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

CVS ‘Guaranteed Net Cost’ Program Is Alternative To High Price/High Rebate Model

Program likely to generate fewer rebates so it remains to be seen whether payers will embrace the new model in a big way.

Pharmacy Benefit Management Reimbursement

P&G's Personal Health Sector Has Merck Consumer Chief As International Head

P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.

International Germany

Pfizer Decides Not To Challenge AbbVie's Humira Biosimilar Patents

Pfizer is the seventh company to enter licensing agreement with AbbVie; it has completed development program for its adalimumab candidate.
Biosimilars Commercial

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Gilead False Claims Case: Government Opposes Supreme Court Review But Thinks Suit Should Be Tossed

US Solicitor General says facts lacking on what government knew about alleged product misrepresentations; FDA may be burdened with discovery requests if suit proceeds to discovery and trial.

Legal Issues Manufacturing

Serialization Update: Industry Warns Of “Significant Disruptions” If FDA Bars Use Of GSI Global Numbers Under DSCSA

The pharmaceutical industry has already been using GTIN numbers on product packaging to comply with pending serialization requirements and US FDA’s plan to replace the GTIN with the NDC code is drawing much criticism. 
United States Manufacturing

Pharmaceutical Industry Slams FDA’s Guidance On Drug Substance Post- Approval Changes; Say More Alignment With ICH Needed

Like the fabled Rip Van Winkle, FDA guidance on post-approval changes for drug substances has awakened after a long nap to a changed world. Industry is urging FDA to revise its draft in a way that’s less prescriptive and more in line with the science- and risk-based approaches, outlined in ICH Q8, Q9 and Q12 guidelines, that have emerged in the years after the agency withdrew its BACPAC guidance.

United States Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Crown Labs Spreads Out, GSK Narrows Focus In OTC Skin Care Brand Deal

GSK further narrows consumer health focus with sale to Crown Labs of North American distribution rights for PanOxyl acne wash, Sarna anti-itch lotion, Zeasorb anti-fungal product, Desenex athlete’s foot treatment and Mineral Ice pain-relieving gel. Deals also helps UK pharma pay for its $5.1bn acquisition of oncology drug firm Tesaro.

Dermatology M & A

P&G's Personal Health Sector Has Merck Consumer Chief As International Head

P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.

International Germany

Coppertone, Dr. Scholl’s On The Block As Bayer Narrows Consumer Health Focus

Bayer will sell Coppertone sunscreen and Dr. Scholl’s foot care brands to focus on growing its core consumer health brands. Although the plan represents ‘failure” in turning around sales for both brands, it is a ‘sensible’ move, say analysts.

Commercial M & A
UsernamePublicRestriction

Register

Advertisement