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Pfizer Price Increases Underscore Rebate Problem, HHS’ Hargan Says

The Trump Administration remains convinced that rebates lead to high list prices and that reform of the system is needed, US HHS Deputy Secretary Eric Hargan emphasizes.

Pricing Debate Pharmacy Benefit Management Regulation

Roche And Shionogi Aim For EU Accelerated Assessment

Roche will learn this week if two potential anticancer it is developing - polatuzumab vedotin and entrectinib - will be okayed for fast track regulatory review when they are filed in the EU.

Europe Cancer Drug Review

ANDA Sponsors Face Tight Controls On Meetings With US FDA After CR Letters

Meetings are intended to help generic sponsors understand deficiencies, but agency won't let them run past 30 minutes.
Generic Drugs Drug Review Review Pathway

Data Integrity Guidance Adds Focus On Culture, Best Practices And APIs

In response to comments, US FDA’s final guidance on data integrity further refines and expands on some of the principles and best practices espoused in the draft version to help pharmaceutical manufacturers counter a growing problem with inaccurate data. This problem continues to consume a good deal of FDA’s GMP enforcement efforts.
United States Manufacturing Quality

US FDA Moves To Codify Size-Based Threshold For Drugs To Be Deemed Biologics

Agency proposes to define by regulation which proteins previously approved as drugs will be deemed licensed biologics, and therefore potentially subject to biosimilars competition. Industry has opposed the size-based thresholds, preferring a structure-based approach.

Biologics Biosimilars Regulation

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

Global Generics & Biosimilars Awards 2018

Generics bulletin was able to celebrate the outstanding progress that both teams and individuals achieved in providing greater healthcare access through generic, biosimilar and value-added medicines. Many of these achievements have been documented in Generics bulletin. Click below and enjoy the selection of articles that reflect the wide array of industry activities.

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Policy & Regulation Explore this Topic

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Tanzanian Drugs Regulator Wins WHO Performance Accolade

The Tanzanian medicines agency has obtained a “level 3” ranking from the WHO, meaning it now runs a “stable, well functioning and integrated” regulatory system.
Middle East and Africa Tanzania Drug Approval Standards

Latest From Regulation

Opioid-Sparing Claims May Be Better Suited For Phase IV Trials Instead Of Phase III

US FDA advisory committee panelists argue that prospective, randomized Phase III trials fail to reflect real-world treatment decisions.

Advisory Committees Neurology

Medicare Part D ‘Enhanced MTM Model’ Saves $325m In First Year

US Centers for Medicare and Medicaid Services announces first-year results from its medication therapy management model, intended to optimize prescription drug use among Medicare beneficiaries.

Medicare Reimbursement

When Drugs Become Biologics: US FDA Guidances Explain 'Transition Provisions'

With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.

Biosimilars Biologics

Latest From Policy

Infectious Diseases Proposed As Focus Of Inter-Korea Health Cooperation

Amid ongoing talks to denuclearize North Korea, the two Koreas are gearing up for bilateral cooperation in various industries including the health and medical sector, if and when international sanctions on the North are lifted. A new report suggests possible ways the two sides can initially work together in the area, with a focus on infectious diseases.

South Korea North Korea

Revamped Cancer Drugs Fund Means More Positive Recommendations, Says NICE

NICE, the health technology appraisal body for England and Wales, has rejected criticism that access to cancer drugs is worsening in the UK. The institute pointed to the revamped Cancer Drugs Fund which it said meant more positive recommendations.

Europe United Kingdom

Older Patents Get Help As Federal Circuit Sides With Novartis In Gilenya, Everolimus Disputes

US court finds no obviousness-type double patenting under statute that changed patent term from 17 years from issuance to 20 years from filing; decisions will impact other cases involving patents issued prior to statute.
Generic Drugs Legal Issues

Clinical / R&D Explore this Topic

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Latest From Research & Development

Major Depressive Disorder Patients Emphasize Long-Term Nature Of Disease In Feedback Meeting

Externally hosted patient focused drug development meeting in MDD brings timely messages to US FDA during period of active regulatory review of new applications. Patients stress need for fewer side effects to encourage long-term medication use, and also want fast-acting meds that can “jump start” lifestyle changes. 
Neurology 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

Commercial Explore this Topic

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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

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Latest From Manufacturing

Counter-Intuitive Thinking To Combat Drug Shortages

Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
Generic Drugs Manufacturing

Industry Advised To ‘Lawyer Up’ If Serialization Systems Don’t Comply With DSCSA

Drug makers must comply with draft FDA guidance on Drug Supply Chain Security Act serialization requirements that took effect Nov. 27 or else “lawyer up” to explain to the agency why their products are not serialized in accordance with it, pharmaceutical lawyer advises.
United States Manufacturing

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

Consumer / OTC Drugs Explore this Topic

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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