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Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders Intellectual Property

US FDA May Ask Congress For More Resources After Withdrawing Generic Label Reg

Label updates for older generics are still planned, Commissioner Gottlieb says, but will depend more on sponsor collaboration as well as additional resources and authorities from Congress.
Generic Drugs FDA Regulation

Has R&D Productivity Rebounded? US FDA Officials Think So

Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review official thinks so – but the data aren’t yet clear.
Drug Review FDA Regulation

UK Inquiry Into ‘Unfair’ Orkambi Pricing Risks Pricing Confidentiality

The UK government has criticized Vertex for the company’s approach to pricing its cystic fibrosis drug Orkambi. In the meantime, a parliamentary inquiry that could expose sensitive pricing details moves forward.

Europe United Kingdom Cost Effectiveness

EMA Clarifies Sponsor Role In Contracting For Investigator Sites

The European Medicines Agency has made it clear that all clinical trial-related medical activities are the responsibility of the investigator and that a sponsor cannot contract these to a third party. Also, the EMA discourages performing trial procedures at a patient's house, unless duly justified.
Europe Clinical Trials Regulation
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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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Cost Concerns May Hinder Naloxone Co-Prescribing Ideas

US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.
Neurology Pricing Debate Advisory Committees

Latest From Regulation

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

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

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

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

US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination

Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.

Enforcement Manufacturing

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

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

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
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