Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
- How Kaiser Built A Biosimilar Empire — The Inside Story
- FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?
- The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter
- Biosimilar Litigation Review: Anticompetitive Conduct Cases & Post-Grant Patent Challenges
- The Nurse’s Perspective On Biosimilars In Oncology Care
- Biosimilar Litigation Review: BPCIA Federal Circuit Appeals Pending & Recently Decided
- An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report
Biosimilar Litigation Review: Anticompetitive Conduct Cases & Post-Grant Patent Challenges
This is the fourth article in a four-part series on 2019 legal developments related to the biosimilar sector. In this final installment, we cover 2019 biosimilar litigation related to anticompetitive conduct and post-grant patent challenges at the Patent Trial and Appeal Board (PTAB), and look ahead to what biosimilar developers can anticipate in 2020.
Biosimilar Litigation Review: BPCIA Federal Circuit Appeals Pending & Recently Decided
This is the third article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding BPCIA district court litigation and reviewed ongoing BPCIA district court cases. Part 2 covered BPCIA district court cases that were settled in 2019. Here in Part 3, we review BPCIA Federal Circuit appeals that are pending and those that were recently decided.
An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report
To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle.
Biosimilar Litigation Review: BPCIA Cases Settled Or Dismissed In 2019
This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding Biosimilars Price Competition and Innovation Act district court litigation and reviewed ongoing BPCIA district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.
Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?
Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.
Biosimilar Litigation Review: Ongoing BPCIA District Court Cases To Watch
Biosimilars Price Competition and Innovation Act (BPCIA) litigants and Federal and district courts grappled with new issues in 2019. In Part 1 of this article series, we summarize BPCIA district court litigation and review ongoing court cases.
6 Important Elements Of The New STRONGER Patents Act
Over the past decade, patent reform has been an area of emphasis for Congress, with the passage of The America Invents Act of 2011 (AIA) and, more recently, the filing of a revised version of the STRONGER Patents Act in July 2019.
BIOSIMILAR WHITE PAPERS
Developing A Scalable Process For Adenovirus Manufacturing
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Manufacturing Of Sterile Aqueous Suspensions: A Primer
Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.
Virus Safety For Continuous Processing
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
More Efficient Bispecific Antibody Purification With Fewer Steps
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
Optimizing Process Efficiency In Upstream Manufacturing
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.
Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
In line with a Congressional directive, the FDA must transition products previously approved as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to biologics under the Public Health Service Act (PHS Act) by March 23, 2020. This collection of articles examines the upcoming regulatory transition in depth, sharing industry and patient perspectives on the changing regulatory requirements and market access strategies and concerns for this critical class of medicines.More Content Collections
LIFE SCIENCE EVENTS
Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program
March 4 - 4, 2020
1pm-2:30pm EST, Online Training
Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs
March 10 - 10, 2020
Online Training; 1:00 - 2:30 PM EST US
Cleanroom Microbiology – A Foundational Introduction
March 11 - 11, 2020
1pm-2:30pm EST, Online Training
Regulatory GCP Inspections: Preparation, Participation & Follow-up
March 12 - 12, 2020
1pm-2:30pm EDT, Online Training
Statistical Hypothesis Tests: Concepts & Applications
March 16, 2020