Newsletter | December 12, 2023

12.12.23 -- Baxalta v. Genentech: The Latest Case In Patenting Functionally Claimed Antibodies



Baxalta v. Genentech: The Latest Case In Patenting Functionally Claimed Antibodies

On September 20, 2023, in Baxalta v. Genentech, the Federal Circuit invalidated patent claims directed to functionally claimed antibodies, finding that they failed to satisfy the enablement requirement. The author of this article is a patent attorney, and he shares the key takeaways for biotech/pharma companies going forward.


Driving Sustainability In Spray Drying Through Enabling Technologies

By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.

End-To-End Development And Manufacturing: Small-Volume Products

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

Process Effects On Drug Product Quality In Pharmaceutical Manufacturing

Here, we discuss the importance of understanding how critical process parameters can impact a product’s CQA and how a systematic approach with validated SPR assays can help in this respect.

Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

The pharma industry is identifying new ways to improve sustainability. Discover how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

The Critical Steps For Protein Therapeutic Potency Assay Development

Learn from an expert about the process of assay development, qualification, and validation for potency assays and how we can support customers through this vital step.

Accelerate Your ADC Journey With Integrated Bioconjugate Solutions

Explore how the ADC landscape is being reshaped by new drug product capabilities that enable end-to-end development and manufacturing of cytotoxic bioconjugates.

Process Redesign For Sustainability In Small Molecule Manufacturing

Review the optimization of the manufacturing process of a pharmaceutical intermediate and discover how yield can be improved substantially via suitable reaction engineering.


Absci Announces Collab With AstraZeneca To Advance AI-Driven Oncology Candidate

BridgeBio Pharma Announces Submission Of NDA To U.S. FDA For Acoramidis

MilliporeSigma Launches First Ever AI Solution To Integrate Drug Discovery And Synthesis

Clarivate Expands Partnership With VeriSIM Life

FDA Grants Lantern Pharma ODD For Drug Candidate LP-284

Vanda Pharmaceuticals Announces That U.S. FDA Accepts NDA For Tradipitant

AbbVie & BigHat Biosciences Announce Research Collab To Leverage AI

Taking Antibiotics Back In Time

Can't Un-Cook An Egg

Potential Schizophrenia Treatment Entering Phase 1 Clinical Trial

New Approach To Drug Discovery: Pain Medication With Fewer Side Effects Developed


Environmentally Controlled Stability Storage And Testing Solutions

Your Molecule. Our Mission.

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