AstraZeneca acquired preclinical biotech Omniose, adding a bioconjugation platform for conjugate vaccines against serious bacterial infections.
|Articles|June 15, 2002
- BioPharm International-06-01-2002
- Volume 15
- Issue 6
Biotechnology Patent Holders Beware! A Supreme Court Ruling may Significantly Reduce the Value of Your Patent Portfolio
by Edward R. Ergenzinger, Jr. and W. Murray Spruill, Alston & Bird, LLP Patents on genes and proteins might be severely ? even retroactively ? affected and lose significant value if the Supreme Court upholds the Appeals Court ruling in the Festo case. Applicants seeking patents may be required to make and test thousands of functional variants and describe them all in patent specifications to claim them. The Supreme Court decision is anticipated this summer.
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Negotiating and Structuring Strategic Alliancesover 24 years ago
Finding Funding in Biotechnology: Keeping the Companies Aliveover 24 years ago
Stem Cells and Xenotransplantation: Ethics, Patents, and Politicsover 24 years ago
Unlocking the Value of R&D: Managing the Risksover 24 years ago
Viewpoint: United Kingdom highlights biomanufacturing capabilitiesover 24 years ago
Inside Washington: Safety, Risk, and Biotechnology Regulationover 24 years ago
Criminal Penalties for Theft of Biological MaterialAdvertisement
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FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
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Larimar Therapeutics has completed its rolling BLA for nomlabofusp, a frataxin replacement fusion protein, seeking accelerated approval based on skin frataxin as a novel surrogate endpoint. The company expects a potential US approval in mid-2027.
FDA granted RMAT and Fast Track designations to AbelZeta’s anti-CD20/CD19 CAR-T therapy prizlon-cel for relapsed or refractory large B-cell lymphoma. The company plans US studies after prior CAR-T therapy and in the second-line setting.
argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.
More monoclonal antibodies are moving from IV infusion to subcutaneous injection, but dose, volume, and viscosity still limit the switch. This FAQ covers the formulation science, the enabling technologies, what regulators require, and what remains unresolved.
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