Feliza Mirasol is the science editor for BioPharm International.
Genmab to Acquire ProfoundBio in $1.8 Billion Deal, Gains ADC Pipeline
In a $1.8 billion transaction, Genmab will gain three clinical-stage next-generation ADC candidates with its acquisition of ProfoundBio.
Evaluating Uses for Both Single-Use and Stainless-Steel Bioreactors
Despite a growing trend toward single-use bioreactors, stainless-steel retains its relevance for certain products.
FDA Grants Fast Track Designation to J&J’s Nipocalimab for Rare Disease
J&J’s nipocalimab is in development for reducing the risk of FNAIT in alloimmunized pregnant adults, a rare disease that may risk the life of the fetus or newborn.
FDA Approves AstraZeneca’s Ultomiris for NMOSD
AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.
AbbVie Acquires Landos Biopharma and Gets Full FDA Nod for ADC Product
AbbVie’s acquisition of Landos includes a lead asset that boosts its portfolio in autoimmune and inflammatory diseases, while the ADC, ELAHERE, gets full FDA approval.
Lonza Acquires Roche’s US Commercial Biologics Manufacturing Site for $1.2 Billion
With the Vacaville, Calif., site acquisition, Lonza gains one of the largest biologics manufacturing sites for mammalian cell-based therapeutics.
Installation of Cytiva’s Aseptic Filling Workcell Aimed at Raising White Raven’s Manufacturing Efficiency
CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.
FDA Approves First Gene Therapy for Pediatric MLD from Orchard Therapeutics, and AGC Biologics Tapped to Manufacture It
Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.
Ricoh Licenses CRISPR/Cas9 Technology from ERS Genomics
In a non-exclusive licensing agreement, Ricoh will have access to ERS Genomics’ CRISPR/Cas9 genome editing technology to create novel disease models.
ProBioGen and Mapp Biopharmaceutical Partner to Develop Antibody Against Marburg Virus Disease
ProBioGen and Mapp Biopharmaceutical will use the former’s GlymaxX technology to develop a cell line for an afucosylated antibody that targets Marburg virus infection
Domain Therapeutics and Chime Biologics Form Manufacturing Pact for Antibody Cancer Immunotherapy
Under a new agreement, Chime Biologics will manufacture Domain Therapeutics’ antibody cancer immunotherapy candidate, DT-7012.
EMA Validates Parallel Applications for Datopotamab Deruxtecan in Two Types of Cancer
EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.
J&J Completes $2 Billion Ambrx Acquisition, Boosts Pipeline for Next-Gen ADCs
Johnson & Johnson’s $2 billion acquisition of Ambrx boosts its pipeline of next-generation ADCs for cancer treatment.
AbbVie Partners with OSE Immunotherapeutics on Novel mAb for Chronic Inflammation
Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.
Moving Biosimilars Forward in a Hesitant Market
Despite a growing number of biosimilar approvals, market uptake remains a challenge.
CordenPharma Launches New LNP Starter Kits for mRNA Formulation
CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.
Nona Biosciences Partners with Boostimmune on ADC Development
Nona Biosciences and Boostimmune will collaborate to develop ADCs against novel targets using Nona’s proprietary platform technology.
CSL Licenses Cytegrity Lentiviral Vector Production System to Genezen
CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.
Daiichi Sankyo Invests Roughly $1.08 Billion to Expand German Production and Development Site for ADCs
Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.
FDA Approves Amtagvi, First Cell Therapy for Skin Cancer
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
BioVaxys Acquires Full Portfolio of Former IMV
BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.
Samsung Biologics Partners with LegoChem Biosciences on ADCs
Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.
Novartis to Acquire MorphoSys for Roughly $2.9 Billion
Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.
Purolite and Repligen Launch New Affinity Resin
Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.
Quantum-Si Launches Platform Enhancements for Protein Sequencer
The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.
Novo Holdings to Acquire Catalent in Deal Valued at $16.5 billion
Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.
Lonza and Oxford Nanopore Partner on mRNA Analytics
Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.
Bracing for a Future Wave of Advanced Therapies
In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.
Milestone Approval to Steady Stream, Gene Editing Revs Up
The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.
Regeneron Forms R&D Cell Therapy Unit from 2seventy bio Platform Acquisition
With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.