Feliza Mirasol is the science editor for BioPharm International.
EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab
The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.
Illumina Establishes New Center in India to Expand Genomics Capabilities
Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.
Nanoparticle Engineering in Drug Delivery Under the Microscope
Nanoparticles offer the potential for a safer, more effective method of drug delivery to the patient.
Bristol Myers Squibb Joins Cellares Program Focused on Automated Cell Therapy Manufacturing as Cellares is Launched as First IDMO
Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.
Three-Way Collaboration Between Rentschler Biopharma, CGT Catapult, and Refeyn Aims to Improve PAT for Gene Therapy Manufacturing
Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.
Danaher to Acquire Abcam in $5.7 Billion Deal
Danaher intends to acquire Abcam, a provider of life sciences assays and reagents, for $5.7 billion.
Regeneron Gets FDA Approvals on New Biologic and New High Dose for Eye Disease Therapy
FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.
FDA Halts Clinical Trial Enrollment for Gilead’s Magrolimab in AML Studies
FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.
Chiesi Global Rare Diseases and Aliada Therapeutics Partner to Advance Blood-Brain Barrier-Crossing Platform Technology for Drug Delivery
With this agreement, Chiesi Global Rare Diseases will co-develop drug delivery systems with Aliada Therapeutics for large molecule therapeutics that can cross the blood-brain barrier.
Teknova Opens New GMP Manufacturing Facility for Life Sciences Reagents
The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.
Lilly Completes Spate of Acquisitions
The completion of three acquisitions of Versanis Bio, Sigilon Therapeutics, and DICE Therapeutics boosts Eli Lilly and Company’s product pipeline in obesity, diabetes, and immunology.
Rakuten Medical Signs Exclusive Licensing Agreement with Hikma for Cancer Treatments in MENA
Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.
iTolerance and Northway Biotech Form Manufacturing Pact for Fusion Protein
Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.
A Look into Biologic Scale-Up Strategies
Scale-up strategies for cell culture will require a deep understanding of overall bioprocess workflows.
Dealing with Data: How to Keep It Manageable
Advanced analytical tools generate more data in today’s labs than ever before.
Teva Pharmaceuticals and Alvotech Expand Existing Biosimilars Partnership
Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.
EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies
Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.
MilliporeSigma Expands Production Facility for Cell Culture Media
MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.
Crossbow Therapeutics Debuts with $80 Million in Series A Financing to Advance Antibody Therapeutics
Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.
Bristol Myers Squibb and Evotec Extend Neuroscience Pact
Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.
Sandoz Spin-off Gets Green Light from Novartis Board
The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.
Novartis Acquires DTx Pharma in Deal Worth Up to $1 Billion
Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.
metabion Expands Oligonucleotide Production Capacity in Germany
German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.
Pushing Forward in Next-Gen Antibody Development
Exploring new fields can bring novel antibody candidates to the pipeline.
Camena Bioscience Raises $10 Million to Pursue DNA Synthesis Technology
Camena Bioscience has completed $10 million in Series A financing on the back of growing demand for DNA synthesis.
Chime Biologics Forms mAb Development and Manufacturing Deal with Leads Biolabs and BeiGene
Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.
FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
Choosing the Right Expression System for Complex Modalities
The choice of expression system requires wise consideration of product complexities.
Andelyn Biosciences Opens New CGT Manufacturing Headquarters
The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.
Saudi Arabia’ PIF Launches Lifera, a New CDMO
PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.