Biopharma News
AstraZeneca mAb Approved by FDA for Endometrial Cancer Patients
Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.
Ascidian Therapeutics Collaborates with Roche on Treatments for Neurological Diseases
The collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.
FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies
Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.
BIO 2024: Finding a More Optimal Way for ATMPs
Pharm Tech Group looks at the challenges surrounding the development and manufacture of ATMPs in more detail with Agne Vaitkeviciene, CEO of Memel Biotech.
BIO 2024: Exploring the Potential of mRNA
Pharm Tech Group sits down with Bernard Sagaert, CEO of etherna, to examine the role of mRNA in the treatment of autoimmune diseases.
BIO 2024: Seeking Excellence with CRISPR
BioPharm International chats with Dr. Monika Paulė, CEO and co-founder of Caszyme about the evolution of CRISPR.
FDA Grants Priority Review to Sanofi’s Sarclisa in Combination Therapy with VRd for Treating Multiple Myeloma
FDA’s priority review status was granted based on positive results from a Phase III study evaluating Sarclisa in combination with VRd in treating transplant-ineligible newly diagnosed multiple myeloma.
FDA Approves Interchangeable Biosimilar to Soliris
Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Johnson & Johnson Pursues Global Rights to Numab Therapeutics’ AD-Targeting Bispecific Antibody in $1.25 Billion Acquisition
Under an agreement, Johnson & Johnson will acquire Numab Therapeutics’ wholly owned subsidiary to gain global rights to NM26, a bispecific antibody targeting atopic dermatitis.
Integrated Biosciences and Illumina Ventures Labs Collaborate on Novel Therapeutics Targeting the Transcriptome
The partnership will create therapeutic assets and new discovery platforms and potentially reshape drug discovery.
Biogen Boosts Immunology Portfolio with $1.8 Billion Acquisition of HI-Bio
Biogen’s acquisition of HI-Bio includes lead investigational mAb, felzartamab, under development for treating a range of immune-mediated diseases.
etherna and Hasselt University to Partner on mRNA Therapeutics Research
The organizations plan to combine etherna’s experience in mRNA and lipid-based nanoparticles with UHasselt’s autoimmune research to treat a variety of auto-immune diseases.
AstraZeneca Invests $1.5 Billion to Build New ADC Manufacturing Facility in Singapore
This new facility will allow AstraZeneca to offer full manufacturing processing for antibody drug conjugates.
FDA Grants Accelerated Approval to CAR-T Cell Therapy for Relapsed or Refractory Follicular Lymphoma
Breyanzi is made from the patient’s own T cells, which are genetically reengineered into CAR-T cells and then delivered through infusion as a one-time treatment.
Kate Therapeutics Reveals Platform and Pipeline Progress at ASGCT 2024
The company presented results from its programs for Duchenne muscular dystrophy and facioscapulohumeral muscular dystrophy.
Chiesi Group and Karolinksa Institutet Partner on Solutions to Urgent Health Challenges
One of the first planned areas of focus is the field of preterm birth-associated early onset respiratory disease.
Improving the Sensitivity and Action of CAR-T Cell Therapies (ASGCT 2024)
Regeneron’s work in CAR-T cell therapy development includes engineering receptor architecture to improve CAR-T cell sensitivity and improve immune response.
At ASGCT, Regeneron Presents Update on Gene Therapy for Genetic Deafness
The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.
Capsida Biotherapeutics Presents Preclinical Data for First-in-Class IV-Administered Gene Therapy to Treat Epilepsy
The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.
Astellas and Poseida Therapeutics Partner to Develop Allogeneic Cell Therapies
The collaboration will target solid tumors using Poseida’s allogeneic CAR-T platform to develop convertibleCAR programs.
Novartis Agrees to Acquire Mariana Oncology for $1 Billion, Gains Small Lung Cancer Candidate
Mariana’s portfolio of radioligand therapies will strengthen Novartis’ radioligand therapy pipeline.
FDA Approves Trastuzumab Biosimilar for the Treatment of HER2-Overexpressing Breast and Gastric Cancers
Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.
FDA Approves Pfizer’s Gene Therapy for Adults with Hemophilia B
Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.
Vertex and TreeFrog Therapeutics Enter Licensing Agreement and Partnership on Production of Type 1 Diabetes Cell Therapies
The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies.
CureVac and MD Anderson Cancer Center Collaborate on mRNA Cancer Vaccines
The collaboration will focus on differentiated cancer vaccine candidates in hematological and solid tumor indications to treat unmet medical needs.
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.
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.
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.