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FDA Grants Orphan Drug Designation to March Biosciences for T-Cell Lymphoma Cell Therapy
On the back of FDA’s designation, March Biosciences is preparing to advance MB-105, a CD5-targeted CAR-T cell therapy, to a Phase II clinical trial in early 2025.
Aikium's AI-Driven mRNA Engine Looks to Address Undruggable Disordered Proteins
Eswar Iyer, MS, PhD, CEO and co-founder at Aikium Inc., describes a tool to overpower the data paucity problem in proteins.
Genentech’s Susvimo Gets FDA Nod as Continuous Delivery Treatment for Diabetes-Related Blindness
The approval makes Susvimo the first and only continuous delivery treatment for diabetic macular edema.
Grifols Teams Up with Startup, FcR Therapeutics, on Recombinant Therapies for Autoimmune Diseases
Under this early stage R&D collaboration, the companies aim to engineer recombinant biologics for blocking Fc receptors, which play a key role in autoimmune diseases.
Life Sciences Pioneer Lee Hood on How the Paradigm Shift Towards Precision Medicine Will Shape the Future of Health Tech and Patient Care
Hood, a pioneer of systems biology and systems medicine, shared his personal interest in starting a new peptide-based, informational-driven pharmaceutical company that would address wellness and longevity during an interview with BioPharm Internaltion at the Precision Medicine World Conference.
CHMP Recommends Imfinzi for Approval in EU for Limited-Stage Small Cell Lung Cancer
The committee’s recommendation was based on results from a Phase III trial that demonstrated a 27% reduction in the risk of death versus placebo.
Enduro Genetics Raises €12 Million to Expand Its Bioproduction Platform in Denmark
Enduro Genetics will use the funding to expand its cell programming technology for scalable biomanufacturing with microbial cells at its Copenhagen, Denmark site.
EMA Recommends Johnson & Johnson Subcutaneous Treatment for Non-Small Cell Lung Cancer
Intravenous administration of amivantamab is the currently approved route, but a Phase III trial showed that subcutaneous treatment was non-inferior.
Broadley-James Expands Distribution of Distek’s Benchtop Controllers in UK and Ireland
Under the expanded distribution service, Distek’s BIOne Benchtop Controllers will now be made available across the UK and Ireland.
Lantern Pharma Advances AI Platform to Optimize ADC Development for Cancer
In a peer-reviewed study, Lantern Pharma said its AI-driven approach successfully identified 82 promising ADC targets, and 290 target-indication combinations.
GSK and Oxford Collaborate to Form GSK-Oxford Cancer Immuno-Prevention Program for Advancing Cancer Research
Under this collaboration, GSK and Oxford will combine their complementary expertise in the immune system, vaccines, and cancer biology.
Rentschler Biopharma Withdraws from Cell and Gene Field, Plans to Close UK Site
Prior to this announcement, Rentschler announced in September 2024 it would be launching an expanded service offering at its advanced therapies site in Stevenage, UK, which is now being shut down.
UK MHRA Approves Garadacimab for Preventing Angioedema Attacks
The UK MHRA has granted approval for garadacimab for use in preventing angioedema attacks in patients 12 years old and older who have hereditary angioedema.
Ozempic Indications for Reducing Risk of Kidney Failure, Cardiovascular Death Approved by FDA
Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.
UK Biocentre and Azenta Life Sciences Partner on Sample Storage Capabilities for Biomedical Research
UK Biocentre will now utilize Azenta Life Sciences’ automated storage system, which gives the center storage capacity for more than 35 million biosamples.
FDA Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Treating HER2-low or HER2-ultralow Breast Cancer
The approval makes Enhertu (fam-trastuzumab deruxtecan-nxki) the first HER2-directed therapy in the United States for treating HER2-low or HER2-ultralow metastatic breast cancer.
LEQEMBI Gains Additional Indication in Maintenance Dosing for Early Alzheimer’s Disease with FDA Approval
FDA has approved an additional indication for LEQEMBI (lecanemab-irmb) as a once-every-four-weeks maintenance therapy for early Alzheimer’s disease.
Pharmapack Announces 2025 Award Winners Who Redefine Pharmaceutical Packaging and Drug Delivery
The 2025 Pharmapack Awards recognize both commercial products and innovations that are shaping the future of pharmaceutical packaging.
AstraZeneca Lung Cancer Treatments Recommended for Patients in England and Wales
Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.
FDA Issues Warning to Sanofi About API CGMP Deviations, Puts Clinical Hold on Atara Immunotherapies
The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.
Trenchant BioSystems and Autolomous to Combine Platforms for Automated CGT Manufacturing
Under the partnership, the companies will combine fully automated and digitalized technologies aimed at reducing CGT manufacturing timelines to 2.5 days.
Cytiva and Cellular Origins Team Up on Delivering Automated CGT Manufacturing
The collaboration will combine Cytiva’s CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.
Buy, Sell, Hold: mRNA - Part 3
Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.
Buy, Sell, Hold: mRNA - Part 2
Buy, Sell, Hold: mRNA - Part 1
Pharmapack Outlines Key Highlights for 2025
Biologic approvals, drug delivery advancements, GLP-1 generics, and the return of funding flow have been identified by Pharmapack as drivers for a record year in 2025.
Samsung Biologics Inks More Than $1.4 Billion Manufacturing Deal with European Pharma Company
The manufacturing agreement is expected to run through December 2030, subject to change, with production to take place at Samsung Biologics’ Songdo, South Korea, site.
Behind the Headlines: 2025 Wish List
Vanessa Almendro, Elliot Berger, Benjamin McCloud, and Turna Ray go behind the headlines to discuss their ‘wish list’ for the progression of trends in the bio/pharmaceutical industry.
Emergent and Hikma Enter Six-Year Partnership to Sell Naloxone Spray in US and Canada
Kloxxado was approved by FDA in 2021 for emergency treatment of opioid overdose, and Emergent also distributes the FDA-approved over-the-counter treatment Narcan.
Scribe, Sanofi Report Milestone for In Vivo Program Collaboration
Although specifics about the milestone were not immediately provided, Scribe is eligible to receive more than $1.2 billion for certain research, development, regulatory, and commercial benchmarks.
