April 14th 2025
Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.
April 11th 2025
The company has plans to invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities.
April 8th 2025
Lack of skills in the AI realm was a distant second among those surveyed about the biggest barrier to innovation while using the technology.
Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.
April 7th 2025
Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.
Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.
Cleaning and Disinfection in Sterile Drug Manufacturing
Webinar Date/Time: Wed, May 15, 2024 2:00 PM EDT
Genmab Expands ADC Pipeline with $1.8 Billion Acquisition of ProfoundBio
Genmab's acquisition of ProfoundBio will boost its clinical and preclinical pipeline of ADCs for targeted cancer treatment.
Development of Mini-Tablet and Multi-Unit Pellet Systems
Advanced oral dosage forms allow for modulation of controlled- and sustained-release profiles.
May I Present the Neoantigen
Experts believe it is likely cancer cells are more common in the body than previously thought, but typically caught early and removed in the body’s cancer-immune cycle. When the system is in good working order (and protecting us), dead cancer cells release neoantigens.
J&J's Nipocalimab for FNAIT Gets on Fast Track for Approval
FDA granted fast track designation to nipocalimab, which J&J is developing for helping alloimmunized pregnant adults treat FNAIT, a rare disease that poses risk to the fetus or newborn.
AstraZeneca Gains FDA Nod for Ultomiris, a Treatment for Managing NMOSD
FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.
QbD Approach to Small-Scale Studies to Enable Rapid Spray Drying Scale-Up
Webinar Date/Time: Tue, Apr 16, 2024 11:00 AM EDT
Mastering QbD for Successful Process Validation Campaigns and Commercial Manufacturing of Biologics
Webinar Date/Time: Thu, Apr 25, 2024 11:00 AM EDT
UpTempoSM Antibody: A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic
Webinar Date/Time: Wed, May 8, 2024 11:00 AM EDT
Mapp Biopharmaceutical Teams Up with ProBioGen and to Develop Antibody Against Marburg Virus Disease
Mapp Biopharmaceutical will use ProBioGen’s GlymaxX technology for the development of an afucosylated antibody against Marburg virus infection
FDA Gives Guidance on Developing Treatments for Early Alzheimer’s
The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.
Chime Biologics to Manufacture Novel Antibody Cancer Immunotherapy for Domain Therapeutics
In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.
From Lab to Launch: Successful Drug Development Strategies Using Lipid-Based Delivery Systems
Webinar Date/Time: Wed, Apr 24, 2024 11:00 AM EDT
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.
Microdosing: A Powder-in-Capsule Technology Pathway from Development to Commercialization
Webinar Date/Time: Tue, Mar 26, 2024 11:00 AM EDT
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.
Examining Contamination Control Strategy in Primary Packaging - A Case Study
Webinar Date/Time: Tue, Apr 9, 2024 11:00 AM EDT
Transferring Energy to Hot Melt Extrusions
Webinar Date/Time: Friday, April 5, 2024 at 11amEDT | 10am CDT | 8am PDT
Research into Cold Cancers Heating Up
A New “Voyage”
The power of collaboration is a critically important for the bio/pharma industry.
Reshaping Dosage Forms
Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil
This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
Development of Gamma-Delta T-Cell Therapies
Activation and expansion are essential for success in both autologous and allogeneic therapies.
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.
Drug Digest: The Rush for Quality Data and the Means to Protect It
This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.
Leveraging the Power of Recipe-Driven Execution and Standardization
Webinar Date/Time: Tue, Apr 9, 2024 2:00 PM EDT
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.
From Concept to Culture: Elevating GMP Compliance in Life Sciences
Webinar Date/Time: Thu, Mar 14, 2024 2:00 PM EDT
Capping and Manufacturing Strategies to Increase mRNA Potency and Reduce Costs
Webinar Date/Time: Wed, Mar 27, 2024 11:00 AM EDT