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.
Lilly and ImmuNext Announce Licensing and Research Collaboration
Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.
French Biotech Signs License Agreement with LG Chem for Lung Cancer Vaccine
PDC*line Pharma has entered into a licensing agreement with LG Chem to develop a lung cancer vaccine in Asia.
Merck KGaA Opens Development Center in France and Invests in Darmstadt Headquarters
Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.
The Link Between Manufacturing and Commercialization in Gene and Cell Therapy
Think ahead to production requirements when planning strategies in early development of gene and cell therapies.
FDA Issues Guidance on HIV-1 PrEP Products
The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.
Alcami Announces Biologics Enterprise
Alcami Biologics formed to meet market demands for biological drug development services.
Catalent Invests in Zydis Ultra Commercialization
Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.
Scientists Discover Common Blueprint for Protein Antibiotics
Findings from the Los Angeles Biomedical Research Institute could enable a new generation of anti-infectives.
Ono Pharmaceutical, twoXAR Collaborate on Drug Discovery Research
The companies announced a collaboration to jointly discover and develop treatments to address unmet medical needs in a specific neurological disease.
Strategic Partnership Forms to Accelerate Drug Development
REPROCELL Europe has announced a strategic partnership with Medicines Discovery Catapult, as part of the virtual R&D platform that is aimed at supporting drug development.
Improving Process Mass Intensity for Bio/Pharmaceutical Production
Process optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.
Iksuda Therapeutics, Femtogenix Sign License Agreement Targeting Difficult-to-Treat Solid Tumors
Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.
Biogen to Acquire Gene-Therapy Company Nightstar in $800-Million Deal
The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.
Caught in a Conundrum
Do patients get what they pay for when they demand cheaper drugs?
Strategic Screening for Solubility Solutions
Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.
Rising to the Challenge of Biologic Drug Formulation
As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
Key Considerations in Stability Testing
Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
Real-Time Measurement of Coating Film Thickness
Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
Exclusive Agreement Forms for Sublingual Delivery
STA Pharmaceuticals and BioLingus have announced the formation of an exclusive technology and marketing collaboration for sublingual delivery.
N4 Pharma Develops Nanoparticle Technology for Vaccine Delivery
The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.
Valitacell, Solentim Collaborate to Accelerate Development of Breakthrough Medicines
Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.
Mustang Bio, Nationwide Children’s Hospital Sign License Agreement for Oncolytic Virus Therapy
Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.
FDA Encourages Development of Regenerative Medicines
The agency clarified the process for development programs for regenerative medicine therapies.
SK Biopharmaceuticals, Arvelle Partner on Anti-Epileptic Drug for Europe
In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.
AbbVie, Teneobio Partner on Multiple Myeloma Treatment
The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.
CatSci Expands Offering to Include Lead Optimization
CatSci has announced an expansion of its offering to include end-to-end services with an additional focus on lead optimization.
Partnership Forms for First-in-Class Therapies for Autoimmune Diseases and Immuno-Oncology
Pathios Therapeutics and Sygnature Discovery have signed a strategic and innovative partnership agreement aimed at accelerating Pathios’ drug discovery and development programs.
Novartis, AbCellera in Antibody Discovery Pact
The multi-year agreement will give Novartis access to AbCellera’s expertise and state-of-the-art antibody discovery technology for up to ten clinically-relevant disease targets.
GSK, Merck KGaA Partner in $4.2-Billion Cancer Immunotherapy Deal
The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.
PDA to Address Technology Transfers at 2019 Annual Meeting
PDA survey and conference discussion will generate information to guidance on technology transfer.