Drug Development Program Articles & Analysis
20 news found
Biopharma PEG, a leading manufacturer of high-quality polyethylene glycol (PEG) derivatives, today announced that its mPEG-pAld (20K) product has successfully achieved DMF (Drug Master File) registration with the U.S. Food and Drug Administration (FDA) under DMF number 040600. “We are thrilled to receive FDA DMF registration for our mPEG-pAld (20K) product,” said Sonia Lee, Marketing ...
Strong market uptake of Nubeqa and Kerendia Asundexian projected peak sales of more than five billion euros as treatment option for thrombosis and stroke prevention High-value late-stage development portfolio Positive study outcomes from cell & gene therapy pipeline would provide potential upside Shift of resources enhances commercialization and competitiveness Acquired arm’s ...
ByBayer AG
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) is pleased to announce that it has received agreement from the US Food and Drug Administration (FDA) on the Phase 3 clinical trial design for its lead candidate for Dry Eye Disease (DED), BRM421, at the End of Phase 2 Meeting. BRIM will submit the Phase 3 study protocol to the FDA in Q4 2022. Dr. Haishan Jang, Chair and CEO ...
The Muscular Dystrophy Association is pleased to announce the award of an MDA Venture Philanthropy (MVP) grant totaling $233,200 to Scottsdale, Ariz.-based Iron Horse Diagnostics to support development of a prognostic test for ALS (amyotrophic lateral sclerosis). Such a test could help improve and accelerate clinical trials and speed the development of life-saving drugs to people with ALS. MVP ...
BynVector
XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to provide a product development report on its Rotigotine transdermal (“TDS”) patch. The Company’s Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”). Over ...
Fluidda, leader in the field of Functional Respiratory Imaging and developer of the medical device Broncholab®, today announced an exclusive collaboration with Nanopharm, an Aptar Pharma company and a leader in contract research and development services for orally inhaled and nasal drug products (OINDPs). The companies will leverage their respective proprietary technology platforms to help ...
ByFluidda
Ariana Pharma, the leading eXplainable Artificial Intelligence (xAI) drug development company, announce the appointments of Dr. Marion Soto as Vice President, Business Development and Bertrand Lellouche as Chief Financial Officer. The financial and commercial experience of Marion and Bertrand will further drive Ariana’s accelerated growth. Marion and Bertrand will be bringing their ...
VeriSIM Life (VeriSIM) www.verisimlife.com, a leading artificial intelligence (AI)-enabled company providing services to de-risk R&D decision making for breakthrough drug development, today announced that it has entered into a collaboration with Mayo Clinic to improve the preclinical translation of promising drug candidates. “We are excited to expand our common mission and work with ...
Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, today announces the exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program, including lead and back-up compounds, preclinical data and a patent estate, from ...
Pronalyse is a new division of Creative Proteomics, which is an integrated CRO company with rich experience in providing drug development service for over 10 years. The company has recently announced Protein Drug Modification Analysis service to help researchers determine the modification type, modification site, and modification structure of protein drugs. Mature protein medicines have complete ...
Lung Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for orphan, pulmonary diseases and conditions, today announced the appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development. In this critical role, she will be responsible for guiding Lung Therapeutics’ clinical programs and will serve as a key member of the ...
The area of drug development is a veritable minefield with many junctures where a project can come to an abrupt end. The early discovery period presents its own significant challenges, but once a client has selected their lead candidate many organizations feel the heavy lifting is over, however this simply isn’t the case. The next steps of plotting out a clinical manufacturing process ...
Atomwise, a leader in using artificial intelligence (AI) for small -molecule drug discovery, today announced it has been named to Fast Company's prestigious annual list of the World's Most Innovative Companies for 2021. Atomwise was recognized for its unmatched AI platform, AtomNet®?, as well as its growing pipeline and portfolio of partnerships and joint ventures tackling some of the most ...
Bexson Biomedical, Inc., a research-stage company developing dosing and delivery solutions for mental health and pain management indications, announced today the addition of medical device and combination product developer, Sheldon Moberg, to its senior leadership team. As Senior VP, Drug Delivery, Moberg will lead the development of Bexson's drug delivery technologies, starting with a wearable ...
BERKELEY, Calif., Jan. 13, 2021 /PRNewswire/ -- Actym Therapeutics Inc., a privately-held company focused on the development of immunotherapies to treat cancer from its attenuated, microbial-based STACT platform, announced today the appointments of Dr. Lawrence Fong, M.D. and Dr. Michel Streuli, Ph.D., to its Scientific Advisory Board (SAB). Actym's SAB comprises world-renowned subject matter ...
SAN DIEGO, CA – Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, today announced that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during breast cancer surgery. Pegloprastide is designed ...
Atomwise, the leader in using artificial intelligence (AI) for small molecule drug discovery, announced today a partnership with GC Pharma (KRX: 006280), a South Korean biopharmaceutical company formerly known as Green Cross Corporation, to discover and develop novel hemophilia therapies. GC Pharma is a pioneer in vaccines and protein therapeutics and has long been dedicated to research and ...
Thermo Fisher Scientific and Daiichi Sankyo have expanded their partnership by signing a new agreement to co-develop a companion diagnostic (CDx) that will utilize Thermo Fisher's next-generation sequencing (NGS)-based Oncomine Dx Target Test. The CDx will be designed to identify non-small cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who may be ...
Led by Future Ventures, includes top healthcare and technology funds Amplitude Ventures, Khosla Ventures, Magnetic Ventures and True Ventures Proceeds will support creating new technology for artificial intelligence-accelerated therapeutic development and advancing Wilson disease program into the clinic Deep Genomics, the leading artificial intelligence (AI) therapeutics company, announced ...
There is the age you say you are – which is not always accurate but always medically irrelevant. There is your chronological age – which is accurate but ignores inter-person variation. And then there is your immune age – the key determinant of future health and response to disease and treatment – quantified now for the first time, creating a potential paradigm shift ...