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BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.
Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
“The submission of the BLA marks a pivotal step for Capricor Therapeutics and those impacted by DMD. This BLA is the culmination of a body of work that has been focused on bringing this potentially transformational therapy to those patients in need,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “We believe that the strength of this application is that deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. We look forward to working with the FDA throughout the review process to support this potential approval.”
PharmaEssentia Reaffirms its Commitment to Robust and Reliable Access to Interferon Therapies Amid Global Supply Challenges
“Our longstanding commitment to operational resilience has positioned us to navigate these challenges effectively,” said Dr. Ko Chung Lin, CEO of PharmaEssentia. “We recognize that dependable medication supply is essential, and we are working closely with our partners around the world to ensure the continuity of these important therapies. We have made substantial investment to ensure that all of our supply chain elements are strong, of the highest quality, and reliable.”
YolTech Therapeutics Granted FDA Orphan Drug and Rare Pediatric Disease Designations for YOLT-203 to Treat Primary Hyperoxaluria Type 1
After reviewing YolTech Therapeutics submission, the FDA determined that the therapy is not only appropriate for primary hyperoxaluria type 1 (PH1), but also applicable to the broader category of primary hyperoxaluria (PH). As a result, the designations were granted for PH, reflecting the expanded scope of the therapy's potential impact. These dual designations underscore the transformative potential of YOLT-203 to address this rare and life-threatening genetic disorder.
Eisai Signs Research Collaboration Agreement with The National Center of Neurology and Psychiatry to Initiate Apolipoprotein E Genetic Testing in the “AD-DMT Registry” in...
Eisai and Biogen Japan will continue to contribute to the advancement of Alzheimer’s disease treatment through ongoing collaboration with academia.
Intensity Therapeutics Presents INT230-6 Phase 1/2 Data in Sarcoma and an Overview of its Ongoing Global Randomized Phase 3 Sarcoma Trial (“INVINCIBLE-3 Study”) in...
Phase 1/2 data showed a median overall survival (“mOS”) of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone notes Intensity Therapeutics.
Immorta Bio Reports | SenoVax™ Reduces Growth and Stops Metastasis of Aggressive Breast Cancer Using its First-In-Class Immune Stimulatory Therapy
SenoVax has previously been demonstrated to reduce lung cancer growth1, which was the subject of the Company's IND #307452. It has also been shown to accelerate recovery of blood cell production after chemotherapy notes Immorta Bio.
BioHub Maryland Opens New Biopharma Workforce Training Center in Montgomery County’s Life Sciences Corridor
BioHub Maryland is a skills-first workforce development initiative of the Maryland Tech Council (MTC), the state’s largest life sciences and technology trade association. Its mission is to accelerate the growth of the life sciences industry by expanding the state’s biopharma manufacturing talent pipeline.
TMRW Life Sciences and Cryoport Systems Form Strategic Partnership
"This partnership with Cryoport reflects our dedication to providing patients and clinics with the highest standard of care," said Louis Villalba, TMRW's CEO. "Cryoport's reputation for excellence in reproductive biologistics, paired with TMRW's cutting-edge specimen management technology and safety certifications, delivers unmatched security and peace of mind for transporting specimens in the fertility space."
Revolo Biotherapeutics Shares New Preclinical Data Showcasing the Potential of Sublingual ‘1104 in Allergic Disease
Revolo Biotherapeutics notes additionally, the data continues to demonstrate the differentiated upstream MOA of ‘1104, restoring immune homeostasis by impacting both the effector and regulatory arms of the immune system with a persistence of effect for multiple weeks.