Market News & Trends
Voyager Therapeutics Receives FDA Clearance of IND Application for Gene Therapy Candidate
Voyager Therapeutics, Inc. recently announced the US FDA has removed its clinical hold on the company’s Investigational New Drug (IND) application for VY-HTT01, a gene…
ENZYVANT Resubmits BLA to FDA for RVT-802 for Pediatric Congenital Athymia
Enzyvant recently announced the resubmission of the Biologics Licensing Application (BLA) to the US FDA for RVT-802, cultured human thymus tissue. RVT-802 is a one-time…
Stirling Ultracold & Catalent Announce Partnership to Establish Energy-Efficient Cold Chain Capabilities for Biologics & Emerging Modalities
Catalent and Stirling Ultracold recently announced a partnership whereby Stirling Ultracold becomes the preferred provider of ULT storage across Catalent’s multiple business units. The growth…
ImCheck Announces Initiation of US Enrollment in Phase 1/2a EVICTION Trial for ICT01
ImCheck Therapeutics recently announced the first patient in the US has been dosed at the Yale University Cancer Center in New Haven, CT, as part…
Clinical Data Shows Noxopharm’s Veyonda May Prevent Cytokine Storm
Australian clinical-stage drug development company Noxopharm Limited recently announced that in a cohort of 18 patients with moderately severe cases of COVID-19, interim data in its…
Brickell Biotech Completes Patient Enrollment in US Phase 3 Pivotal Cardigan I Study
Brickell Biotech, Inc. recently announced completion of patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed…
MacroGenics Adopts Genedata Profiler to Enhance Development of Immunotherapies
Genedata recently announced a long-term partnership agreement with MacroGenics, a biopharmaceutical company and an emerging leader in developing and commercializing innovative immune-oncology therapeutics…..
Agenus Submits Balstilimab Biologics License Application to the US FDA for Patients With Recurrent or Metastatic Cervical Cancer
Agenus Inc. recently announced the submission of a Biologics License Application (BLA) to the US FDA for the accelerated approval of….
ERS Genomics & NUVISAN ICB Sign CRISPR/Cas9 License Agreement
ERS Genomics Limited and NUVISAN Innovation Campus Berlin (ICB) GmbH recently announced a non-exclusive license agreement granting NUVISAN ICB access to….
CureVac Swiss AG Initiates Rolling Submission Process for mRNA-Based COVID-19 Vaccine Candidate
The CureVac Swiss AG, the Swiss subsidiary of CureVac N.V. recently announced initiation of a rolling submission for CVnCoV, the company’s mRNA-based COVID-19 vaccine….
XOMA’s Royalty Portfolio Grows With Addition of Three Royalty Assets
XOMA Corporation recently announced its portfolio of potential future milestone and royalty assets has increased with the addition of three Affimed N.V. innate cell engager…
CordenPharma Colorado Expands Lipid Excipients Purfication
In response to the COVID-19 pandemic, mRNA (messenger RNA) vaccines have catapulted to center stage of the pharmaceutical and biotechnology industry. As of early 2021,…
New Biomaterial Regrows Blood Vessels & Bone According to RCSI Research
Scientists have developed a new biomaterial that regrows blood vessels and bone, potentially providing a single-stage approach when repairing large bone defects. The study, led…
Longeveron Announces Successful Completion of Phase 1/2 Clinical Study
Longeveron Inc. recently announced the completion of the company’s Phase 1/2 clinical study of the use of Lomecel-B to improve immune response to influenza (flu)…
LEXEO Therapeutics Announces FDA Fast-Track Designation
LEXEO Therapeutics recently announced the US FDA has granted Fast Track designation to LX1001, the company’s adeno-associated virus (AAV) mediated gene therapy program, for the…
Catalent Adds Cryogenic Capabilities at Philadelphia Clinical Supply Services Facility to Meet Growing Demand for Cell & Gene Therapy Development
Catalent recently announced it has made an investment to expand capabilities at its clinical supply services facility in Philadelphia to support sponsors developing cell and…
Context Therapeutics & Integral Molecular Enter Collaboration & License Agreement
Context Therapeutics and Integral Molecular recently announced a research collaboration and licensing agreement for the development of an anti-claudin 6 (CLDN6) bispecific monoclonal antibody….
AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis
AzurRx BioPharma, Inc. recently announced it has entered into an agreement with PPD, Inc. for its planned Phase 1b/2a clinical trial evaluating proprietary formulations of micronized….
SOTIO Demonstrates Strong Potential of SOT102 (ADC Targeting Claudin 18.2) for Treatment of Solid Tumors in Preclinical Studies
SOTIO recently announced new preclinical data of its antibody-drug conjugate (ADC), SOT102 (formerly SO-N102), for the treatment of solid tumors in a virtual….
Artelo Biosciences Doses First Patient in CAReS Study for the Treatment of Cancer-Related Anorexia & Weight Loss
Artelo Biosciences, Inc. recently announced the first patient has been dosed in the company’s Phase 1/2 Cancer Appetite Recovery Study (CAReS) of ART27.13….
