Market News & Trends
Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients With Krabbe Disease
Forge Biologics recently announced Chief Medical Officer Maria Escolar, MD, MS, presented updated clinical data from the RESKUE Phase 1/2 clinical trial for FBX-101—the company’s…
HUTCHMED Initiates a Phase 2/3 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia
HUTCHMED (China) Limited recently announced it has initiated a Phase 2/3 trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia….
FDA Approves New Treatment Option for Patients With ALS
The US FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “This approval provides another…
Evonik & Phathom Pharmaceuticals Partner to Produce Novel Acid-Blocker Vonoprazan
Evonik has entered into a long-term supply agreement with Phathom Pharmaceuticals, a US biopharmaceutical company focused on developing and commercializing new treatments for gastric acid-related…
Daré Bioscience Announces IDE Approval for a Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Investigational Hormone-Free Monthly Intravaginal Contraceptive
Daré Bioscience, Inc. recently announced the US FDA approved an Investigational Device Exemption (IDE) application allowing Daré to conduct a single arm, open-label pivotal contraceptive…
Silo Pharma Initiates Toxicity Study of its Proprietary Ketamine Formulation for Treatment of Fibromyalgia
Silo Pharma, Inc. recently announced it has initiated a preclinical toxicity study of its novel time-released, dosage controlled formulation of ketamine, designated as….
Opiant Pharmaceuticals Announces Completion of Enrollment in Phase 2 Clinical Trial of Nasal Naltrexone in Patients With Alcohol Use Disorder
Opiant Pharmaceuticals, Inc. recently announced the last patient has been enrolled in the Phase 2 clinical trial of OPNT002, nasal naltrexone, for patients with….
Two Cell & Gene Therapies Manufactured at Lonza Houston Reach US FDA Approval
Lonza recently announced two additional cell and gene therapies manufactured at its Houston (US) site have reached commercial approval in Q3 2022. ZYNTEGLO, for the…
Mustang Bio Announces First Patient Treated in Its Multicenter Phase 1/2 Clinical Trial of a First-in-Class CD20-targeted, Autologous CAR T Cell Therapy
Mustang Bio, Inc. recently announced the first patient has been treated in its multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy…
Monopar Announces Completion of Phase 2b Enrollment & Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis
Monopar Therapeutics Inc. recently announced an update on its actively enrolling Validive Phase 2b/3 VOICE clinical trial for the prevention of severe oral mucositis (SOM)…
MBX Biosciences Advances Phase 1 Clinical Trial of Long-Acting Parathyroid Hormone Peptide Prodrug
MBX Biosciences, Inc. recently announced it has initiated the multiple ascending dose portion of its ongoing Phase 1 clinical trial of MBX 2109. MBX 2109,…
Thermo Fisher Scientific Introduces Decentralized Clinical Trials Network
The PPD clinical research business of Thermo Fisher Scientific Inc. recently announced the creation of the PPD DCT Network to support global investigators and research…
Icosavax Initiates Phase 1 Trial of IVX-A12 Against RSV & hMPV in Older Adults
Icosavax, Inc. recently announced the initiation of a Phase 1 clinical trial of IVX-A12, a combination bivalent RSV and hMPV VLP vaccine candidate, in older…
Nutriband & Kindeva Drug Delivery Demonstrate Enhanced Abuse-Deterrent Characteristics for Aversa Fentanyl
Nutriband Inc. and Kindeva Drug Delivery have demonstrated enhanced abuse deterrence kinetics of the company’s patented lead product, Aversa Fentanyl, an abuse-deterrent fentanyl transdermal system….
Ascendia Pharmaceuticals Named to Inc. 5000 List of America’s Fastest-Growing Private Companies for Third Consecutive Year
Ascendia Pharmaceuticals recently announced it has been named to the prestigious Inc. 5000 rankings of the fastest growing privately-owned companies in the United States for…
Alexion, AstraZeneca Rare Disease to Acquire LogicBio Therapeutics to Accelerate Growth in Genomic Medicine
LogicBio Therapeutics, Inc. recently announced it has entered into a definitive agreement under which AstraZeneca Rare Disease will acquire LogicBio. The proposed acquisition…
Biogen & Denali Therapeutics Announce Initiation of Phase 3 LIGHTHOUSE Study in Parkinson’s Disease Associated With LRRK2 Pathogenic Mutations
Biogen Inc. and Denali Therapeutics Inc. recently announced dosing has commenced in the global Phase 3 LIGHTHOUSE study to evaluate the efficacy and safety profile…
Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide in Patients With Short Bowel Syndrome (EASE 1)
Zealand Pharma A/S recently announced positive topline results from the pivotal Phase 3 trial of glepaglutide, a long-acting GLP-2 analogue designed for once or twice…
Spectradyne Launches New ARC Particle Analyzer
Spectradyne recently launched its second-generation product, the ARC particle analyzer. Spectradyne’s ARC is a ground-breaking technology for analyzing biological nanoparticles in complex….
Thermo Fisher Scientific Announces FDA Approval of Oncomine Dx Target Test as the First NGS-Based Companion Diagnostic to Aid in Therapy Selection for Patients with RET Mutations/Fusions in Thyroid Cancers
The US FDA has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients…
