Market News & Trends
Heat Biologics Announces Planned Acquisition of Elusys Therapeutics
Heat Biologics, Inc. recently announced it has executed a definitive merger agreement to acquire Elusys Therapeutics, a commercial-stage biodefense company and the manufacturer of ANTHIM (obiltoxaximab) Injection,….
First US Patients With Persistent Cardiac Arrythmias Treated Using Volta Medical’s Artificial Intelligence-Based Analysis
Volta Medical recently announced the introduction of its leading-edge product, VX1, at three leading US hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital…
Certara Announces FDA Renewal & Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions
Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, recently announced the US FDA has renewed and expanded its licenses of Certara’s proprietary biosimulation software,…
Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer
Hepion Pharmaceuticals, Inc. recently announced the US FDA has accepted its investigational new drug (IND) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the…
TFF Pharmaceuticals Announces Final Data From Phase 1b Study of Inhaled Voriconazole Powder in Asthma Patients
TFF Pharmaceuticals, Inc. recently announced the full readout of safety and pharmacokinetic (PK) data from its Phase 1b study (NCT #04576325) of Inhaled Voriconazole Powder (TFF VORI) in asthma patients….
PharmaTher Enters Process Development Agreement Eith LTS for Ketamine Microneedle Patch
PharmaTher Holdings Ltd. and LTS LOHMANN Therapie-Systeme AG recently announced they have entered into a process development agreement for the clinical trial scale up of PharmaTher’s proprietary….
Merck Acquires Chord Therapeutics to Expand Neuroinflammatory Pipeline
Chord Therapeutics recently announced it is being acquired by Merck; the strategic acquisition enables Merck to expand its neurology pipeline to develop Chord’s lead drug….
Kenox Pharmaceuticals Announces Successful Completion of a Pre-IND Meeting With US-FDA for Novel Inhaled Drug-Device Combination Product
Kenox Pharmaceuticals Inc. has submitted Type B Pre-Investigational New Drug (IND) meeting request with the US FDA for its lead program KNX018, a novel inhaled drug-device combination product as an….
Novartis Strengthens Immunotherapy Pipeline With Option, Collaboration & License Agreement With BeiGene
Novartis recently announced the signing of an option, collaboration and license agreement with BeiGene, Ltd. for ociperlimab (BGB-A1217), expanding the company’s research and development activities in immuno-oncology….
Intra-Cellular Therapies Announces US FDA Approval of CAPLYTA for the Treatment of Bipolar Depression in Adults
Intra-Cellular Therapies, Inc. recently announced the US FDA approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults,…
Viridian Therapeutics Announces First Subject Dosed in Phase 1/2 Clinical Trial of VRDN-001 for Thyroid Eye Disease (TED)
Viridian Therapeutics, Inc. recently announced the first subject was dosed in a Phase 1/2 proof-of-concept clinical trial for VRDN-001, a monoclonal antibody that blocks the…
Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine
Novavax, Inc. recently announced the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine (also known as NVX-CoV2373) to…
Editas Medicine Announces FDA Clearance of IND Application for EDIT-301 for the Treatment of Transfusion-Dependent Beta Thalassemia
Editas Medicine, Inc. recently announced the US FDA has cleared the IND for EDIT-301 for the treatment of transfusion-dependent beta thalassemia (TDT), enabling the company…
Eton Pharmaceuticals & ANI Pharmaceuticals Announce Commercial Availability of Carglumic Acid Tablets, the First & Only FDA-Approved Generic Version of Carbaglu (carglumic acid)
Eton Pharmaceuticals, Inc. and ANI Pharmaceuticals, Inc. recently announced the commercial launch of Carglumic Acid tablets. The product will be marketed by Eton Pharmaceuticals and…
Oral Splicing Modifiers That Systemically Lower Huntington Disease Protein Discovered Through PTC Therapeutics' Innovative Splicing Platform
PTC Therapeutics, Inc. recently announced the Nature Communications publication characterizing the novel splicing mechanism induced by compounds identified from the Huntington Disease (HD) program. These…
Poseida Therapeutics Announces FDA Clearance of IND Application for P-MUC1C-ALLO1, a Fully Allogeneic CAR-T Targeting Multiple Solid Tumors
Poseida Therapeutics, Inc. recently announced the US FDA has cleared its Investigational New Drug (IND) application for P-MUC1C-ALLO1, the company’s allogeneic CAR-T product candidate targeting…
Vincerx Pharma Announces First Patient Dosed in Phase 1 Dose-Escalation Study of VIP152 in Relapsed or Refractory Chronic Lymphocytic Leukemia or Richter Syndrome
Vincerx Pharma, Inc. recently announced the first patient has been dosed in the company’s Phase 1 dose-escalation study of VIP152 in relapsed or refractory (R/R)…
Dyadic Announces Research, License & Collaboration Agreement With Janssen for the Manufacture of Therapeutic Protein Candidates Using its C1 Platform
Dyadic International, Inc. recently announced it has entered into a Research, License and Collaboration Agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson…..
Hyloris Enters Strategic Partnership With Vaneltix for Treatment of Acute Pain in Interstitial Cystitis
Hyloris Pharmaceuticals SA recently announced it has entered into a strategic collaboration with Vaneltix Pharma, Inc. for the development and commercialization of Alenura as first-line…
Gerresheimer Enters Agreement With Major American Biotech to Develop Innovative Pump for Rare Diseases
Gerresheimer has recently entered into an important agreement involving its Advanced Technologies division. An established US biotech company will rely on Gerresheimer's innovative strength and…
