Formulation Development
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…
Metrion Biosciences & Bioqube Ventures Collaborate on Venture Creation Project to Identify Novel Ion Channel Inhibitors for Autoimmune Diseases
Metrion Biosciences Limited and Bioqube Ventures recently announced they have entered into a collaboration, backed by Bioqube Factory Fund I, to incubate a drug discovery research project targeting….
Cerevel Therapeutics & Herophilus Announce Collaboration to Evaluate Novel Neuroimmune Modulating Therapeutic Strategies for Schizophrenia
Cerevel Therapeutics and Herophilus recently announced a phased multi-year, joint research collaboration in neuropsychiatry. The collaboration integrates the deep expertise in neuroscience drug discovery at…
Sosei Heptares Enters Antibody Discovery Agreement with Twist Bioscience to Discover & Develop Novel Therapeutic Antibodies Against GPCR Targets
Sosei Group Corporation and Twist Bioscience Corporation recently announced a strategic collaboration to discover therapeutic antibodies against G protein-coupled receptors (GPCR) identified by….
Aptinyx Initiates Phase 2b Study in Patients With Post-Traumatic Stress Disorder
Aptinyx Inc. recently announced the initiation of a Phase 2b study evaluating 50 mg QD of NYX-783 in 300 patients with post-traumatic stress disorder (PTSD).…
Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron
Vaxart, Inc. recently announced it plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different…
Albireo Announces Positive Topline Data from Phase 1 Study of A3907
Albireo Pharma, Inc recently announced positive topline results from its Phase 1 clinical trial of A3907, the first oral systemic apical sodium-dependent bile acid transporter…
uniQure Announces Clinical Update on First Patients in Phase 1/2 Clinical Trial of AMT-130 Gene Therapy for the Treatment of Huntington’s Disease
uniQure N.V. recently announced initial observations on the first four patients enrolled in the lower-dose cohort of its ongoing Phase 1/2 clinical trial of AMT-130…
Fortress Biotech Announces Initiation of Phase 2 Clinical Trial of Triplex for Adults Co-Infected With HIV & CMV
Fortress Biotech, Inc. and its partner company, Helocyte, Inc., recently announced a Phase 2 double-blind, randomized, placebo-controlled clinical trial has been initiated to evaluate the…
Alcami Announces the Acquisition of Masy BioServices.
Alcami Corporation recently announced it has completed the acquisition of Masy Systems Inc. (Masy or Masy BioServices), a preferred provider of cGMP Biostorage and pharma support services…..
Aragen Acquires Intox Pvt. Ltd
Aragen Life Sciences recently announced it has signed a definitive agreement to acquire Pune-based Intox Pvt. Ltd. This acquisition will expand Aragen’s end-to-end….
Travere Therapeutics Announces Positive Topline Results From Ongoing Phase 1/2 COMPOSE Study of Pegtibatinase in Classical Homocystinuria
Travere Therapeutics, Inc. recently announced positive topline results from the ongoing Phase 1/2 COMPOSE Study of pegtibatinase, a novel investigational enzyme replacement therapy being evaluated…
Apellis & Sobi Announce EU Approval of Aspaveli (pegcetacoplan) for Treatment of PNH
Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB recently announced the European Commission (EC) has approved Aspaveli (pegcetacoplan), the first and only targeted C3 therapy, for the treatment of….