Formulation Development
Spero Therapeutics Announces FDA Acceptance & Priority Review of NDA for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis
Spero Therapeutics, Inc. recently announced the US FDA has granted Priority Review designation and confirmed the acceptance for substantive review of the New Drug Application…
Allarity Therapeutics & Oncoheroes Biosciences Sign Agreements to Advance Pediatric Cancer Development of Dovitinib & Stenoparib
Allarity Therapeutics, Inc. and Oncoheroes Biosciences, Inc. recently announced they have entered into licensing agreements under which Oncoheroes will acquire exclusive, global development rights to Allarity’s therapeutic candidates….
US FDA Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children
Immix Biopharma, Inc. recently announced the US FDA has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening form of…
FDA Approves First Pill to Treat COVID After Pfizer's Oral Medication Reduced Hospitalizations by 88% in Key Study
US health regulators recently authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst…
Atossa Therapeutics Begins Enrollment of Phase 2 Clinical Study of Oral Endoxifen in Sweden
Atossa Therapeutics, Inc. recently announced it has initiated enrollment of its Phase 2 clinical study of oral Z-Endoxifen in Sweden. Participants in the study will…
UAB & Mereo Announce Positive Top-line Results From Phase 1b/2 Trial of Alvelestat in Hospitalized Patients With COVID-19 Respiratory Disease
The University of Alabama at Birmingham (UAB) and Mereo BioPharma Group plc recently announced top-line data from a Phase 1b/2 clinical trial evaluating alvelestat, a…
Cocrystal Pharma’s COVID-19 Oral & Intranasal/Pulmonary Protease Inhibitors Exhibit Powerful In Vitro Potency Against the SARS-CoV-2 Omicron Variant
Cocrystal Pharma, Inc. recently announced in vitro studies demonstrate its oral and intranasal/pulmonary SARS-CoV-2 main protease inhibitors exhibit antiviral potency against the Omicron variant…..
Allarity Therapeutics Submits NDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma
Allarity Therapeutics, Inc. recently announced the submission of a new drug application (NDA) with the US FDA seeking marketing approval for dovitinib for the third-line…
Insightful Science Acquires Protein Metrics to Expand its R&D Solution to Include Proteomics
Insightful Science recently announced it has completed the transaction to acquire Protein Metrics, Inc. to expand the company’s R&D value chain to widen the biopharmaceutical protein analysis arena….
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,….
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…
