Formulation Development
US FDA Approves Orphan Drug Designation for NXC-201 as a Treatment for Multiple Myeloma
Nexcella, Inc. recently announced the US FDA has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening form of blood…
Revive Therapeutics Announces Initiation of Novel Bucillamine Formulation Development
Revive Therapeutics Ltd. recently announced it has initiated the development of a next-generation formulation of Bucillamine for the potential treatment of public health medical emergencies,…
Review of IND Application for IHL-42X by US FDA Completed; Clinical Trial for Patients With Obstructive Sleep Apnoea May Proceed
Incannex Healthcare Limited recently announce it has received approval from the US FDA to conduct the company’s Investigational New Drug (IND) opening pivotal IHL-42X Phase…
Foundery Launches Inaugural Biotech Venture Creation Fund to Accelerate the Development of Novel Immunotherapies
Foundery’s co-development venture studio model aligns first-in-class drug development opportunities with financing and experimental execution to catalyze university discoveries….
Phathom Pharmaceuticals Announces Submission of 6-Month Stability Data in Support of Erosive GERD NDA
Phathom Pharmaceuticals, Inc. recently announced it has submitted to the FDA 6-month stability data from its long-term and accelerated stability program for its reformulated vonoprazan…
Imbria Pharmaceuticals Completes Enrollment in the Phase 2 Clinical Trial of Ninerafaxstat in Patients With Stable Angina
Imbria Pharmaceuticals, Inc. recently announced it has completed enrollment in the IMPROVE-ISCHEMIA Phase 2 placebo-controlled clinical trial of the investigational therapy, ninerafaxstat, in patients with…
BriaCell Awarded National Cancer Institute Grant to Advance its Bria-OTS Immunotherapy for Cancer
BriaCell Therapeutics Corp. recently announced the National Cancer Institute (NCI), the US federal government's principal agency for cancer research and training, has awarded the company…
Avidity Biosciences Receives FDA Orphan Drug Designation for for Treatment of Duchenne Muscular Dystrophy in People With Mutations Amenable to Exon 44 Skipping
Avidity Biosciences, Inc. recently announced the US FDA has granted Orphan Drug designation to AOC 1044, the company's investigational therapy in development for the treatment…
Tiziana Life Sciences Announces FDA IND Clearance of Intranasal Foralumab for the Treatment of Alzheimer’s Disease
Tiziana Life Sciences Ltd. recently announced the US FDA has cleared the IND application for intranasal foralumab to be studied in Alzheimer’s disease. Foralumab could be a potentially….
Biostax Corp Announces FDA Acceptance of Three Investigational New Drug Applications Transfers for JKB-122 for the Treatment of NASH, NAFLD, and AIH
Immune Therapeutics, Inc. d/b/a Biostax Corp. recently announced it has accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122,…
BioCorRx Submits Expanded Access Treatment Protocol to FDA for Implantable Biodegradable Naltrexone Pellet for Opioid Use Disorder Treatment
Company hopes in 30 days to begin making its drug candidate available to help patients and address public health crisis….
2023 Analytical Testing eBook – Analytical Testing Evolves With the Pharma Industry
In this fourth annual Analytical Testing e-book, learn more about Alcami, Stevanati Group, and West and their current contributions and offerings in the outsourcing analytical testing market, as it continues to be a time and money saver for bio/pharma companies.
Ketabon GmbH Reports Top-Line Results From Phase 2 Trial of Take-at-Home, Oral Ketamine Option for Treatment-Resistant Depression
Ketabon, a joint venture between HMNC Brain Health and Develco Pharma, recently announced top-line results from its Phase 2 KET01-02 Ketabon study with lead asset…
PDS Biotech Announces Submission of Phase 3 Protocol to FDA to Initiate VERSATILE-003 Trial
PDS Biotechnology Corporation recently announced the submission to the US FDA of an updated Chemistry, Manufacturing and Controls (CMC) package and a Phase 3 multicenter…
Absci & Caltech Join Forces to Accelerate Affordable HIV Therapeutic Vaccine Development
Absci Corporation recently announced leading researchers at the California Institute of Technology (Caltech) in conjunction with Absci, a leader in AI drug creation, received a…
GeoVax Announces First Patients Vaccinated in Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients With Chronic Lymphocytic Leukemia
GeoVax Labs, Inc. recently announced vaccinations have begun in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 in patients with chronic lymphocytic leukemia (CLL),…
Jnana Therapeutics Announces Dosing of First Participant in Phase 1b Clinical Trial in Individuals With PKU
Jnana Therapeutics recently announced the first participant has been dosed in its Phase 1b clinical trial of JNT-517 in individuals with phenylketonuria (PKU). JNT-517 is…
CalciMedica Announces First Patient Enrolled in International Expansion of CARPO Trial of Auxora in Acute Pancreatitis
CalciMedica Inc. recently announced its ongoing CARPO trial, a Phase 2b trial evaluating Auxora for the treatment of acute pancreatitis (AP) with accompanying systemic inflammatory…
Cardiff Oncology Announces New Lead Program in First-Line Metastatic Colorectal Cancer & Expanded Pfizer Relationship
Cardiff Oncology, Inc. recently announced plans to advance the company’s lead program to the first-line setting of metastatic colorectal cancer (mCRC) and conduct its new CRDF-004 trial with study execution support from Pfizer….
