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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

March 28, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
AIM ImmunoTech Ampligen Locally advanced pancreatic cancer Approval for a phase 2 trial granted by the FDA
NeuroSense Therapeutics PrimeC (ciprofloxacin and celecoxib) Amyotrophic lateral sclerosis IND approved by the FDA
Oryzon Genomics Iadademstat Relapsed/refractory acute myeloid leukemia with FLT3 mutation IND approved by the FDA
Phanes Therapeutics PT199 Advanced solid tumors IND approved by the FDA
Palisade Bio LB1148 Return of bowel function in patients undergoing abdominal surgery Study-may-proceed letter issued by the FDA
TC BioPharm OmnImmune Acute myeloid leukemia Approval for a phase 2/3 study granted by the UK’s regulatory authority
Trials Initiated
Evommune EVO101 Inflammatory skin diseases Initiation of phase 1 trial
Rani Therapeutics RT-102 Osteoporosis Initiation of phase 1 trial
Ribon Therapeutics RBN-3143 Atopic dermatitis Initiation of phase 1 trial
South Rampart Pharma SRP-3D (DA) Acute and chronic pain Initiation of phase 1 trial
Plus Therapeutics Rhenium-186 NanoLiposome Leptomeningeal metastases Initiation of phase 1/2 trial
Zentalis Pharmaceuticals ZN-d5 Relapsed or refractory light chain amyloidosis Initiation of phase 1/2 trial
Bayer BAY 2395840 Diabetic neuropathic pain Initiation of phase 2 trial
Jazz Pharmaceuticals Zepzelca (lurbinectedin) Select advanced or metastatic solid tumors Initiation of phase 2 trial
Recursion REC-994 Cerebral cavernous malformation Initiation of phase 2 trial
CARsgen Therapeutics CT041 CLDN18.2-positive advanced gastric/gastroesophageal junction cancer Initiation of phase 2 trial in China
XNK Therapeutics Autologous natural killer cell-based therapy plus isatuximab Newly diagnosed multiple myeloma Initiation of phase 2 trial in Sweden
AlloVir Posoleucel Prevention of infections from six common viruses in high-risk, allogeneic hematopoietic-cell transplant patients Initiation of phase 3 trial
Visus Therapeutics Brimochol PF Presbyopia Initiation of two phase 3 trials
Approvals
Bristol Myers Squibb Opdualag (nivolumab and relatlimab-rmbw) Metastatic melanoma patients age 12 years and older Approved by the FDA
Marinus Pharmaceuticals Ztalmy (ganaxolone) Seizures associated with CDKL5-deficiency disorder Approved by the FDA
Merck Keytruda (pembrolizumab) MSI H/dMMR advanced endometrial carcinoma Approved by the FDA
Novartis Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer Approved by the FDA
Advanced Oxygen Therapy Topical wound oxygen (TWO2) therapy Diabetic foot ulcer Approved in China
Moderna Therapeutics Spikevax COVID-19 Approved in Canada for expanded age indication
CanSino Biologics Convidecia COVID-19 booster Approved in Malaysia and Indonesia

 

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