Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EC’s Marketing Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease

Date: May 05, 2023 | Tags: Chiesi Global Rare Diseases, Protalix BioTherapeutics, PRX-102, pegunigalsidase alfa, Fabry Disease, Regulatory, EC, Marketing Authorization 

Kinoxis Therapeutics Signs a License Agreement with Boehringer Ingelheim to Develop Novel Treatments for Psychiatric Patients with Social Dysfunction Symptoms

Date: May 05, 2023 | Tags: Kinoxis Therapeutics, Boehringer Ingelheim, KNX100, Psychiatric, Social Dysfunction Symptoms, Pharma

Sanofi’s Dupixent (dupilumab) Receives Health Canada’s Approval for Adults and Adolescent Patients Aged ≥12 Years with Eosinophilic Esophagitis

Date: May 05, 2023 | Tags: Sanofi, Dupixent, dupilumab, Eosinophilic Esophagitis, Regulatory, Health Canada, Approval 

Cumulus Neuroscience Receives the US FDA’s Clearance of User-Friendly EEG Device At-Home Use for Neuropsychiatric and Neurodegenerative Conditions

Date: May 05, 2023 | Tags: Cumulus Neuroscience, Neuropsychiatric, Neurodegenerative Conditions, Regulatory, DigiHealth, US, FDA, EEG Device

Bicycle Therapeutics Collaborated with German Cancer Research Center to Discover and Develop Bicycle Radio Conjugates for a Range of Oncology Targets

Date: May 05, 2023 | Tags: Bicycle Therapeutics, German Cancer Research Center, Bicycle Radio Conjugates, BT8009, BT5528, BT7480, Oncology, Biotech

Tonix Pharmaceuticals Receives the US FDA’s IND Clearance of TNX-1500 for the Prevention of Organ Rejection in Kidney Transplant Patients

Date: May 05, 2023 | Tags: Tonix Pharmaceuticals, TNX-1500, Organ Rejection, Kidney Transplant, Regulatory, US, FDA, IND 

Gilead Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Hepcludex (bulevirtide) for Hepatitis Delta Virus

Date: May 04, 2023 | Tags: Gilead, Hepcludex, bulevirtide, Hepatitis Delta Virus, Regulatory, EMA, CHMP, Marketing Authorization 

Alvotech Reports an Initiation of AVT05, a Proposed Biosimilar for Simponi and Simponi Aria to Treat Moderate to Severe Rheumatoid Arthritis

Date: May 04, 2023 | Tags: Alvotech, AVT05, golimumab, Rheumatoid Arthritis, Clinical Trial, biosimilar

Magenta Therapeutics Entered into a Definitive Merger Agreement with Dianthus Therapeutics to Advance DNTH103 for Severe Autoimmune Diseases

Date: May 04, 2023 | Tags: Magenta Therapeutics, Dianthus Therapeutics, DNTH103, Autoimmune Diseases, generalized myasthenia gravis, M&A 

ImmunoGen Reports P-III Trial (MIRASOL) Results of Elahere (mirvetuximab soravtansine) for FRα-Positive Platinum-Resistant Ovarian Cancer

Date: May 04, 2023 | Tags: ImmunoGen, Elahere, mirvetuximab soravtansine, FRα-Positive Platinum-Resistant Ovarian Cancer, Clinical Trial, P-III, MIRASOL Trial

GSK’s Arexvy Receives the US FDA’s Approval for the Prevention of Lower Respiratory Tract Disease in Individuals Aged ≥60 Years

Date: May 04, 2023 | Tags: GSK, Arexvy, Lower Respiratory Tract Disease, Regulatory, US, FDA, Approval 

Otsuka’s Lupkynis (voclosporin) Receives NICE Recommendation for the Treatment of Active Lupus Nephritis

Date: May 04, 2023 | Tags: Otsuka, Lupkynis, voclosporin, mycophenolate mofetil, Active Lupus Nephritis, Regulatory, NICE 

BMS’ Breyanzi (lisocabtagene maraleucel) Receives EC’s Approval for Relapsed or Refractory Large B-cell Lymphoma

Date: May 03, 2023 | Tags: BMS, Breyanzi, lisocabtagene maraleucel, Large B-cell Lymphoma, Regulatory, EC, Approval 

Eli Lilly Reports P-III Study (TRAILBLAZER-ALZ 2) Results of Donanemab for the Treatment of Early Alzheimer's Disease

Date: May 03, 2023 | Tags: Eli Lilly, Donanemab, Early Alzheimer's Disease, Clinical Trial, P-III, TRAILBLAZER-ALZ 2 Study 

NeuroBo’s DA-1241 Receives the US FDA’s IND Clearance to Initiate the P-IIa Clinical Trial for Nonalcoholic Steatohepatitis

Date: May 03, 2023 | Tags: NeuroBo, DA-1241, Nonalcoholic Steatohepatitis, Regulatory, US, FDA, IND, P-IIa Clinical Trial 

Amolyt Pharma to Initiate P-III Clinical Trial of Eneboparatide for the Treatment of Hypoparathyroidism

Date: May 03, 2023 | Tags: Amolyt Pharma, Eneboparatide, Hypoparathyroidism, Clinical Trial, P-III Trial

BrightPath Biotherapeutics Signs a Research and License Agreement with Artisan Bio to Advance Allogeneic iPSC Derived Cell Therapy Platform across Multiple Indications

Date: May 03, 2023 | Tags: BrightPath Biotherapeutics, Artisan Bio, Allogeneic iPSC Derived Cell Therapy, STAR-CRISPR system, SyionAI platform, Biotech

Janssen Entered into a Worldwide Collaboration and License Agreement with Cellular Biomedicine to Develop and Commercialize CAR-T Therapies for Non-Hodgkin Lymphoma

Date: May 03, 2023 | Tags: Janssen, Cellular Biomedicine, CAR-T Therapies, C-CAR039, C-CAR066, Non-Hodgkin Lymphoma, biotech

Medtronic Receives the US FDA’s Approval for Micra AV2 and Micra VR2 Leadless Pacing Systems

Date: May 02, 2023 | Tags: Medtronic, Micra AV2, Micra VR2, Micra Leadless Pacing Systems, MedTech, Regulatory, US, FDA, Approval 

Elanco Animal Health’s Varenzin-CA1 Receives the US FDA’s Conditionally Approval for Nonregenerative Anemia in Cats with Chronic Kidney Disease

Date: May 02, 2023 | Tags: Elanco Animal Health, Varenzin-CA1, Nonregenerative Anemia, Chronic Kidney Disease, Animal Heath, Regulatory, US, FDA

Eli Lilly Presents P-III Clinical Development Program Results of Lebrikizumab for Atopic Dermatitis at 5th Annual RAD Congress

Date: May 02, 2023 | Tags: Eli Lilly, Lebrikizumab, Atopic Dermatitis, Clinical Trial, ADvocate 1 & 2 trial, ADhere study, RAD Congress

Soligenix Entered into an Exclusive Option Agreement with Silk Road Therapeutics to Acquire Pentoxifylline for Behçet's Disease

Date: May 02, 2023 | Tags: Soligenix, Silk Road Therapeutics, Pentoxifylline, Behçet's Disease, Pharma

Avadel’s Lumryz Receives the Full Approval from the US FDA for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy

Date: May 02, 2023 | Tags: Avadel, Lumryz, sodium oxybate, US FDA for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy

Incyte Presents P-II Trial (SCRATCH-AD) Results of Opzelura (ruxolitinib) for the Treatment of Atopic Dermatitis at RAD 2023

Date: May 02, 2023 | Tags: Incyte, Opzelura, ruxolitinib, Atopic Dermatitis, Clinical Trial, P-II, SCRATCH-AD Trial, RAD, 2023

BMS Reports the US FDA Acceptance of sBLA for Priority Review and EMA Validation of Application for Reblozyl (luspatercept-aamt) as 1L Treatment of Anemia

Date: May 01, 2023 | Tags: BMS, Reblozyl, luspatercept-aamt, Anemia, Myelodysplastic Syndromes, Regulatory, US, FDA, sBLA, Priority Review, EMA 

Maze Therapeutics Signs an Exclusive Worldwide License Agreement with Sanofi for MZE001 to Treat Pompe Disease

Date: May 01, 2023 | Tags: Maze Therapeutics, Sanofi, MZE001, Pompe Disease, Pharma

Starton Therapeutics to go Public via Healthwell Acquisition Corp. I SPAC Merger for ~$374M

Date: May 01, 2023 | Tags: Starton Therapeutics, Healthwell Acquisition Corp. I, SPAC Merger, ~$374M, cancer, chronic lymphocytic leukemia, multiple myeloma, M&A

Astellas Entered into a Definitive Agreement to Acquire Iveric Bio for ~$5.9B

Date: May 01, 2023 | Tags: Astellas, Iveric Bio, avacincaptad, Age-Related Macular Degeneration, M&A, GATHER Clinical Trials, ~$5.9B

Teva and MedinCell Receive the US FDA’s Approval of Uzedy (risperidone) Extended-Release Injectable Suspension for Schizophrenia

Date: May 01, 2023 | Tags: Teva, MedinCell, Uzedy, risperidone, Schizophrenia, Regulatory, US, FDA, Approval 

Janssen Reports P-II Study (SunRISe-1) Results of TAR-200 for the Treatment of Patients with BCG-Unresponsive HR-NMIBC CIS

Date: May 01, 2023 | Tags: Janssen, TAR-200, BCG-Unresponsive HR-NMIBC CIS, Clinical Trial, P-II, SunRISe-1 Study

Related Post: PharmaShots Weekly Snapshots (April 24 - 28, 2023)