Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD

Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial 

G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023

Date: May 12, 2023 | Tags: G1 Therapeutics, Trilaciclib, Triple-Negative Breast Cancer, Clinical Trial, P-II, Trial, ESMO 2023

Otsuka and Lundbeck Receive the US FDA’s Approval for Rexulti (brexpiprazole) sNDA to Treat Agitation Associated with Dementia Due to Alzheimer’s Disease

Date: May 12, 2023 | Tags: Otsuka, Lundbeck, Rexulti, brexpiprazole, Agitation, Dementia, Alzheimer’s Disease, sNDA Regulatory, US, FDA, Approval  

Cyclerion Therapeutics Sell Rights of Zagociguat and CY3018 to NewCo for the Treatment of Mitochondrial and Neurological Disease

Date: May 12, 2023 | Tags: Cyclerion Therapeutics, NewCo, Zagociguat, CY3018, Mitochondrial, Neurological Disease, Pharma

Jaguar Animal Health Reports an Availability of Canalevia-CA1 on Chewy for Chemotherapy-Induced Diarrhea in Dogs

Date: May 12, 2023 | Tags: Jaguar Animal Health, Canalevia-CA1, Chemotherapy-Induced Diarrhea, Dogs, Chewy, Animal Health

SERB Acquires US Rights from SFJ for Bentracimab

Date: May 12, 2023 | Tags: SERB, SFJ, Bentracimab, Brilinta, Ticagrelor, heart attack, stroke, acute coronary syndromes, coronary artery disease, Pharma, NEJM, US 

Angelini Pharma Collaborated with JCR Pharmaceuticals to Develop and Commercialize Novel Biologic Therapies for Epilepsy

Date: May 11, 2023 | Tags: Angelini Pharma, JCR Pharmaceuticals, Biologic, Epilepsy, J-Brain Cargo, Biotech

Bayer Entered into a Collaboration Agreement with Bicycle Therapeutics for the Development of Novel Targeted Radionuclide Therapies in Oncology

Date: May 11, 2023 | Tags: Bayer, Bicycle Therapeutics, Radionuclide Therapies, Oncology, peptide-based technology, Biotech

UCB Entered into a Research Collaboration with Ariceum Therapeutics to Discover New Modalities for Immune-related Diseases and Cancer

Date: May 11, 2023 | Tags: UCB, Ariceum Therapeutics, 177Lu-satoreotide tetraxetan, ExtremeDiversity, Immune-related Diseases, Cancer, biotech

AstraZeneca’s Ultomiris (ravulizumab) Receives EC’s Approval for the Treatment of Neuromyelitis Optica Spectrum Disorder in EU

Date: May 11, 2023 | Tags: AstraZeneca, Ultomiris, ravulizumab, Neuromyelitis Optica Spectrum Disorder, Regulatory, EU, Approval

Innovent Reports P-II Clinical Trial Results of Mazdutide (IBI362) for the Treatment of Obesity in Chinese Adults

Date: May 11, 2023 | Tags: Innovent, Mazdutide, IBI362, OXM3, Obesity, Clinical Trial, P-II Trial 

Servier’s Tibsovo (ivosidenib) Receives EC’s Approval for IDH1-Mutated Acute Myeloid Leukemia and IDH1-Mutated Cholangiocarcinoma

Date: May 11, 2023 | Tags: Servier, Tibsovo, ivosidenib, IDH1-Mutated, Acute Myeloid Leukemia, Cholangiocarcinoma, Regulatory, EC, Approval

Alvotech Entered into an Exclusive Agreement with Polifarma to Commercialize AVT06, a Proposed Biosimilar to Eylea (aflibercept) in Turkey

Date: May 10, 2023 | Tags: Alvotech, Polifarma, AVT06, Biosimilar, Eylea, aflibercept, neovascular, age-related macular degeneration, ophthalmology, Turkey, Pharma

Innovent and Eli Lilly Receive the NMPA’s Approval of Tyvyt (sintilimab) sNDA for EGFR-Mutated Non-Squamous NSCLC 

Date: May 10, 2023 | Tags: Innovent, Eli Lilly, Tyvyt, sintilimab, EGFR-mutated, Non-Squamous, NSCLC, Regulatory, NMPA, Approval, Lancet Respiratory Medicine 

Janssen Presents P-III Induction Study (QUASAR) Results of Tremfya (guselkumab) for Moderately to Severely Active Ulcerative Colitis at DDW 2023

Date: May 10, 2023 | Tags: Janssen, Tremfya, guselkumab, Ulcerative Colitis, DDW, 2023, Clinical Trial, P-III, QUASAR Study 

Sobi to Acquire CTI BioPharma for ~$1.7B

Date: May 10, 2023 | Tags: Sobi, CTI BioPharma, Vonjo, hematology, ~$1.7B, M&A,

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for the Treatment of Heart Failure

Date: May 10, 2023 | Tags: AstraZeneca, Farxiga, dapagliflozin, Heart Failure, Regulatory, US, FDA, Approval 

Amgen Entered into a Multi-Year Collaboration Agreement with Tscan Therapeutics to Identify Novel Targets for Crohn's Disease

Date: May 10, 2023 | Tags: Amgen, Tscan Therapeutics, Crohn's Disease, target discovery platform, Pharma

Amgen Reports Real-World Study Results of Prolia (denosumab) for Osteoporosis Associated with High Fracture Risk

Date: May 09, 2023 | Tags: Amgen, Prolia, denosumab, Osteoporosis, major osteoporotic, Real-World Study, Clinical Trial, WCO-IOF-ESCEO, 2023  

Sanofi and Regeneron Report P-III Trial (PRIME) and (PRIME2) Results of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis

Date: May 09, 2023 | Tags: Sanofi, Regeneron, Dupixent, dupilumab, Prurigo Nodularis, Clinical Trial, P-III, PRIME, PRIME2 Trial 

Rhythm’s Imcivree (setmelanotide) Receives Health Canada Approval for Weight Management in Adult and Pediatric Patients with Obesity

Date: May 09, 2023 | Tags: Rhythm, Imcivree, setmelanotide, Obesity, Regulatory, Health Canada, Approval 

Genentech Reports the US FDA Acceptance of sBLA for Vabysmo to Treat Retinal Vein Occlusion

Date: May 09, 2023 | Tags: Genentech, Vabysmo, Retinal Vein Occlusion, sBLA, Regulatory, US, FDA, BALATON, COMINO Trial

Zion Pharma Signs an Agreement with Roche to Develop and Commercialize ZN-A-1041 for HER2-Positive Breast Cancer

Date: May 09, 2023 | Tags: Zion Pharma, Roche, ZN-A-1041, Breast Cancer, Pharma

Acorda Therapeutics Entered into a Distribution and Supply Agreement with Chance Pharmaceuticals to Commercialize Inbrija in China

Date: May 09, 2023 | Tags: Acorda Therapeutics, Chance Pharmaceuticals, Inbrija, China, Ampyra, dalfampridine, Pharma

Seres Therapeutics and Nestlé Health Science Present P-III Study (ECOSPOR IV) Results Vowst for Prevention of Recurrence of C. Difficile Infection at DDW 2023

Date: May 08, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, Recurrence of C. Difficile Infection, Clinical Trial, DDW 2023, P-III, ECOSPOR IV Study 

AstraZeneca’s Koselugo (selumetinib) Receives the NMPA’s Approval for the Treatment of Rare Genetic Disorder in Paediatric Patients

Date: May 08, 2023 | Tags: AstraZeneca, Koselugo, selumetinib, Neurofibromatosis Type 1, Plexiform Neurofibromas, Regulatory, NMPA, Approval  

Zoetis’ Librela (bedinvetmab) Receives the US FDA’s Approval to Control Osteoarthritis Pain in Dogs

Date: May 08, 2023 | Tags: Zoetis, Librela, bedinvetmab, Osteoarthritis Pain, Dogs, Regulatory, Animal Health, US, FDA, Approval 

Junshi Biosciences Collaborated with Dr. Reddy’s to Develop and Commercialize Toripalimab for the Treatment of Cancer

Date: May 08, 2023 | Tags: Junshi Biosciences, Dr. Reddy’s, Toripalimab, Cancer, Latin America, India, South Africa, biotech 

Innovent Reports P-III Study (ORIENT-31) Results of Sintilimab for EGFR-TKI Failed EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Date: May 08, 2023 | Tags: Innovent, Sintilimab, EGFR-TKI, EGFR-Mutated, Non-Squamous, Non-Small Cell Lung Cancer, Clinical Trial, P-III, ORIENT-31 Study, Lancet Respiratory Medicine

Bliss Biopharmaceutical Entered into a Clinical Trial Collaboration Agreement with Eisai for BB-1701 to Treat Cancers

Date: May 08, 2023 | Tags: Bliss Biopharmaceutical, Eisai, BB-1701, Cancers, solid tumors, Pharma

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