PharmaShots Weekly Snapshots (January 16

SOTIO Reports First Patient Dosing of Nanrilkefusp Alfa in P-II Trial (AURELIO-05) for Colorectal Cancer

Date: Jan 20, 2023 | Tags: SOTIO, Nanrilkefusp Alfa, Colorectal Cancer, Clinical Trial, P-II, AURELIO-05 Trial

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia

Date: Jan 20, 2023 | Tags: BeiGene, Brukinsa, zanubrutinib, Chronic Lymphocytic Leukemia, Regulatory, US, FDA, Approval

Sun Pharma to Acquire Concert Pharmaceuticals for ~$576M

Date: Jan 20, 2023 | Tags: Sun Pharma, Concert Pharmaceuticals, deuruxolitinib, Alopecia Areata, M&A, ~$576M

Compass Therapeutics to Present P-II Study Results of CTX-009 + Paclitaxel for Biliary Tract Cancers at ASCO GI 2023

Date: Jan 20, 2023 | Tags: Compass Therapeutics, CTX-009, Paclitaxel, Biliary Tract Cancers, Clinical Trial, P-II Study, ASCO GI, 2023

Seagen Receive the US FDA’s Accelerated Approval of Tukysa (tucatinib) for RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer

Date: Jan 20, 2023 | Tags: Seagen, Tukysa, tucatinib, Colorectal Cancer, Regulatory, US, FDA, Approval

Takeda’s Ninlaro (ixazomib) Receives NICE Recommendation for the Treatment of Multiple Myeloma

Date: Jan 20, 2023 | Tags: Takeda, Ninlaro, ixazomib, Multiple Myeloma, Regulatory, NICE

APRINOIA Therapeutics to go Public via Ross Acquisition Corp II SPAC Merger for ~$319.6M

Date: Jan 19, 2023 | Tags: APRINOIA Therapeutics, APN-1607, APN-005, neurodegenerative disease, SPAC Merger, ~$319.6M, M&A

Magstim Receives the US FDA’s Clearance of Transcranial Magnetic Stimulation for Obsessive Compulsive Disorder

Date: Jan 19, 2023 | Tags: Magstim, Transcranial Magnetic Stimulation, Obsessive Compulsive Disorder, Regulatory, US, FDA

Genentech Reports P-III Study (IMbrave050) Results of Tecentriq (atezolizumab) + Avastin (bevacizumab) for Early-Stage Liver Cancer

Date: Jan 19, 2023 | Tags: Genentech, Tecentriq, atezolizumab, Avastin, bevacizumab, Early-Stage Liver Cancer, Clinical Trial, P-III, IMbrave050

Teon Therapeutics Entered into a Clinical Trial Collaboration with Merck to Evaluate TT-816 + Keytruda (pembrolizumab) for Solid Tumors

Date: Jan 19, 2023 | Tags: Merck, Teon Therapeutics, TT-816, Keytruda, pembrolizumab, Solid Tumors, Pharma

Taiho Oncology Publishes P-II Trial (FOENIX*-CCA2) Results of Futibatinib for Metastatic Intrahepatic Cholangiocarcinoma in NEJM

Date: Jan 19, 2023 | Tags: Taiho Oncology, Futibatinib, Metastatic Intrahepatic Cholangiocarcinoma, P-II, FOENIX*-CCA2, Clinical Trial, NEJM

UCB Published P-III Studies (BE MOBILE 1 & 2) Results of Bimekizumab for Axial Spondyloarthritis in the Annals of the Rheumatic Diseases

Date: Jan 19, 2023 | Tags: UCB, Bimekizumab, Axial Spondyloarthritis, P-III, BE MOBILE 1, BE MOBILE 2, Clinical Trial

JCR Pharmaceuticals’ JR-141 Receives the US FDA’s Rare Pediatric Disease Designation for the Treatment of Mucopolysaccharidosis Type II

Date: Jan 18, 2023 | Tags: JCR Pharmaceuticals, JR-141, Mucopolysaccharidosis Type II, Regulatory, US, FDA, Rare Pediatric Disease Designation

Pfizer Entered into a Research Collaboration with Longevity Biotech Gero to Discover Targets for Fibrotic Diseases

Date: Jan 18, 2023 | Tags: Pfizer, Longevity Biotech Gero, Fibrotic Diseases, machine-learning technology platform, Pharma

Alexion’s Ultomiris (ravulizumab) Receives the Health Canada’s Approval for Generalized Myasthenia Gravis

Date: Jan 18, 2023 | Tags: Alexion, Ultomiris, ravulizumab, Generalized Myasthenia Gravis, Regulatory, Health Canada, Approval

Abbott’s Navitor Device Receives the US FDA’s Approval for the Treatment of Aortic Stenosis

Date: Jan 18, 2023 | Tags: Abbott, Navitor Device, Aortic Stenosis, Regulatory, MedTech, US, FDA, Approval

Elicio Therapeutics Entered into a Definitive Merger Agreement with Angion to Advance ELI-002 for Cancer

Date: Jan 18, 2023 | Tags: Elicio Therapeutics, ELI-002, Cancer, M&A, AMPLIFY-201, P-I Trial, Merger Agreement

Servier and Taiho Oncology to Present P-III Trial (SUNLIGHT) Results of Lonsurf (trifluridine/tipiracil) for Metastatic Colorectal Cancer at 2023 ASCO GI

Date: Jan 18, 2023 | Tags: Servier, Taiho Oncology, Lonsurf, trifluridine, tipiracil, Metastatic Colorectal Cancer, Clinical Trial, P-III, SUNLIGHT Trial

Henlius’ Hansizhuang (serplulimab) Receives the NMPA’s Approval as 1L Treatment of Extensive Stage Small Cell Lung Cancer

Date: Jan 17, 2023 | Tags: Henlius, Hansizhuang, serplulimab, Stage Small Cell Lung Cancer, Regulatory, NMPA, Approval

Shionogi Initiated P-I/II/III Clinical Trial (Part 2) and P-III Additional Dose Clinical Trial of S-268019 for COVID-19

Date: Jan 17, 2023 | Tags: Shionogi, S-268019, COVID-19, Clinical Trial, P-I/II/III Trial

EverImmune Reports the First Patient Dosing of Oncobax AK in the P-I Clinical Trial for Lung and Kidney Cancer

Date: Jan 17, 2023 | Tags: EverImmune, Oncobax AK, Lung, Kidney Cancer, P-I Clinical Trial

Amylyx Pharmaceuticals Entered into an Exclusive Distribution Agreement with Neopharm for AMX0035

Date: Jan 17, 2023 | Tags: Amylyx Pharmaceuticals, Neopharm, AMX0035, Relyvrio, Albrioza, amyotrophic lateral sclerosis, Pharma

Faron Pharmaceuticals Provides Update of Bexmarilimab in P-I/II Study (BEXMAB) for the Treatment of Hematological Malignancies

Date: Jan 17, 2023 | Tags: Faron Pharmaceuticals, Bexmarilimab, Hematological Malignancies, Clinical Trial, P-I/II, BEXMAB Study

ABIONYX Pharma Reports P-IIa Study (RACERS) of CER-001 for the Treatment of Septic Patients

Date: Jan 17, 2023 | Tags: ABIONYX Pharma, CER-001, Septic, Acute Kidney Injury, Clinical Trial, P-IIa, RACERS Study

Bio-Thera Solutions Receives the NMPA’s Approval of BAT1806, a Biosimilar to Actemra

Date: Jan 16, 2023 | Tags: Bio-Thera Solutions, BAT1806, Actemra, tocilizumab, NMPA, Approval, Regulatory

Eisai Reports MAA Submission of Leqembi (lecanemab) for Early Alzheimer’s Disease in Japan

Date: Jan 16, 2023 | Tags: Eisai, Leqembi, lecanemab, Early Alzheimer’s Disease, Japan, MAA Submission, Clinical Trial

Seno Medical Signs an Exclusive Distributor Agreement with Genetik for Imagio Breast Imaging System in Southeast Asia

Date: Jan 16, 2023 | Tags: Seno Medical, Genetik, Imagio Breast Imaging System, Southeast Asia, MedTech

Ascletis Reports the Dosing of Four Healthy Patients of ASC11 in Multiple-Dose Escalation P-I Trial for COVID-19

Date: Jan 16, 2023 | Tags: Ascletis, ASC11, COVID-19, Clinical Trial, P-I Study

Luye Pharma’s Rykindo (risperidone) Receives the US FDA’s Approval for the Treatment of Schizophrenia and Bipolar 1 Disorder

Date: Jan 16, 2023 | Tags: Luye Pharma, Rykindo, Schizophrenia, Bipolar 1 Disorder, Regulatory, US, FDA, Approval

Arcutis Reports P-II Study Results of Roflumilast for the Treatment of Chronic Plaque Psoriasis

Date: Jan 16, 2023 | Tags: Arcutis, Roflumilast, Chronic Plaque Psoriasis, Clinical Trial, P-II Study

Related Post:  PharmaShots Weekly Snapshots (January 09 – 13, 2023)

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