PharmaShots Weekly Snapshots (January 16 - 20, 2023)

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PharmaShots Weekly Snapshots (January 16 - 20, 2023)

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)

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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