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PharmaShots Weekly Snapshots (January 30 - February 03, 2023)

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PharmaShots Weekly Snapshots (January 30 - February 03, 2023)

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema

Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND 

AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma

Date: Feb 03, 2023 | Tags: AstraZeneca, Amgen, Tezspire, Tezepelumab, Severe Asthma, Regulatory, US, FDA, Approval  

Abbott Receives the US FDA and EU Approvals for Ablation Technologies to Treat Abnormal Heart Rhythms

Date: Feb 03, 2023 | Tags: Abbott, TactiFlex Sensor Enabled Ablation Catheter, FlexAbility SE Ablation Catheter, Abnormal Heart Rhythms, Regulatory, US, FDA, EU

Shanghai Henlius Biotech Reports the First Patient Dosing of HLX15 (biosimilar, daratumumab) in P-I Clinical Trial for Multiple Myeloma

Date: Feb 03, 2023| Tags: Shanghai Henlius Biotech, HLX15, biosimilar, daratumumab, Multiple Myeloma, Clinical Trial, P-I Trial 

Amylyx Reports the Completion of Patient Enrollment in P-III Trial (PHOENIX) of AMX0035 for Amyotrophic Lateral Sclerosis

Date: Feb 03, 2023 | Tags: Amylyx, AMX0035, Amyotrophic Lateral Sclerosis, Clinical Trial, P-III, PHOENIX Trial

Guardant Health Collaborated with AnHeart Therapeutics to Develop Guardant360 CDx and Guardant360 TissueNext for Taletrectinib 

Date: Feb 03, 2023 | Tags: Guardant Health, AnHeart Therapeutics, Taletrectinib, Guardant360 CDx, Guardant360 TissueNext

Karuna Therapeutics Entered into an Exclusive License Agreement with Goldfinch Bio for TRPC4/5 Product Candidates

Date: Feb 02, 2023 | Tags: Karuna Therapeutics, Goldfinch Bio, TRPC4/5, GFB-887, psychiatric, neurological conditions, mood, anxiety disorders, Pharma 

Tonix Signs a Research Agreement with University of Maryland to Develop TNX-1500 for the Prevention of Rejection in Heart Xenograft Transplantation in Animals

Date: Feb 02, 2023 | Tags: Tonix, University of Maryland, TNX-1500, Rejection, Heart Xenograft Transplantation, Animals Health

Aulos Bioscience Reports the First Patient Dosing of AU-007 in P-I/II Clinical Trial for the Treatment of Solid Tumors

Date: Feb 02, 2023 | Tags: Aulos Bioscience, AU-007, Solid Tumors, Clinical Trial, P-I/II

Orbit Entered into a Multi Target Research Agreement with Endevica Bio to Advance Development of Cachexia Therapies

Date: Feb 02, 2023 | Tags: Orbit Discovery, Endevica Bio, Cachexia, Pharma

Miromatrix Entered into a Collaborative Research Agreement with Baxter to Test Bioengineered Liver Replacement Therapy

Date: Feb 02, 2023 | Tags: Miromatrix, Baxter, Bioengineered Liver Replacement Therapy, miroliverELAP, Acute Liver Failure, PrisMax system, Biotech

GSK’s Jesduvroq (daprodustat) Receives the US FDA’s Approval for the Treatment of Anaemia

Date: Feb 02, 2023 | Tags: GSK, Jesduvroq, daprodustat, Anaemia, chronic kidney disease, Regulatory, US, FDA, Approval 

Roche’s Hemlibra (emicizumab) Receives the Label Expansion Approval from EC for Moderate Haemophilia A

Date: Feb 01, 2023 | Tags: Roche, Hemlibra, emicizumab, Moderate Haemophilia, Label Expansion, Approval, EC, Regulatory 

Biosynex Entered into a Definitive Merger Agreement to Acquire Chembio Diagnostics for ~$17.2M

Date: Feb 01, 2023 | Tags: Biosynex, Chembio Diagnostics, infectious diseases, ~$17.2M, M&A

Jazz Pharmaceuticals’ Epidyolex (cannabidiol) Receives NICE Recommendation for the Reimbursement to Treat Seizures in England

Date: Feb 01, 2023 | Tags: Jazz Pharmaceuticals, Epidyolex, cannabidiol, Seizures, tuberous sclerosis complex, NICE, England, Regulatory

Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US

Date: Feb 01, 2023 | Tags: Amgen, Humira, adalimumab, biosimilar, Amjevita, US

Context Therapeutics’ Clinical Partner Stemline Therapeutics Receives the US FDA’s Approval of Orserdu (elacestrant) for ER+, HER2-, ESR1-Mutated Breast Cancer

Date: Feb 01, 2023 | Tags: Context Therapeutics, Stemline Therapeutics, Orserdu, elacestrant, Breast Cancer, Regulatory, US, FDA, Approval 

uniQure Entered into a License Agreement with Apic Bio for APB-102 to Treat Amyotrophic Lateral Sclerosis in Patients with SOD1 Mutations

Date: Feb 01, 2023 | Tags: uniQure, Apic Bio, APB-102, Amyotrophic Lateral Sclerosis, SOD1 Mutations, Pharma

Sciwind Biosciences Initiates the Patient Dosing of Ecnoglutide (XW003) in P-III Clinical Trials for the Treatment of Type 2 Diabetes in China

Date: Jan 31, 2023 | Tags: Sciwind Biosciences, Ecnoglutide, XW003, Type 2 Diabetes, China, Clinical Trial, P-III Trials 

Idorsia Reports MAA Submission of Aprocitentan to EMA for the Treatment of Resistant Hypertension

Date: Jan 31, 2023 | Tags: Idorsia, Aprocitentan, Resistant Hypertension, MAA, EMA, Regulatory

Alpha Biopharma Reports the NMPA Acceptance of NDA for Zorifertinib to Treat EGFR-Mutated NSCLC with CNS Metastases

Date: Jan 31, 2023 | Tags: Alpha Biopharma, Zorifertinib, EGFR-Mutated NSCLC, CNS, Metastases, Regulatory, NMPA Acceptance, NDA

Sandoz Receives EMA’s CHMP Positive Opinion of Adalimumab Biosimilar

Date: Jan 31, 2023 | Tags: Sandoz, Hyrimoz, Adalimumab, Biosimilar, rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis, Regulatory, EMA, CHMP  

Daiichi Sankyo Reports the First Patient Dosing of Datopotamab Deruxtecan in P-III Trial (TROPION-Lung07) for Metastatic Non-Small Cell Lung Cancer

Date: Jan 31, 2023 | Tags: Daiichi Sankyo, Datopotamab Deruxtecan, Non-Small Cell Lung Cancer, Clinical Trial, P-III, TROPION-Lung07 Trial  

Guardant Health Receives the US FDA’s Approval of Guardant360 CDx Liquid Biopsy Test for Breast Cancer

Date: Jan 31, 2023 | Tags: Guardant Health, Guardant360 CDx Liquid Biopsy Test, Breast Cancer, Regulatory, US, FDA, Approval, MedTech 

Janssen Reports P-III Study (CARTITUDE-4) Results of Carvykti (cilta-cel) for the Treatment of Multiple Myeloma

Date: Jan 30, 2023 | Tags: Janssen, Carvykti, cilta-cel, Multiple Myeloma, P-III, CARTITUDE-4 Study, Clinical Trial

Regeneron and Sanofi Receive EC’s Approval of Dupixent (dupilumab) for the Treatment of Eosinophilic Esophagitis

Date: Jan 30, 2023 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, Eosinophilic Esophagitis, Regulatory, EC, Approval 

Abbott’s Proclaim XR Spinal Cord Stimulation System Receives the US FDA’s Approval for Painful Diabetic Peripheral Neuropathy

Date: Jan 30, 2023 | Tags: Abbott, Proclaim XR Spinal Cord Stimulation System, Painful Diabetic Peripheral Neuropathy, Regulatory, US, FDA, Approval, MedTech

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for the Treatment of Non-Small Cell Lung Cancer

Date: Jan 30, 2023 | Tags: Merck, Keytruda, pembrolizumab, Non-Small Cell Lung Cancer, Regulatory, US, FDA, Approval 

BMS Receives EMA’s CHMP Positive Opinion of Reblozyl (luspatercept) for Anemia-Associated Non-Transfusion-Dependent Beta Thalassemia

Date: Jan 30, 2023 | Tags: BMS, Reblozyl, luspatercept, Anemia-Associated, Non-Transfusion-Dependent Beta Thalassemia, Regulatory, EMA, CHMP 

Eli Lilly’s Jaypirca (pirtobrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of Mantle Cell Lymphoma

Date: Jan 30, 2023 | Tags: Eli Lilly, Jaypirca, pirtobrutinib, Mantle Cell Lymphoma, US, FDA, Approval 

Related Post: PharmaShots Weekly Snapshots (January 23 - 27, 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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