PharmaShots Weekly Snapshots (January 30

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