PharmaShots Weekly Snapshots (August 29 – September 02, 2022)

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PharmaShots Weekly Snapshots (August 29 – September 02, 2022)

Ibex & Medipath Entered into a Multi-Tissue Expansion of AI for Cancer in France
Published: Sept 2, 2022 | Tags: Ibex, Medipath, ai, cancer, pharma, france, multi-tissue expansion

Intellia’s NTLA-2002 Receives the US FDA’s ODD for the Treatment of Hereditary Angioedema
Published: Sept 2, 2022 | Tags: Intellia, ntla-2002, hereditary angioedema, us, fda, odd, p-I, p-ii

Zimmer Biomet Entered into an Exclusive Multi-Year Co-Marketing Agreement with Surgical Planning Associates for HipInsight Mixed Reality System
Published: Sept 2, 2022 | Tags: Zimmer Biomet, Surgical planning associates, hipinsight mixed reality system, total hip replacement, Medtech

Novavax’s Nuvaxovid COVID-19 Vaccine Receives the CHMP Recommendation for Expanded Conditional Marketing Authorization

Published: Sept 2, 2022 | Tags: Novavax, Nuvaxovid, COVID-19 Vaccine, Regulatory, CHMP, Conditional Marketing Authorization, COV-BOOST trial

Bayer’s Kerendia (finerenone) Receives the US FDA’s Approval for New Label Update to Treat Chronic Kidney Disease and Type 2 Diabetes

Published: Sept 2, 2022 | Tags: Bayer, Kerendia, finerenone, Chronic Kidney Disease, Type 2 Diabetes, Regulatory, US, FDA, Approval

Novo Nordisk to Acquire Forma Therapeutics for ~$1.1B

Published: Sept 2, 2022 | Tags: Novo Nordisk, Forma Therapeutics, etavopivat, sickle cell disease, inherited haemoglobinopathy, Acquire, ~$1.1B

Medtronic Published (ADAPT) Study Results of MiniMed 780G System for Type 1 Diabetes in The Lancet Diabetes & Endocrinology

Published: Sept 1, 2022 | Tags: Medtronic, MiniMed 780G System, Type 1 Diabetes, Clinical Trial, ADAPT Study, Lancet Diabetes & Endocrinology

Pfizer and BioNTech Receive the US FDA’s Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine

Published: Sept 1, 2022 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine, US, FDA, Emergency Use Authorization

Juniper Entered into an Exclusive License Agreement with Helsinn for Ledaga (chlormethine) to Treat Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma

Published: Sept 1, 2022 | Tags: Juniper, Helsinn, Ledaga, chlormethine, Pharma, Australia, Asia, Middle East

REGENXBIO Presents Interim Results of RGX-121 in P-I/II/III (CAMPSIITE) Trial for MPS II (Hunter Syndrome) at SSIEM 2022

Published: Sept 1, 2022 | Tags: REGENXBIO, RGX-121, MPS II, Hunter Syndrome, Clinical Trial, P-I/II/III CAMPSIITE Trial, SSIEM, 2022

Sanofi’s Xenpozyme (olipudase alfa-rpcp) Receives the US FDA’s Approval as First Disease-Specific Treatment for Acid Sphingomyelinase Deficiency

Published: Sept 1, 2022 | Tags: Sanofi, Xenpozyme, olipudase alfa-rpcp, Acid Sphingomyelinase Deficiency, Regulatory, US, FDA, Approval

Ocean Biomedical to Go Public via Aesther Healthcare SPAC Merger for ~$345M

Published: Sept 1, 2022 | Tags: Ocean Biomedical, Aesther Healthcare, oncology, fibrosis, infectious diseases, M&A, SPAC Merger, ~$345M

Curis Resumes Patient Enrolment in the Dose Escalation Study of Emavusertib for the Treatment of Leukemia

Published: Sept 31, 2022 | Tags: Curis, Emavusertib, Leukemia, Lymphoma, Regulatory, US, FDA, Dose Escalation, P-I, P-II, TakeAIM

Amgen Reports Results of Lumakras in P-III Trial for the Treatment of Non-Small Cell Lung Cancer

Published: Aug 31, 2022 | Tags: Amgen, Lumakras, Non-Small Cell Lung Cancer, Clinical Trial, P-III, CodeBreak 100, CodeBreak 101, CodeBreak 200, US, EU, Japan, MAA

Outlook Therapeutics Re-Submitted a BLA to the US FDA for ONS-5010 to Treat Wet Age-Related Macular Degeneration

Published: Aug 31, 2022 | Tags: Outlook Therapeutics, ONS-5010, Wet Age-Related Macular Degeneration, Regulatory, BLA, US, FDA, Australia, NORSE ONE, NORSE TWO, NORSE THREE, NORSE SEVEN

Jaguar Health Submitted an IND Application to the US FDA for NP-300 to Treat Cholera-Related Diarrhea

Published: Aug 31, 2022 | Tags: Jaguar Health, Napo Pharmaceuticals, NP-300, Cholera-Related Diarrhea, Animal Health, IND, US FDA, Streeterville Capital, TDPRV

Cybin Reports Dosing of First Two Patients in P-I/IIa Clinical Trial of CYB003 for the Treatment of Major Depressive Disorder

Published: Aug 31, 2022 | Tags: Cybin, CYB003, Major Depressive Disorder, Clinical Trial, MADRS

Indica Labs Collaborated with iCAIRD to Develop AI-Based Algorithm for the Detection of Lymph Node Status in Colon Cancer

Published: Aug 31, 2022 | Tags: Indica Labs, iCAIRD, AI-Based Algorithm, Digital Pathology Solution, Lymph Node, Colon Cancer, Pharma, HALO AI, HALO AP

Sangamo Therapeutics Reports Results of ST-920 in P-I/II (STAAR) Study for the Treatment of Fabry Disease

Published: Aug 30, 2022 | Tags: Sangamo Therapeutics, ST-920, Fabry Disease, Clinical Trial, P-I, P-II, STAAR Study

Valneva Reports P-III (VLA2001-301) Cov-Compare Study Results of VLA2001 (COVID-19 Vaccine) for COVID-19

Published: Aug 30, 2022 | Tags: Valneva, VLA2001, COVID-19 Vaccine, COVID-19, Clinical Trial, P-III VLA2001-301, Cov-Compare Study

Sanofi and Sobi’s Efanesoctocog Alfa (BIVV001) Report the US FDA Acceptance for Priority Review of BLA to Treat Hemophilia A

Published: Aug 30, 2022 | Tags: Sanofi, Sobi, Efanesoctocog Alfa, BIVV001, Hemophilia A, Regulatory, US, FDA, Priority Review, BLA

Abbott Reports (MOMENTUM 3) Trial Results of HeartMate 3 Heart Pump for the Treatment of Advanced Heart Failure

Published: Aug 30, 2022 | Tags: Abbott, HeartMate 3 Heart Pump, Advanced Heart Failure, Clinical Trial, MOMENTUM 3 Trial 

Alnylam Presented P-II Study Results of Cemdisiran for the Treatment of IgA Nephropathy at EMCHD 2022

Published: Aug 30, 2022 | Tags: Alnylam, Cemdisiran, IgA Nephropathy, Clinical Trial, P-II Study

Amgen Presents P-III (FOURIER) OLE Results of Repatha (evolocumab) for Atherosclerotic Cardiovascular Disease at ESC 2022, Published in Circulation

Published: Aug 30, 2022 | Tags: Amgen, Repatha, evolocumab, Atherosclerotic Cardiovascular Disease, Clinical Trial, P-III (FOURIER) OLE Result, ESC, 2022, Circulation

IDEAYA Receives Milestones in its Pol Theta Helicase Inhibitor with GSK for Patients Harboring Tumors with BRCA

Published: Aug 29, 2022 | Tags: IDEAYA, Pol Theta Helicase Inhibitor, GSK, Tumors, BRCA, Pharma

Medtronic Reported (EV ICD) Study Results of Extravascular ICD System for the Treatment of Arrhythmias

Published: Aug 29, 2022 | Tags: Medtronic, Extravascular ICD System, Arrhythmias, Clinical Trial, MedTech, EV ICD Study

BMS Reports P-II (AXIOMATIC-SSP) Study Results of Milvexian for Recurrent Symptomatic Ischemic Stroke

Published: Aug 29, 2022 | Tags: BMS, Milvexian, Recurrent Symptomatic Ischemic Stroke, Clinical Trial, P-II AXIOMATIC-SSP Study

Amarin Reports (REDUCE-IT) Trial Results of Vascepa/Vazkepa (icosapent ethyl) for Cardiovascular Diseases

Published: Aug 29, 2022 | Tags: Amarin, Vascepa, Vazkepa, icosapent ethyl, Cardiovascular Diseases, Clinical Trial,REDUCE-IT Trial

Incyte’s Pemazyre (pemigatinib) Receives the US FDA’s Approval for the Treatment of Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement

Published: Aug 29, 2022 | Tags: Incyte, Pemazyre, pemigatinib, Myeloid/Lymphoid Neoplasms, FGFR1 Rearrangement, Regulatory, US, FDA, Approval

AstraZeneca Reports P-III (DELIVER) Trial Results of Farxiga (dapagliflozin) for Heart Failure

Published: Aug 29, 2022 | Tags: AstraZeneca, Farxiga, dapagliflozin, Heart Failure, Clinical Trial, P-III, DELIVER Trial

Related Post: PharmaShots Weekly Snapshots (August 22 - 26, 2022)

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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