PharmaShots Weekly Snapshots (August 29

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