PharmaShots Weekly Snapshots (September 19

Ionis Provides Updates of ION449 in P-IIb (SOLANO) Study for the Treatment of Hypercholesterolemia

Published: Sept 23, 2022 | Tags: Ionis, ION449, Hypercholesterolemia, Clinical Trial, P-IIb, SOLANO Study

Inventiva Entered into a License and Collaboration Agreement with Sino Biopharm to Develop and Commercialize Lanifibranor in Greater China

Published: Sept 23, 2022 | Tags: Inventiva, Sino Biopharm, Lanifibranor, Greater China, non-alcoholic steatohepatitis, Pharma

Vir Biotechnology Reports the First Patient Dosing in the P-II (SOLSTICE) Trial of VIR-2218 and VIR-3434 for Chronic Hepatitis D Virus Infection

Published: Sept 23, 2022 | Tags: Vir Biotechnology, VIR-2218, VIR-3434, Chronic Hepatitis D Virus Infection, Clinical Trial, P-II, SOLSTICE Trial

Merck Animal Health Signed a Definitive Agreement to Acquire Vence

Published: Sept 23, 2022 | Tags: Merck Animal Health, Vence, veterinary pharmaceuticals, vaccines, animal intelligence solutions, Acquire, virtual fencing technology, US, Australia, M&A, Animal Health

Alvotech and STADA Launch Hukyndra (biosimilar, adalimumab) in Switzerland

Published: Sept 23, 2022 | Tags: Alvotech, STADA, Hukyndra, biosimilar, adalimumab, Simlandi, Switzerland, Pharma

Novo Nordisk Presents P-IIIa (ONWARDS 2) Trial Results of Insulin Icodec for the Treatment of Type 2 Diabetes at EASD 2022

Published: Sept 23, 2022 | Tags: Novo Nordisk, Insulin Icodec, Type 2 Diabetes, P-IIIa ONWARDS 2 Trial, Clinical Trial, EASD, 2022

AstraZeneca and Merck’s Lynparza (olaparib) Receive NMPA’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Sept 22, 2022 | Tags: AstraZeneca, Merck, Lynparza, Olaparib, NMPA, Approval, HRD-Positive, Advanced Ovarian Cancer, Regulatory

Biogen Publishes P-III (VALOR) Study Results of Tofersen for the Treatment of Amyotrophic Lateral Sclerosis at NEJM

Published: Sept 22, 2022 | Tags: Biogen, Tofersen, Amyotrophic Lateral Sclerosis, Clinical Trial, P-III (VALOR) Study, NEJM

GSK Entered into an Exclusive License Agreement with Spero Therapeutics for Tebipenem HBr to Treat Urinary Tract Infections

Published: Sept 22, 2022 | Tags: GSK, Spero Therapeutics, Tebipenem HBr, Urinary Tract Infections, pyelonephritis, Pharma

Eli Lilly's Retevmo (selpercatinib) Receives the US FDA’s Approval for Advanced or Metastatic Solid Tumors with a RET Gene Fusion

Published: Sept 22, 2022 | Tags: Eli Lilly, Retevmo, selpercatinib, Solid Tumors, RET Gene Fusion, Regulatory, US, FDA, Approval

Abpro Collaborated with Celltrion to Develop and Commercialize ABP 102 for the Treatment of HER2+ Cancer

Published: Sept 22, 2022 | Tags: Abpro, Celltrion, ABP 102, HER2+ Cancer, breast, gastric, pancreatic cancer, Pharma

Carisma Therapeutic to Go Public through Reverse Merger with Sesen Bio for CAR-M Therapies

Published: Sept 22, 2022 | Tags: Sesen Bio, Carisma Therapeutic, CAR-M Therapies, CT-0508, Cancer, Public, Merger, M&A

Merck KGaA Entered into Option to License Agreement with Nerviano Medical Sciences to Develop NMS-293

Published: Sept 21, 2022 | Tags: Merck KGaA, Option, License Agreement, Nerviano Medical Sciences, NMS-293, Pharma

BridgeBio Pharma and Sentynl Therapeutics Receive EC’s Conditional Marketing Authorization for Nulibry (fosdenopterin) to Treat MoCD Type A

Published: Sept 21, 2022 | Tags: BridgeBio Pharma, Sentynl Therapeutics, Nulibry, fosdenopterin, MoCD Type A, Regulatory, EC, Conditional Marketing Authorization

argenx Reports the BLA Submission to the US FDA for Efgartigimod to Treat Generalized Myasthenia Gravis

Published: Sept 21, 2022 | Tags: argenx, Efgartigimod, Generalized Myasthenia Gravis, Regulatory, BLA, US, FDA

CytoReason Expands its 2019 Collaboration with Pfizer for AI Drug Development

Published: Sept 21, 2022 | Tags: CytoReason, Pfizer, AI, Drug Development, disease models, immuno-oncology disorders, Pharma

Alnylam’s Amvuttra (vutrisiran) Receives EC’s Approval for the Treatment of Hereditary Transthyretin-mediated Amyloidosis

Published: Sept 21, 2022 | Tags: Alnylam, Amvuttra, vutrisiran, Hereditary Transthyretin-mediated Amyloidosis, Regulatory, EC, Approval

Takeda Entered into an Exclusive License Agreement with Puma Biotechnology for the Development and Commercialization of Alisertib

Published: Sept 21, 2022 | Tags: Takeda, Puma Biotechnology, Alisertib, metastatic estrogen receptor-positive HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer, Pharma

Rocket to Acquire Renovacor for ~$53M

Published: Sept 20, 2022 | Tags: Rocket, Renovacor, AAV-based Cardiac Gene Therapy, REN-001, dilated cardiomyopathy, M&A, Acquire, ~$53M

Basilea Entered into an Asset Purchase and Sub-License Agreement with SillaJen for BAL0891

Published: Sept 20, 2022 | Tags: Basilea, SillaJen, BAL0891, Asset Purchase, Sub-License Agreement, Pharma, Solid Tumor

Aurinia’s Lupkynis (voclosporin) Receives EC’s Approval for the Treatment of Lupus Nephritis

Published: Sept 20, 2022 | Tags: Aurinia, Lupkynis, voclosporin, Receives, EC’s Approval for the Treatment of Lupus Nephritis

AXIM Biotechnologies Entered into an Exclusive Commercial Agreement with Verséa Ophthalmics for Novel Ophthalmic Diagnostics Solutions

Published: Sept 20, 2022 | Tags: AXIM Biotechnologies, Verséa Ophthalmics, Ocular Immunoglobulin E test, Lactoferrin test, MMP-9 test Novel Ophthalmic Diagnostics Solutions, Pharma, Commercial Agreement

BeiGene’s Brukinsa (zanubrutinib) Receives NICE Recommendation for the Treatment of Waldenström’s Macroglobulinemia

Published: Sept 20, 2022 | Tags: BeiGene, Brukinsa, zanubrutinib, Waldenström’s Macroglobulinemia, Regulatory, NICE, Recommendation

Roche’s Vabysmo (faricimab) Receives EC’s Approval for Neovascular Age-Related Macular Degeneration and Visual Impairment due to Diabetic Macular Edema

Published: Sept 20, 2022 | Tags: Roche, Vabysmo, faricimab, Neovascular Age-Related Macular Degeneration, Visual Impairment, Diabetic Macular Edema, Regulatory, EC, Approval

BeiGene’s Receive EMA’s CHMP Positive Opinion for Brukinsa (zanubrutinib) to Treat Marginal Zone Lymphoma

Published: Sept 19, 2022 | Tags: BeiGene, Brukinsa, zanubrutinib, Marginal Zone Lymphoma, Regulatory, EMA, CHMP

GENFIT to Acquire Versantis for ~$108.5M

Published: Sept 19, 2022 | Tags: GENFIT, Versantis, VS-01-ACLF, VS-01-UCD, urea cycle disorder, VS-02-HE, hepatic encephalopathy, M&A, Acquire, ~$108.5M

Kite Receives EMA’s CHMP Positive Opinion for Yescarta (axicabtagene ciloleucel) to Treat Second-line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

Published: Sept 19, 2022 | Tags: Kite, Yescarta, axicabtagene ciloleucel, Second-line Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma, Regulatory, EMA, CHMP

Abbott Highlights the Five Presentations of Minimally Invasive Structural Heart Technologies for Heart Diseases at TCT 2022

Published: Sept 19, 2022 | Tags: Abbott, Minimally Invasive Structural Heart Technologies, MitraClip G4 system, TriClip, Heart Diseases, Amulet, Portico, atrial fibrillation, aortic stenosis, MedTech, EXPAND G4 Post-Approval Study, TRILUMINATE Trial, TCT, 2022

Boston Presents (PROTECTED TAVR) Trial Results of Sentinel Cerebral Protection System for Aortic Stenosis at TCT 2022, Published in the NEJM

Published: Sept 19, 2022 | Tags: Sentinel Cerebral Protection System, Aortic Stenosis, Clinical Trial, DigiHealth PROTECTED TAVR Trial TCT, 2022, NEJM

BMS’ Opdualag (nivolumab and relatlimab) Receives EC’s Approval as 1L Treatment for Unresectable or Metastatic Melanoma

Published: Sept 19, 2022 | Tags: BMS, Opdualag, nivolumab, relatlimab, Metastatic Melanoma, Regulatory, EC, Approval, Fixed-Dose Dual Immunotherapy