PharmaShots Weekly Snapshots (December 05

Akero’s Efruxifermin Receives the US FDA’s Breakthrough Therapy Designation for Nonalcoholic Steatohepatitis

Published: Dec 09, 2022 | Tags: Akero, Efruxifermin, Nonalcoholic Steatohepatitis, Regulatory, US, FDA, Breakthrough Therapy Designation

BeiGene Entered into a Clinical Supply Agreement with Phanes Therapeutics to Evaluate PT199 + Tislelizumab for Multiple Advanced Solid Tumors

Published: Dec 09, 2022 | Tags: BeiGene, Phanes Therapeutics, PT199, Tislelizumab, Multiple Advanced Solid Tumors, Pharma

Vertex Collaborated with Entrada Therapeutics to Develop Endosomal Escape Vehicle Therapies for Myotonic Dystrophy Type 1

Published: Dec 09, 2022 | Tags: Vertex, Entrada Therapeutics, Endosomal Escape Vehicle Therapies, Myotonic Dystrophy Type 1, Pharma

Daiichi Sankyo Presents P-I Trial (TROPION-PanTumor01) Results of Datopotamab Deruxtecan (Dato-DXd) for Metastatic Breast Cancer at SABCS 2022

Published: Dec 09, 2022 | Tags: Daiichi Sankyo, Datopotamab Deruxtecan, Dato-DXd, Metastatic Breast Cancer, Clinical Trial, P-I, TROPION-PanTumor01, SABCS, 2022

Guardant Health Entered into a Collaboration with AstraZeneca to Develop Guardant360 CDx Blood Test for ESR1-Mutated Metastatic Breast Cancer

Published: Dec 09, 2022 | Tags: Guardant Health, AstraZeneca, Guardant360 CDx Blood Test, ESR1-mutated Metastatic Breast Cancer, MedTech

AstraZeneca Presents P-III Trial (CAPItello-291) of Faslodex (fulvestrant) + Capivasertib for Advanced HR-Positive Breast Cancer at SABCS 2022

Published: Dec 09, 2022 | Tags: AstraZeneca, Faslodex, fulvestrant, Capivasertib, Advanced HR-Positive Breast Cancer, Clinical Trial, P-III, CAPItello-291 Trial, SABCS, 2022

Takeda’s Qdenga Receives EC’s Approval for the Prevention of Dengue Disease in Patients Aged ≥4 Years

Published: Dec 08, 2022 | Tags: Takeda, Qdenga, Dengue Tetravalent Vaccine, Dengue Disease, Regulatory, EC, Approval, EU

Roche Entered into Master Clinical Trial Collaboration and Supply Agreement with Replimune for RP2/3 Program to Treat Colorectal Cancer and Hepatocellular Carcinoma

Published: Dec 08, 2022 | Tags: Roche, Replimune, RP3, RP2, Colorectal Cancer, Hepatocellular Carcinoma, Master Clinical Trial Collaboration, Supply Agreement, Pharma

UCB Publishes P-III (BE OPTIMA) and (BE COMPLETE) Studies Results of Bimekizumab for Psoriatic Arthritis in The Lancet

Published: Dec 08, 2022 | Tags: UCB, Bimekizumab, Psoriatic Arthritis, Clinical Trial, P-III, BE OPTIMA, P-III, BE COMPLETE, Studies, The Lancet

Boehringer Ingelheim and Eli Lilly Report P-III (DINAMO) Trial Results of Jardiance (empagliflozin) for the Treatment of Type 2 Diabetes at IDF 2022

Published: Dec 08, 2022 | Tags: Boehringer Ingelheim, Eli Lilly, Jardiance, empagliflozin, Type 2 Diabetes, P-III, DINAMO Trial, Clinical Trial, IDF, 2022

Novartis Presents P-II (RIGHT Choice) Trial Results of Kisqali (ribociclib) as 1L Treatment of HR+/HER2− Metastatic Breast Cancer at SABCS

Published: Dec 08, 2022 | Tags: Novartis, Kisqali, ribociclib, Metastatic Breast Cancer, P-II (RIGHT Choice) Trial, Clinical Trial, SABCS, 2022

Daiichi Sankyo and AstraZeneca Present P-III (DESTINY-Breast03) Trial Results of Enhertu for HER2 Positive Metastatic Breast Cancer at SABCS 2022

Published: Dec 08, 2022 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, trastuzumab deruxtecan, HER2 Positive Metastatic Breast Cancer, Clinical Trial, P-III, DESTINY-Breast03 Trial, SABCS, 2022

Ascletis Receives the US FDA’s IND Approval of ASC11 for the Treatment of COVID-19

Published: Dec 07, 2022 | Tags: Ascletis, ASC11, COVID-19, Regulatory, US, FDA, IND, Approval

Eli Lilly Presents P-III (monarchE) Trial Results of Verzenio (abemaciclib) for Early Breast Cancer at SABCS 2022

Published: Dec 07, 2022 | Tags: Eli Lilly, Verzenio, abemaciclib, Early Breast Cancer, P-III (monarchE) Trial, Clinical Trial, SABCS, 2022

Ultromics’ EchoGo Heart Failure as a Breakthrough Device Receives the US FDA’s Clearance for the Detection of Heart Failure with Preserved Ejection Fraction

Published: Dec 07, 2022 | Tags: Ultromics, EchoGo Heart Failure, Preserved Ejection Fraction, Regulatory, MedTech, US, FDA, Clearance

AbbVie Entered into an Exclusive Worldwide Collaboration and Option to License Agreement with HotSpot Therapeutics for IRF5 Program

Published: Dec 07, 2022 | Tags: AbbVie, HotSpot Therapeutics, IRF5 Program, Smart Allostery drug discovery platform, autoimmune diseases, Option to License Agreement, Pharma

Akeso Out Licenses its Ivonescimab to Summit for ~$5B

Published: Dec 07, 2022 | Tags: Akeso, Summit, Ivonescimab, AK112, SMT112, Keytruda, Non-Small Cell Lung Cancer, Out Licenses, ~$5B, Biotech

Equillium Entered into an Exclusive Option and Asset Purchase Agreement with Ono to Develop and Commercialize Itolizumab

Published: Dec 07, 2022 | Tags: Equillium, Ono, Itolizumab, Acute Graft-Versus-Host Disease, alopecia areata, celiac disease, Option, Asset Purchase Agreement, Pharma

Tonix Entered into a Sponsored Research Agreement with Boston Children's Hospital to Study TNX-1500 for the Prevention of Graft-Versus-Host Disease in Animals

Published: Dec 06, 2022 | Tags: Tonix, Boston Children's Hospital, TNX-1500, Graft-Versus-Host Disease, Animals, Sponsored Research Agreement, Animal Health

Evaxion Signed a Vaccine Discovery Collaboration Agreement with ExpreS²ion for the Joint Development of Cytomegalovirus Vaccine Candidate

Published: Dec 06, 2022 | Tags: Evaxion, ExpreS²ion, Cytomegalovirus Vaccine, Discovery Collaboration Agreement, Pharma

Ionis Reports EMA Acceptance of MAA for Tofersen to Treat Superoxide Dismutase 1 Amyotrophic Lateral Sclerosis

Published: Dec 06, 2022 | Tags: Ionis, Tofersen, Superoxide Dismutase 1 Amyotrophic Lateral Sclerosis, Regulatory, EMA, MAA

Mirati to Present P-II (KRYSTAL-7) & P-Ib (KRYSTAL-1) Trials Results of MRTX849 (adagrasib) + Pembrolizumab as 1L Treatment of NSCLC at ESMO 2022

Published: Dec 06, 2022 | Tags: Mirati, MRTX849, adagrasib, Pembrolizumab, NSCLC, ESMO, 2022, Clinical Trial, P-II, KRYSTAL-7, P-Ib, KRYSTAL-1 Trials

Medtronic Reports the Completion of Patient Enrollment of Pulsed Field Ablation Catheter in (SPHERE Per-AF) Trial for the Treatment of Atrial Fibrillation

Published: Dec 06, 2022 | Tags: Medtronic, Pulsed Field Ablation Catheter, Atrial Fibrillation, Clinical Trial, SPHERE Per-AF Trial

Incyte and Syndax Published P-I/II Trial Results of Axatilimab for Chronic Graft-Versus-Host Disease in the Journal of Clinical Oncology

Published: Dec 06, 2022 | Tags: Incyte, Syndax, Axatilimab, Chronic Graft-Versus-Host Disease, Journal of Clinical Oncology, Clinical Trial, P-I/II Trial

Innovent and UNION Therapeutics Report First Patient Dosing of Orismilast (IBI353) in P-I Study for Atopic Dermatitis and Psoriasis

Published: Dec 05, 2022 | Tags: Innovent, UNION Therapeutics, Orismilast, IBI353, Atopic Dermatitis, Psoriasis, Clinical Trial, P-I Study

MaxCyte Signs a Strategic Platform License with Curamys for Cell and Gene Therapies to Treat Rare Intractable Diseases

Published: Dec 05, 2022 | Tags: MaxCyte, Curamys, Cell, Gene Therapies, Rare Intractable Diseases, Strategic Platform License

Mayne Pharma Signs License Agreement with TherapeuticsMD to Commercialize Women’s Health Products in the US

Published: Dec 05, 2022 | Tags: Mayne Pharma, TherapeuticsMD, Imvexxy, Bijuva, BocaGreenMD, vitaMedMD, Annovera, License Agreement, Pharma

Immunocore Entered into an Agreement with Gadeta to Develop Gamma Delta TCR ImmTAC for Solid Tumors

Published: Dec 05, 2022 | Tags: Immunocore, Gadeta, Gamma Delta TCR ImmTAC, Solid Tumors, Biotech

Incyte Entered into a Collaboration and License Agreement with CMS to Develop and Commercialize Ruxolitinib in Greater China and Southeast Asia

Published: Dec 05, 2022 | Tags: Incyte, CMS, Ruxolitinib Cream, immune-mediated dermatologic conditions, Greater China, Southeast Asia, Pharma

AnaptysBio and GSK Report P-III Trial Results of Jemperli (dostarlimab) for the Treatment of Primary Advanced or Recurrent Endometrial Cancer

Published: Dec 05, 2022 | Tags: AnaptysBio, GSK, Jemperli, dostarlimab, Endometrial Cancer, Clinical Trial, P-III Trial