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PharmaShots Weekly Snapshots (December 05–09, 2022)

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PharmaShots Weekly Snapshots (December 05–09, 2022)

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

Related Post: PharmaShots Weekly Snapshots (November 28 – December 02, 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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