PharmaShots Weekly Snapshots (November 07-11 2022)

NanOlogy Reports the Completion of Patient Enrollment of LSAM-PTX in P-IIa Trial for the Treatment of Nonoperable Lung Cancer

Published: Nov 11, 2022 | Tags: NanOlogy, LSAM-PTX, Nonoperable Lung Cancer, Clinical Trial, P-IIa Trial

ImmunityBio Reports P-II/III (QUILT 3.032) Trial Results of N-803 + BCG for the Treatment of Bladder Cancer

Published: Nov 11, 2022 | Tags: ImmunityBio, N-803, BCG, Bladder Cancer, Clinical Trial, P-II/III, QUILT 3.032 Trial

Takeda’s Livtencity (maribavir) Receives the EC’s Marketing Authorization for the Treatment of Post-Transplant Cytomegalovirus Infection

Published: Nov 11, 2022 | Tags: Takeda, Livtencity, maribavir, Post-Transplant Cytomegalovirus Infection, Regulatory, EC, Marketing Authorization

Parthenon Entered into a Multi-Year Non-Exclusive License and Supply Agreement with ImaginAb to Advance Anti-Cancer Therapies

Published: Nov 11, 2022 | Tags: Parthenon, ImaginAb, PRTH-101, Anti-Cancer Therapies, CD8 ImmunoPET imaging technology, P-I trial, Pharma

Janssen Reports Post-Hoc Analysis of Tremfya (guselkumab) in P-III (DISCOVER-2) Study for Active Psoriatic Arthritis

Published: Nov 11, 2022 | Tags: Janssen, Tremfya, guselkumab, Active Psoriatic Arthritis, Clinical Trial, P-III, DISCOVER-2 Study

Pfizer and BioNTech Receive EMA’s CHMP Positive Opinion Recommending Marketing Authorization for Omicron BA.4/BA.5- Bivalent Booster Vaccine

Published: Nov 11, 2022 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5- Bivalent Booster Vaccine, Regulatory, EMA, CHMP, Marketing Authorization

Minoryx Therapeutics Entered into a License Agreement with Neuraxpharm for Leriglitazone to Treat Rare Central Nervous System Disease

Published: Nov 10, 2022 | Tags: Minoryx Therapeutics, Neuraxpharm, leriglitazone, Rare Central Nervous System Disease, Pharma

Alvotech to Present Switching Study Results of AVT02, a Proposed Biosimilar to Humira at ACR 2022

Published: Nov 10, 2022 | Tags: Alvotech, AVT02, Biosimilar, Humira, Switching Study, Clinical Trial, ACR, 2022

ORYZON Receives the US FDA’s IND Clearance to Initiate a Collaborative P-II Basket Study of Iadademstat for Neuroendocrine Carcinomas

Published: Nov 10, 2022 | Tags: ORYZON, Iadademstat, Neuroendocrine Carcinomas, Regulatory, US FDA, IND, P-II Basket Study

Novartis’ Cosentyx (secukinumab) Receives the MHRA’s Marketing Authorisation for Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis

Published: Nov 10, 2022 | Tags: Novartis, Cosentyx, secukinumab, Enthesitis-Related Arthritis, Juvenile Psoriatic Arthritis, Regulatory, MHRA, Marketing Authorisation

Clearside Biomedical Reports P-I/IIa (OASIS) Clinical Trial Results of CLS-AX for the Treatment of Neovascular Age-Related Macular Degeneration

Published: Nov 10, 2022 | Tags: Clearside Biomedical, CLS-AX, Neovascular Age-Related Macular Degeneration, Clinical Trial, P-I/IIa OASIS Trial

Novavax’s Nuvaxovid (NVX-CoV2373) Booster Dose Receives the MHRA Recommendation for Expanded Conditional Marketing Authorization to Prevent COVID-19

Published: Nov 10, 2022 | Tags: Novavax, Nuvaxovid, NVX-CoV2373, COVID-19, MHRA Recommendation, Conditional Marketing Authorization, Regulatory

AstraZeneca Reports P-III (DELIVER) Trial Results of Farxiga (dapagliflozin) for Heart Failure Associated with Mildly Reduced or Preserved Ejection Fraction

Published: Nov 09, 2022 | Tags: AstraZeneca, Farxiga, dapagliflozin, Heart Failure, Ejection Fraction, Clinical Trial, P-III DELIVER Trial

Ocuphire Pharma Signs an Exclusive License Agreement with FamyGen for Nyxol Eye Drops to Treat Reversal of Mydriasis, Presbyopia and Night Vision Disturbances

Published: Nov 09, 2022 | Tags: Ocuphire Pharma, FamyGen, Nyxol Eye Drops, Reversal of Mydriasis, Presbyopia, Night Vision Disturbances, Pharma

Ipsen Reports P-III (NAPOLI 3) Trial Results of Onivyde for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

Published: Nov 09, 2022 | Tags: Ipsen, Onivyde, fluorouracil, leucovorin, oxaliplatin, Metastatic Pancreatic Ductal Adenocarcinoma, Clinical Trial, P-III NAPOLI 3 Trial

Regeneron’s Libtayo (cemiplimab-rwlc) Receives the US FDA’s Approval as 1L Treatment for Advanced Non-small Cell Lung Cancer

Published: Nov 09, 2022 | Tags: Regeneron, Libtayo, cemiplimab-rwlc, Non-small Cell Lung Cancer, US, FDA, Approval

Sanofi Entered into a Research Collaboration with Insilico Medicine for ~$1.2B

Published: Nov 09, 2022 | Tags: Sanofi, Insilico Medicine, Pharma.AI, ~$1.2B, Pharma

MSD’s Keytruda (pembrolizumab) Receives the NICE Recommendation for the Treatment of Triple-Negative Breast Cancer

Published: Nov 09, 2022 | Tags: MSD, Keytruda, pembrolizumab, Triple-Negative Breast Cancer, NICE Recommendation, Regulatory

Salipro Biotech Signed a Research Collaboration and License Agreement with Sanofi to Advance Discovery Programs

Published: Nov 08, 2022 | Tags: Salipro Biotech, Sanofi, Discovery Programs, Salipro platform, License Agreement, Pharma

SciBase Entered into an Agreement with Johnson & Johnson to Develop AI-Based Solution for the Detection of Skin Barrier Dysfunction

Published: Nov 08, 2022 | Tags: SciBase, Johnson & Johnson, AI-Based Solution, Skin Barrier Dysfunction, Electrical Impedance Spectroscopy technology, Pharma

Cyagen Collaborated with Neurophth to Develop AI-Designed AAV Gene Therapy Vectors for Ophthalmic Disorders

Published: Nov 08, 2022 | Tags: Cyagen, Neurophth, AI-Designed AAV Gene Therapy Vectors, Ophthalmic Disorders, Biotech

Medtronic Presents Six-Month (SPYRAL HTN-ON MED) Study Results of Symplicity Spyral Renal Denervation System for Hypertension at AHA 2022

Published: Nov 08, 2022 | Tags: Medtronic, Symplicity Spyral Renal Denervation System, SPYRAL HTN-ON MED Study, Hypertension, MedTech, Clinical Trial, AHA, 2022

Incyte Entered into a Clinical Trial Collaboration and Supply Agreement with Mirati to Evaluate INCB99280 and Adagrasib for KRASG12C-Mutated Solid Tumors

Published: Nov 08, 2022 | Tags: Incyte, Mirati, INCB99280, Adagrasib, KRASG12C-Mutated Solid Tumors, Pharma

AbbVie Reports Exploratory P-II (NOVA) Trial Results of AGN-151607 for the Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery Patients

Published: Nov 08, 2022 | Tags: AbbVie, AGN-151607, Postoperative Atrial Fibrillation, Cardiac Surgery, Clinical Trial,P-II (NOVA) Trial

Asieris Reports the Completion of First Patient Dosing of Hexvix for the Treatment of Bladder Cancer

Published: Nov 07, 2022 | Tags: Asieris, Hexvix, Bladder Cancer, P-III bridging trial, Clinical Trial

ReCor Medical Presents RADIANCE Clinical Trial Program Results of Paradise Ultrasound Renal Denervation System for Hypertension at AHA 2022

Published: Nov 07, 2022 | Tags: ReCor Medical, Paradise Ultrasound Renal Denervation System, Hypertension, Medtech, RADIANCE Clinical Trial Program, AHA, 2022

NKGen Biotech Collaborated with the Parkinson’s Foundation for Novel Natural Killer Cell Therapy to Treat Advanced Parkinson’s Disease

Published: Nov 07, 2022 | Tags: NKGen Biotech, Parkinson’s Foundation, Natural Killer Cell Therapy, SNK01, Advanced Parkinson’s Disease, Pharma

Innovent Presents P-III (CREDIT-1) Trial Results of Tafolecimab for Non-Familial Hypercholesterolemia at AHA 2022

Published: Nov 07, 2022 | Tags: Innovent, Tafolecimab, Non-Familial Hypercholesterolemia, Clinical Trial, P-III (CREDIT-1) Trial, AHA, 2022

Boehringer Ingelheim and Eli Lilly Report P-III (EMPA-KIDNEY) Trial Results of Jardiance (empagliflozin) for Chronic Kidney Disease

Published: Nov 07, 2022 | Tags: Boehringer Ingelheim, Eli Lilly, Jardiance, empagliflozin, Chronic Kidney Disease, Clinical Trial, P-III, EMPA-KIDNEY Trial

Bayer Reports P-III (PULSAR) and P-II/III (PHOTON) Trial Results of Aflibercept for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema

Published: Nov 07, 2022 | Tags: Bayer, Aflibercept, Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, Clinical Trial, P-III, PULSAR, P-II/III, PHOTON Trial