PharmaShots Weekly Snapshots (July 04 – 08, 2022)

Bausch + Lomb and Novaliq Report the NDA Submission of NOV03 (perfluorohexyloctane) to the US FDA for Dry Eye Disease Associated with Meibomian Gland Dysfunction

Published: July 8, 2022 | Tags: Bausch + Lomb, Novaliq, NOV03, perfluorohexyloctane, Dry Eye Disease, Meibomian Gland Dysfunction, Regulatory, US, FDA, NDA

ADC Entered into an Exclusive License Agreement with Sobi to Develop and Commercialize Zynlonta (loncastuximab tesirine-lpyl) in EU and Select International Territories

Published: July 8, 2022 | Tags: ADC, Sobi, Zynlonta, loncastuximab tesirine-lpyl, Pharma EU, International Territories

EarlySign Collaborated with Roche to Develop AI Solution for Early Detection of Lung Cancer

Published: July 8, 2022 | Tags: EarlySign, Roche, AI Solution, Lung Cancer, Pharma, LungFlag

Alvotech Initiates (ALVOEYE) Clinical Study of AVT06, a Proposed Biosimilar to Eylea for Eye Disorders

Published: July 8, 2022 | Tags: Alvotech, AVT06, Biosimilar, Eylea, Eye Disorders, Clinical Trial, ALVOEYE Clinical Study, 

Portage Acquires Tarus and Adds Four Adenosine Products to its Pipeline

Published: July 8, 2022 | Tags: Portage, Tarus, PORT-6, PORT-7, PORT-8, PORT-9, Acquire

SD Biosensor and SJL Partners Entered into a Definitive Merger Agreement to Acquire Meridian for ~$1.53B

Published: July 8, 2022 | Tags: SD Biosensor, SJL, Meridian, M&A, ~$1.53B, Consortium, Acquire

Lysogene Presents Preliminary Results of LYS-SAF302 in P-II/III (AAVance) Trial for the Treatment of MPS IIIA in Children at ADVANCE 2022

Published: July 7, 2022 | Tags: Lysogene, LYS-SAF302, MPS IIIA, Clinical Trial, P-II/III, AAVance Trial, ADVANCE, 2022

BeiGene Collaborated with InnoRNA to Discover Novel mRNA-LNP Therapies

Published: July 7, 2022 | Tags: BeiGene, InnoRNA, Novel mRNA Therapies, Pharma

Calithera Reports the First Patient Enrollment of Sapanisertib in P-II Clinical Trial for NRF2-Mutated Squamous Non-Small Cell Lung Cancer

Published: July 7, 2022 | Tags: Calithera, Sapanisertib, NRF2-Mutated, Squamous, Non-Small Cell Lung Cancer, P-II Clinical Trial

Exelixis Entered into an Exclusive License Agreement with Ryvu to Develop Novel STING Agonist-Based Targeted Cancer Therapies

Published: July 7, 2022 | Tags: Exelixis, Ryvu, Novel STING Agonist-Based Targeted, Cancer, Therapies, Pharma

Brii Biosciences Launches Amubarvimab/Romlusevimab Combination in China for the Treatment of COVID-19

Published: July 7, 2022 | Tags: Brii Biosciences, Amubarvimab, Romlusevimab, Pharma, COVID-19, China, P-III, ACTIV-2

DiaMedica Reports the US FDA’s Clinical Hold on the P-II/III (ReMEDy2) Trial of DM199 for the Treatment of Acute Ischemic Stroke

Published: July 7, 2022 | Tags: DiaMedica, DM199, Acute Ischemic Stroke, Regulatory, US, FDA, P-II/II, ReMEDy1, ReMEDy2

Nordic Nanovector to Discontinue P-IIb (PARADIGME) Trial of Betalutin in 3L Treatment of Relapsed and Anti-CD20 Refractory Follicular Lymphoma

Published: July 6, 2022 | Tags: Nordic Nanovector, Betalutin, Follicular Lymphoma, Clinical Trial, P-IIb, PARADIGME Trial, 

BioArctic Partner Eisai Report the US FDA Acceptance of BLA for Lecanemab to Treat Alzheimer’s Disease

Published: July 6, 2022 | Tags: BioArctic, Eisai, Lecanemab, Alzheimer’s Disease, US, FDA, BLA

Urovant Entered into an Exclusive License Agreement with Pierre Fabre Médicament to Commercialize Vibegron for Overactive Bladder

Published: July 6, 2022 | Tags: Urovant, Pierre Fabre Médicament, Vibegron, Overactive Bladder, Pharma

Genentech Reports the US FDA Acceptance of BLA and Granted Priority Review of Mosunetuzumab for Relapsed or Refractory Follicular Lymphoma

Published: July 6, 2022 | Tags: Genentech, Mosunetuzumab, Follicular Lymphoma, US, FDA, BLA, Priority Review

Sanofi Signs an Exclusive Worldwide Collaboration Agreement with Skyhawk to Discover Novel Small Molecules for Oncology and Immunology Targets

Published: July 6, 2022 | Tags: Sanofi, Skyhawk, Novel Small Molecules, Oncology, Immunology, Pharma, SkySTAR Platform

AstraZeneca to Acquire TeneoTwo for ~$1.27B

Published: July 6, 2022 | Tags: AstraZeneca, TeneoTwo, TNB-486, Calquence, acalabrutinib, B-Cell Haematologic Malignancies, ~$1.27B, Acquire

Astellas Entered into a Research Agreement with Mogrify for In Vivo Regenerative Therapy in Sensorineural Hearing Loss

Published: July 5, 2022 | Tags: Astellas, Mogrify, Sensorineural Hearing Loss, In Vivo Regenerative Therapy, Biotech

EditForce Entered into a License Agreement with Mitsubishi Tanabe Pharma to Develop and Commercialize Gene Therapies for Central Nervous System

Published: July 5, 2022 | Tags: EditForce, Mitsubishi Tanabe Pharma, Gene Therapies, Central Nervous System, Biotech, PPR Protein Platform Technology

Livemetric Receives the US FDA’s Clearance for LiveOne Blood Pressure Monitoring Technology

Published: July 5, 2022 | Tags: Livemetric, LiveOne, Blood Pressure Monitoring Technology, Hypertension, Cardiovascular Diseases, Regulatory, US, FDA, Clearance

Pfizer’s Cibinqo (abrocitinib) Receives Health Canada Approval for the Treatment of Moderate to Severe Atopic Dermatitis

Published: July 5, 2022 | Tags: Pfizer, Cibinqo, abrocitinib, Atopic Dermatitis, Regulatory, Health Canada, Approval

JW Therapeutics Reports Initiation of P-I clinical study for JWATM204 to Treat Advanced Hepatocellular Carcinoma

Published: July 5, 2022 | Tags: JW Therapeutics, JWATM204, Advanced Hepatocellular Carcinoma, Clinical Trial, P-I clinical study

Arctic Vision Reports the First Patient Enrollment in P-III Clinical Trial of ARVN003 for the Treatment of Presbyopia

Published: July 5, 2022 | Tags: Arctic Vision, ARVN003, Presbyopia, Clinical Trial, P-III Clinical Trial, VISION-1, MicroLine

Abbisko Therapeutics Reports the Completion of First Patient Dosing of ABSK061 in P-I (ABSK061-101) Clinical Trial for the Treatment of Solid Tumors

Published: July 4, 2022 | Tags: Abbisko Therapeutics, ABSK061, Solid Tumors, Clinical Trial, P-I, ABSK061-101

Oxford Biomedica Signs Three Year Master Services & Development Agreement with Astrazeneca to Manufacture COVID-19 Vaccines

Published: July 4, 2022 | Tags: Oxford Biomedica, Astrazeneca, COVID-19 Vaccines, Master Services, Pharma, COVID-19 Development Agreement

Nurix Therapeutics Receives the US FDA’s IND Clearance for NX-1607 to Treat Advanced Malignancies

Published: July 4, 2022 | Tags: Nurix Therapeutics, US FDA, IND, Clearance, NX-1607, Advanced Malignancies

Innovent Reports the First Patient Dosing of IBI112 in a P-II Clinical Study for the Treatment of Moderate-to-Severe Active Ulcerative Colitis

Published: July 4, 2022 | Tags: Innovent, IBI112, Active Ulcerative Colitis, Clinical Trial, P-II, Clinical study

Seagen Presents Results of Tukysa (tucatinib) + Trastuzumab in P-II (MOUNTAINEER) Trial for HER2-Positive Metastatic Colorectal Cancer at ESMO 2022

Published: July 4, 2022 | Tags: Seagen, Tukysa, tucatinib, Trastuzumab, HER2-Positive, Metastatic Colorectal Cancer, Clinical Trial, P-II, MOUNTAINEER Trial, ESMO, 2022

AstraZeneca Presents Results of Imfinzi in P-III (HIMALAYA) and (TOPAZ-1) Trial for Liver and Biliary Tract Cancer at EASL 2022 and ESMO World GI 2022

Published: July 4, 2022 | Tags: AstraZeneca, Imfinzi, Liver, Biliary Tract Cancer, Clinical Trial, P-III, HIMALAYA, TOPAZ-1 Trial, EASL, 2022, ESMO, World GI, 2022

Related Post: PharmaShots Weekly Snapshots (June 27 – July 01, 2022)