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PharmaShots Weekly Snapshots (November 14 - 18 2022)

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PharmaShots Weekly Snapshots (November 14 - 18 2022)

PharmaShots Weekly Snapshots (November 14 - 18 2022)

Iveric Bio’s Zimura (avacincaptad pegol) Receives the US FDA’s Breakthrough Therapy Designation for Geographic Atrophy

Published: Nov 18, 2022 | Tags: Iveric Bio, Zimura, avacincaptad pegol, Geographic Atrophy, Regulatory, US, FDA, Breakthrough Therapy Designation

Evaxion Reports P-I/IIa Results of EVX-02 for the Treatment of Resected Melanoma

Published: Nov 18, 2022 | Tags: Evaxion, EVX-02, Resected Melanoma, Clinical Trial, P-I/IIa Trial

Immunic Reports P-II (EMPhASIS) Trial Results of IMU-838 (vidofludimus calcium) for the Treatment of Relapsing-Remitting Multiple Sclerosis
Published: Nov 18, 2022 | Tags: Immunic, IMU-838, vidofludimus calcium, Relapsing-Remitting Multiple Sclerosis, Clinical Trial, P-II EMPhASIS Trial

Attralus Entered into Option and License Agreement with Ossianix to Deliver AT-04 for the Treatment of Neurodegenerative Disorders

Published: Nov 18, 2022 | Tags: Attralus, AT-04, Neurodegenerative Disorders, VNAR antibody-based brain shuttle

BeiGene’s Brukinsa (zanubrutinib) Receives EC’s Approval for the Treatment Chronic Lymphocytic Leukemia

Published: Nov 18, 2022 | Tags: Beigene, Brukinsa, zanubrutinib, Chronic Lymphocytic Leukemia, Regulatory, EC, Approval

Regeneron Entered into a Research Collaboration with CytomX to Develop Conditional Bispecific Therapies for the Treatment of Cancer

Published: Nov 18, 2022 | Tags: Regeneron, Bispecific Therapies, Cancer, Probody therapeutic platform, Veloci-Bi bispecific Ab, Biotech

VISEN Pharmaceuticals Reports P-III Results of Lonapegsomatropin in Children with Growth Hormone Deficiency

Published: Nov 17, 2022 | Tags: Visen Pharmaceuticals, Lonapegsomatropin, Growth Hormone Deficiency, Clinical Trial, P-III, China

Ayala Pharmaceuticals Reports First Patient Dosing of AL102 in P-III (RINGSIDE) trial for the Treatment of Desmoid Tumors

Published: Nov 17, 2022 | Tags: Ayala Pharmaceuticals, AL102, Desmoid Tumors, Clinical Trial, P-III, RINGSIDE Trial

Horizon Entered into a Multi-Year Scientific Collaboration with Johns Hopkins University School of Medicine to Advance Research in Autoimmunity and Inflammation

Published: Nov 17, 2022 | Tags: Horizon,  Autoimmunity, Inflammation, Pharma

Mineralys Therapeutics Reports P-II (Target-HTN) Trial Results of MLS-101 for Uncontrolled and Resistant Hypertension

Published: Nov 17, 2022 | Tags: Mineralys Therapeutics, MLS-101, Hypertension, Clinical Trial, P-II, Target-HTN Trial

Regeneron Entered into a Clinical Supply Agreement with Grey Wolf Therapeutics to Evaluate GRWD5769 + Libtayo (cemiplimab) for Solid Tumour

Published: Nov 17, 2022 | Tags: Regeneron, GRWD5769, Libtayo, cemiplimab, Solid Tumour, Pharma

Horizon Reports the Completion of Patients Enrollment of Tepezza (teprotumumab-trbw) in the P-III (OPTIC-J) Trial for the Treatment of Active Thyroid Eye Disease

Published: Nov 17, 2022 | Tags: Horizon, Tepezza, teprotumumab-trbw, Active Thyroid Eye Disease, Clinical Trial, P-III OPTIC-J Trial

NextCure Entered into a Collaboration and Co-Development Agreement with LegoChem Biosciences to Develop Antibody Drug Conjugates for Cancer

Published: Nov 16, 2022 | Tags: Nextcure,  Antibody Drug Conjugates, Cancer, B7-H4 Ab, FIND-IO platform, ConjuAll ADC technology, Biotech

Antengene Reports P-I/II (TORCH-2) Study Results of ATG-008 for the Treatment of Relapsed/Metastatic Cervical Cancer

Published: Nov 16, 2022 | Tags: Antengene, ATG-008, Cervical Cancer, Clinical Trial, P-I/II, TORCH-2 Study

Reistone Biopharma’s Ivarmacitinib Meets its Primary Endpoint in P-III (QUARTZ3) Trial for the Treatment of Atopic Dermatitis

Published: Nov 16, 2022 | Tags: Reinston Biopharma, Ivarmacitinib, Atopic Dermatitis, Clinical Trial, P-III, QUARTZ3 Trial

Arcutis Reports P-III (INTEGUMENT-1) Trial Results of Roflumilast Cream for Atopic Dermatitis in Adults and Children Aged ≥6 Years

Published: Nov 16, 2022 | Tags: Arcutis, Roflumilast Cream, Atopic Dermatitis, Clinical Trial, P-III, INTEGUMENT-1 Trial

Simcere Entered into an Exclusive License Agreement with Idorsia for Daridorexant in China

Published: Nov 16, 2022 | Tags: Simcere, Idorsia, Daridorexant, Pharma, License Agreement, China

Jnana Therapeutics Entered into a Second Collaboration and License Agreement with Roche to Discover Small Molecule Drugs

Published: Nov 16, 2022 | Tags: Roche, Jnana Therapeutics, Small Molecule Drugs, License Agreement, RAPID chemoproteomics platform, biotech

Junshi Reports MAA Submission of Toripalimab to the EMA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

Published: Nov 15, 2022 | Tags: Junshi, Toripalimab, Nasopharyngeal Carcinoma, Esophageal Squamous Cell Carcinoma, Regulatory, MAA, EMA

UCB Reports the US FDA Acceptance of NDA and EMA’s Validation of MAA for Zilucoplan to Treat Generalized Myasthenia Gravis

Published: Nov 15, 2022 | Tags: UCB, Zilucoplan, Generalized Myasthenia Gravis, Regulatory, MAA, US, FDA, NDA, EMA

Biotheus Entered into a License and Collaboration Agreement with Hansoh Pharma for PM1080

Published: Nov 15, 2022 | Tags: Hansoh Pharma, Biotheus, PM1080, non-small cell lung cancer, Pharma

Ono Collaborated with Captor Therapeutics to Develop Small Molecule Protein Degraders for the Treatment of Neurodegenerative Diseases

Published: Nov 15, 2022 | Tags: Ono, Captor Therapeutics, Protein Degraders, Neurodegenerative Diseases, OptigradeTM TPD platform, Pharma

Innovent Reports First Participant Dosing of Mazdutide (IBI362) in the P-III (GLORY-1) Trial for the Treatment of Overweight or Obesity

Published: Nov 15, 2022 | Tags: Innovent, Mazdutide, IBI362, Overweight, Obesity, Clinical Trial, P-III GLORY-1 Trial

Lantheus Entered into an Exclusive License Agreements with POINT Biopharma to Commercialize PNT2002 and PNT2003

Published: Nov 15, 2022 | Tags: lantheus, Point BiopharmaPNT2002, PNT2003, metastatic castration-resistant prostate cancer, gastroenteropancreatic neuroendocrine tumors, Pharma

Akeso's Ivonescimab Receives the NMPA’s Breakthrough Therapy Designation for the Treatment of Non-Small-Cell Lung Carcinoma

Published: Nov 14, 2022 | Tags: Akeso, Ivonescimab, Non-Small-Cell Lung Carcinoma, Regulatory, NMPA, Breakthrough Therapy Designation

Genentech's Gantenerumab Missed Primary Endpoints in P-III (GRADUATE I & II) Studies for Early Alzheimer’s Disease

Published: Nov 14, 2022 | Tags: Genentech, Gantenerumab, Early Alzheimer’s Disease, Clinical Trials, P-III (GRADUATE I & II) Studies

Indivior to Acquire Opiant Pharmaceuticals for ~$145M

Published: Nov 14, 2022 | Tags: Indivior, Opiant Pharmaceuticals, OPNT003, Acquire ~$145M, M&A

OncoSec Reports P-II (KEYNOTE-695) Trial Results of TAVO-EP + Keytruda (pembrolizumab) for Advanced Melanoma

Published: Nov 14, 2022 | Tags: OncoSec, TAVO-EP, Keytruda, pembrolizumab, Advanced Melanoma, Clinical Trial, P-II KEYNOTE-695 Trial

AstraZeneca’s Imfinzi (durvalumab) + Imjudo (tremelimumab) Receive the US FDA’s Approval for Metastatic Non-Small Cell Lung Cancer

Published: Nov 14, 2022 | Tags: AstraZeneca, Imfinzi, durvalumab, Imjudo, tremelimumab, Non-Small Cell Lung Cancer, Regulatory, US, FDA, Approval

Regeneron Receives EMA’s CHMP Positive Opinion of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis

Published: Nov 14, 2022 | Tags: Regeneron, Dupixent, dupilumab, Prurigo Nodularis, Regulatory, EMA, CHMP, Positive Opinion

Related Post: PharmaShots Weekly Snapshots (November 07-11 2022)


Neha

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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