PharmaShots Weekly Snapshots (September 12

Enzolytics Collaborated with Abveris to Discover Monoclonal Antibodies Against Multiple Viral Infectious Diseases

Published: Sept 16, 2022 | Tags: Enzolytics, Abveris, Monoclonal Antibodies, Multiple Viral Infectious Diseases, Biotech

Agios’ Pyrukynd (mitapivat) Receives EMA's CHMP Positive Opinion Recommending the Marketing Authorization for the Treatment of PK Deficiency

Published: Sept 16, 2022 | Tags: Agios, Pyrukynd, mitapivat, PK Deficiency, Regulatory, EMA, CHMP, Positive Opinion, Marketing Authorization

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) Receive EMA's CHMP Positive Opinion for the Prevention of RSV Lower Respiratory Tract Disease

Published: Sept 16, 2022 | Tags: AstraZeneca, Sanofi, Beyfortus, nirsevimab, RSV Lower Respiratory Tract Disease , Regulatory, EMA, CHMP, Positive Opinion

Sanofi and Regeneron Published P-III Trial Results of Dupixent (dupilumab) for Atopic Dermatitis in The Lancet

Published: Sept 16, 2022 | Tags: Sanofi, Regeneron, Dupixent, dupilumab, Atopic Dermatitis, Clinical Trial, P-III Trial

Gilead’s Veklury (remdesivir) Receives WHO’s Recommendation for the Treatment of COVID-19

Published: Sept 16, 2022 | Tags: Gilead, Veklury, remdesivir, COVID-19, Regulatory, WHO, Recommendation

NeuroBo Entered into a Conditional Exclusive License Agreement with Dong-A to Develop and Commercialize DA-1241 and DA-1726

Published: Sept 16, 2022 | Tags: NeuroBo, Dong-A, DA-1241, DA-1726, nonalcoholic steatohepatitis, obesity, type 2 diabetes, Pharma

Ascletis Pharma Reports the Completion of Patient Enrollment of ASC22 (envafolimab) + Chidamide in Clinical Study for HIV Infection

Published: Sept 15, 2022 | Tags: Ascletis Pharma, ASC22, envafolimab, Chidamide, HIV Infection, Clinical Trial

Pfizer Reports P-III Trial Results of Pentavalent Meningococcal Vaccine (MenABCWY) for Invasive Meningococcal Disease

Published: Sept 15, 2022 | Tags: Pfizer, Pentavalent Meningococcal Vaccine, MenABCWY, Invasive Meningococcal Disease, Clinical Trial, P-III Trial

Qurient Entered into a Clinical Collaboration Agreement with MSD to Evaluate Q901 + Keytruda (pembrolizumab) for Advanced Solid Tumors

Published: Sept 15, 2022 | Tags: Qurient, MSD, Q901, Keytruda, pembrolizumab, Advanced Solid Tumors, Pharma

Mallinckrodt’s Terlivaz (terlipressin) Receives the US FDA’s Approval for the Treatment of Hepatorenal Syndrome

Published: Sept 15, 2022 | Tags: Mallinckrodt, Terlivaz, terlipressin, Hepatorenal Syndrome, Regulatory, US, FDA, Approval

Horizon Published P-IV (MIRROR) Trial Results of Krystexxa (pegloticase) for the Treatment of Uncontrolled Gout in Arthritis & Rheumatology

Published: Sept 15, 2022 | Tags: Horizon, Krystexxa, pegloticase, Uncontrolled Gout, Clinical Trial, P-IV (MIRROR) Trial, Arthritis & Rheumatology

Neuron23 Collaborated with QIAGEN to Develop CDx for LRRK2 inhibitor to Treat Parkinson's Disease

Published: Sept 15, 2022 | Tags: Neuron23, QIAGEN, CDx, LRRK2 inhibitor, Parkinson's Disease, Pharma, US, FDA, PMA

Valeo Pharma Enters into a Commercial Services Agreement with Veru for Sabizabulin to Treat COVID-19 in Canada

Published: Sept 14, 2022 | Tags: Valeo Pharma, Veru, Sabizabulin, COVID-19, Canada, Commercial Services Agreement, Pharma

Coave Collaborated with Institute of Neurodegenerative Diseases to Develop Gene Therapy for Neurodegenerative Disorders

Published: Sept 14, 2022 | Tags: Coave, Institute of Neurodegenerative Diseases, Gene Therapy, Biotech, Neurodegenerative Disorders

MD Anderson Collaborated with Radiopharm Theranostics to Launch Joint Venture for Novel Radiopharmaceuticals Therapies

Published: Sept 14, 2022 | Tags: MD Anderson, Radiopharm Theranostics, Joint Venture, Radiopharmaceuticals Therapies, Cancer, Pharma

Otsuka and Lundbeck Report the US FDA Acceptance of NDA for Aripiprazole to Treat Schizophrenia and Bipolar I Disorder

Published: Sept 14, 2022 | Tags: Otsuka, Lundbeck, Aripiprazole, Schizophrenia, Bipolar I Disorder, Regulatory, US, FDA, NDA

Merck’s Keytruda (pembrolizumab) Receives the Health Canada Approval as Adjuvant Treatment for Stage IIB or IIC Melanoma

Published: Sept 14, 2022 | Tags: Merck, Keytruda, pembrolizumab, Stage IIB or IIC Melanoma, Regulatory, Health Canada, Approval

Nacuity Entered into an Exclusive License Agreement with Arctic to Develop and Commercialize NPI-001 in Iceland

Published: Sept 14, 2022 | Tags: Nacuity, Arctic. NPI-001, Hereditary Cystatin C Amyloid Angiopathy, Pharma, Iceland

METiS Entered into a License Agreement with Voronoi to Develop and Commercialize Pan-RAF Inhibitor Program

Published: Sept 13, 2022 | Tags: METiS, Voronoi, Pan-RAF Inhibitor Program, Class II & III BRAF mutant cancer, CNS metastasis, Pharma, License Agreement

CStone Reports NMPA Acceptance of sNDA and Granted Priority Review for Sugemalimab to treat Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma

Published: Sept 13, 2022 | Tags: CStone, Sugemalimab, Extranodal Natural Killer, T-Cell Lymphoma, regulatory, NMPA, sNDA, Priority Review

Novo Nordisk Collaborated with Microsoft to Advance Drug Discovery and Development Using AI

Published: Sept 13, 2022 | Tags: Novo Nordisk, Microsoft, atherosclerosis, AI, Drug Discovery, Pharma

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

Published: Sept 13, 2022 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5 Bivalent Booster Vaccine, Regulatory, EMA, CHMP, Conditional Marketing Authorization

Astellas, Seagen and Merck Report P-Ib/II (EV-103/KEYNOTE-869) Cohort K Trial Results of Padcev (enfortumab vedotin-ejfv) as 1L Treatment of Advanced Urothelial Cancer

Published: Sept 13, 2022 | Tags: Astellas, Seagen, Merck, Padcev, enfortumab vedotin-ejfv, Advanced Urothelial Cancer, Clinical Trial, P-Ib/II EV-103/KEYNOTE-869, Cohort K Trial

AmerisourceBergen to Acquire PharmaLex for ~$1.30B

Published: Sept 13, 2022 | Tags: AmerisourceBergen, PharmaLex, Acquire, ~$1.30B, M&A

AstraZeneca Reports P-III (POSEIDON) Trial Results of Imfinzi (durvalumab) for Metastatic Non-Small Cell Lung Cancer

Published: Sept 12, 2022 | Tags: AstraZeneca, Imfinzi, durvalumab, Metastatic Non-Small Cell Lung Cancer, Clinical Trial, P-III POSEIDON Trial

Ra Medical Systems & Catheter Precision Entered into a Definitive Merger Agreement to Treat Cardiac Arrhythmias

Published: Sept 12, 2022 | Tags: Ra Medical Systems, Catheter Precision, VIVO, Amigo, Cardiac Arrhythmias, M&A, Merger Agreement

Cellusion Entered into an Exclusive License Agreement with Celregen for CLS001 in the Greater China

Published: Sept 12, 2022 | Tags: Cellusion, Celregen, CLS001, bullous keratopathy, Pharma, Greater China

BMS’ Sotyktu (deucravacitinib) Receives the US FDA’s Approval for the Treatment of Moderate-to-Severe Plaque Psoriasis

Published: Sept 12, 2022 | Tags: BMS, Sotyktu, deucravacitinib, Plaque Psoriasis, Regulatory, US, FDA, Approval

Amgen Presents P-III (CodeBreaK 200) Trial Results of Lumakras/Lumykras (sotorasib) for Non-Small Cell Lung Cancer at ESMO 2022

Published: Sept 12, 2022 | Tags: Amgen, Lumakras, Lumykras, sotorasib, Non-Small Cell Lung Cancer, Clinical Trial, P-III, CodeBreaK 200 Trial

AstraZeneca and Merck Present P-III (PAOLA-1) & (SOLO-1) Trial Results of Lynparza (olaparib) as 1L Treatment of Advanced Ovarian Cancer at ESMO

Published: Sept 12, 2022 | Tags: AstraZeneca, Merck, Lynparza, Olaparib, Advanced Ovarian Cancer, P-III, PAOLA-1, SOLO-1, Trial