PharmaShots Weekly Snapshots (December 27

Vericel and MediWound Receive the US FDA’s Approval of NexoBrid for Severe Thermal Burns

Published: Dec 30, 2022 | Tags: Vericel, MediWound, NexoBrid, Severe Thermal Burns, Regulatory, US, FDA, Approval

Mayflower Bioventures Launches Primera Therapeutics as First Startup with Cellectis to Develop a Gene Editing Platform for Mitochondrial Diseases

Published: Dec 30, 2022 | Tags: Mayflower Bioventures, Primera Therapeutics, Cellectis, Mitochondrial Diseases, Gene Editing Platform, Biotech

Opus Genetics Acquires Two Gene Therapy Candidates from Iveric Bio for the Treatment of Inherited Retinal Diseases

Published: Dec 30, 2022 | Tags: Opus Genetics, IC-100, IC-200, BEST1, RHO-adRP, Inherited Retinal Diseases, Pharma

PDS Biotech Reports P-II Clinical Trial Results of Triple Combination Therapy for Human Papillomavirus-Positive Cancers

Published: Dec 30, 2022 | Tags: PDS Biotech, PDS0101, M9241, bintrafusp alfa,anal, cervical, head and neck, vaginal, vulvar cancers, Clinical Trial, P-II

SeaStar Medical Signed US License and Distribution Agreement with Nuwellis for Selective Cytopheretic Device to Treat Acute Kidney Injury in Pediatric Patients

Published: Dec 30, 2022 | Tags: SeaStar Medical, Nuwellis, Selective Cytopheretic Device, Acute Kidney Injury, MedTech

Pfizer Reports P-III Study (BENEGENE-2) Results of Fidanacogene Elaparvovec for Hemophilia B

Published: Dec 30, 2022 | Tags: Pfizer, Fidanacogene Elaparvovec, Hemophilia B, Clinical Trial, P-III, BENEGENE-2

AstraZeneca’s Imfinzi (durvalumab) + Imjudo (tremelimumab) Receive MHLW’s Approval for Advanced Liver and Non-Small Cell Lung Cancers

Published: Dec 29, 2022 | Tags: AstraZeneca, Imfinzi, durvalumab, Imjudo, tremelimumab, Liver, Non-Small Cell Lung Cancers, Regulatory, MHLW, Approval

Junshi Biosciences Reports P-III Clinical Trial Results of VV116 for Severe COVID-19

Published: Dec 29, 2022 | Tags: Junshi Biosciences, VV116, COVID-19, Clinical Trial, P-III, Clinical Trial

TG Therapeutics’ Briumvi (ublituximab-xiiy) Receives the US FDA’s Approval for Relapsing Multiple Sclerosis

Published: Dec 29, 2022 | Tags: TG Therapeutics, Briumvi, ublituximab-xiiy, Multiple Sclerosis, Regulatory, US, FDA, Approval

Mitsui to Acquire Sumitomo Pharma Animal Health

Published: Dec 29, 2022 | Tags: Mitsui, Sumitomo Pharma Animal Health, Marupi Lifetech, M&A, Japan, Animal Health

Pfizer’s BLA for MenABCWY is Accepted by the US FDA as Preventive Measure for Meningococcal Disease

Published: Dec 29, 2022 | Tags: Pfizer, MenABCWY, Meningococcal Disease, Regulatory, US, Europe, US FDA, FDA, BLA

Acasti Reports Results of GTX-102 in P-I Bridging Study for the Treatment of Ataxia Telangiectasia

Published: Dec 29, 2022 | Tags: Acasti, GTX-102, Ataxia Telangiectasia, Clinical Trial, P-I, Bridging Study, Crossover Study, US FDA

AstraZeneca’s Calquence (acalabrutinib) Receives the MHLW’s Approval for Treatment-Naïve Chronic Lymphocytic Leukaemia

Published: Dec 28, 2022 | Tags: AstraZeneca, Calquence, acalabrutinib, Chronic Lymphocytic Leukaemia, Regulatory, MHLW, Approval

Kala Pharmaceuticals Reports the US FDA’s Acceptance of IND Application of KPI-012 for Persistent Corneal Epithelial Defect

Published: Dec 28, 2022 | Tags: Kala Pharmaceuticals, KPI-012, Persistent Corneal Epithelial Defect, Regulatory, US, FDA, IND

SpringWorks Reports the Completion of NDA Submission to the US FDA for Nirogacestat to Treat Desmoid Tumors

Published: Dec 28, 2022 | Tags: SpringWorks, Nirogacestat, Desmoid Tumors, Regulatory, NDA, US, FDA

EOFlow Seeks Approval of Wearable Disposable Insulin Pump for Diabetes in the US

Published: Dec 28, 2022 | Tags: EOFlow, Wearable Disposable Insulin Pump, EOPatch, Diabetes, Regulatory, Medtech, US

Eli Lilly Entered into New Research and Collaboration Agreement with PeptiDream to Discover Novel Peptide Drug Conjugates

Published: Dec 28, 2022 | Tags: Eli Lilly, PeptiDream, Novel Peptide Drug Conjugates, Peptide Discovery Platform System, Biotech

Henlius Entered into an Exclusive License Agreement with Fosun Pharma for HANSIZHUANG in the US

Published: Dec 28, 2022 | Tags: Henlius, Fosun Pharma, HANSIZHUANG, MSI-H solid tumours, extensive-stage small cell lung cancer, small cell lung cancer, US, Pharma

Nanobiotix Initiates US Patient Enrollment of P-III Trial (NANORAY-312) for Head and Neck Cancer

Published: Dec 27, 2022 | Tags: Nanobiotix, NBTXR3, Head, Neck Cancer, Clinical Trial, P-III, NANORAY-312 trial

Orthofix Reports Clinical Trial Results of Trinity Elite Cellular Bone Allograft in Lumbar Fusion Procedures

Published: Dec 27, 2022 | Tags: Orthofix, Trinity Elite Cellular Bone Allograft, Lumbar Fusion Procedures, MedTech

Junshi Signs an Exclusive License and Commercialization Agreement with Hikma for Toripalimab in Middle East and North Africa Region

Published: Dec 27, 2022 | Tags: Junshi, Hikma, Toripalimab, Cancer, Pharma, Middle East, North Africa

Antengene Entered into a Clinical Collaboration with MSD to Evaluate ATG-037 + Keytruda (pembrolizumab) for Solid Tumors

Published: Dec 27, 2022 | Tags: Antengene, MSD, ATG-037, Keytruda, pembrolizumab, Solid Tumors, Pharma

Jiangsu Recbio Technology Reports P-II Study Results of Two-Component COVID-19 Vaccine ReCOV

Published: Dec 27, 2022 | Tags: Jiangsu Recbio Technology, COVID-19 Vaccine, Omicron BF.7, BA.2.75, ReCOV, Clinical Trial

Regeneron’s Libtayo (cemiplimab) Receives the MHLW’s Approval for Advanced or Recurrent Cervical Cancer in Japan

Published: Dec 27, 2022 | Tags: Regeneron, Libtayo, cemiplimab, Cervical Cancer, Regulatory, MHLW, Approval