PharmaShots Weekly Snapshots (December 27 - 30, 2022)

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PharmaShots Weekly Snapshots (December 27 - 30, 2022)

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

Related Post: PharmaShots Weekly Snapshots (December 19 - 23, 2022)

Senior Editor

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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