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PharmaShots Weekly Snapshots (December 19 - 23, 2022)

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PharmaShots Weekly Snapshots (December 19 - 23, 2022)

Outlook Therapeutics Reports EMA's Validation of MAA for ONS-5010 to Treat Wet AMD

Published: Dec 23, 2022 | Tags: Outlook Therapeutics, ONS-5010, Lytenava, bevacizumab, wet age-related macular degeneration, Regulatory, EMA, MAA

BridgeBio Pharma Initiates P-III Study (CALIBRATE) of Encaleret for Autosomal Dominant Hypocalcemia Type 1

Published: Dec 23, 2022 | Tags: BridgeBio Pharma, Encaleret, Autosomal Dominant Hypocalcemia Type 1, Clinical Trial, P-III CALIBRATE Study

Genentech’s Lunsumio (mosunetuzumab-axgb) Receives the US FDA’s Approval for Relapsed or Refractory Follicular Lymphoma

Published: Dec 23, 2022 | Tags: Genentech, Lunsumio, mosunetuzumab-axgb, Follicular Lymphoma, Regulatory, US, FDA, Approval

Merck Signs a Research Collaboration and Commercial License Agreement with Mersana for Novel Antibody-Drug Conjugates

Published: Dec 23, 2022 | Tags: Merck, Mersana, Immunostimulatory, Antibody-Drug Conjugates, Immunosynthen STING-agonist platform, Biotech

Eli Lilly Expands its 2021 Agreement with ProQR Therapeutics for New Genetic Therapies

Published: Dec 23, 2022 | Tags: Eli Lilly, ProQr Therapeutics, New Genetic Therapies, Biotech, 2021, Axiomer technology

Merck Signs an Exclusive License and Collaboration Agreement with Kelun-Biotech for Seven Antibody-drug Conjugate Candidates

Published: Dec 23, 2022 | Tags: Merck, Antibody-drug Conjugate Candidates, Cancer, Biotech

CSL’s Hemgenix (etranacogene dezaparvovec-drlb) Receives the US FDA’s Approval for the Treatment of Hemophilia B

Published: Dec 22, 2022 | Tags: CSL, Hemgenix, etranacogene dezaparvovec-drlb, Hemophilia B, Regulatory, US, FDA, Approval

Abbott’s Freestyle Libre 3 Combine with Automated Insulin Delivery System Mylife Loop in Germany

Published: Dec 22, 2022 | Tags: Abbott, Freestyle Libre 3 Integrated, Insulin Delivery System Mylife Loop, Germany

Everest Medicines Licensing Partner Pfizer Reports the US FDA and EMA’s Acceptance of NDA and MAA for Etrasimod in Ulcerative Colitis

Published: Dec 22, 2022 | Tags: Everest Medicines, Pfizer, Etrasimod, Ulcerative Colitis, Regulatory, US, FDA, EMA

Mirati’s Krazati (adagrasib) Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Advanced KRAS-Mutated Colorectal Cancer

Published: Dec 22, 2022 | Tags: Mirati, Krazati, adagrasib, KRAS-Mutated Colorectal Cancer, Regulatory, US, FDA, Breakthrough Therapy Designation

Novan's EPI Health Entered into Exclusive License Agreement with Sato Pharma for Rhofade in Japan

Published: Dec 22, 2022 | Tags: EPI Health, Novan, Rhofade, Japan, Pharma

Jazz Pharmaceuticals Exercised its Option to Advance Zymeworks' Zanidatamab for Cancer Patients

Published: Dec 22, 2022 | Tags: Jazz Pharmaceutials, Zymeworks, Zanidatamab, Biliary Tract Cancers, Pharma

Sobi and ADC Therapeutics Zynlonta (loncastuximab tesirine) Receives EC’s Conditional Marketing Authorisation for Diffuse Large B-Cell Lymphoma

Published: Dec 21, 2022 | Tags: Sobi, ADC Therapeutics, Zynlonta, loncastuximab tesirine, Diffuse Large B-Cell Lymphoma, Regulatory, EC, Conditional Marketing Authorisation

Anzac Animal Health’s Zycosan Receives the US FDA’s Approval as First Injectable

Published: Dec 21, 2022 | Tags: Anzac Animal Health, Zycosan, pentosan polysulfate sodium injection, Equine Osteoarthritis, Regulatory, US, FDA, Approval

Altimmune Reports 24-Week (12-Week Extension) Trial Results of Pemvidutide for the Treatment of Non-Alcoholic Fatty Liver Disease

Published: Dec 21, 2022 | TagsAltimmune, Pemvidutide, Non-Alcoholic Fatty Liver Disease, Clinical Trial,

Sosei Heptares Partner Pfizer Report the First Patient Dosing of PF-07081532 in the P-II Clinical Trial for the Treatment of Type 2 Diabetes and Obesity

Published: Dec 21, 2022 | Tags: Sosei Heptares, Pfizer, PF-07081532, Type 2 Diabetes, Obesity, Clinical Trial, P-II, Clinical Trial

Radius Health's Tymlos (abaloparatide) Receives the US FDA’s Approval for the Treatment of Osteoporosis

Published: Dec 21, 2022 | Tags: Radius Health, Tymlos, abaloparatide, Osteoporosis, Regulatory, US, FDA, Approval

Verona Pharma Reports P-III Trial (ENHANCE-1) Results of Ensifentrine for the Treatment of Chronic Obstructive Pulmonary Disease

Published: Dec 21, 2022 | Tags: Verona Pharma, Ensifentrine, Chronic Obstructive Pulmonary Disease, Clinical Trial, P-III, ENHANCE-1 Trial

Atara Biotherapeutics Ebvallo (tabelecleucel) Receives EC’s Approval for Epstein‑Barr Virus Positive Post‑Transplant Lymphoproliferative Disease

Published: Dec 20, 2022 | Tags: Atara Biotherapeutics, Ebvallo, tabelecleucel, Epstein‑Barr Virus Positive Post‑Transplant, Regulatory, EC, Approval

Abbott’s Eterna Spinal Cord Stimulation System Receives the US FDA’s Approval for the Treatment of Chronic Pain

Published: Dec 20, 2022 | Tags: Abbott, Eterna Spinal Cord Stimulation System, Chronic Pain, Regulatory, US, FDA, Approval

Takeda Reports P-III Trial (AURORA) Results of Maribavir for Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Patients

Published: Dec 20, 2022 | Tags: Takeda, Maribavir, Cytomegalovirus Infection, Hematopoietic Stem Cell Transplant, Clinical Trial, P-III, AURORA Trial

Catalyst to Acquire Commercial Rights of Eisai’s Fycompa (perampanel) CIII in the US

Published: Dec 20, 2022 | Tags: Catalyst, Eisai, Fycompa, perampanel CIII, epileptic disorders, neurological diseases, Pharma

Gilead and Arcus to Present P-II Study (ARC-7) Results of Domvanalimab for Non-Small Cell Lung Cancer at ASCO Plenary 2022

Published: Dec 20, 2022 | Tags: Gilead, Arcus, Domvanalimab, Non-Small Cell Lung Cancer, Clinical Trial, P-II, ARC-7 Study, ASCO, 2022

Sanofi Expands its 2016 Agreement with Innate Pharma for Natural Killer Cell Therapies in Oncology

Published: Dec 20, 2022 | Tags: Sanofi, Innate Pharma, Natural Killer Cell Therapies, Oncology, B7H3 ANKET, 2016, Biotech

Merck Entered into a Clinical Trial Collaboration with GenFleet Therapeutics to Initiate P-Ib/II Trial of GFH925 + Erbitux (cetuximab) for Non-Small cell lung cancer

Published: Dec 19, 2022 | Tags: Merck, GlenFeet Therapeutics, GFH925, Erbitux, cetuximab, Non-small cell lung cancer, Pharma

Dr. Reddy's Subsidiary Aurigene Stops Clinical Development of AUR-101 for the Treatment of Psoriasis

Published: Dec 19, 2022 | Tags: Dr Reddy, Aurigene, AUR-101, Psoriasis, Clinical Trial, P-IIb, INDUS-3 Trial,

Dr. Reddy's Laboratories Entered into a License and Distribution Agreement with CardiaCare to Commercialize Digital Neuromodulation Wearable for Non-invasive Atrial Fibrillation

Published: Dec 19, 2022 | Tags: Dr Reddy, CardiaCare, Digital Neuromodulation Wearable, Non-invasive Atrial Fibrillation, MedTech

Bionomics Reports P-II Study (PREVAIL) Results of BNC210 for the Treatment of Social Anxiety Disorder

Published: Dec 19, 2022 | Tags: Bionomics, BNC210, Social Anxiety Disorder, Clinical Trial, P-II, PREVAIL Study

AbbVie’s Vraylar (cariprazine) Receives the US FDA’s Approval as an Adjunctive Treatment for Major Depressive Disorder

Published: Dec 19, 2022 | Tags: AbbVie, Vraylar, cariprazine, Major Depressive Disorder, Regulatory, US, FDA, Approval

uniQure Receives EMA’s CHMP Positive Opinion of Etranacogene Dezaparvovec for the Treatment of Adults with Hemophilia B

Published: Dec 19, 2022 | Tags: uniQure, Etranacogene Dezaparvovec, Hemophilia B, Regulatory, EMA, CHMP

Related Post: PharmaShots Weekly Snapshots (December 12 - 16, 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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