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PharmaShots Weekly Snapshots (April 25-29, 2022)

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PharmaShots Weekly Snapshots (April 25-29, 2022)

PharmaShots Weekly Snapshots (April 25-29, 2022)

AstraZeneca Reports First Patient Dosing in P-III PACIFIC-9 Study for NSCLC

Published: Apr 29, 2022 | Tags: AstraZeneca, P-III, PACIFIC-9 Study, NSCLC

Pfizer to Initiate P-III Study of Fordadistrogene Movaparvovec After FDA Lift Clinical Hold

Published: Apr 29, 2022 | Tags: Pfizer, Fordadistrogene Movaparvovec, FDA, Clinical Hold, CIFFREO

Abbott Launches Amplatzer Steerable Delivery Sheath for Amulet Device to Treat Atrial Fibrillation

Published: Apr 29, 2022 | Tags: Abbott, Launches, Amplatzer Steerable Delivery Sheath, Amulet Device, Atrial Fibrillation

Genentech Reports Three-Year Data of Evrysdi (risdiplam) in (FIREFISH) Study for the Treatment of Type 1 Spinal Muscular Atrophy

Published: Apr 29, 2022 | Tags: Genentech, Evrysdi, risdiplam, FIREFISH Study, Type 1, Spinal Muscular Atrophy

BMS’ Camzyos (mavacamten) Receives the US FDA’s Approval for the Treatment of Symptomatic New York Heart Association Class II-III Obstructive HCM

Published: Apr 29, 2022 | Tags: BMS, Camzyos, mavacamten, US, FDA, Approval, Symptomatic, New York, Heart Association, Class II-III, Obstructive HCM

Abbvie Entered into an Exclusive Collaboration with Plexium to Develop and Commercialize Novel Targeted Protein Degradation Therapies for Neurological Conditions

Published: Apr 29, 2022 | Tags: Abbvie, Plexium, Targeted Protein Degradation, Therapies, Neurological Conditions

AstraZeneca’ Ultomiris (ravulizumab-cwvz) Receives the US FDA’s Approval for the Treatment of Generalized Myasthenia Gravis

Published: Apr 28, 2022 | Tags: AstraZeneca, Ultomiris, ravulizumab-cwvz, US, FDA, Approval, Generalized Myasthenia Gravis

Transcenta Reports First Patient Dosing in P-I Study of TST002 for the Treatment of Osteoporosis in China

Published: Apr 28, 2022 | Tags: Transcenta, P-I Study, TST002, Osteoporosis, China

Amgen Reports Results of Repatha (evolocumab) in P-III (FOURIER) OLE Studies for the Treatment of Atherosclerotic Cardiovascular Disease

Published: Apr 28, 2022 | Tags: Amgen, Repatha, evolocumab, P-III, FOURIER, OLE Studies, Atherosclerotic Cardiovascular Disease

Harmony Biosciences Reports the Initiation of P-III (INTUNE) Withdrawal Study for Pitolisant to Treat Idiopathic Hypersomnia

Published: Apr 28, 2022 | Tags: Harmony Biosciences, P-III, INTUNE, Withdrawal Study, Pitolisant, Idiopathic Hypersomnia

Vifor & Cara’s Kapruvia (difelikefalin) Receive EC’s Approval for the Treatment of Pruritus in Hemodialysis Patients

Published: Apr 28, 2022 | Tags: Vifor, Cara, Kapruvia, difelikefalin, EC, Approval, Pruritus, Hemodialysis

Statera Signs a License Agreement with Immune for Naltrexone and Met-Enkephalin to Treat Immune-Related Diseases

Published: Apr 28, 2022 | Tags: Statera, Immune, Naltrexone, Met-Enkephalin, Immune-Related Diseases

Pfizer and Biohaven’s Vydura (Rimegepant) Receive EC's Marketing Authorization for the Treatment of Migraine and Prophylaxis of Episodic Migraine

Published: Apr 27, 2022 | Tags: Pfizer, Biohaven, Vydura, rimegepant, EC, Marketing Authorization, Migraine, Prophylaxis, Episodic Migraine

BeiGene Reports Results of Tislelizumab in P-III (RATIONALE 306) Trial as 1L Treatment of Advanced Esophageal Squamous Cell Carcinoma

Published: Apr 27, 2022 | Tags: BeiGene, Tislelizumab, P-III, RATIONALE 306 Trial, Esophageal Squamous Cell Carcinoma

Novaliq Presents Results of Cyclasol in P-III (ESSENCE-2) Trial for the Treatment of Dry Eye Disease at ASCRS 2022

Published: Apr 27, 2022 | Tags: Novaliq, Cyclasol, P-III, ESSENCE-2 Trial, Dry Eye Disease, ASCRS, 2022

Pfizer and BioNTech Seek the US FDA’s EUA for Booster Dose of their COVID-19 Vaccine in Children Aged 5 Through 11 Years

Published: Apr 27, 2022 | Tags: Pfizer, BioNTech, US, FDA, EUA, Booster Dose, COVID-19 Vaccine, Children,

Protagonist Reports Results of PN-943 in P-II (IDEAL) Study for the Treatment of Ulcerative Colitis

Published: Apr 27, 2022 | Tags: Protagonist, PN-943, P-II, IDEAL Study, Ulcerative Colitis

Daiichi Sankyo and AstraZeneca’ Enhertu Receive the US FDA’s Breakthrough Therapy Designation for HER2 Low Metastatic Breast Cancer

Published: Apr 27, 2022 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, US, FDA, Breakthrough Therapy Designation, HER2, Breast Cancer

Gamida Cell Receives the US FDA’s IND Clearance and Removal of Clinical Hold of GDA-201 for the Treatment of Follicular and Diffuse Large B Cell Lymphoma

Published: Apr 26, 2022 | Tags: Gamida Cell, US, FDA, IND, Clinical Hold, GDA-201, Follicular, Diffuse Large B Cell Lymphoma

Valneva and Pfizer Report Results of VLA15 in P-II (VLA15-221) Trial for the Treatment of Lyme Disease

Published: Apr 26, 2022 | Tags: Valneva, Pfizer, VLA15, P-II, VLA15-221 Trial, Lyme Disease

Bergenbio Reports Results of Bemcentinib in P-II (ACCORD2) Study for the Treatment of COVID-19

Published: Apr 26, 2022 | Tags: Bergenbio, Bemcentinib, P-II, ACCORD2 Study, COVID-19

Abbott Launches Upgraded Version of NeuroSphere myPath Digital Health App to Boost Connected Care Technology for Chronic Pain

Published: Apr 26, 2022 | Tags: Abbott, Launches, NeuroSphere myPath Digital Health App, Connected Care Technology, Chronic Pain

AstraZeneca Reports the US FDA Acceptance of BLA for Priority Review of Tremelimumab for the Treatment of Hepatocellular Carcinoma

Published: Apr 26, 2022 | Tags: AstraZeneca, US, FDA, BLA, Priority Review, Tremelimumab, Hepatocellular Carcinoma

Gilead Receives the US FDA Approval for Veklury's (remdesivir) sNDA to Treat COVID-19 in Pediatric Patients Aged ≥12 Years

Published: Apr 26, 2022 | Tags: Gilead, Veklury, remdesivir, US, FDA, sNDA, Approval, COVID-19

Mundipharma and Cidara Present Results of Rezafungin in P-III (ReSTORE) Trial for Treatment of Candidemia or Invasive Candidiasis at ECCMID 2022

Published: Apr 25, 2022 | Tags: Mundipharma, Cidara, Rezafungin, P-III, ReSTORE, Trial, Candidemia, Invasive Candidiasis, ECCMID, 2022

Shionogi Presents Results of S-217622 in P-IIb Study for the Treatment of COVID-19 at ECCMID 2022

Published: Apr 25, 2022 | Tags: Shionogi, S-217622, P-IIb Study, COVID-19, ECCMID, 2022

Amryt Receives CHMP Positive Opinion of Filsuvez for the Treatment of Dystrophic and Junctional EB

Published: Apr 25, 2022 | Tags: Amryt, CHMP, Positive Opinion, Filsuvez, Dystrophic, Junctional EB

Gilead Presents Results of Veklury (remdesivir) in Multiple Studies for COVID-19 at ECCMIC 2022

Published: Apr 25, 2022 | Tags: Gilead, Veklury, remdesivir, Multiple, Studies, COVID-19, ECCMIC, 2022

Incyte Receives CHMP Positive Opinion of Tabrecta (capmatinib) for the Treatment of METex14 Advanced Non-Small Cell Lung Cancer

Published: Apr 25, 2022 | Tags: Incyte, CHMP, Tabrecta, capmatinib, METex14, Non-Small Cell Lung Cancer

Scynexis Reports Interim Results of Ibrexafungerp in P-III (FURI) and (CARES) Studies for the Treatment of Severe Fungal Infections

Published: Apr 25, 2022 | Tags: Scynexis, Ibrexafungerp, P-III, FURI, CARES Studies, Fungal Infections

Related Post: PharmaShots Weekly Snapshots (April 18-22, 2022)

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