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PharmaShots Weekly Snapshots (April 25-29, 2022)

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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)


Dr. Anish Desai

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent and nurturing strong relationships with external stakeholders. Holding Senior Management Position for last 20 years and involved in strategic decision making. 'IntelliMed Healthcare Solutions' is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business. IntelliMed specializes in scientific, Clinical & medical support from conceptualization/Ideation to launch.

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