PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021

Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021

Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis

Published: June 4, 2021 | Tags: Dermavant, NDA, US, FDA, Tapinarof Cream, Plaque Psoriasis

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021

Published: June 4, 2021 | Tags: BMS, Opdivo, nivolumab, CT, Yervoy, ipilimumab, P-III, CheckMate -648 Trial, Unresectable, Advanced, Metastatic, ESCC, ASCO 2021

United Therapeutics Reports the First Patient Enrollment in P-III TETON Study of Tyvaso for Idiopathic Pulmonary Fibrosis

Published: June 4, 2021 | Tags: United Therapeutics, P-III, TETON Study, Tyvaso, Idiopathic Pulmonary Fibrosis

Merck Presents Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 as Adjuvant Therapy for Renal Cell Carcinoma at ASC0 2021

Published: June 4, 2021 | Tags: Merck, Keytruda, pembrolizumab, P-III, KEYNOTE-564, Renal Cell Carcinoma, ASC0 2021

Innovent and Lilly’s Tyvyt (sintilimab injection) + Gemcitabine and Platinum CT Receive NMPA’s Approval as 1L Therapy for Squamous Non-Small Cell Lung Cancer

Published: June 4, 2021 | Tags: Innovent, Lilly, Tyvyt, sintilimab injection, Gemcitabine, Platinum CT, NMPA, Approval, Squamous Non-Small Cell Lung Cancer

Biogen and Bio-Thera Report Results of BAT1806 (biosimilar, tocilizumab) in P-III Study for Moderate to Severe Rheumatoid Arthritis

Published: June 3, 2021 | Tags: Biogen, Bio-Thera, BAT1806, biosimilar, tocilizumab, P-III, Study, Rheumatoid Arthritis

Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim Biosimilar

Published: June 3, 2021 | Tags: Lupin, US, FDA, Acceptance, BLA, Pegfilgrastim Biosimilar

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021

Published: June 3, 2021 | Tags: Celltrion, Yuflyma, biosimilar, adalimumab, P-III, CT-P17 3.1 Trial, Rheumatoid Arthritis, EULAR 2021

Novartis Presents Results of Kymriah in P-II ELARA Study for Relapsed or Refractory Follicular Lymphoma at ASCO 2021

Published: June 3, 2021 | Tags: Novartis, Kymriah, P-II, ELARA Study, Follicular Lymphoma, ASCO 2021

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) Receive EC’s Approval for 1L Treatment for Unresectable Malignant Pleural Mesothelioma

Published: June 3, 2021 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, EC, Approval, Unresectable, Malignant Pleural Mesothelioma

MorphoSys to Acquire Constellation Pharmaceuticals for ~$1.7B

Published: June 3, 2021 | Tags: MorphoSys, Acquire, Constellation Pharmaceuticals, ~$1.7B

AbbVie Presents Results of Long-Term Efficacy and Safety Analyses for Rinvoq (upadacitinib) in P-III SELECT-COMPARE Study for Rheumatoid Arthritis at EULAR 2021

Published: June 2, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, P-III, SELECT-COMPARE Study, Rheumatoid Arthritis, EULAR 2021

Novartis Presents Two-Year Data of Cosentyx in P-III JUNIPERA Study for JPsA and ERA at EULAR 2021

Published: June 2, 2021 | Tags: Novartis, Cosentyx, P-III, JUNIPERA Study, JPsA, ERA, EULAR 2021

AstraZeneca Presents Results of Anifrolumab in New Post-Hoc Analysis of P-III TULIP Study for Systemic Lupus Erythematosus at EULAR 2021

Published: June 2, 2021 | Tags: AstraZeneca, Anifrolumab, P-III, TULIP Study, Systemic Lupus Erythematosus, EULAR 2021

Alnylam Reports Completion of Patient Enrollment in P-III APOLLO-B Study for Patisiran to Treat Transthyretin-Mediated (ATTR) Amyloidosis with Cardiomyopathy

Published: June 2, 2021 | Tags: Alnylam, P-III, APOLLO-B Study, Patisiran, Transthyretin-Mediated (ATTR) Amyloidosis, Cardiomyopathy

Janssen’s Teclistamab Receives the US FDA’s Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma

Published: June 2, 2021 | Tags: Janssen, Teclistamab, US, FDA, Breakthrough Therapy Designation, Multiple Myeloma

Novartis’ Cosentyx (secukinumab) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Plaque Psoriasis

Published: June 2, 2021 | Tags: Novartis, Cosentyx, secukinumab, US, FDA, Approval, Moderate,  Severe, Plaque Psoriasis

Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy

Published: June 1, 2021 | Tags: Santhera, ReveraGen, Vamorolone, P-IIb, VISION-DMD Study, Duchenne Muscular Dystrophy

Amgen and Kyowa Kirin Collaborate to Develop and Commercialize KHK4083 for Atopic Dermatitis

Published: June 1, 2021 | Tags: Amgen, Kyowa Kirin, Develop, Commercialize, KHK4083, Atopic Dermatitis

Biohaven’s Nurtec ODT (rimegepant) Receives the US FDA’s Approval for Treatment of Migraine

Published: June 1, 2021 | Tags: Biohaven, Nurtec ODT, Rimegepant, US, FDA, Approval, Migraine

AB Science Holds the Clinical Studies of Masitinib Globally

Published: June 1, 2021 | Tags: AB Science, Holds, Clinical Studies, Masitinib

Sanofi Stops the P-II/III STAGED-PKD Study of Venglustat for Autosomal Dominant Polycystic Kidney Disease

Published: June 1, 2021 | Tags: Sanofi, P-II/III, STAGED-PKD Study, Venglustat, Autosomal Dominant Polycystic Kidney Disease

BMS’ Abecma (idecabtagene vicleucel) Receives the Health Canada’s Approval as the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma

Published: June 1, 2021 | Tags: BMS, Abecma, idecabtagene vicleucel, Health Canada, Approval, Anti-BCMA, CAR T Cell Therapy, Multiple Myeloma

Ipsen Reports the US FDA’s Acceptance of NDA for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva

Published: May 31, 2021 | Tags: Ipsen, US, FDA, NDA, Palovarotene, Fibrodysplasia Ossificans Progressiva

Novo Nordisk Resubmits Label Expansion Application to the US FDA for Semaglutide (2.0mg)

Published: May 31, 2021 | Tags: Novo Nordisk, Resubmits, Label Expansion Application, US, FDA, Semaglutide (2.0mg)

BridgeBio and Helsinn’s Truseltiq (infigratinib) Receive the US FDA’s Approval for Cholangiocarcinoma

Published: May 31, 2021 | Tags: BridgeBio, Helsinn, Truseltiq, infigratinib, US, FDA, Approval, Cholangiocarcinoma

Novartis Reports One Year Results of Beovu (brolucizumabin) in P- III MERLIN Study to Treat Wet Age-Related Macular Degeneration

Published: May 31, 2021 | Tags: Novartis, Beovu, brolucizumabin, P- III, MERLIN Study, Wet Age-Related Macular Degeneration

Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents

Published: May 31, 2021 | Tags: Pfizer, BioNTech, EC, Conditional Marketing Approval, COVID-19 Vaccine

Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy

Published: May 31, 2021 | Tags: Amgen, Lumakras, sotorasib, US, FDA, Approval, KRAS Blocking Cancer Therapy

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