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PharmaShots Weekly Snapshots (June 21 - 25, 2021)

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PharmaShots Weekly Snapshots (June 21 - 25, 2021)

Regeneron and Sanofi's Libtayo (cemiplimab) Receive the EC's Approval as 1L Treatment for Advanced Basal Cell Carcinoma

Published: June 25, 2021 | Tags: Regeneron, Sanofi, Libtayo, cemiplimab, EC, Approval, Advanced Basal Cell Carcinoma

Regeneron and Sanofi's Libtayo (cemiplimab) Receive the EC's Approval as 1L Treatment for Advanced NSCLC

Published: June 25, 2021 | Tags: Regeneron, Sanofi, Libtayo, cemiplimab, EC, Approval, Advanced NSCLC

Roche's Actemra/RoActemra (tocilizumab) Receives the US FDA's EUA for Hospitalized Patients with COVID-19

Published: June 25, 2021 | Tags: Roche, Actemra, RoActemra, tocilizumab, US, FDA, EUA, COVID-19

AbbVie Receive the CHMP's Positive Opinion Recommending Approval of Rinvoq (upadacitinib) for Atopic Dermatitis

Published: June 25, 2021 | Tags: AbbVie, CHMP, Approval, Rinvoq, upadacitinib, Atopic Dermatitis

Lilly's Donanemab Receives the US FDA's Breakthrough Therapy Designation for the Treatment of Alzheimer's Disease

Published: June 25, 2021 | Tags: Lilly, Donanemab, US, FDA, Breakthrough Therapy Designation, Alzheimer Disease

AbbVie Acquire TeneoOne and its TNB-383B for the Treatment of Relapsed or Refractory Multiple Myeloma

Published: June 25, 2021 | Tags: AbbVie, Acquire, TeneoOne, TNB-383B, Multiple Myeloma

Tecan to Acquire Paramit for ~$1.0B

Published: June 24, 2021 | Tags: Tecan, Acquire, Paramit, ~$1.0B

Janssen Reports Submission of NDA to the US FDA for Xarelto (rivaroxaban) to Prevent and Treat Blood Clots in Children

Published: June 24, 2021 | Tags: Janssen, NDA, US, FDA, Xarelto, rivaroxaban, Venous Thromboembolism, Children

Chugai's Evrysdi (risdiplam) Receives MHLW's Approval for the Treatment of Spinal Muscular Atrophy

Published: June 24, 2021 | Tags: Chugai, Evrysdi, risdipla, MHLW, Approval, Spinal Muscular Atrophy

Bayer's Verquvo (vericiguat) Receives MHLW's Approval for Chronic Heart Failure

Published: June 24, 2021 | Tags: Bayer, Verquvo, vericiguat, MHLW, Approval, Chronic Heart Failure

Eisai and Biogen Receive FDA's Breakthrough Therapy Designation for Lecanemab (BAN2401) to Treat Alzheimer's Disease

Published: June 24, 2021 | Tags: Eisai, Biogen, FDA, Breakthrough Therapy Designation, Lecanemab, BAN2401, Alzheimer Disease

Roche Report the US FDA's Acceptance of BLA for Port Delivery System with Ranibizumab to Treat Neovascular Age-Related Macular Degeneration

Published: June 24, 2021 | Tags: Roche, US, FDA, BLA, Port Delivery System, Ranibizumab, Neovascular Age-Related Macular Degeneration

Sorrento Enters a Multi-Year Research and Development Agreement with US NAMRU-3 Against COVID-19

Published: June 23, 2021 | Tags: Sorrento, Research, Development Agreement, US, NAMRU-3, COVID-19

Pear Therapeutics to Become Public Via THMA SPAC Merger for ~$1.6B

Published: June 23, 2021 | Tags: Pear, Public, THMA, SPAC Merger, ~$1.6B, PDTs

uniQure to Acquire Corlieve Therapeutics for $55M

Published: June 23, 2021 | Tags: uniQure, Acquire, Corlieve Therapeutics, $55M, Upfront Payment

uniQure Reports 52-Week Clinical Data of Etranacogene Dezaparvovec in P-III HOPE-B Trial for Hemophilia B

Published: June 23, 2021 | Tags: uniQure, Etranacogene Dezaparvovec, P-III, HOPE-B Trial, Hemophilia B

Novartis Reports New Data of Kesimpta (ofatumumab) in ALITHIOS Study for Multiple Sclerosis

Published: June 23, 2021 | Tags: Novartis, Kesimpta, ofatumumab, ALITHIOS Study, Multiple Sclerosis

LEO Pharma' Adtralza (tralokinumab) Receives EC's Approval for Moderate-To-Severe Atopic Dermatitis

Published: June 23, 2021 | Tags: LEO Pharma, Adtralza, tralokinumab, EC, Approval, Atopic Dermatitis

GSK and Vir Report Results of Sotrovimab in P-III COMET-ICE Trial for High-Risk Adult Patients with Mild-To-Moderate COVID-19

Published: June 22, 2021 | Tags: GSK, Vir, Sotrovimab, P-III, COMET-ICE Trial, COVID-19

ViiV Healthcare Signs a License Agreement with Halozyme for ENHANZE Drug Delivery Technology to Develop Ultra Long-Acting Medicines for HIV

Published: June 22, 2021 | Tags: ViiV Healthcare, License Agreement, Halozyme, ENHANZE Drug Delivery Technology, Ultra Long-Acting Medicines, HIV

AstraZeneca and MSD's Koselugo (selumetinib) Receive the EU's Approval for Neurofibromatosis Type 1 and Plexiform Neurofibromas

Published: June 22, 2021 | Tags: AstraZeneca, MSD, Koselugo, selumetinib, EU, Approval, Neurofibromatosis Type 1, Plexiform Neurofibromas

Innovent Publishes the Results of Sintilimab + IBI305 (bevacizumab, biosimilar) in P-II/III ORIENT-32 Study as 1L Treatment for HCC in The Lancet Oncology

Published: June 22, 2021 | Tags: Innovent, Sintilimab, IBI305, biosimilar, bevacizumab, P-II/III, ORIENT-32 Study, HCC, The Lancet Oncology

Arrowhead Signs a License Agreement with Horizon to Develop siRNA Therapeutic Targeting XDH for Uncontrolled Gout

Published: June 22, 2021 | Tags: Arrowhead, License Agreement, Horizon Therapeutics, Develop, siRNA Therapeutic, XDH Uncontrolled Gout

Bayer Reports sNDA Submission to US FDA and MAA to EMA for Copanlisib + Rituximab to Treat B-iNHL and Relapsed MZL

Published: June 22, 2021 | Tags: Bayer, sNDA, Copanlisib, Rituximab, US, FDA, MAA, EMA, B-iNHL, Relapsed MZL, EU

FibroGen Collaborates with HiFiBiO to Advance Next-Generation Therapies for Patients with Cancer and Autoimmune Disease

Published: June 21, 2021 | Tags: FibroGen, HiFiBiO, Next-Generation Therapies, Cancer, Autoimmune Disease

BeiGene's Brukinsa (zanubrutinib) Receives the NMPA's Approval for Relapsed or Refractory Waldenström's Macroglobulinemia

Published: June 21, 2021 | Tags: BeiGene, Brukinsa, zanubrutinib, NMPA, Approval, Waldenström's Macroglobulinemia, WM

Eisai Collaborates with BMS for the Co-Development and Co-Commercialization of MORAb-202

Published: June 21, 2021 | Tags: Eisai, BMS, Co-Development, Co-Commercialization, MORAb-202

Novartis Presents New Data of Zolgensma in P-III Studies in Symptomatic Children with SMA at EAN2021

Published: June 21, 2021 | Tags: Novartis, Zolgensma, P-III, SPR1NT Two-Copy Cohort Trial, SMA, EAN2021

BMS' Onureg (azacytidine) Receives EC's Approval for as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia

Published: June 21, 2021 | Tags: BMS, Onureg, azacytidine, EC, Approval, Acute Myeloid Leukemia

Sanofi's Aubagio (teriflunomide) Receives EC's Approval as First Oral MS Therapy for 1L Treatment with Relapsing-Remitting Multiple Sclerosis in Children and Adolescents

Published: June 21, 2021 | Tags: Sanofi, Aubagio, teriflunomide, EC, Approval, Relapsing-Remitting Multiple Sclerosis

Related Post: PharmaShots Weekly Snapshots (June 14 - 18, 2021)


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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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