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)