PharmaShots Weekly Snapshots (May 24 – 28, 2021)

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis

Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis

The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes

Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes

uniQure Provides Positive Recommendation to Advance P- I/II Study of AMT-130 for Huntington Disease

Published: May 28, 2021 | Tags: uniQure, Positive Recommendation, Advance, P- I/II, Study, AMT-130, Huntington Disease

AstraZeneca’s Tagrisso (osimertinib) Receives EU’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Published: May 28, 2021 | Tags: AstraZeneca, Tagrisso, Osimertinib, EU, Approval, Early-Stage, EGFR-Mutated Lung Cancer

BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval for Ulcerative Colitis

Published: May 28, 2021 | Tags: BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval for Ulcerative Colitis

ONO and BMS’ Opdivo + Yervoy Receive Approval for 1L Treatment for Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma

Published: May 28, 2021 | Tags: ONO, BMS, Opdivo, Yervoy, Approval, Unresectable Advanced, Recurrent, Malignant Pleural Mesothelioma

Eli Lilly to Initiate P-I Study of LY3819469 for Cardiometabolic Diseases

Published: May 27, 2021 | Tags: Eli Lilly, P-I Study, LY3819469, Cardiometabolic Diseases

Senti Bio Collaborates with BlueRock to Develop Gene Circuit Engineered Cell Therapies for Regenerative Medicine

Published: May 27, 2021 | Tags: Senti Bio, BlueRock, Gene Circuit, Engineered Cell Therapies,  Regenerative Medicine

Novartis and Molecular Partners Initiate P-II/III EMPATHY Study to Evaluate Ensovibep (MP0420) for the Treatment of COVID-19

Published: May 27, 2021 | Tags: Novartis, Molecular Partners, P-II/III, EMPATHY Study, Ensovibep, MP0420, COVID-19

Sanofi and GSK Initiate P-III Clinical Study of their COVID-19 Vaccine

Published: May 27, 2021 | Tags: Sanofi, GSK, P-III, Clinical Study, COVID-19 Vaccine

Pfizer and Myovant’s Myfembree Receive the US FDA’s Approval for Heavy Menstrual Bleeding Associated with Uterine Fibroids

Published: May 27, 2021 | Tags: Pfizer, Myovant, Myfembree, US, FDA, Approval, Heavy Menstrual Bleeding, Uterine Fibroids

GSK and Vir Receive the US FDA’s EUA for Sotrovimab (VIR-7831) to Treat COVID-19 in Adults and Pediatric Patients

Published: May 27, 2021 | Tags: GSK, Vir, US, FDA, EUA, Sotrovimab, VIR-7831, COVID-19

TG Therapeutics Reports the US FDA’s Acceptance of BLA for Ublituximab + Ukoniq (umbralisib) to Treat Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Published: May 26, 2021 | Tags: TG Therapeutics, US, FDA, BLA, Ublituximab, Ukoniq, umbralisib, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents

Published: May 26, 2021 | Tags: Moderna, mRNA-1273, P-II/III, TeenCOVE Study, COVID 19

AbbVie’s Venclyxto Receives the EC’s Approval for Patients with Newly Diagnosed Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy

Published: May 26, 2021 | Tags: AbbVie, Venclyxto, EC, Approval, Newly Diagnosed, Acute Myeloid Leukemia, Intensive Chemotherapy

BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia and New Zealand

Published: May 26, 2021 | Tags: BioFactura, P-I, Study, BFI-751, biosimilar, ustekinumab, Australia, New Zealand

QIAGEN Collaborates with Mirati to Develop KRASG12C CDx for Non-Small Cell Lung Cancer

Published: May 26, 2021 | Tags: QIAGEN, Mirati, KRASG12C CDx, Non-Small Cell Lung Cancer

BMS and Xencor Collaborate to Use Xtend XmAb Technology in SARS-CoV-2 Neutralizing mAb Combination for COVID-19

Published: May 26, 2021 | Tags: BMS, Xencor, Xtend XmAb Technology, SARS-CoV-2, Neutralizing mAb Combination, COVID-19

Merck Signs a Clinical Trial Collaboration with Xilio for Anti-CTLA-4 Monoclonal Antibody Program

Published: May 25, 2021 | Tags: Merck, Clinical Trial, Xilio, Anti-CTLA-4 Monoclonal Antibody Program

Boehringer Ingelheim’s BI 425809 Receives the US FDA’s Breakthrough Therapy Designation for Cognitive Impairment Associated with Schizophrenia

Published: May 25, 2021 | Tags: Boehringer Ingelheim, BI 425809, US, FDA, Breakthrough Therapy Designation, Cognitive Impairment, Schizophrenia

Bayer Seeks Approval of Larotrectinib for Advanced Solid Tumors in China

Published: May 25, 2021 | Tags: Bayer, Approval, Larotrectinib, Advanced, Solid Tumors, China

AbbVie Presents New Late-Breaking Data Analyses of Skyrizi (risankizumab) for Crohn’s Disease at DDW 2021

Published: May 25, 2021 | Tags: AbbVie, Presents Skyrizi, Risankizumab, Crohn Disease, DDW 2021

Janssen’s Stelara Fails to Show Superiority over AbbVie’s Humira in P-IIIb SEAVUE Study for Crohn’s Disease, Presented at DDW 2021

Published: May 25, 2021 | Tags: Janssen, Stelara, AbbVie, Humira, P-IIIb, SEAVUE Study, Crohn Disease, DDW 2021

Boehringer Ingelheim to Develop Dicerna’s GalXC RNAi Candidate for NASH

Published: May 25, 2021 | Tags: Boehringer Ingelheim, Dicerna, GalXC RNAi Candidate, NASH

Pfizer Initiates Study to Evaluate its Pneumococcal Vaccine with Booster dose of its COVID-19 Vaccine

Published: May 24, 2021 | Tags: Pfizer, Study, Pneumococcal Vaccine, Booster dose, COVID-19 Vaccine

Lilly Presents Results of Mirikizumab in P-II SERENITY Study for Crohn’s Disease at DDW 2021

Published: May 24, 2021 | Tags: Lilly, Mirikizumab, P-II, SERENITY Study, Crohn’s Disease, DDW 2021

Takeda Reports Long-Term Safety and Efficacy Results of its Dengue Vaccine Candidate

Published: May 24, 2021 | Tags: Takeda, Long-Term Safety, Efficacy, Dengue Vaccine Candidate

Regeneron Receives CHMP’s Positive Opinion Recommending the Approval of Libtayo (cemiplimab) for NSCLC and BCC

Published: May 24, 2021 | Tags: Regeneron, CHMP, Positive Opinion, Approval, Libtayo, cemiplimab, NSCLC, BCC

Janssen’s Rybrevant (amivantamab-vmjw) Receives the US FDA’s Approval as the First Targeted Treatment for Patients with NSCLC with EGFR Exon 20 Insertion Mutations

Published: May 24, 2021 | Tags: Janssen, Rybrevant, amivantamab-vmjw, US, FDA, Approval, First Targeted, NSCLC, EGFR Exon 20 Insertion Mutations

BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy

Published: May 24, 2021 | Tags: BMS, CHMP, Approval, Opdivo, nivolumab, Yervoy, ipilimumab, dMMR, MSI-H mCRC

Related Post: PharmaShots Weekly Snapshots (May 17 – 21, 2021)