PharmaShots Weekly Snapshots (May 24 – 28, 2021)

 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)

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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