PharmaShots Weekly Snapshots (May 10 – 14, 2021)

AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

Published: May 14, 2021 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency

Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy

Published: May 14, 2021 | Tags: Goldfinch Bio, P-I, Clinical Trial, GFB-024, Severe Insulin Resistant Diabetic Nephropathy

Reistone Reports First Patient Dosing in P-III RSJ10333 Trial of SHR0302 for the Treatment of Atopic Dermatitis

Published: May 14, 2021 | Tags: Reistone, P-III, RSJ10333 Trial, SHR0302, Atopic Dermatitis

Heron Therapeutics’ ZYNRELEF (HTX-011) Receives the US FDA’s Approval for the Management of Postoperative Pain

Published: May 14, 2021 | Tags: Heron Therapeutics, Zynrelef, HTX-011, US, FDA, Approval, Postoperative Pain

Novo Nordisk Reports Results of Semaglutide from P-IIIa STEP 1 Trial in Patients with Obesity

Published: May 14, 2021 | Tags: Novo Nordisk, Semaglutide, P-IIIa, STEP 1 Trial, Obesity

Biogen and Envisagenics Enter into a Collaboration for the Advancement of RNA Splicing Research to Treat Central Nervous System Diseases

Published: May 14, 2021 | Tags: Biogen, Envisagenics, RNA Splicing Research, AI Technology, Central Nervous System Diseases

Dr Reddy’s Acquires an Exclusive License for Pregene’s PRG1801 in India

Published: May 13, 2021 | Tags: Dr. Reddy’s, Exclusive License, Pregene, PRG1801, India

Fulcrum Therapeutics’ Losmapimod Receives the US FDA’s Fast Track Designation to Treat Facioscapulohumeral Muscular Dystrophy

Published: May 13, 2021 | Tags: Fulcrum Therapeutics, US FDA, Fast Track Designation, Losmapimod, Facioscapulohumeral Muscular Dystrophy

AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021

Published: May 13, 2021 | Tags: AstraZeneca, Amgen, Tezepelumab, P-III, NAVIGATOR Study, Severe Asthma, ATS2021

Antengene Receives IND Approval for P-III SIENDO Trial of XPOVIO (Selinexor) to Treat Advanced or Recurrent Endometrial Cancer in China

Published: May 13, 2021 | Tags: Antengene, IND, Approval, P- III, SIENDO Trial, Selinexor, Advanced, Recurrent Endometrial Cancer

Biogen Exercises its Option to Acquire TMS-007 for Acute Ischemic Stroke

Published: May 13, 2021 | Tags: Biogen, TMS, TMS-007, Acute Ischemic Stroke, Acquisition

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021

Published: May 13, 2021 | Tags: Regeneron, Sanofi, Libtayo, cemiplimab, P-III, Trial, Cervical Cancer, ESMO2021

InflaRx Reports Results of Vilobelimab in P- II IXPLORE Study in Patients with Anti-Neutrophil Cytoplasmic Autoantibody Associated Vasculitis

Published: May 12, 2021 | Tags: InflaRx, Vilobelimab, P- II, IXPLORE Study, Anti-Neutrophil Cytoplasmic Auto-Antibody, Vasculitis

Medtronic Launches SonarMed Airway Monitoring System to Detect Airway Obstruction During Ventilation in Pediatric Patients

Published: May 12, 2021 | Tags: Medtronic, SonarMed Airway Monitoring System, Airway Obstruction, Ventilation, Pediatric Patients

Nanobiotix Collaborates with Lianbio to Develop and Commercialize NBTXR3 in China and other Asian Countries

Published: May 12, 2021 | Tags: Nanobiotix, Lianbio, NBTXR3, Head & Neck Squamous Cell Carcinoma, China, Korea, Singapore, Thailand

Incyte and MorphoSys Report First Patient Dosing in P-III frontMIND Study of Tafasitamab + Lenalidomide as a 1L Treatment for DLBCL

Published: May 12, 2021 | Tags: Incyte, MorphoSys, P-III, frontMIND Study, Tafasitamab, Lenalidomide, DLBCL

Cellectis Collaborates with Sanofi for Alemtuzumab to be Utilized in CART-Cell Trials

Published: May 12, 2021 | Tags: Cellectis, Sanofi, Alemtuzumab, CART-Cell Trials

Autobahn Acquires Global Rights to Astellas’ ASP3652 to Bolster its Brain Targeting Chemistry Platform

Published: May 12, 2021 | Tags: Autobahn, Global Rights, Astellas, ASP3652, Brain Targeting Chemistry Platform

Lilly Signs a ~$1.25B Research Collaboration with MiNA Therapeutics to Develop saRNA Therapies

Published: May 11, 2021 | Tags: Lilly, ~$1.25B, MiNA Therapeutics, saRNA Therapies

Biogen Collaborates with Capsigen to Discover Novel AAV Capsids for Targeted CNS and Neuromuscular Disorders

Published: May 11, 2021 | Tags: Biogen, Capsigen, Novel AAV Capsids, CNS, Neuromuscular Disorders

Allergan Aesthetics to Acquire Soliton and its Resonic Device for ~$550M

Published: May 11, 2021 | Tags: Allergan Aesthetics, Soliton, Resonic Device, ~$550M

AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma

Published: May 11, 2021 | Tags: AstraZeneca, Amgen, BLA, US, FDA, Tezepelumab, Severe Asthma

Pfizer and BioNTech Receive the US FDA’s EMA for COVID-19 Vaccine in Adolescents

Published: May 11, 2021 | Tags: Pfizer, BioNTech, US, FDA, EMA, COVID-19 Vaccine, Adolescents

Bayer Reports Results of Finerenone in P- III FIGARO-DKD CV Outcomes Study for Chronic Kidney Disease and Type 2 Diabetes

Published: May 11, 2021 | Tags: Bayer, Finerenone, P- III, FIGARO-DKD CV Outcomes Study, Chronic Kidney Disease, Type 2 Diabetes

Aurinia Publishes the Results of Lupkynis (voclosporin) in P-III AURORA 1 Study for Patients with Active Lupus Nephritis in The Lancet

Published: May 10, 2021 | Tags: Aurinia, Lupkynis, voclosporin, P-III, AURORA 1 Study, Active Lupus Nephritis, The Lancet

Pfizer and BioNTech Initiate Rolling Submission of BLA for the US FDA’s Approval of their COVID-19 Vaccine

Published: May 10, 2021 | Tags: Pfizer, BioNTech, BLA, US, FDA, Approval, COVID-19 Vaccine

Walmart Health Signs an Agreement to Acquire MeMD for its Telehealth Services

Published: May 10, 2021 | Tags: Walmart Health, MeMD, Telehealth Services

Eli Lilly Signs an International Agreements with Four Diabetes Technology Companies for Connected Insulin Pen Solutions

Published: May 10, 2021 | Tags: Eli Lilly, Diabetes Technology Companies, Connected, Insulin Pen Solutions

BD to Spin Off its Diabetes Care Business into New Public Company

Published: May 10, 2021 | Tags: BD, Spin Off, Diabetes Care Business, New Public Company

GSK and Vir Report Initiation of EMA Rolling Review of VIR-7831 (sotrovimab) for the Early Treatment of COVID-19

Published: May 10, 2021 | Tags: GSK, Vir, EMA, VIR-7831, sotrovimab, COVID-19

Related Post: PharmaShots Weekly Snapshots (May 03 – 07, 2021)

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