Biotech - Spark Newswire

1 minute read

FDA Casts Doubts Over Roche’s Polivy Label Expansion For Untreated Lymphoma Setting

Today, 6:44 AM

Today, the FDA Oncologic Drugs Advisory Committee is discussing the supplemental marketing application for Polivy (polatuzumab vedotin-piiq) plus Rituxan (rituximab)…

RHHBF

1 minute read

William Blair Initiates Mesoblast Soon After Its Lead Product Goes Under FDA Review In Pediatric Indication

By Vandana Singh

Today, 6:44 AM

William Blair has initiated coverage on Mesoblast Ltd (NASDAQ:MESO) with an Outperform rating and a price target of $8. Mesoblast’s lead product,…

MESO

1 minute read

Clene’s Amyotrophic Lateral Sclerosis Candidate Delays Disease Progression, New Data Shows

By Vandana Singh

Today, 6:44 AM

Clene Inc (NASDAQ:CLNN) announced new results from exploratory analyses, including delayed time to key clinical progression events in amyotrophic lateral sclerosis…

CLNN

1 minute read

AstraZenceca’s Tagrisso Shows Survival Benefit In Early-Stage Lung Cancer Settings

By Vandana Singh

Today, 6:44 AM

AstraZeneca Plc (NASDAQ:AZN) released topline data from the ADAURA Phase 3 trial demonstrating Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement…

AZN

1 minute read

AstraZeneca’s Immunotherapy Imfinzi Shows Improvement In Survival Chances In Lung Cancer Patients

By Vandana Singh

Today, 6:44 AM

In a trial, lung cancer patients treated with AstraZeneca plc’s (NASDAQ:AZN) immunotherapy Imfinzi (durvalumab) pre- and post-surgery lived significantly longer without the…

AZN

1 minute read

The FDA has Cleared Vertex Pharmaceuticals’ Investigational New Drug Application For VX-264, Stem Cell-Derived Fully Differentiated Pancreatic Islet Cell Therapy Encapsulated Into Vertex-Developed, Immunoprotective Device For Type 1 Diabetes

By Benzinga Newsdesk

Today, 6:44 AM

Vertex plans to initiate a Phase 1/2 clinical trial in the first half of 2023 to study the safety, tolerability and efficacy of VX-264 in patients with T1D. The company previously received approval from Health Canada

VRTX

1 minute read

AstraZeneca Announces TAGRISSO Demonstrated Statistically And Clinically Meaningful Improvement In Overall Survival

By Benzinga Newsdesk

Today, 6:44 AM

Positive high-level results from the ADAURA Phase III trial showed AstraZeneca's TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival

AZN

5 minute read

Reported Late Wednesday March 08, Bionomics Reports Promising Full Results Analysis From PREVAIL Phase 2 Study Of BNC210 Social Anxiety Disorder; PREVAIL Did Not Meet Its Primary Endpoint

By Happy Mohamed

Today, 6:44 AM

Both doses of BNC210 as an acute treatment resulted in reductions in anxiety across multiple phases of the public speaking challenge Results achieved statistical significance in post-hoc analysis of the full

BNOX

3 minute read

Reported Late Wednesday March 08, ProMIS Neurosciences Announces FY22 Financial Results And Recent Highlights; Cash And Cash Equivalents Were $5.9M As Of December 31, 2022 Vs $16.9M YoY

By Happy Mohamed

Today, 6:44 AM

Completed all preclinical studies and manufacturing to support PMN310 IND submission to U.S. Food and Drug Administration Preclinical data that further characterize ongoing programs, including PMN310, to be presented

PMN