Biotech - Spark Newswire

3 minute read

G1 Therapeutics Initiates PRESERVE 3, A Randomized Phase 2 Study Of COSELA In Bladder Cancer

Today, 8:55 PM

G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, today announced that the Company has initiated PRESERVE 3, a Phase 2, randomized, open-label study of COSELA™ (trilaciclib) administered

GTHX

2 minute read

Landos Biopharma Announces Outcome Of End-Of-Phase 2 Meeting With FDA For Omilancor In Mild-To-Moderate Active Ulcerative Colitis; Co. And FDA Agreed On Key Elements Necessary For Approval

By Bill Haddad

Today, 8:55 PM

Landos Biopharma, Inc. (NASDAQ:LABP), a late-clinical-stage biopharmaceutical company utilizing its LANCE Advanced Artificial Intelligence (A.I.) platform to discover and develop novel oral therapeutics for patients with

LABP

1 minute read

Avenue Therapeutics Receives Complete Response Letter From FDA For IV Tramadol; CRL States That ‘the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain’

By Bill Haddad

Today, 8:55 PM

Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that it has received a second Complete

ATXI

1 minute read

Anavex Life Sciences Highlights Publication In Medical Journal Elucidating the Mechanism of ANAVEX2-73 And ANAVEX3-71 Related To The Treatment Of Alzheimer’s Disease

By Bill Haddad

Today, 8:55 PM

Anavex Life Sciences Corp. ("Anavex" or the "Company") (NASDAQ:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and

AVXL

2 minute read

Long-awaited Novavax’s COVID-19 Vaccine Results Hit 90% Efficacy In Pivotal US Trial, 100% Efficacy Against Moderate, Severe Infection

By Vandana Singh

Today, 8:55 PM

Novavax Inc (NASDAQ:NVAX) has finally completed its U.S. Phase 3 trial for its protein-based COVID-19 vaccine candidate. Overall efficacy in the…

NVAX

1 minute read

Novavax’s COVID-19 Vaccine Candidate Showed Immune Response, Protection Against Variants

By Vandana Singh

Today, 8:55 PM

Novavax Inc (NASDAQ:NVAX) announced preclinical and clinical data on its recombinant protein COVID-19 vaccine candidate, NVX-CoV2373, directed against the SARS-CoV-2 Beta…

NVAX

2 minute read

Novavax Announces Co.’s COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial

By Benzinga Newsdesk

Today, 8:55 PM

Novavax, Inc. (NASDAQ:NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and

NVAX

3 minute read

The Week Ahead In Biotech: Takeda, Blueprint Medicines, Orphazyme, Eton On The Radar Ahead Of FDA Decisions, IPOs

By Shanthi Rexaline

Today, 8:55 PM

Biotech stocks extended their gains in the week ended June 11, supported by the broader market strength and some stock-specific moves.

ALXN

1 minute read

Emergent BioSolutions Saus Two Batches Of COVID-19 Vaccine Manufactured By Co. Were Determined Suitable For Use By FDA

By Bill Haddad

Today, 8:55 PM

Emergent BioSolutions Inc. (NYSE:EBS) today announced that two batches of COVID-19 vaccine manufactured by Emergent BioSolutions at its Baltimore Bayview facility were determined to be suitable for use by the U.S.

EBS

2 minute read

FDA
News

Quidel Receives Amended Emergency Use Authorization For New Sofia Q Rapid Antigen Test Device

By Benzinga Newsdesk

Today, 8:55 PM

Sofia® Q device features a miniaturized, AI-powered design Quidel plans initial release to professional and point-of-care segments with a goal of expansion to serve telemedicine and home markets SAN

QDEL