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580 News Found

LivaNova announces first patient implanted in OSPREY clinical study
Medical Device | February 27, 2022

LivaNova announces first patient implanted in OSPREY clinical study

Study to evaluate effectiveness of hypoglossal nerve stimulation


USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy
Biotech | February 25, 2022

USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy

Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases


Moderna and Thermo Fisher Scientific to deepen mRNA collaboration
Medical Device | February 23, 2022

Moderna and Thermo Fisher Scientific to deepen mRNA collaboration

The 15-year agreement will leverage dedicated commercial fill-finish manufacturing capacity in the US for mRNA vaccines and therapies


USFDA lifts clinical hold on submission of Covaxin
News | February 20, 2022

USFDA lifts clinical hold on submission of Covaxin

Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades


US FDA to review Amylyx new drug application for AMX0035
Drug Approval | February 19, 2022

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).


Tremfya achieves greater clinical responses in patients with ulcerative colitis
Biotech | February 19, 2022

Tremfya achieves greater clinical responses in patients with ulcerative colitis

Data from the Phase 2b QUASAR Induction Study showed approximately 60% of patients achieved the primary endpoint of clinical response, and approximately 30% showed endoscopic improvement with TREMFYA treatment compared with placebo


Hetero’s molnupiravir Phase III studies show 65 % reduction in hospitalisation
News | February 19, 2022

Hetero’s molnupiravir Phase III studies show 65 % reduction in hospitalisation

Early viral clearance (negative RT-PCR) and significant clinical improvement were observed within five days of administering the antiviral drug. There were no fatalities reported during the study


Arrowhead Pharmaceuticals initiates study of ARO-C3
News | February 19, 2022

Arrowhead Pharmaceuticals initiates study of ARO-C3

AROC3-1001 is a phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3


Abbott recalls powder formula manufactured at Sturgis, Mich., plant
News | February 19, 2022

Abbott recalls powder formula manufactured at Sturgis, Mich., plant

Recall does not include any metabolic deficiency nutrition formulas


Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose