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Enhertu Phase III results to redefine how metastatic breast cancer is classifed
Biotech | February 21, 2022

Enhertu Phase III results to redefine how metastatic breast cancer is classifed

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.


WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients
Drug Approval | February 20, 2022

WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients

Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra


Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy
Drug Approval | February 20, 2022

Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy

Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear


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


EC approves Tepmetko to treat non-small cell lung cancer
Drug Approval | February 19, 2022

EC approves Tepmetko to treat non-small cell lung cancer

Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment


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).


Aizon’s CEO John Vitalie named one of the top 25 Biotech CEOs of 2022
News | February 19, 2022

Aizon’s CEO John Vitalie named one of the top 25 Biotech CEOs of 2022

The Healthcare Technology Report provides market research and insights, business news, investment activity updates and important corporate developments related to the healthcare technology sector


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


ValGenesis selected for validating French pharma firm
Digitisation | February 18, 2022

ValGenesis selected for validating French pharma firm

With ValGenesis VLMS, change control driven validation activities are reduced from weeks to mere hours, and the company gains faster access to detailed metrics that help reduce costs and cycle time


USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
Drug Approval | February 18, 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022