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Singapore first to top WHO’s classification of medical regulator
News | March 01, 2022

Singapore first to top WHO’s classification of medical regulator

Achieving ML 4 brings Singapore closer to becoming a WHO listed authority, a new scheme that will be operational later this year and will list the world’s regulators of reference


Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib
Biotech | March 01, 2022

Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib

The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors


Bruker releases CCS-Enabled TIMScore and TIMS DIA-NN 4D Proteomics Software
Biotech | March 01, 2022

Bruker releases CCS-Enabled TIMScore and TIMS DIA-NN 4D Proteomics Software

Innovative TIMScore for dda-PASEF and dia-PASEF libraries, combined with TIMS DIA-NN identifies 9000 protein groups from 200 ng K562 lysate in just 35 min gradient


Novavax UK Phase 3 trial demonstrates protection from Covid-19 over six-month period
Biotech | March 01, 2022

Novavax UK Phase 3 trial demonstrates protection from Covid-19 over six-month period

High level of vaccine efficacy maintained over a 6-month period of surveillance


AstraZeneca and Neurimmune enter licencing agreement to develop and commercialise NI006
Biotech | March 01, 2022

AstraZeneca and Neurimmune enter licencing agreement to develop and commercialise NI006

Under the terms of the agreement, the upfront payment from Alexion to Neurimmune is US $ 30m


South Korea's OCI acquires 11% stake in Bukwang Pharmaceutical
Biotech | March 01, 2022

South Korea's OCI acquires 11% stake in Bukwang Pharmaceutical

Company has bought 7.73 million shares for KRW 146.1 billion thus securing the largest shareholder status in Bukwang Pharmaceutical


Biocon Biologics acquires Viatris’ biosimilar assets for up to US $ 3.3 billion
News | February 28, 2022

Biocon Biologics acquires Viatris’ biosimilar assets for up to US $ 3.3 billion

BBL will gain Viatris’ global biosimilars business whose revenues are estimated to be USD 1 billion next year, along with its portfolio of in-licensed biosimilar assets


China’s NMPA accepts supplemental NDA for Carteyva
Drug Approval | February 28, 2022

China’s NMPA accepts supplemental NDA for Carteyva

The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China


Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

Unichem receives ANDA approval for bipolar disorder drug

Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches


Europe clears blood test to predict Alzheimer’s disease
Medical Device | February 28, 2022

Europe clears blood test to predict Alzheimer’s disease

It is the first approved blood test that can predict likely progression to Alzheimer's Disease up to six years in advance