15th March 2022 | Pharma Updates

PharmaState Updates – Latest Pharma Happenings

Zydus Lifesciences received USFDA approval for colestipol hydrochloride tablets

Zydus Lifesciences Ltd. has gained final approval from the US Food and Drug Administration to launch its generic version of colestipol hydrochloride tablets, which is used to decrease cholesterol.

Illumina and Trivitron are teaming for NGS-based IVD diagnostics

Illumina Singapore and Trivitron Healthcare have formed a strategic agreement to develop and extend the usage of next-generation sequencing (NGS)-based in-vitro diagnostic testing (IVD) in India.

Corium's ADLARITY has been approved by FDA

Corium’s ADLARITY (donepezil transdermal system) has been approved by the Food and Drug Administration (FDA) as a treatment for people with mild, moderate, or severe Alzheimer’s dementia.

FDA has approved BRACAnalysis CDx as an Olaparib companion diagnostic

FDA approved the BRACAnalysis CDx test as a companion diagnostic for olaparib treatment of individuals with germline BRCAmutated HER2 negative high-risk early-stage breast cancer.

FDA rejected AstraZeneca's therapy for chronic nasal ailment

USFDA rejected AstraZeneca’s asthma drug, Fasenra, for the treatment of chronic rhinosinusitis with nasal polyps, a condition in which benign growths can cause pain and stuffiness.

Niramai receive FDA approval for medical device in women's health

Niramai Health Analytix, a deeptech healthcare firm, has won US FDA approval for their first device, the SMILE-100 System. It is the first Indian business to receive FDA approval for a medical device.

Sinovac's paediatric Covid-19 vaccine has been approved by the Philippines FDA

Chinese manufacturer Sinovac’s Covid-19 vaccine, CoronaVac, has received emergency use permission from the FDA of the Philippines for use in paediatric patients.

Alembic Pharmaceuticals received tentative approval from the USFDA for Macitentan tablets, 10 mg

Alembic Pharmaceuticals stated that the US Food and Drug Administration (FDA) has tentatively approved its Abbreviated New Drug Application (ANDA) for Macitentan tablets, 10 mg.

Eisai began the process of requesting approval for Lecanemab in Japan

Eisai has commenced submitting data to Japan’s PMDA in support of its application for approval of its investigational lecanemab (BAN2401) for the treatment of early Alzheimer’s disease.

WHO initiates molnupiravir safety monitoring project

WHO has initiated a safety monitoring study of the recently launched antiviral medication molnupiravir in low and middle-income (LMI) countries for the treatment of mild to moderate COVID-19 infection.