05th April 2022 | Pharma Updates
Biological E in Hyderabad receive mRNA technology from the WHO for COVID vaccines
Biological E Limited, which created the Corbevax for Covid-19 recombinant subunit protein vaccine, has been chosen as a beneficiary of mRNA technology from the WHO technology transfer centre.
WHO: Bharat Bio's Telangana unit failed a GMP test; leading Covaxin suspension
WHO suspended Covaxin supplies for UN purchase due to non-compliance with good manufacturing procedures (GMP) at Bharat Biotech’s flagship vaccine manufacturing facility in Hyderabad’s Genome Valley.
FDA approved Abbott's Aveir VR leadless pacemaker system
Aveir single-chamber leadless pacemaker has been approved by the USFDA for the treatment of patients with slow cardiac rhythms in US. This is a big step forward in patient care, bringing patients and doctors new, never-before-seen features.
FDA expanded approval of Gilead's Yescarta, bringing CAR-T therapy closer to reality
The approval is a first for CAR-T therapy, which is a sophisticated medicine made from a patient’s immune cells that has been genetically reengineered to better target malignancies.
GE Healthcare's first-ever software to help automate anaesthesia delivery received FDA approval
GE Healthcare’s End-tidal (Et) Control software for general anaesthetic delivery on its Aisys CS2 Anesthesia Delivery System has received FDA pre-market clearance (PMA).
FDA Approves the First Topical Therapy for Facial Angiofibroma
Nobelpharma reported that the FDA has approved sirolimus 0.2 percent gel as the first topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC).
Medical Device User Fee Amendments (MDUFA V) is getting closer to being approved
The FDA and the medtech industry have finally reached an agreement that will establish the FDA’s goals for the next five years, after more than two months of delays.
Apyx Medical Corporation has filed a 510(k) application with the FDA
Apyx, branded and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market, has filed a 510(k) premarket notification with USFDA.
CanSinoBIO's COVID vaccine approved for clinical studies in China
CanSino Biologics announced that their possible COVID-19 vaccine, which uses messenger RNA (mRNA) technology, has been licenced for clinical trials by China’s medical goods regulator.
Tocilizumab granted priority evaluation by FDA for COVID-19 treatment
FDA has given intravenous tocilizumab priority evaluation for people hospitalised with COVID-19 who require supplementary oxygen, mechanical ventilation, or extracorporeal membrane oxygenation who are receiving systemic corticosteroids.