16th February 2022 | Pharma Updates
Medical Device Firms told to Register Again
Medical devices companies have been urged to re-register themselves under the Medical Devices Rules, by September 2022 or else face consequences.
CDSCO Tells MSN Labs to Submit Revised Protocol for Ticagrelor SR Tablets
This came right after the drugmaker submitted the raw data of the bioequivalence study of Ticagrelor SR Tablets coupled with the Phase 3 trial protocol.
FDA Okays Under-Eye Filler
Allergan has received a nod from US’s drug regulator for Juvéderm Volbella XC.
US FDA Approves Generic Version of Brovana
The generic version of Brovana is indicated for treating bronchoconstriction in patients with COPD.
FDA Clears Motus GI’s Pure-Vu EVS System
The Pure-Vu EVS System is developed to manage the poorly prepared colon.
Guard Medical gets FDA nod for NPseal
The device is used to treat patients with complications related to closed surgical incisions.
CLOUDCATH to launch FDA-approved Novel Peritoneal Dialysis
The medical device company is planning to introduce the remote monitoring platform for PD patients in USA.
Pfizer Scores European Medicines Agency Approval for 20-Valent Pneumococcal Conjugate Vaccine
According to drug major, its conjugate vaccine works against 20 serotypes responsible for the majority of invasive disease and pneumococcal pneumonia.
ImmunityBio Buys Manufacturing Plantin NY
A clinical-stage immunotherapy company has purchased the manufacturing facility in western New York from Athenex.
Integrity Bio and LakePharma Become Curia
Curia acquired Integrity Bio in Aug’21 and closed the LakePharma transaction in Sept’21.