Drug Approval | December 28, 2021
Optimus Pharma to manufacture and market molnupiravir
The company has developed the API in house at its R&D center in Hyderabad
The company has developed the API in house at its R&D center in Hyderabad
Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000
The single-dose vaccine has been approved in China, Mexico, Ecuador, Chile, Argentina, Hungary, Kirghizstan, Pakistan, Indonesia and Malaysia
With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1
The investment in Yapan Bio allows Piramal Pharma Solutions to broaden its service offerings in the fast-growing biologics CDMO space
Acquisition will add GT005 to the Novartis portfolio, an investigational, one-time gene therapy currently in Phase 2 for the treatment of people living with Geographic atrophy
Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
Authorized booster increases Omicron neutralizing antibody levels approximately 37-fold
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
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