USFDA

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorization for the Moderna COVID-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The U.S. Food and Drug Administration approved a new indication for Xywav for idiopathic hypersomnia in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep. Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.

Saniona a clinical stage biopharmaceutical company focused on rare diseases announced that the U.S. Food and Drug Administration has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity. Tesomet is the first and only investigational treatment for HO to receive orphan drug designation. Saniona is preparing to initiate two Phase 2b studies of Tesomet in the second half of this year, one in HO and the other in Prader-Willi syndrome, for which Tesomet has already received orphan drug status.

Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

Affinivax, Inc and Astellas Pharma Inc announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. Developed using Affinivaxs proprietary MAPS (Multiple Antigen-Presenting System) platform technology, ASP3772 is designed to offer both B-cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides, as well as two conserved pneumococcal proteins. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated.

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

Merck known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.