The U.S. FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 21-0, June 8 in support of Astrazeneca plc’s nirsevimab as a one-dose prophylactic for infants born during or entering their first respiratory syncytial virus (RSV) season.
Bronchiectasis is an irreversible chronic respiratory condition arising from secondary infections that presents as chronic cough with daily purulent sputum due to a permanent abnormal widening of bronchi.
Aegis Life Inc. and its parent company Entos Pharmaceuticals Inc. (Entos) have entered into a grant agreement with the Bill & Melinda Gates Foundation in the area of infectious disease.
Scientists from the Hospital for Sick Children Research Institute and collaborators have reported the application of a multispecific, multiaffinity antibody (Multabody, MB) platform derived from the human apoferritin protomer to enable the multimerization of antibody fragments against SARS-CoV-2. These MBs showed high potency to neutralize SARS-CoV-2 even at lower concentrations than their corresponding MAb counterparts.
Having already notched approvals in the EU and U.K., Astrazeneca plc hopes to prime the pump for a U.S. approval of nirsevimab as a respiratory syncytial virus (RSV) prophylactic for infants when it makes its case June 8 before the FDA’s Antimicrobial Drugs Advisory Committee.
As it nears the end of its cash runway and its lead antibiotic, Nuzyra, approaches a phase IIb readout, Paratek Pharmaceuticals Inc. agreed to be acquired by Gurnet Point Capital and Novo Holdings A/S for up to $3 per share in a deal that will take the company private.
Suzhou Spring-Sea Bio-Pharmaceuticals Co. Ltd. has prepared and tested prodrugs of N4-hydroxycytidine (NHC) that are reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Qilu Regor Therapeutics Inc. has divulged protein-arginine deiminase type-4 (PADI4) inhibitors reported to be useful for the treatment of sepsis, cancer, bacterial, viral infections, inflammatory disorders, autoimmune diseases and metabolic diseases.
Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation.