FDA Approves Merck’s Keytruda of 400 mg in 6 weeks for adults
FDA has approves Merck’s Keytruda, pembrolizumab, for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications.
Pharmaceuticals, Biotechnology and Life Sciences
FDA has approves Merck’s Keytruda, pembrolizumab, for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications.
Mylan and Biocon have launched Fulphila, a biosimilar to Neulasta (pegfilgrastim), as it was approved by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
LabCorps’s Q1 revenue of $2.82 billion is up 1% over $2.79 billion last year, while the same period diluted EPS of ($3.27), which include goodwill and other asset impairments of $4.43 per share.
First-Quarter 2020 Revenues of $12.0 Billion, Reflecting 7% Operational Decline; Excluding the Impact from Consumer Healthcare(1), Revenues Declined 1% Operationally.
Merck reported first quarter 2020 worldwide sales at $12.1 billion, an increase of 11%, while – due to the impact of COVID-19, it lowered 2020 full-year revenue range to be between $46.1 billion and $48.1 billion.
Incyte last week named new Canada Biosciencess head, announcing establishing key development and commercialization capabilities in preparation for potential launches of multiple products in the near future.
Collaboration with Astellas supports advancement of Harvard biomedical research and Astellas drug discovery research in a range of therapeutic areas, Harvard said in a press release.
Moderna has submitted IND to USFDA for 600 participant Phase 2 study to continue from ongoing NIH-led Phase 1 study, as planning underway for Phase 3 study expected to begin in the fall of 2020.
Crestone, Inc. today announced a grant award from the National Institutes of Health for the preclinical evaluation of its antibiotic candidate CRS3123 to treat infections caused by Helicobacter pylori.
Teva Pharmaceuticals USA, Inc., an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the autoinjector device for AJOVY® (fremanezumab-vfrm) injection is now available in the U.S.