The FDA’s Cardiovascular and Renal Drugs Advisory Committee (RDAC) will meet Wednesday to review GlaxoSmithKline’s daprodustat, intended to treat anemia due to chronic kidney disease (CKD) in adults.
Gene-sequencing company Pacific BioSciences of California Inc. on Tuesday announced the launch of a new, more affordable, higher-throughput “long-read” sequencer as well as customer testing of its first “short-read” sequencer aimed at emerging markets such as multi-cancer early detection.
Daily global COVID-19 infections are projected to rise slowly to about 18.7 million by February from the current 16.7 million average daily cases, driven by the northern hemisphere’s winter months, the University of Washington said in an analysis.
Ipsen’s fibrodysplasia ossificans progressiva (FOP) odyssey continues as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
In the near future, painful jabs and muscle soreness that persists for days could be replaced by new immunization approaches including intradermal delivery, edible and intranasal vaccines.
Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.
The company is planning to produce and donate investigational Sudan ebolavirus vaccine to a global non-profit organization’s research program in Uganda, which is facing an outbreak of the disease. The virus circulating in Uganda is the Sudan strain of Ebola, for which there is no proven vaccine.
Drugmaker AstraZeneca said on Tuesday that its asthma drug Fasenra failed to meet one of two main goals of a late-stage study assessing the treatment’s benefits in a chronic allergic condition that causes difficulty in swallowing.
Most clinical-phase drug development projects fail due to a lack of efficacy in the intended disease indication. Employing virtual patients during the drug development process has the potential to help guide decisions around dosing and efficacy.
The FDA greenlit AstraZeneca’s anti-CTLA-4 antibody tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
