HONG KONG – U.S. regulators have given the green light to 12 biosimilars and the EU has cleared a whopping 53. China, however, has lagged behind, though industry experts are predicting the first biosimilar could clear regulatory hurdles this year. Read More
A study by Agency for Science, Technology and Research (A*STAR) researchers in Singapore has discovered that the Plasmodium parasite responsible for malaria triggers immune pathways that reduce the severity of symptoms caused by infection with the Chikungunya virus (CHIKV) in mice. Read More
PERTH, Australia – Dimerix Ltd. has begun recruiting patients for two separate phase II trials of its kidney disease candidate, DMX-200, in diabetic kidney disease and in orphan disease focal segmental glomerulosclerosis (FSGS). The Perth, Australia-based company hopes to replicate compelling data it saw in a subgroup of patients with type 2 diabetes, which could significantly open up the potential patient population for the drug. Read More
HONG KONG – Japan's Daiichi Sankyo Co. Ltd. has moved its HER2-targeting antibody-drug conjugate (ADC), DS-8201 ([fam-] trastuzumab deruxtecan), into a pivotal program, including a study that pits it against Roche Holding AG's Kadcyla (ado-trastuzumab emtansine, TDM-1), an ADC first approved in 2013 that's expected to hit blockbuster status this year. Read More
Prana Biotechnology Ltd., of Melbourne, Australia, reported that further preclinical evidence for PBT-434 will be presented at the International Congress of Parkinson's Disease and Movement Disorders in Hong Kong. The data demonstrate in the most widely accepted animal model of multiple system atrophy (MSA), a fatal neurodegenerative disease and an important form of atypical Parkinsonism, that PBT-434 prevents alpha-synuclein aggregation, preserves neurons, decreases the number of glial cell inclusions and slows motor dysfunction. Read More
The global biopharmaceutical sector generated $16 billion in the third quarter of the year, adding to the almost $38 billion it raised in the first half of the year. According to BioWorld data, the collective $54 billion the sector has brought in at the three quarter post is 4 percent more than the total it raised at this point last year. The sector is poised to post a record year for the amount of cash it hauled in and to top the $69 billion raised in 2015. Read More
