Clinical data in the first half of 2023 is up 1.51% compared to the same time period last year. So far in 2023 BioWorld reported on 1,810 drugs in phase I-III, compared to 1,783 in the first half of 2022. The number of trial updates is down 13.6% from the 2,095 in 2021, but more than 2020’s 1,799 and 2019’s 1,477.
Investors will have to wait for durability of response (DoR) data from Urogen Pharma Ltd.’s phase III Envision study with UGN-102 (mitomycin intravesical solution) in low-grade, intermediate-risk, non-muscle invasive bladder cancer, but urologists already characterize what’s available so far from that study, as well as Atlas – another late-stage experiment – as practice-changing.
Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
News from Truvian Health Inc. that its benchtop blood testing platform can deliver results similar to those generated by central laboratory is promising for the diagnostic sector still coming to terms with fraudulent claims from companies such as Theranos Inc. and Arrayit Corp. that their various technologies were able to run an array of tests with just a few drops of blood.
Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
Mersana Therapeutics Inc. followed grim June news with an even worse headline as the phase Ib/II study called Uplift with upifitamab rilsodotin (upri) did not meet its primary endpoint in platinum-resistant ovarian cancer (prOC). The antibody-drug conjugate (ADC) targets the sodium-dependent phosphate transport protein NaPi2b and was developed via the company’s platform called Dolaflexin. Shares of Mersana (NASDAQ:MRSN) tumbled 73%, or $2.84, to close July 27 at $1.07 on word of the failure of the trial.
Art Medical Ltd. released data from a study which demonstrated that its Smart+ Platform can maximize feeding efficiency and improve patient outcomes by reducing both ICU length of stay and the length of time on a ventilation by approximately three days. ICU complications related to nutrition pose significant challenges in critical care.
Medical device company Know Labs Inc. reported results from a new study showing that continued algorithm refinement combined with more high-quality data significantly increased the accuracy of its Body-Radio Frequency Identification, or Bio-RFID, sensor technology to measure and detect changes in blood glucose levels.
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
The growing number of drugs gaining U.S. FDA approval for Alzheimer’s disease has kept their ability to reduce amyloid beta and tau proteins in the news, but the degenerative disease is not simply a matter of tangles and deposits. A loss of synaptic plasticity and disrupted neural networks underlie the signature impairment of memory and cognition – and those, researchers showed in a recent study in Brain, can be strengthened by non-invasive stimulation that addresses the brain’s electrical dysfunction.
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