Natera’s evolution in molecular diagnostics
Natera’s success traces to pioneering research isolating and analyzing fetal DNA fragments circulating in a pregnant woman’s bloodstream. Natera capitalized on the emerging space of non-invasive prenatal tests (NIPT) with products such as Panorama that represented a major advance over risky amniocentesis procedures used for definitive diagnosis. Commencing its journey in the NIPT space as […]
AbbVie acquires Mitokinin in its Neuroscience pipeline
Earlier this month, AbbVie acquired Mitokinin, a discovery-stage biotechnology company developing a disease modifying treatment for Parkinson’s Disease (PD). PD is a neurodegenerative movement disorder where dopaminergic neurons of the brain that control movement are preferentially lost, causing slowness in movement, rigidity of limbs and trunk, tremors, and postural instability. It affects over 10 million […]
NeuroSense receives patent approval for ALS candidate drug, PrimeC from multiple countries
After the U.S., Canada, and Australia, it was turn for Europe, Israel and Japan to approve NeuroSense Therapeutic’s patent application on “Compositions comprising an anti-inflammatory drug and a dicer activator for use in treatment of neuronal diseases.” The patents relate to the formulation of two known FDA (US Food and Drug Administration) approved drugs viz. Ciprofloxacin and […]
Guardant Health in liquid biopsy cancer diagnosis
Cancer treatment experienced a seismic shift in the 2010s with the rise of personalized precision medicine. Cofounded in Silicon Valley by entrepreneur Helmy Eltoukhy with fellow Stanford and Illumina alum AmirAli Talasaz in 2012, Guardant Health has been at the forefront of developing liquid biopsy technology for cancer diagnosis. Guardant aimed to provide non-invasive approaches […]
Cancer early diagnosis and liquid biopsies: Are We There Yet?
The field of liquid biopsy-based cancer diagnostics stands at an inflection point, primed to enable earlier detection, precise monitoring, and tailored cancer management. Myriad companies, predominantly startups but also including seasoned diagnostics players, are steering rapid innovations through blood tests that analyse circulating tumor DNA, cells, and other cancer biomarkers. Central to this transformation is […]
WaveBreak’s Small-Molecule Inhibits Toxic Oligomers of alpha synuclein in Pre-clinical study
WTX-A is a small-molecule oral drug developed by WaveBreak. In a recent pre-clinical study, it efficiently blocked α-synuclein oligomers and aggregates in both cell and mouse models of Parkinson’s disease (PD) in a dose-dependent manner. Oligomers are toxic intermediate forms of abnormally folded proteins directly responsible for neurotoxicity in PD, Alzheimer’s Disease, and Amyotrophic Lateral […]
Lack of ethnic diversity in Alzheimer’s disease clinical trials – how patients of color get side-lined.
Under-representation of people of color in clinical trials is a long-standing problem in medical research with far-reaching consequences on research outcomes and equity towards access to treatments. Clinical trials on the newly approved Alzheimer’s disease (AD) drug, Leqembi and Eli Lilly’s Donanemab, currently awaiting FDA’s decision, have both been criticized (1) for having less diverse […]
Lily’s Donanemab poised for FDA’s approval
The positive outcome of Eli Lilly’s 18 months phase 3 randomized clinical trial on donanemab among 1736 participants with early Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology was simultaneously presented and published at Alzheimer’s Association International Conference in Amsterdam and the journal JAMA respectively. Donanemab, an antibody designed […]
LEQEMBI approved by FDA for early Alzheimer’s disease treatment
The U.S. Food and Drug Administration (FDA) has now approved LEQEMBI under the traditional pathway making it the first approved treatment for early AD with a significant reduction in disease progression rate and slowing cognitive and functional decline. It marks Eisai’s success in research collaboration with Biogen and BioArctic for joint development and commercialization of […]
FDA clears Roche’s Elecsys CSF diagnosis assays for Alzheimer’s disease
Roche’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays received FDA’s 510(k) clearance (also called pre-market notification) for early and accurate diagnosis of Alzheimer’s disease (AD). This assay pair measures the ratio of two biomarkers of AD viz., tau (tTau) and beta-amyloid (Abeta42). It will hit the market in Q4 of 2023 […]
Chronic oral dosage of HT-ALZ improves spatial memory in mouse model of Alzheimer’s disease
Hoth Therapeutics announced the pre-clinical results of its oral soluble film formulation, HT-ALZ, for the treatment of Alzheimer’s disease (AD) and associated symptoms (dementia). The study performed on an established AD mouse model (APP/PS1+/-) showed those receiving over 5 weeks of the oral treatment had significant improvement in spatial memory tests indicating a positive therapeutic potential of HT-ALZ […]
Recommendations of the advisory committee on pneumococcal immunization practices
“Currently, the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) are recommended for U.S. children, and the recommendations vary by age group and risk group. Use of PCV15 as an alternative to PCV13 is expected to further reduce pneumococcal disease incidence in children and adolescents. PCV15 as an option for pneumococcal […]
New recommendations for influenza vaccine composition
“The World Health Organization has announced the recommended viral composition of influenza vaccines for the 2023 southern hemisphere influenza season. The recommendations issued today will be used by national vaccine regulatory agencies and pharmaceutical companies to develop, produce, and license influenza vaccines for the following influenza season. The periodic update of viruses contained in influenza […]
AB Science submits Application to EMA for Conditional Marketing of Masitinib for the treatment of ALS
Application for Conditional Marketing Authorization to European Medicines Agency (EMA) by AB Science for Masitinib for the treatment of ALS. The application now validated by EMA was submitted based on the results of the phase II/III AB10015 study. The AB10015 trial was conducted on 394 ALS patients over 48 weeks as a randomized double-blind placebo-controlled […]
Phase 2a clinical trial data for COYA-101 in ALS announced
“We believe this Phase 2a study, with the limitations of a small sample size, supports that COYA 101 was well tolerated and biologically active in ALS patients and may slow or halt disease progression in the right patient population. We believe the findings that high levels of inflammation and oxidative stress may limit the effectiveness […]
Amydis receives NIH Grant Award to develop a novel TDP-43 retinal tracer for ALS patients
Dr. Clive Svendsen, Executive Director of the Cedars-Sinai Board of Governors Regenerative Medicine Instiute and a consultant on the grant said that “the ability to detect and monitor TDP-43 at micron-level precision in CNS tissue could significantly facilitate regenerative medicine research focused on slowing progression of ALS and FTD.” On the other hand, Dr. Stella […]
Submission of New Drug Application to the FDA for the treatment of Parkinson’s Disease
Amneal Pharmaceuticals Inc. has submitted a new drug application for the treatment of Parkinson’s Disease to the U.S. Food and Drug Administration (FDA). The new drug IPX203, is a novel oral formulation of carbidopa/levidopa capsules for patients suffering from Parkinson’s Disease (PD). The submission was initiated based on the promising data received from the RISE-PD […]
BrainVectis receives clearance to conduct Phase I/II clinical trial for early-stage Huntington’s Disease
BrainVectis, an AskBio subsidiary, has received clearance to conduct the Phase I/II clinical trial for Huntington’s disease (HD) gene therapy BV-101 in France. BV-101, a novel adeno-associated virus gene therapy vector helps in the clearance of the mutant huntingtin protein in the diseased condition. BV-101 has been shown to provide neuroprotection and restore the function […]