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The U.S. FDA’s effort to push companies toward more and better randomized, controlled trials ahead of accelerated approvals – apparently driven by the lack of confirmatory studies done afterward – is “an important and meaningful move by the agency,” said Day One Pharmaceuticals Inc. CEO Jeremy Bender. “The industry’s history in that space has been a little mixed.” Bender’s remarks came Aug. 9 as part of a wide-ranging panel discussion hosted by analyst Robert Driscoll during the Wedbush Pacgrow Healthcare Conference.
Researchers around the world are making advances in understanding how HIV becomes latent and seeking out vulnerabilities that could provide routes to targeting reservoirs and eliminating them.
Data on C2N Diagnostic LLC’s new blood test combining a proprietary p-tau217 measurement with the amyloid beta (a-beta) 42/40 ratio, a component of C2N’s commercially available PrecivityAD blood test, could help to predict people at risk for Alzheimer’s disease (AD) – even at the earliest stages.
Beta-site APP-cleaving enzyme 1 (BACE1) inhibitors have a long history of failure in patients with Alzheimer’s disease. Clinical development of verubecestat, elenbecestat, lanabecestat, umibecestat, atabecestat and LY-3202626 were all discontinued. The drugs largely showed that inhibiting BACE1 reduced amyloid beta (AB) in both cerebrospinal fluid and plasma, reduced AB plaques on PET scans and reduced phosphorylated tau. Unfortunately, patients had early cognitive worsening, and there were signs of lowering of brain volume and increases in psychiatric adverse events.
Big pharma is increasingly turning to Taiwan to leverage the power of the country’s data and computing power as precision medicine takes center stage in drug development, speakers said during the recent BIO Asia-Taiwan conference in Taipei.
Keeping innovation growing at a fast clip while retaining new global supply chain capacity built up during the pandemic were the main topics of discussion at the Bio Asia-Taiwan conference July 27 in Taipei. With the theme of the conference, “Connecting the Asia Value Chain,” Taiwan Vice President Ching-Te Lai said the pandemic has demonstrated Taiwan’s resilience as well as the strength of the global biopharma industry.
During a presentation at the Alzheimer's Association International Conference 2022, researchers from the Genetic Frontotemporal Dementia (FTD) Initiative consortium presented data from a study following nearly 1,300 patients with FTD caused by a genetic mutation, their presymptomatic family members who have the inherited mutation and unaffected family members to serve as controls. Researchers have used data from the study, which has been enrolling patients for over 10 years, to develop biomarkers that can be used to assess progression of FTD in interventional clinical trials.
Growing collaborations between pharma and technology companies in digital health are beginning to create a new ecosystem in Taiwan that it hopes will increase its value in the global supply chain, speakers said during the BIO Asia-Taiwan conference in Taipei, running July 27-31.
Keeping innovation growing at a fast clip while retaining new global supply chain capacity built up during the pandemic were the main topics of discussion at the Bio Asia-Taiwan conference July 27 in Taipei. With the theme of the conference, “Connecting the Asia Value Chain,” Taiwan Vice President Ching-Te Lai said the pandemic has demonstrated Taiwan’s resilience as well as the strength of the global biopharma industry.
After three years of clinical research, Royal Philips NV said its Tack (4-F) endovascular system has shown promising results for arterial dissection repair following balloon angioplasty in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. The data was collected from a 36-month follow-up in the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee clinical trial.