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Amygdala scores $2m NIAAA grant to develop alcohol use disorder therapy

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) in the US has awarded a $2m grant to Amygdala Neurosciences to support investigational new drug (IND) application and early development of the aldehyde dehydrogenase (ALDH2) inhibitor for the treatment of alcohol use disorder. According to the 2021 survey by the NIAAA, 29.5 million people aged 12 years and older have experienced alcohol use disorder. Current treatments include behavioural therapy, medication, support groups, and counselling. ANS-858 is an investigational selective and reversible ALDH2 inhibitor, which has been reported to reduce craving and drug-seeking behaviour in preclinical studies. Amygdala CEO Brent Blackburn said in the press release: “This award will enable the development of ANS-858 through pre-clinical evaluation required of an investigational new drug (IND) application to the FDA.” There are multiple drugs currently in development for treating alcohol use disorder. These mainly investigate the use of psychedelic compounds, including Beckly Psytech’s ...
- Source: drugdu
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- August 4, 2023
CS Pharmaceuticals snaps up AxeroVision to shore up ophthalmology portfolio

CS Pharmaceuticals (CSP) has acquired AxeroVision for an undisclosed fee, in a move that will involve a dry eye disease (DED) candidate being transferred over to the UK-based ocular therapeutics company. CSP, which is headquartered in London but develops and commercialises treatments for eye diseases in China, will continue developing AXR-270, a selective glucocorticoid receptor agonist. The drug has been in a phase of developmental dormancy. In August 2021, AxeroVision released positive Phase II results for the candidate in 129 patients with DED with meibomian gland dysfunction (MGD). In a statement announcing the 2021 results, AxeroVision – which spun out from GSK in 2016 – said it was planning to enrol around 800 patients in a Phase III trial comparing the eye cream with a vehicle, and a new drug application/marketed authorisation application filing expected in 2024. However, the company did not issue any further updates on the drug since ...
- Source: drugdu
- 167
- August 4, 2023
Terumo receives FDA clearance for automated whole blood processing system

Dive Brief Terumo Blood and Cell Technologies received clearance from the Food and Drug Administration for what it claims is the first whole blood automation device available in the U.S. The Reveos Automated Whole Blood System processes blood into platelets and other components in a single centrifugation cycle, eliminating some manual steps to separate platelets from the rest of the blood. The device can help blood centers make the process of collecting platelets from blood donations more efficient, increasing availability for people who need them for treatment, Chetan Makam, general manager of Terumo’s global blood solutions business, said in an interview. Dive Insight Platelets are used to treat trauma patients, for procedures like heart surgeries, and for patients who are undergoing chemotherapy. Demand for platelets continues to increase, Makam said. Currently, the majority of platelets available for transfusion in the U.S. come from a process called apheresis, where a donor’s ...
- Source: drugdu
- 116
- August 3, 2023
Fructose identified as central conduit to obesity

Researchers at the University of Colorado Anschutz Medical Campus have officially identified a central conduit to obesity: fructose. While fructose’s contribution to obesity is well-known, a study published today in Philosophical Transactions aggregates a large amount of work to make a full argument for how fructose drives obesity and diseases such as diabetes and fatty liver disease. “This is an in-depth review on a hypothesis that puts nature at the center of weight gain, examining how fructose works differently than other nutrients by lowering active energy,” says Richard Johnson, MD, professor at the University of Colorado School of Medicine and study lead author. “We determine a recently discovered function of fructose in survival that stores fuel in case resources become scarce. This is known as the ‘survival switch,'” he says. Fructose is the source of sweetness in fruit, but is primarily consumed in Western society as table sugar and high ...
- Source: drugdu
- 122
- August 3, 2023
Quest Launches Alzheimer’s Beta-Amyloid Blood Test for Consumers

By Tristan Manalac Monday, Quest Diagnostics launched the AD-Detect Test, a direct-to-consumer blood test designed to catch abnormal levels of the beta-amyloid protein to assess a patient’s risk of developing Alzheimer’s disease. According to Quest, AD-Detect is the first direct-to-consumer blood-based biomarker test for Alzheimer’s disease, though the company is quick to point out that it is not a diagnostic test. “Only a physician or healthcare professional can provide an Alzheimer’s disease diagnosis,” the company said in its announcement. “The risk of having Alzheimer’s disease as the underlying cause for mild cognitive impairment (MCI) or dementia should be considered in conjunction with the findings from medical and family history, physicals, nutritional deficiency biomarkers, neurological and neuropsychological examinations, and neuroimaging,” according to Quest. AD-Detect works by measuring two types of beta-amyloid biomarkers in the blood and determining the beta-amyloid 42/40 ratio, a validated tool used to assess a patient’s risk of ...
- Source: drugdu
- 214
- August 3, 2023
GSK’s Jemperli Beats Merck’s Keytruda for Frontline Endometrial Cancer Approval

By Tristan Manalac The FDA has approved GSK’s Jemperli (dostarlimab-gxly) for the treatment of primary advanced or recurrent endometrial cancer, the company announced Monday. The label expansion covers a combination regimen of Jemperli, carboplatin and paclitaxel, followed by Jemperli as a single agent. Monday’s approval also only applies to patients who are mismatch repair deficient (dMMR), as confirmed by an FDA-approved test, or who have high microsatellite instability (MSI-H). Jemperli is the first immuno-oncology treatment and PD-1 inhibitor to be authorized for frontline use in this patient population, according to GSK. The expanded approval “redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” for whom chemotherapy alone has been the standard of care, though many patients still see disease progression, Hesham Abdullah, GSK’s senior vice president and global head of oncology development, said in a statement. Jemperli is an anti-PD-1 antibody that was first approved ...
- Source: drugdu
- 122
- August 3, 2023
New study finds vaccines could avert 500,000 antimicrobial resistance deaths each year

A new study published in BMJ Global Health has revealed that over 500,000 deaths associated with antimicrobial resistance (AMR) could be averted each year with the effective use of existing vaccines and continued development of new vaccines to tackle priority pathogens. The modelling study, Global and regional burden of attributable and associated bacterial antimicrobial resistance avertable by vaccination, was carried out by the World Health Organization (WHO), the International Vaccine Institute, Korea (IVI) and the London School of Hygiene and Tropical Medicine. AMR occurs when bacteria, viruses, fungi and parasites change over time and become resistant to medicines. The condition has been declared by WHO as one of the top ten global threats to global public health, associated with around 4.95 million deaths globally per year. Science has been playing catch-up to mitigate AMR due to the strain that was faced by health systems worldwide throughout the COVID-19 pandemic. Using ...
- Source: drugdu
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- August 3, 2023
As COVID revenues disappoint, once-high-flying Pfizer looks at possible cost cuts

As COVID-19 revenues ebb and flow—but mostly ebb—Pfizer is eyeing the cost-cutting shears. “Clearly, there is a higher level of uncertainty regarding the demand projections for our COVID-19 products than for the rest of our business,” Pfizer chief Albert Bourla, Ph.D., admitted on a conference call Tuesday. While the shift to a traditional commercial market for Paxlovid and Comirnaty could help, a veil of uncertainty persists. In turn, “we are also preparing to have the ability to adjust our 2024 total cost base” to align with future COVID needs, the CEO added. “In fact, we have already identified specific areas where we can make adjustments primarily within our COVID-19 cost base,” he said. Paxlovid generated just $143 million in worldwide sales for the second quarter, down 98% from the $8.1 billion it pulled down over the same stretch in 2022. MRNA vaccine Comirnaty, for its part, brought home $1.4 billion, ...
- Source: drugdu
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- August 3, 2023
US DoD backs potential treatment for Fragile X-linked neurodegenerative disorder

The US Department of Defense (DoD) has awarded PureTech Health $11.4m to help target Fragile X-associated tremor/ataxia syndrome (FXTAS), a late-onset neurological condition that is difficult to diagnose and currently has no effective treatments. Based in Massachusetts, US, Puretech Health will use the funds to advance LYT-300 in a Phase II trial. LYT-300 is an oral prodrug of allopregnanolone, which is known to regulate mood via its positive allosteric modulation of gamma-aminobutyric-acid type A (GABAA) receptors. It is already approved by the US Food and Drug Administration (FDA) as an infusion treatment for postpartum depression. PureTech Health said administration limitations have previously restricted the wider use of the neurosteroid. Developed using the company’s Glyph platform that harnesses natural lipid absorption and transport processes, LYT-300 can be orally administered. FXTAS occurs in premutation carriers of Fragile X Syndrome. Estimates suggest that 30%-40% of male carriers, and 8%-16% of premutation carriers will ...
- Source: drugdu
- 100
- August 3, 2023
Neuraxpham gears up to market TG’s relapsing MS treatment Briumvi in Europe

TG Therapeutics has signed an ex-US commercialisation agreement with Neuraxpham Group to launch its multiple sclerosis treatment Briumvi (ublituximab) in Europe. Briumvi is an anti-CD20 monoclonal antibody that has been approved in the US and European Union (EU) for relapsing forms of multiple sclerosis (RMS). Following the agreement, Neuraxpharm will also seek approvals in the UK and Switzerland. As per the agreement, TG will receive a $140m upfront payment followed by an additional $12.5m after the launch of Briumvi in the first EU country. Additional milestone-based payments of up to $492.5m are based on certain launch and commercial milestones. The deal news came on the same day as the company’s Q2 financial results. Following both announcements, there was a 42.5% decline in TG’s stock price at market open today, compared to the market close yesterday. In the Q2 earnings, TG Therapeutics reported he a loss of $86.8m and $47.6m for ...
- Source: drugdu
- 196
- August 3, 2023

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