PharmaFocus Today – Page 168 – media

Point-Of-Care Tool Diagnoses Genetic Mutations within Hours

Blood disorders like sickle cell anemia arise from genetic mutations. Typically, newborns are screened for sickle cell disease at birth, with any irregularities reported within 96 hours. However, a follow-up blood test is necessary to confirm the diagnosis, and obtaining these results can take between two to four weeks. Often, seeking genetic analysis through specialized private laboratories can be both time-consuming and expensive. Now, a new tool can detect the presence of genetic mutations within hours instead of weeks. Researchers at the University of Calgary (Alberta, Canada) have created a system named One-pot DTECT. This innovation is designed for simplicity and ease of use, enabling any laboratory in the world to quickly set up its own kit for same-day genetic mutation analysis at a minimal cost per sample. One-pot DTECT comprises multiple enzymes and distinct DNA fragments that work together to identify and detect genetic signatures. The compact kit includes ...
- Source: drugdu
- 84
- February 8, 2024
Stalicla secures funds for late-stage assets amid CNS buzz

Stalicla announced the successful closing of a $17.4m Series B funding round as deal-making interest stirs in the central nervous system disorder space. “In the current environment, we see this [financing round] as a huge success, but we’re targeting a much larger round in Q3 2024 with the involvement of large venture capital funds,” says Stalicla CEO Lynn Durham in an exclusive interview with Pharmaceutical Technology. Stalicla aims to use the extra funds to launch a Phase III substance use disorder (SUD) study for its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform in 2025. The US National Institute on Drug Abuse and the National Institutes of Health are supporting Stalicla’s development of STP7.Stalicla acquired the therapy through an in-licensing agreement with Novartis in January 2023. In this deal, the Swiss company acquired the worldwide rights for studies using the STP7 platform for SUD, neurodevelopmental disorders, and other indications in ...
- Source: drugdu
- 102
- February 8, 2024
Non-Endoscopic Capsule Sponge Device Helps Detect Esophageal Cancer

Barrett’s esophagus is a condition often resulting from reflux, characterized by stomach acid damaging the esophagus lining and causing cell changes. While these cells aren’t initially cancerous, there’s a risk they might transform into esophageal cancer, a type where cells in the esophagus proliferate uncontrollably, potentially spreading to other body parts. Esophageal cancer is among the deadliest cancers in adults, and early detection significantly improves survival rates compared to a diagnosis at an advanced stage. Since the symptoms of esophageal cancer can mimic heartburn and reflux, conducting early tests for cancer detection is crucial. Now, a non-endoscopic capsule sponge device has been designed to collect pan-esophageal samples which are then sent for laboratory testing to detect esophageal pre-cancer and other conditions. Cyted’s (Cambridge, UK) EndoSign cell collection device is designed to detect and monitor conditions such as chronic reflux and Barrett’s esophagus, ultimately aiming to prevent esophageal adenocarcinoma. The EndoSign ...
- Source: drugdu
- 86
- February 8, 2024
AnaMar secures double orphan drug designation for systemic sclerosis drug

AnaMar has received orphan drug designations for its systemic sclerosis candidate AM1476 from the FDA and the EMA. The Swedish biotech is now eligible for several incentives in the two regions, according to the designations. Both agencies will provide regular feedback during the application process and waive certain fees. The FDA also offers seven years of market exclusivity while the EMA promises ten years of protection from competition. AnaMar’s AM1476 is an oral antagonist of the 5-hydroxytryptamine receptor (5-HT2B) receptor, which is also known as a serotonin receptor. The company says its candidate halts key signalling pathways associated with fibrosis in a 5 February press release. Systemic sclerosis, also known as scleroderma, is a progressive autoimmune disease characterised by inflammation and fibrosis. Not only is skin hardened in this condition, but internal organs can be affected too. Interstitial lung disease (ILD) is one of the most common disease consequences, occurring ...
- Source: drugdu
- 102
- February 8, 2024
BMS reports 2% revenue loss in 2023 after Revlimid generics hurt sales

BMS has reported its results for the 2023 financial year (FY), revealing a 2% decrease in revenues of $45bn from $46.2bn reported in 2022. The company saw a decrease in sales of Revlimid (lenalidomide) following the entry of generic versions after its patent loss in 2022. Revlimid generated $6bn in 2023, compared to $12.9bn in 2021 before the loss. BMS’ blockbuster cancer drug Opdivo generated $9bn in 2023, a 9% increase from 2022. The human IgG4 anti-PD-1 monoclonal antibody saw a label expansion, as well as increased demand from patients with gastric, bladder, non-small cell lung cancer (NSCLC) and melanoma. BMS’ top-seller is anti-stroke drug Eliquis (apixaban), generating $12.2bn in 2023, however, Eliquis loses its patent in 2026, with GlobalData predicting that sales will drop to $3bn by 2029.In a strategic move to counteract anticipated revenue declines from upcoming patent expirations on certain BMS drugs in the next few years, ...
- Source: drugdu
- 93
- February 8, 2024
Automated Mass Spectrometry-Based Clinical Analyzer Could Transform Lab Testing

Mass spectrometry, known for its higher sensitivity and specificity compared to immunoassays, is particularly effective for testing molecules like Vitamin D and certain hormones where antibody-based tests struggle to differentiate between similar forms. This method allows for more precise testing. Researchers and clinicians have been investigating the use of mass spectrometry for such assays for several years. However, due to its complexity compared to standard immunoassays, mass spectrometry has largely been limited to large clinical reference laboratories and specialized testing companies that have the necessary resources and expertise to develop and conduct these tests. Now, a fully automated clinical mass spectrometry system being developed for routine lab testing could change that. Roche Diagnostics (Basel, Switzerland) is currently developing a fully automated, standardized liquid chromatography-mass spectrometry (LC-MS) solution that will seamlessly integrate into existing clinical chemistry and immunochemistry testing as part of its cobas Pro integrated solutions, as well as laboratory ...
- Source: drugdu
- 116
- February 7, 2024
Cell Sorter Chip Technology to Pave Way for Immune Profiling at POC

Monitoring the response of the immune system of cancer patients during disease and treatment is important for achieving favorable outcomes. To do this, labs utilize flow cytometry to perform immune profiling, which involves identifying and quantifying a patient’s immune cells at a specific time. This information is vital for determining the most effective treatment for a cancer patient. Continuing this profiling during treatment helps clinicians understand how well the treatment is working. Despite the promise of immune profiling in guiding therapy being a burgeoning area in cancer research and treatment, it hasn’t been widely adopted in clinical practice due to the high cost, large size, and complexity of flow cytometry equipment. These machines are confined to specialized labs, and transporting blood samples to these facilities is time-consuming and requires special conditions to keep the cells viable, making routine monitoring of cancer patients challenging. Now, a novel cell sorter chip technology ...
- Source: drugdu
- 91
- February 7, 2024
Valneva sells Ixchiq priority voucher for $103m to fuel R&D

Valneva has sold its US Food and Drug Administration (FDA) priority review voucher for €95m ($103m) to an undisclosed party. The French company received the priority review voucher when its chikungunya vaccine, Ixchiq, got FDA approval in November 2023.Valneva plans to use the funds from the voucher sale to advance its research and development (R&D) efforts, as per a 5 February press release. The voucher sale price is in line with the company’s previous projections of gaining €90m-€110m with such a sale. One of the projects that the company plans to use its proceeds for is the Lyme disease vaccine, VLA15. Valneva is co-developing the vaccine in partnership with Pfizer. VLA15 is an experimental multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. The vaccine is being evaluated in a placebo-controlled Phase III trial (NCT05477524). The trial suffered a delay when both companies paused patient ...
- Source: drugdu
- 92
- February 7, 2024
Contentious Medicare price negotiations underway as US drug prices rise

The US’ HHS has sent the first offers to participating drug companies eligible for negotiation under the Medicare price negotiation programme as required by the Inflation Reduction Act (IRA). The Centers for Medicare and Medicaid Services is managing these talks, with a 30-day window given to involved drug companies to indicate acceptance of the suggested prices or present an alternative offer. Once both Medicare and the drug company agree on a price, the revised prices will become effective within Medicare in 2026.The IRA allows Medicare to directly negotiate to reduce prescription prices for certain drugs and requires certain companies to pay rebates back to Medicare if the drug prices exceed the rate of inflation. The first ten drugs selected to be negotiated in the programme include those marketed by pharma giants AstraZeneca and Merck & Co’s anti-diabetic drugs, Farxiga (dapagliflozin), and Januvia (sitagliptin), respectively. In the announcement accompanying the offers, CMS administrator Chiquita ...
- Source: drugdu
- 91
- February 7, 2024
Moderate kimchi intake linked to lower obesity rates, study shows

In a recent study published in the journal BMJ Open, researchers explored the relationship between kimchi consumption and obesity in South Korea. Obesity is associated with nutritional, environmental, and lifestyle factors and is a significant risk factor for diabetes, chronic kidney disease, cardiovascular disease, and hyperlipidemia. Obesity prevalence in South Korea has increased steadily over the years. Meanwhile, the prevalence of abdominal obesity has also increased over time. Increased obesity prevalence is associated with higher medical expenditure; thus, obesity prevention remains a public health priority. In Korea, kimchi is a traditional side dish low in calories but rich in vitamins, dietary fiber, polyphenols, and lactic acid bacteria. There are concerns about kimchi as one of the major contributors to sodium intake. A 2019-20 survey revealed that daily sodium intake from kimchi was 500 mg (15% of total sodium intake). Studies have shown associations between increased sodium intake and a greater ...
- Source: drugdu
- 85
- February 6, 2024

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