Current point-of-care (POC) diagnostic technologies are typically limited to measuring a single disease biomarker or several biomarkers from the same class of molecules, such as various RNAs, proteins, or antibodies. However, the ability to measure multiple biomarkers from different molecular classes could provide a more comprehensive understanding of a disease’s state, severity, progression, and individual variations in its development. Electrochemical biosensors, which convert the chemical signal of a biomarker found in a small biofluid sample (like blood, saliva, or urine) into an electrical signal proportional to the biomarker’s amount, could potentially address many diagnostic challenges at the point of care. These sensors can be assembled into multiplexed arrays to detect different biomarkers, and recent advances have overcome the challenge of “biofouling” – the degradation of electrode surfaces by nonspecific biological molecules in samples – through the development of thin antifouling coatings. Now, researchers at Wyss Institute at Harvard University (Boston, ...
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Johnson & Johnson’s (J&J) nipocalimab for alloimmunised pregnant people at increased risk of increased severe haemolytic disease of the foetus and newborn (HDFN), which can cause life-threatening anaemia. This investigational therapy is the only one in the clinics for the condition, which occurs when the blood types of the pregnant individual and the foetus are incompatible. Nipocalimab is a fully human, aglycosylated, effectorless, monoclonal antibody designed to hinder the neonatal fragment crystallisable receptor (FcRn) and reduce levels of circulating immunoglobulin G antibodies. The regulator granted BTD based on findings from the proof-of-concept, open-label Phase II UNITY clinical trial of the therapy. The multicentre, international, non-blinded trial assessed nipocalimab’s efficacy, safety, pharmacodynamics and pharmacokinetics. The study met this primary endpoint with 54% of pregnant subjects. A small number of severe adverse events were reported in the study. ...
AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for the fiscal year (FY) 2023 from $3.29bn in the previous year. Despite a $3.73m decline in the sales of Covid-19 medicines, the company’s total revenue for the full year 2023 grew by 6% to $45.81bn, up from $44.35bn in FY 2022. Excluding Covid-19 medicines, AstraZeneca saw a 15% increase in total revenue. The company experienced growth across oncology, where revenues rose by 21%, cardiovascular, renal and metabolism (a rise of 18%), respiratory and immunology (a rise of 10%) and rare disease (a rise of 12%). Reported earnings per share (EPS) stood at $3.84, an 81% increase from the $2.12 reported in the previous year. Core EPS, a key profitability measure, rose 15% to $7.26. The company’s earnings before interest, taxes, depreciation and amortisation also saw a notable increase of 47% ...
Regeneron Pharmaceuticals marketing authorisation application (MAA) for linvoseltamab has received acceptance for review from the European Medicines Agency (EMA) to treat adults with r/r MM. Linvoseltamab is a bispecific antibody designed to target and destroy cancer cells by bridging the B cell maturation antigen on MM cells with CD3 (cluster of differentiation 3, a protein complex)-expressing T cells. The MAA submission is based on findings from the Phase I/II LINKER-MM1 clinical trial of linvoseltamab in r/r MM patients. The open-label, multicentre, dose-escalation and dose-expansion study is designed to evaluate the investigational drug in patients who have undergone multiple prior treatments. All 282 enrolled trial subjects had received a minimum of three lines of therapy or were considered triple refractory. They subsequently received linvoseltamab through an initial step-up dosing regimen, followed by a full dose. The completed Phase I portion of the trial evaluated the tolerability, safety ...
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, ...
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 ...
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 ...
This study was led by Professor Jin Li of Dongfang Hospital, Tongji University, with the participation of a total of 17 centers across China. Previously, four other indications of SHR-A1811 have been included in the list of breakthrough therapeutic varieties by the Drug Evaluation Center of the State Drug Administration, and the indications are: recurrent or metastatic breast cancer with low expression of HER2, HER2-positive recurrent or metastatic breast cancer, HER2-mutated advanced non-small-cell lung cancer that has failed previous platinum-containing chemotherapy, and advanced non-small-cell lung cancer that has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan, and has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan. irinotecan treatment failure, and HER2-positive colorectal cancer. In 2020, gastric cancer ranks 5th in global cancer incidence and 4th in mortality. HER2-positive gastric cancer is a unique disease subtype that requires different treatment strategies from HER2-negative gastric cancer. The global HER2-positive rate of gastric ...
Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing shows. External experts invited by the FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal ...
One day after Roche said it was starting to establish Vabysmo as the new standard of care in age-related macular degeneration (AMD) and diabetic macular edema (DME), Regeneron clapped back with the same claim about its new treatment—high-dose Eylea. “We continue to see physicians prescribe Eylea HD in both treatment experienced and treatment naïve settings as Eylea HD is increasingly recognized as the new standard of care,” Marion McCourt, Regeneron’s commercial chief, said as the company presented its fourth-quarter and 2023 earnings. Eylea HD is Regeneron’s response to Vabysmo, which hit the market in the first quarter of 2022 as a game-changing, longer-acting treatment. Vabysmo allowed many patients to reduce dosing from six times a year—with Regeneron’s original version of Eylea—to three times a year. Vabysmo has been an immediate hit as illustrated by Roche’s sales figures, which were presented on Thursday. In its first full year on the market, ...
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