Search Results for “antibody” – Page 34 – media

Regeneron’s linvoseltamab application accepted for review

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 ...
- Source: https://www.echnology.com/news/regeneron-linvoseltamab-application-review/
- 95
- February 11, 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
- 117
- 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
- 93
- February 7, 2024
Hengrui ADC Innovative Drug SHR-A1811 HER2 Positive Gastric Cancer Indication Proposed to be Included in Breakthrough Therapy Variety

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 ...
- Source: drugdu
- 114
- February 6, 2024
FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

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 ...
- Source: drugdu
- 98
- February 6, 2024
Will the real standard of care please stand up?

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, ...
- Source: drugdu
- 89
- February 5, 2024
SINOVAC Influenza Vaccine Exported to Chile for the First Time, Helping to Prevent and Control the 2024 Influenza Season in the Southern Hemisphere

On February 2, 2024, a batch of trivalent influenza vaccine Anflu® produced by SINOVAC arrived in Santiago, Chile. This is the first time that SINOVAC influenza vaccines have exported finished influenza vaccines prepared from the candidate strains recommended by the World Health Organization for influenza vaccines in the southern hemisphere to a country in the southern hemisphere. The vaccine will be distributed to private vaccination centers in Santiago and other major cities across the country for the local 2024 Southern Hemisphere Influenza Season vaccination campaign starting in March. Bárbara Ester Orellana Álvarez, SINOVAC’s Director of Registration in Chile, said the vaccine is now safely stored in cold storage under license from the Chilean Institute of Public Health (ISP). The timely arrival of this shipment demonstrates SINOVAC’s commitment to providing the Chilean people with vaccines of the highest quality and safety standards. “We are confident that this operation will contribute to ...
- Source: drugdu
- 85
- February 5, 2024
Roche’s Vabysmo Shows Sustained Improvements in Vision, Retinal Drying in Retinal Vein Occlusion

Davy James Vabysmo is the first bispecific antibody approved to treat ocular conditions such as diabetic macular edema and wet age-related macular degeneration. Findings from the global Phase III BALATON (NCT04740905) and COMINO (NCT04740931) trials show Roche’s Vabysmo (faricimab-svoa) produced sustained retinal drying and improved vision in patients with retinal vein occlusion (RVO).1 Vabysmo, the first bispecific antibody approved to treat ocular conditions, inhibits a pair of disease pathways involved in multiple vision-threatening retinal conditions by neutralizing angipoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).2 In February 2022, Vabysmo became the first and only FDA-approved injectable eye medicine for diabetic macular edema and wet age-related macular degeneration. “This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion,” Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global ...
- Source: drugdu
- 91
- February 4, 2024
Johnson & Johnson Seeks Approval for Darzalex Faspro Combo in Newly Diagnosed Multiple Myeloma

Pharmaceutical Executive Editorial Staff Darzalex Faspro has previously been approved by the FDA for eight indications in multiple myeloma. The FDA will evaluate Johnson & Johnson’s supplemental Biologics License Application (sBLA) for Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy and in combination with lenalidomide (D-R) for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1 Darzalex Faspro, a CD38-directed antibody, has previously been approved by the FDA for eight indications in multiple myeloma, with three in the frontline treatment of newly diagnosed patients who are transplant eligible or ineligible. “We are committed to changing the course of multiple myeloma through building combination regimens such as D-VRd with complementary mechanisms of action. The Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in the risk of progression or death for transplant-eligible, newly ...
- Source: drugdu
- 131
- February 2, 2024

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