Search Results for “ oncology” – Page 20 – media

Legend Biotech’s “CARVYKTI®” was approved for second-line indications in the United States

Recently, Legend Biotech announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of relapsed or refractory multiple myeloid(RRMM) patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and are resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies and antibody-drug conjugates (ADCs). The FDA’s approval is based on positive results from the CARTITUDE-4 study, which showed that compared with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (PVd), DPd) these two standard treatment regimens, CARVYKTI® can significantly improve the progression-free survival (PFS) of adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received first- to third-line treatment. This result has statistical and clinical significance. The approval ...
- Source: drugdu
- 109
- April 8, 2024
Disco tunes into new cancer drug targets

EUR 20m to identify new targets and develop first in class drugs DISCO Pharmaceuticals – a company specialising in unlocking the surfaceome of cancer cells at scale – has raided EUR 20m to identify new targets and develop first in class drugs. The funding round was backed by a formidable investor syndicate, including Sofinnova Partners, Panakes Partners, M Ventures and AbbVie Ventures. The development of new treatment modalities in oncology is increasing, however, the lack of cell surface targets limits the application to some clinically effective targets. Also, the development of new biologics, such as bi-specific antibodies and antibody drug conjugates, is increasing and there are currently less than 30 molecular targets, which form the basis of all antibody-based therapies. Consequently, there is a significant need to identify novel cancer-selective targets and target pairs. DISCO’s surfaceome mapping platform transforms the current approach of target discovery for large molecule R&D. This ...
- Source: drugdu
- 113
- April 7, 2024
Xilio fires 21% of its workforce and reprioritises pipeline

XIlio Therapeutics has implemented cost-cutting measures which include a 21% workforce reduction and the termination of investments for developing one of its assets, XTX202, as a monotherapy. Xilio expects to incur one-time cost of approximately $1m for reducing its workforce by 15 employees. The company has reported $44.7m in cash reserves, which are expected to fund the company’s activities into Q2 2025. The Waltham, Massachusetts-based company’s market cap currently stands at $42.1m. Following the recent round of layoffs, Xilio joins a list of pharmaceutical companies including Atreca, Candel Therapeutics, Kinnate Bio, and NexImmune that have fired workers to funnel more money into their clinical development pipelines in the last few months. The company plans to not investigate XTX202, a tumour-activated beta-gamma biased interleukin (IL)-2, as a monotherapy and instead will explore partnerships to develop the therapy as a combination treatment. The therapy was evaluated in an open label Phase I/II ...
- Source: drugdu
- 78
- April 5, 2024
Eisai to divest rights for two therapies to Kaken

Eisai has signed an agreement for the divestiture of rights for Merislon and Myonal, two of its long-standing products in Japan, to Kaken Pharmaceutical. The transaction is valued at Y3.8bn ($25.10m). Merislon treats vertigo and equilibrium disturbances and Myonal is a muscle relaxant, which patients have used since their respective launches in 1969 and 1983. The agreement stipulates that Eisai will complete the transfer of marketing capabilities by March 2025, followed by manufacturing and marketing approval transfer. The deal will not impact Eisai’s consolidated financial forecast for 31 March 2024. The company stated: “Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the optimal choice to ensure they continue contributing to a greater number of patients.” Eisai will continue to focus on creating and delivering products to target diseases with higher unmet medical needs such as neurology, oncology and ...
- Source: drugdu
- 164
- April 5, 2024
Jazz Pharmaceuticals Completes Biologics License Application for Zanidatamab for HER2-Positive Metastatic Biliary Tract Cancer

Don Tracy, Associate Editor Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States. Jazz Pharmaceuticals announced that it has completed its Biologics License Application (BLA) for zanidatamab, an investigational bispecific antibody treatment targeting HER2-positive metastatic(BTC). Aiming for accelerated approval, zanidatamab has the potential to be the first HER2-targeted therapy indicated for BTC in the United States. According to the company, the BLA was based on findings from the Phase IIb HERIZON-BTC-01 trial for zanidatamab. The primary study endpoint of confirmed objective response rate (cORR) by independent central review (ICR) was deemed a success, as the 80 enrolled patients demonstrated a cORR of 41.3%. The HERIZON-BTC-302 Phase III started recently and is currently in the process of enrollment.1 “This important milestone brings us one step closer to delivering zanidatamab, a targeted treatment option, to patients living with HER2-positive BTC, a type of cancer that is associated ...
- Source: drugdu
- 133
- April 5, 2024
FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis

Don Tracy, Associate Editor Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis. Alexion, AstraZeneca Rare Disease announced that the FDA has approved Voydeya (danicopan) as an add-on therapy for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH), in combination with ravulizumab or eculizumab. According to the company, the medication treats patients with significant EVH despite receiving C5 inhibitor therapy. The approval was based on positive results from the Phase III ALPHA trial, which found that Voydeya improved hemoglobin levels while providing the benefit of avoiding transfusions after a primary 12-week period. Additionally, there was no significant increases reported related to safety concerns, with common adverse reactions including headache, nausea, arthralgia, and diarrhea.1 “The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on ...
- Source: drugdu
- 91
- April 4, 2024
Ipsen joins the ADC club with deal worth up to $900m

Ipsen has joined the slew of companies developing antibody-drug conjugates (ADC) with the announcement of a new global licensing agreement with Sutro Biopharma for the development of the latter’s STRO-003. Ipsen declared that the deal would give it exclusive worldwide rights to develop and commercialise the ROR1-targeting ADC STRO-003. Ipsen is accountable for Phase I preparations, including investigational new drug application (IND) submissions. The Paris, France-headquartered company will also be responsible for the later clinical development and global commercialisation of STRO-003. Under the partnership, Sutro Biopharma could receive up to $900m in prospective upfront, development, and commercial milestone-based payments. This is inclusive of $90m in near-term payments in the form of tiered royalties on global sales, and an equity investment, dependent on Ipsen’s successful development and commercialisation strategy. STRO-003 is one of three named ADCs being developed in Sutro’s clinical pipeline. In June 2023, Sutro announced plans to submit INDs ...
- Source: drugdu
- 153
- April 4, 2024
Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
- Source: drugdu
- 96
- April 3, 2024
GlobalData

In the dynamic landscape of the pharma industry, collaboration often serves as the key to innovation and expanding market presence. In recent years, the Asia-Pacific (APAC) market has emerged as a hub for pharmaceutical development and investment, attracting attention from both local and global players. While cooperation between APAC-based pharmaceutical companies and their global counterparts has been on the rise, active cooperation among pharma companies within the APAC region is gaining traction, observes GlobalData. According to GlobalData’s Pharmaceutical Intelligence Center, from 2019 to 2023, 673 deals (strategic alliances) occurred among companies that are purely based in APAC, with 360 deals* of them being for unique therapy areas. It is interesting to note that 44 per cent of these deals* are for oncology, followed by infectious diseases (20 per cent), central nervous system disorders (12 per cent), cardiovascular disorders (4 per cent), and ophthalmology (4 per cent). The infectious disease space ...
- Source: drugdu
- 84
- April 3, 2024
Labcorp’s $237M Tuck-In Deal Brings Lab Testing Assets From BioReference Health

Labcorp is buying the clinical diagnostics and reproductive women’s health businesses of BioReference Health, excluding those assets in New York and New Jersey. Labcorp has returned to being fully focused on lab testing after last year’s spinoff of Fortrea, its former clinical trial services business. By FRANK VINLUANLabcorp’s testing capabilities are getting a little broader with the $237.5 million acquisition of certain laboratory assets from BioReference Health, a subsidiary of Opko Health. The BioReference assets going to Labcorp span clinical diagnostics and reproductive women’s health across the U.S. and account for about $100 million in annual revenue. The deal announced Thursday excludes those assets in New York and New Jersey, where BioReference will continue to maintain its full operations. BioReference will also continue to offer oncology and urology diagnostic services nationwide. Burlington, North Carolina-based Labcorp was founded as a laboratory testing company in 1969. In 2015, it entered drug development ...
- Source: drugdu
- 131
- April 2, 2024

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