Search Results for “antibody” – Page 26 – media

Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies

Don Tracy, Associate Editor Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts. Invenra Inc. and Astellas Pharma announced that they have agreed to terms on a collaboration that seeks to utilize Invenra’s B-Body bispecific antibody platform to bolster Astellas’ research and development efforts in bispecific therapeutic research. Per the agreement, Astellas will acquire full access to the B-Body platform, with the opportunity for further license negations upon the completion of this initiative. Both teams stated that they remain dedicated to pushing the boundaries of healthcare through innovative research, with the ultimate goal of providing new, effective treatments to patients worldwide.1 “We are honored to partner with the Astellas team, one of the world’s foremost developers of therapeutics,” said Roland Green, PhD, CEO, Invenra, in a press release. “We are excited by the potential of this partnership to yield profound benefits to ...
- Source: drugdu
- 140
- April 15, 2024
Rallybio and J&J collaborate to tackle maternal-foetal blood disorder

Following Johnson & Johnson’s (J&J) recent US Food and Drug Administration (FDA) fast track designation of nipocalimab for the reduction of foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in pregnant adults, Rallybio has announced a collaboration with the pharma giant to advance complementary therapeutic solutions for the rare disorder. The collaboration will see the development of therapeutic approaches that comprehensively address FNAIT, as J&J aims to treat patients who have already alloimmunised while Rallybio focuses on preventing alloimmunisation altogether, Dr. Steve Uden, Rallybio’s CEO, told Pharmaceutical Technology in an exclusive interview. “They are very much complementary and not competitive approaches; and both are needed,” said Uden. As per the 10 April press release, the clinical-stage biotech received an equity investment of $6.6m from J&J, with eligibility for future milestone payments. The funds will be deployed to support a FNAIT natural history study that will be conducted across North America and ...
- Source: drugdu
- 108
- April 13, 2024
AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
- Source: drugdu
- 87
- April 11, 2024
Enhertu Gets FDA Accelerated Approval for Unresectable, Metastatic HER2-Positive Solid Tumors

Davy James The approval of AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug’s approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. The FDA has granted accelerated approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive, immunohistochemistry (IHC) 3+ solid tumors who were previously administered systemic therapy and who have no satisfactory alternative treatment options.1 The regulatory action for the HER2-directed antibody-drug conjugate (ADC) adds to Enhertu’s approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction adenocarcinoma. “As the first antibody drug conjugate to be granted a tumor-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumors,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a press release. “This approval also ...
- Source: drugdu
- 128
- April 10, 2024
Hengrui Adebelizumab, SHR-A1811 Combination Chemotherapy for HER2 Expressing Adenocarcinoma of Gastric or Gastroesophageal Bundle Phase Ib/II Clinical Trial Approved

Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. have received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which authorizes to conduct the Phase Ib/II clinical study of Adebelizumab Injection in combination with SHR-A1811 and chemotherapy for HER2-expressing advanced adenocarcinoma of the stomach or the gastroesophageal junction. In 2020, gastric cancer ranked 5th in global cancer incidence and 4th in mortality. Among them, 43.9% of new cases and 48.6% of deaths will occur in China, with 479,000 new cases and 374,000 deaths, both ranking third in China in terms of cancer incidence and mortality. Human Epidermal Growth Factor Receptor (HER2)-positive gastric cancer is a unique subtype of the disease, which requires different diagnostic and therapeutic strategies from HER2-negative gastric cancer. The global reported HER2-positive rate of gastric cancer is 7.3%-20.2%, and the HER2-positive rate of gastric cancer in ...
- Source: drugdu
- 163
- April 10, 2024
FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy

Davy James Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy. The FDA has approved Bristol Myers Squibb’s and 2seventy bio’s Abecma (idecabtagene vicleucel) to treat adults with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy that included an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.1 The regulatory action expands the indication for Abecma to earlier lines of treatment in patients whose disease relapsed or became refractory following administration of the three primary treatment classes following two prior lines of therapy. “Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the ...
- Source: drugdu
- 84
- April 9, 2024
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
- 108
- 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
- 76
- 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

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