Search Results for “AstraZeneca” – Page 13 – media

Innovent sells its share in CAR T-cell therapy to IASO Bio for 18% equity

Chinese pharmaceutical manufacturer Innovent Biologics has transferred the licence for Fucaso (equecabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy, to its development and commercialisation partner IASO Biotechnology (IASO Bio). Although the companies did not disclose the sale price of the deal, Innovent stated that it would use the proceeds to acquire an 18% stake in IASO Bio. Following the agreement, IASO Bio holds global commercial rights to Fucaso. Fucaso is a B-cell maturation antigen (BCMA) targeting CAR T-cell therapy. It was approved by China’s National Medical Products Administration (NMPA) as a fourth-line therapy to treat relapsed and/or refractory multiple myeloma (r/r MM), last month. The companies have also received an investigational new drug (IND) application for Fucaso as a treatment for r/r MM patients who have undergone up to two lines of prior therapies and are refractory to Revlimid (lenalidomide). Fucaso has also received orphan drug, medicine advanced therapy ...
- Source: drugdu
- 86
- July 9, 2024
Phase III Trial Data Presented at ASCO Show Imfinzi Improves Survival in Limited-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Results of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.AstraZeneca announced a significant milestone from the ADRIATIC trial, which is evaluating the safety and efficacy of Imfinzi (durvalumab) for the treatment of limited-stage small cell lung cancer (LS-SCLC) in patients who haven’t progressed following concurrent chemoradiotherapycCRT. According to the company, the trial found that administration of Imfinzi after standard-of-care cCRT greatly improves overall survival (OS) and progression-free survival (PFS) compared to placebo. These results were presented at the 2024 American Society of Clinical Oncology Annual Meeting during the Plenary Session.1 “The ADRIATIC results represent a breakthrough in limited-stage small cell lung cancer, a highly aggressive disease where recurrence rates are high and only 15 to 30 per cent of patients survive five years,” said David R. Spigel, chief ...
- Source: drugdu
- 129
- June 6, 2024
The Crick announces new partnerships with SMEs and MRC for research

The projects will focus on a range of research areas, including Down’s syndrome and ALS The Francis Crick Institute has announced six new partnerships with small and medium-sized enterprises (SMEs) with support from the Medical Research Council (MRC) focused on innovative discovery projects led by Crick researchers. Supported by an MRC Business Engagement Fund Award, as part of UK Research and Innovation, the collaborations will focus on the application of novel cutting-edge technologies, encompassing a diverse range of research to deliver impactful outcomes. Paul Mercer, head of collaboration, the Crick, commented: “We are… excited to be able to develop these research partnerships with SMEs, diversifying the opportunity for development of Crick discoveries through the application of disruptive innovations.” Partners include Perha Pharmaceuticals, Scalable Minds, Broken String Biosciences, Hertility Health, Automata Technologies and Mytos. The projects will focus on a range of research, including pharmacological treatments for congenital heart defects in ...
- Source: drugdu
- 87
- June 4, 2024
Insmed’s Trial Results Pave Way for FDA Filing in a Lung Disease With No Approved Therapies

Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders. By Frank VinluanAn Insmed drug developed for a serious chronic lung disorder with no FDA-approved therapies handily beat a placebo in a pivotal clinical trial, preliminary results that set the stage for a regulatory submission planned for later this year. It could be the first of several. The drug is also in development for other inflammatory conditions, giving the drug multiple opportunities to achieve its blockbuster potential. The first disease target of the Insmed drug is non-cystic fibrosis bronchiectasis (NCFB), a chronic lung disease characterized by excess production of sputum that’s persistently coughed up from the respiratory tract. Patients who have NCFB also experience frequent respiratory infections. There’s no ...
- Source: drugdu
- 99
- May 30, 2024
Datopotamab deruxtecan demonstrates positive results in TROPION-Lung01 Phase III trial

High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favoured datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. The final analysis of OS builds on the positive progression-free survival (PFS) results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC. In TROPION-Lung01, patient enrolment by tumour histology ...
- Source: drugdu
- 103
- May 29, 2024
Roche targets obesity market with early positive trial data

Roche is looking to share in the windfall from the sales in obesity therapies as it announces positive results from the Phase Ib trial of its investigational obesity and type 2 diabetes (T2D) therapy. CT-388 is a once-weekly subcutaneous dual glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) receptor agonist. It selectively targets two incretin receptors that control food intake, energy absorption and assimilation. The therapy has a similar mechanism of action as Eli Lilly’s Mounjaro (tirzepatide), which generated $1.81bn in sales in Q1 this year, according to Lilly’s financials. Following today’s news, the Swiss company’s share was up by over 3.5% in trading today on the Swiss stock market. Roche’s market cap is SFr190.6bn ($210.8bn). The placebo-controlled Phase Ib trial (NCT04838405) enrolled approximately 96 overweight or obese participants with or without T2D. The participants in the CT-388 group achieved a mean placebo-adjusted weight loss of 18.8% at 24 ...
- Source: drugdu
- 108
- May 20, 2024
Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
- Source: drugdu
- 79
- May 17, 2024
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
- Source: drugdu
- 128
- April 30, 2024
Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose

Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
- Source: drugdu
- 87
- April 30, 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
- 129
- April 10, 2024

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