Search Results for “antibody” – Page 35 – media

Daiichi Sankyo again dials up Enhertu sales forecast, advances 2nd AstraZeneca-partnered ADC

AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate. But this time, the rosier outlook reflects developments outside the U.S. Daiichi now expects Enhertu sales to come in at 383.9 billion Japanese yen (about $2.6 billion) for the 12 months ending March 31. The number includes profits from regions where AstraZeneca books Enhertu sales. Daiichi had already once dialed up its Enhertu forecast for its current fiscal year. The drugmaker’s projection was originally 320 billion yen back in April 2023, then Daiichi raised it to 381.7 billion yen in October. Despite rolling out the higher global forecast, Daichii actually reduced Enhertu’s 12-month sales estimate in the U.S. by $30 million to $1.58 billion. For the first nine months of the company’s fiscal year, Enhertu generated $1.14 billion in the U.S., an increase of ...
- Source: drugdu
- 132
- February 2, 2024
CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13i) Receives Phase III Clinical Trial Summary Report

Recently, CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as “PCV13i”) has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population. CanSinoBio’s PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory. At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines. In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal ...
- Source: drugdu
- 163
- February 1, 2024
FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo’s Enhertu for HER2+ Solid Tumors

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
- Source: https://www.pharmexec.com/authors/pharmaceutical-executive-editorial-staff
- 139
- January 31, 2024
Merck’s Keytruda extends life for kidney cancer patients after surgery, while Bristol’s Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
- Source: drugdu
- 100
- January 30, 2024
With record year, Samsung Biologics bucks CDMO industry’s troublesome 2023

Last year proved a challenging year for contract manufacturers across the board, but Korea’s Samsung Biologics appears to have bucked the losing trend by charting what it called an “exceptional” performance. In the fourth quarter, Samsung reeled in 1.07 trillion Korean won (about $802 million), growing sales 11% over the same period in 2022. For the full year, Samsung grew sales 23.1% to 3.69 trillion Korean won ($2.8 billion), the company said in an earnings release Wednesday. Also last year, Samsung Biologics became Korea’s first domestic biopharma firm to generate 1 trillion won in annual profit, Business Korea reports. The 2023 result marks another revenue record for the CDMO giant, which has enjoyed fast growth over the last 8 years, according to Companies Market Cap. Samsung Biologics credited the “exceptional” performance to the ramp-up of operations at its massive Plant 4 in Songdo, South Korea, plus a “robust” sales backlog. ...
- Source: drugdu
- 86
- January 27, 2024
Announcement of AOSAIKANG Pharmaceuticals on the Completion of Registered Clinical Phase III Study of its Subsidiary’s Bio-Innovative Drug ASKB589 in the First Patient in China

(“AOSAIKANG”) has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study: I. About the Registrational Clinical Phase III Study of ASKB589 The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety ...
- Source: drugdu
- 99
- January 27, 2024
IASO Bio’s IND application for new autoimmune indication of Equecabtagene Autoleucel Injection approved

January 25, 2024, Nanjing, Shanghai, China, and San Jose, California, USA – IASO Bio, a biopharmaceutical company dedicated to the development, production and sales of innovative cell-based drugs, announced the National Medical Products Administration (NMPA) Review Center (CDE) has officially approved its fully human BCMA-targeted chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel Injection, R&D code: CT103A) for the new expanded indication of refractory generalized myasthenia gravis (Myasthenia gravis, MG). ) clinical trial application (IND) (acceptance number: CXSL2300759). Equecabtagene Autoleucel Injection (trade name: Equecabtagene Autoleucel®) has been approved for marketing by the State Food and Drug Administration on June 30, 2023, for the treatment of relapsed and refractory multiple myeloma. The approval of this IND for myasthenia gravis further expands This is the second autoimmune indication approved for IND after Neuromyelitis Optica Spectrum Disease (NMOSD). IASO Bio is the first company in China to use CAR-T products for autoimmune ...
- Source: drugdu
- 89
- January 27, 2024
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 103
- January 26, 2024
Gilead’s Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
- Source: drugdu
- 92
- January 25, 2024
Harbour BioMed Announces Positive Profit Alert

Cambridge, MA, Rotterdam, NL, Suzhou, CN – Jan 19, 2023 Harbour BioMed (the “Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces a positive profit alert for the year ended December 31, 2023. As disclosed before, there was a turnaround from a loss of US$73.1 million for the six months ended June 30, 2022 to a profit of US$2.9 million for the six months ended June 30, 2023. Based on the preliminary review of the unaudited consolidated management accounts, it is expected that there will be a profit of approximately US$18 million for the year ended December 31, 2023, as compared to a loss of approximately US$137 million for the year ended December 31, 2022. This is the first time that the Company has recorded a net profit on its annual financial statements. The anticipated ...
- Source: drugdu
- 138
- January 25, 2024

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