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New Biomarkers for Diabetic Kidney Disease to Improve Diagnosis and Monitoring

Diabetic kidney disease (DKD) is a major microvascular complication arising from type 2 diabetes mellitus (T2DM), leading to end-stage renal disease (ESRD). Despite advancements in treatment options such as hyperglycemic and blood pressure control and renin-angiotensin system blockades, DKD continues to prevail at alarming rates. Clinically, DKD often progresses from microalbuminuria to macroalbuminuria, marked by increased levels of albumin in the urine and an initial hyperfiltration phase followed by a gradual decline in renal function. However, variations in clinical presentations and progression rates to ESRD have been noted in recent studies. As scientific understanding evolves, the need for specific biomarkers for DKD has become increasingly vital. Now, an analysis of urinary and exosome proteome profiling by a team of scientists has led to the discovery of biomarkers for DKD, offering the potential for early diagnosis and treatment. The research carried out by scientists at the Chinese Academy of Sciences (Beijing, ...
- Source: drugdu
- 128
- January 10, 2024
ProfoundBio’s Rinatabart Sesutecan Granted FDA Fast Track Designation for Ovarian Cancer

Pharmaceutical Executive Editorial Staff Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. The FDA has granted Fast Track designation to ProfoundBio’s rinatabart sesutecan (Rina-S; PRO1184) to treat patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.1 The novel folate receptor alpha (FRα)–targeted antibody-drug conjugate (ADC) is comprised of an FRα-directed antibody linked to sesutecan, which is an investigational, cleavable hydrophilic linker, and the topoisomerase 1 inhibitor payload exatecan. “Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,” said Naomi Hunder, chief medical officer of ProfoundBio, in a press release.1 “FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in ...
- Source: drugdu
- 88
- January 10, 2024
J&J Joins the Cancer ADC Dealmaking Spree With $2B Ambrx Acquisition

Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
- Source: drugdu
- 135
- January 10, 2024
FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

Today, the U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency’s multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency’s efforts to advance medical device supply chain resiliency. Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms. In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must ...
- Source: drugdu
- 135
- January 10, 2024
Shanghai Argo Announces Multi-Program RNAi Licenses and Strategic Collaborations with Novartis

SHANGHAI, Jan. 07, 2024 /PRNewswire/ — Shanghai Argo Biopharmaceutical Co., Ltd. (“Argo”), a biotechnology company focused on the discovery and development of next-generation RNAi therapeutics, today announced that it has entered into two exclusive license and collaboration agreements with Novartis PHARMA AG (“Novartis”). Under the first agreement, Argo has granted Novartis exclusive global licenses to develop and commercialize a Phase 1 stage program. The first agreement also includes a research collaboration and Novartis also receives an option to potentially license compounds directed against up to two additional targets for cardiovascular disease treatment. Under the second agreement, Argo granted Novartis an exclusive ex-Greater China license to develop and commercialize a Phase 1/2a clinical-stage program for cardiovascular disease treatment. Discovered and developed with Argo’s cutting-edge RNAi platform technology, these clinical-stage assets offer industry-leading efficacy and durability therapies. The transactions have a combined potential value of up to $4.165 billion for Argo and ...
- Source: drugdu
- 84
- January 10, 2024
As cancer players jump head-first into ADC field, Novartis CEO explains how he’s resisted the temptation

San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he’s resisted the temptation. The answer is radioligand therapies, Narasimhan said Monday during the 2024 J.P. Morgan Healthcare Conference in response to a question from Fierce Pharma. “We have a long history within research of ADCs, but we have not been successful,” Narasimhan said. “To be clear, part of our focus strategy is looking at places where we think we can create long-term sustainable leadership. And we are investing in radioligand therapies.” ADCs and radioligand therapies are similar in that both technologies act as guided missiles. For ADCs, the guiding force is an antibody, and the cancer-killing payload is a chemotherapy. A radioligand therapy uses a ligand to target cancer cells and kills them with a therapeutic radioisotope. Radiotherapies may have a safety ...
- Source: drugdu
- 90
- January 10, 2024
AbbVie ends 2023 on a high taking the leading spots as the biggest drug ad spender in December

AbbVie took the top two TV drug ad spending spots with its immunology duo Rinvoq and Skyrizi, respectively, in December as it looks to cement its place as the pharma with the deepest direct-to-consumer pockets. AbbVie spent nearly identical amounts on all DTCs for each drug: $39.8 million for Rinvoq across its five spots and $39.7 million for Skyrizi across seven spots. In November, the positions of the two drugs were swapped, with Skyrizi taking the top spot and Rinvoq coming in second. Coming in third place was rival Dupixent, marketed by Sanofi and Regeneron, with a much smaller $27.6 million spent across its ads for the blockbuster med. And Pfizer has suddenly started to spend big on its new RSV vaccine Abrysvo, coming in fourth place with a strong spend of $18 million last month, more than five times the $4 million it spent in November. In fifth place ...
- Source: drugdu
- 155
- January 10, 2024
Kanghua Biologicals Signs License Agreement with HilleVax for Recombinant Hexavalent Norovirus Vaccine

Recently, Chengdu Kanghua Biological Products Company Limited (“Kanghua Biological” or the “Company”) signed an Exclusive License Agreement with HilleVax.INC (“HilleVax”). INC (“HilleVax”). Kanghua Biologicals licensed HilleVax to develop, manufacture and commercialize Recombinant Hexavalent Norovirus Vaccine and its derivatives in areas other than China (including Hong Kong, Macao and Taiwan). Kanghua Biologicals will receive an initial payment of US$15 million for this transaction and is expected to receive milestone payments of US$255.5 million upon the achievement of certain development and sales milestones, and Kanghua Biologicals is also entitled to a single-digit percentage sales commission on net sales in territories other than China (including Hong Kong, Macao and Taiwan). Using genetic engineering technology, Kanghua Biologicals has constructed a recombinant hexavalent norovirus vaccine based on Virus-Like Particles (VLPs), which encompasses the six major prevalent genotypes of norovirus, and theoretically protects against more than 90% of norovirus infections and acute gastroenteritis caused by norovirus, ...
- Source: drugdu
- 76
- January 10, 2024
Study of Hengrui’s Innovative Drug Pyrrolitinib Combined with Radiotherapy for Brain Metastases in HER2-Positive Breast Cancer Published in JAMA Oncology

Recently, a phase II, non-randomized study of brain radiotherapy combined with pyrrolitinib and capecitabine for the treatment of brain metastasis in HER2-positive breast cancer (BROPTIMA study) was published online in JAMA Oncology, an authoritative international oncology journal (IF: 28.4). Prof. Guo Xiaomao and Prof. Yu Xiaoli of the Affiliated Cancer Hospital of Fudan University are the co-corresponding authors of this article, and Prof. Yang Zhaozhi and Prof. Meng Jin are the co-authors. The results of this study showed that the one-year central nervous system-progression-free survival (CNS-PFS) rate for combination therapy reached 74.9%, with a median CNS-PFS of up to 18 months and a central nervous system-objective remission rate (CNS-ORR) of 85%. In terms of safety, with a median follow-up of 17.3 months, the neurological status of most patients remained stable. This is the first prospective clinical study exploring pyrrolitinib in combination with brain radiotherapy for the treatment of patients with ...
- Source: drugdu
- 132
- January 10, 2024
Thermo Fisher to lay off 74 California workers in restructuring

Dive Brief Thermo Fisher Scientific has notified the state of California that it plans to lay off 74 employees in Petaluma by Feb. 1, as the laboratory instruments maker further streamlines operations to reduce costs. The layoffs were reported in a Worker Adjustment and Retraining Notification (WARN) notice. The Waltham, Massachusetts-based company is not renewing its 10-year lease on the Petaluma facility, which expires in July, the North Bay Business Journal reported in November. Severance actions associated with facility consolidations and cost reduction measures affected about 4% of the company’s workforce in 2023, Thermo Fisher said in its third-quarter report. Dive Insight Workforce reductions rippled through the medtech industry last year as companies focused on improving margins while navigating an uncertain post-pandemic economy. After closing some facilities and reducing staff levels in California earlier in the year due to reduced COVID testing demand, Thermo Fisher signaled in July that it ...
- Source: drugdu
- 98
- January 9, 2024

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