US-based Comanche Biopharma has raised $75m in an oversubscribed Series B financing round to develop its small interfering RNA (siRNA) therapy, CBP-4888, as a treatment for preeclampsia. The financiers included Google Ventures, F-Prime Capital, Lilly Asia Ventures, Longview Healthcare Ventures, New Enterprise Associates (NEA), and Atlas Venture. Furthermore, Scott Gottlieb from NEA and David Grayzel from Atlas will join Comanche’s board. Preeclampsia is persistent high blood pressure that develops during the second trimester of pregnancy or up to six weeks following delivery. It can be associated with high levels of proteins in the blood, decreased blood platelets, fluid in the lungs, or seizures. It occurs in 2-9% of pregnancies and the only management is premature delivery. Recent studies have found that excess circulating placental soluble fms-like tyrosine kinase 1 (sFlt1) is present in patients with preeclampsia, and can therefore, contribute to its pathogenesis. A 2023 study found that the administration ...
On January 16, China Biopharmaceutical announced that the Group has initiated a Phase III clinical study of Semaglutide Injection in China for the indication of type 2 diabetes mellitus. Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog with 94% sequence homology to human GLP-1, a peptide secreted by small intestinal L-cells, which is known for its ability to increase insulin synthesis and secretion, inhibit appetite, and delay gastric emptying. Semaglutide reduces blood glucose by stimulating insulin secretion and decreasing glucagon secretion. Semaglutide is the first weekly GLP-1 formulation in China with both hypoglycemic and cardiovascular indications, and its effects in lowering blood glucose, reducing body weight, and cardiovascular protection in diabetes have been well proven. Compared with the previous generation of glucose-lowering drugs, Semaglutide’s outstanding advantage is its longer half-life, which allows it to be administered once a week, greatly improving patient compliance. Currently, Semaglutide has become one of the ...
Important Note: Recently, Beijing Shenzhou Cell Biotechnology Group Co. (hereinafter referred to as the “Company”) has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing that the Company’s self-developed product, SCTC21C Injection, can be used for the treatment of CD38+. (the “Company”) received a Notice of Approval for Clinical Trial of Drugs from the State Drug Administration (the “SDA”), agreeing to carry out clinical trials for the treatment of CD38+ hematologic malignancies for the Company’s self-developed product SCTC21C Injection. As there are many unpredictable factors in the process of clinical trials of pharmaceutical products, the results and timing of clinical trials, review and approval are subject to certain uncertainties, investors are advised to make decisions with caution and take precautions against investment risks. The relevant information is announced as follows: I. Basic Product Information 1. Product name: SCTC21C ...
Pharma giant AstraZeneca will spend $26.5 million to build a new production line for its diabetes treatments dapagliflozin and metformin hydrochloride at the Taizhou National Medical High-tech Development Zone in Jiangsu, China Daily reports. The facility is forecast to have an annual output value of $1.4 billion and is expected to become a global manufacturing outpost for the company’s diabetes therapies, according to the publication. Marketed in the U.S. as Farxiga, dapagliflozin helps prevent absorption of glucose in the kidneys to help lower blood sugar. Metformin, meanwhile, reduces the absorption of sugar from the stomach. As a combination therapy, the medicines are marketed as Xigduo. Fierce Pharma Manufacturing has reached out to AstraZeneca for additional details on the project. AstraZeneca’s operations in China were the focus of market speculation last summer when the Financial Times reported that the company had explored separating its business in the country amid increasing geopolitical ...
Lundbeck wants migraine suffers to say “nope” to doing more and “yep” to doing less with their condition as the core message of its new campaign for Vyepti. The “Say Yep” initiative plays on the yep in Vyepti, the pharma’s intravenous migraine prevention therapy that was approved by the FDA exactly four years ago next month. The therapy brought in DKK 1 billion ($145.9 million) in 2022, double what it made in 2021 and driven by what Lundbeck said was “strong demand.” The multi-channel media campaign is trying to reach the 40 million Americans who suffer from the often-debilitating condition. The message is to slow down and not push through the pain of a migraine. The campaign “brings to life the brand’s empathetic understanding that people are doing a lot to manage migraine and deserve to do a little less, if possible,” a spokesperson from Lundbeck said. “Say Yep subtly ...
Considering trial setbacks and cash concerns, Satsuma Pharmaceuticals faced an uphill climb to even file for approval of its migraine spray treatment at the FDA. Now, the agency has thrown another wrench in the company’s commercial hopes by issuing a manufacturing-related complete response letter. In rejecting the application, the agency cited chemistry, manufacturing and controls concerns, Satsuma’s parent company, Shin Nippon Biomedical Laboratories, said in a press release. The agency did not flag issues with the clinical data package or request new trials. “We remain committed to working expeditiously with the FDA to complete the review for STS101 as soon as possible,” Satsuma’s CEO Ryoichi Nagata, M.D., Ph.D., said in the release. The company will detail potential timing for a resubmission after consulting with the FDA. The update is just the latest in a series of setbacks for Satsuma and its migraine asset, dubbed STS101. After coming up short two ...
Oral squamous cell carcinoma, the most common type of oral cancer and globally the ninth most prevalent cancer, currently relies on surgical biopsies for diagnosis. This additional referral step poses the risk of losing patients who may not return for follow-up until the cancer has progressed to advanced, more challenging stages. Additionally, surgical biopsies can be problematic as they often collect a mix of cell types, complicating the analysis, and creating the risk of spreading cancerous cells to other parts of the mouth. General blood tests looking for cancer’s genetic signals also have limitations, as they do not specify the tumor’s location, preventing quick initiation of treatment after detection. Now, a new test that allows dentists to screen for oral squamous cell carcinoma with a simple brush could early detection of oral cancer without surgery. The diagnostic kit, created by researchers at the University of Illinois Chicago (Urbana, IL, USA), ...
Several animals ranging from fireflies to lantern fish have the chemical tools needed to produce light. Such a reaction usually requires the substrate luciferin and the enzyme luciferase. However, a class of less discriminating luciferins, termed as imidazopyrazinone-type (IPT) compounds, has the ability to glow upon coming into contact with other proteins, including ones that are not considered to be enzymes. Previous studies have suggested that IPT luciferins could act as the basis for a new type of medical test that utilizes luminescence to indicate the presence of a target protein in a specimen. Now, a team of researchers has developed a glowing test, based on their belief that an IPT luciferin can react with the SARS-CoV-2 spike protein, which allows the virus particles to invade cells and cause COVID-19. In their research, the team at the National Institute of Advanced Industrial Science and Technology (AIST, Ibaraki, Japan) focused on ...
BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital. By FRANK VINLUAN BridgeBio Pharma is preparing to compete against a blockbuster Pfizer product for a rare disease with few treatment options. A new financing deal provides the company with the capital to support planned commercialization of its drug, which is currently under FDA review. The agreement announced Thursday calls for Blue Owl Capital and Canada Pension Plan Investment Board to pay BridgeBio $500 million cash in exchange for royalties of 5% from sales of the biotech’s drug, acoramidis. The deal provides the Palo Alto, California-based biotech an additional $450 million in committed capital by refinancing its lending agreement with Blue Owl. The company could also receive ...
Ovarian cancer remains a significant cause of mortality globally. While advancements in cytoreductive surgery and chemotherapy have improved survival for those with epithelial ovarian cancer, prognosis heavily depends on the stage at diagnosis. Early detection, particularly at stage I, offers a five-year survival rate exceeding 90%. However, this rate drops to around 70% for stage II, where cancer is confined to the pelvis, and declines further for later stages, plummeting to a mere 20% at stage IV. Computational models suggest that detecting ovarian cancer in stages I or II could increase the cure rate by 10-30%. Currently, Cancer Antigen 125 (CA125), a protein found in various cells, including those of ovarian cancer, is the only tumor marker recommended for clinical use in diagnosing and managing ovarian cancer. Now, a new study has shown that a panel of four biomarkers is more sensitive than CA125 alone for early ovarian cancer detection, ...
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