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Nanowear gets FDA clearance for undergarment that estimates blood pressure

Dive Brief Nanowear has received 510(k) clearance for AI-enabled software that allows its wearable undergarment to estimate blood pressure. The Food and Drug Administration decision covers software that processes electrocardiogram (ECG) data, heart sounds and thoracic impedance captured by the Simplesense wearable device to monitor blood pressure at home, in healthcare facilities and during medical research. Nanowear is pitching the software as the “first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic.” The company cited Biobeat Technologies’ wrist and chest monitor as a predicate blood pressure device in its 510(k) filing. Dive Insight Simplesense is a cloth-based undergarment that wraps around the wearer’s torso and over one shoulder. The medical device features two ECG leads, plus sensors for recording heart sounds and activity, and for measuring respiration rate through thoracic impedance. Nanowear made the device to enable physicians and researchers to remotely capture data on patients without disrupting their lives. ...
- Source: drugdu
- 173
- January 9, 2024
Will It Be Different Next Time?

Contract development and manufacturing organizations cannot develop or distribute vaccines alone, but through partnerships, their infrastructure can provide the foundation for delivering life-saving tools swiftly and equitably when a new public health crisis emerges. By MARC FUNK When the Covid-19 pandemic hit, contract development and manufacturing organizations (CDMOs) became indispensable partners to the biopharmaceutical companies that developed vaccines, rapidly producing billions of urgently needed vaccine doses for patients around the globe. But as the health crisis wanes, these organizations risk missing a pivotal opportunity to reinforce preparedness for the next – inevitable – pandemic. CDMOs play an indispensable role in the pharmaceutical ecosystem, acting as key partners to produce medications and vaccines for biopharma companies. By providing specialized manufacturing and development services, CDMOs ensure innovative medicines are produced at scale, meeting global demand and helping enable patient access to vital treatments. This flexible, efficient model proved invaluable when Covid-19 vaccine ...
- Source: drugdu
- 209
- January 9, 2024
With Phase 3 Studies Ongoing in Bladder Cancer, CG Oncology Plots Course for IPO

CG Oncology’s main asset is cretostimogene, an oncolytic virus in late-stage development as a treatment for advanced bladder cancer. The IPO filing follow the report of interim efficacy data showing a 75% complete response rate. By FRANK VINLUAN When bladder cancer does not respond to the current standard of care therapy, the next treatment option is surgery to completely remove the bladder. CG Oncology aims to give patients another choice. The biotech has reached late-stage development with an oncolytic virus and it’s now looking to the public markets to finance clinical testing. Irvine, California-based CG has not yet set financial terms for the planned offering, outlined in paperwork filed with the Securities and Exchange Commission this past week. IPO research firm Renaissance Capital estimates the stock offering could raise up to $100 million. CG has applied for a Nasdaq listing under the stock symbol “CGON.” CG is developing treatments for ...
- Source: drugdu
- 82
- January 9, 2024
BridGene inks collaboration and licensing agreement with Galapagos to discover small molecule drugs for oncology targets

BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditional “hard-to-drug” targets, announced a strategic collaboration and licensing agreement with Galapagos NV. Under the collaboration, BridGene will use its chemoproteomics platform, IMTAC, to discover novel small molecule drug candidates against the collaboration targets. The parties will collaborate to advance the molecules to clinical candidates, which Galapagos has the exclusive rights to develop and commercialize. The preclinical research collaboration will focus on oncology targets named by Galapagos. Galapagos will pay BridGene up to $27 million in upfront and preclinical research milestone payments and more than $700 million in clinical and commercial milestones, assuming success of the programs. BridGene is also eligible to receive tiered royalties on net sales of each product resulting from the collaboration. “BridGene’s proven expertise in discovering small molecule drugs for challenging targets positions them as an ideal partner in pioneering new avenues in ...
- Source: drugdu
- 101
- January 9, 2024
Owkin and Evotec partner to accelerate therapeutics in oncology and I&I

The companies will aim to select targets, discover and develop new therapeutics Owkin and Evotec have entered into an artificial intelligence (AI)-powered strategic partnership in oncology, immunology and inflammation (I&I). Both companies will collaborate to accurately select targets, discover and develop new therapeutics. As part of the agreement, the French-American techbio company, Owkin, will identify indication-relevant targets and subgroups using AI applied to multimodel patient data with its cutting-edge target discovery engine. Evotec will utilise its shared research and development (R&D) platform to accelerate and de-risk the validation of targets, the identification of drug candidates and the successful completion of pre-clinical development activities up to an investigational new drug application (IND). In addition, an Owkin-Evotec joint research strategy team will steer the collaboration to design fully tailored strategic programme plans from target selection to IND, as well as ensuring the delivery of the programmes. Evotec will receive R&D funding from ...
- Source: drugdu
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- January 9, 2024
FDA Authorizes Florida’s Drug Importation Program

Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada. Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety. Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs ...
- Source: drugdu
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- January 9, 2024
UK online pharmacies selling prescription drugs without proper checks

Some UK online pharmacies are selling high-risk prescription drugs based on online questionnaires, a BBC investigation has found. The news organisation was able to buy over 1,600 pills from 20 pharmacies without challenge, raising concerns over the level of regulation these companies face. The BBC found that unnamed prescription-only drugs including painkillers anti-anxiety medication and benzodiazepines (a depressant drug group including Valium) were available by providing false information and without the need for a video consultation or medical records. Online pharmacies in the UK are regulated by the General Pharmaceutical Council (GPhC) and are unable to prescribe drugs without approval from a qualified pharmacist. This should in theory make these sites safe, but it also allows them to operate without heavy oversight. The GPhC gives guidance, and is able to take regulatory action should breaches be deemed dangerous enough, but pharmacist and former chair of the Royal Pharmaceutical Society Thorrun ...
- Source: drugdu
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- January 9, 2024
China Biological Wuhan Institute of Biological Products Receives Another International Registration Certificate for Influenza Vaccine

On January 3, 2024, the quadrivalent influenza virus lysate vaccine independently developed by Wuhan Institute of Biological Products of China Biologicals (WIBP) was granted a certificate of drug registration by the Ministry of Health and Prevention (MOHAP) of the United Arab Emirates (UAE). This is another international registration certificate obtained after the Kenyan registration certificate in 2023, marking the steady progress of the internationalization strategy of Wuhan Bioproducts Research Institute and the gradual opening of a new channel for exporting vaccine products to the Middle East. Influenza is an acute respiratory infectious disease caused by influenza virus. According to WHO’s estimation, about 600 million people are infected with influenza virus globally every year, and as many as 250,000 to 500,000 cases of death. Influenza vaccination is the most cost-effective preventive measure. Influenza vaccine of Wuhan Institute of Biological Products is prepared by a patented process without antibiotics and preservatives. It ...
- Source: drugdu
- 76
- January 9, 2024
China’s first self-developed! Hengrui Pharmaceuticals’ New Sugar-Lowering Compound Drug Henggrexin Metformin Extended-Release Tablets (I)(II) Approved for Marketing

Recently, Hengrui Pharmaceuticals’ subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Certificate of Drug Registration approved for issuance by the State Drug Administration, approving the company’s self-developed Hengrui Pharmaceuticals Metformin Extended-Release Tablets (I) (II) (Ruicinda®) for marketing, which, together with dietary control and exercise, is applicable to adult patients with type 2 diabetes mellitus (T2DM) who are suitable for receiving treatment with Hengrui Pharmaceuticals and Metformin, in order to improve the glycemic control of such patients. This marks the successful launch of China’s first self-developed sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) combined with metformin in a fixed-complex, extended-release formulation, which will bring more convenience to T2DM patients in China. Diabetes mellitus has become the third chronic disease that seriously endangers human health after tumor and cardiovascular disease. At present, China has become the first country with diabetes, in which patients with type 2 diabetes mellitus (T2DM) have a progressive decline ...
- Source: drugdu
- 83
- January 9, 2024
BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod

By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
- Source: drugdu
- 123
- January 8, 2024

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