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【EXPERT Q&A】How to distinguish a class, Class II, Class III medical devices?

Drugdu.com expert’s response: Medical devices are typically classified into different categories, including Class I, Class II, and Class III, based on their level of risk and intended use. Here is a general overview of how these categories are distinguished: Class I Medical Devices: Class I medical devices are generally considered to have low risk and may have little or no impact on the human body. They typically do not require specialized regulatory controls.These devices include simple, non-invasive devices such as thermometers, disposable gloves, non-invasive blood pressure monitors, etc. Class II Medical Devices: Class II medical devices pose higher risks compared to Class I devices and may have a moderate impact on the human body, requiring stricter regulatory controls.Examples of Class II devices include diagnostic equipment, infusion pumps, medical imaging devices, implantable medical devices, etc. Class III Medical Devices: Class III medical devices carry the highest level of risk and may cause ...
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- March 5, 2024
Interphex —NewYork biopharmaceutical Exhibition

Organiser: American pharmaceutical association Time:16 – 18 April 2024 address：655 West 34th Street New York, NY 10001-1188 USA Exhibition hall: Javits Convention Center, NYC Product range: Analytical instruments, automation and process control, batch processing systems/equipment, biological process equipment, packaging equipment, process equipment and parts, pilot plant equipment and custom components, tablet/capsule filling machine facility engineering and maintenance, environmental treatment and equipment, clean room equipment; Processing systems, control systems, automation instruments, pharmaceutical packaging materials, containers, etc About Interphex： The New York Biopharmaceutical Exhibition (Interphex) is one of the largest pharmaceutical exhibitions in North America. Held since 1979, it is the most trusted life science show in North America across both chemical and biopharmaceutical fields. Exhibitors meet decision buyers from the world’s top pharmaceutical companies through the exhibition.
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- March 5, 2024
New POC Malaria Test 12 Times Faster Than Currently Available Laboratory-Based Tests

Malaria continues to pose a major global health threat, with approximately 247 million cases and over 600,000 deaths annually, predominantly in sub-Saharan Africa. Particularly alarming is cerebral malaria, a severe form of the disease, which has a high mortality rate, especially among children under five. The existing rapid diagnostic tests (RDTs) for malaria offer a basic positive or negative result, but often fail to detect asymptomatic infections and lack the sensitivity required for early detection of severe cases. More sensitive molecular assays that exist are costly, time-consuming, and need specialized skills and equipment, rendering them unsuitable for widespread application in areas with limited resources. In light of these challenges, researchers have now developed a new test for diagnosing malaria that is both rapid and accurate. This POC rapid malaria test offers a significant improvement over traditional tests and will be especially beneficial for rural areas with limited healthcare facilities. Researchers ...
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- March 5, 2024
New Discoveries of Prostate Cancer Evolution Pave Way for Genetic Test

Prostate cancer ranks as one of the most common cancers affecting men, and while it accounts for a significant number of male cancer fatalities, many men live with it rather than die from it. Understanding when to avoid unnecessary treatments is crucial, as it can prevent side effects like incontinence and impotence. Now, new research has identified two distinct subtypes of prostate cancer, referred to as evotypes. This discovery could lead to major advancements in the diagnosis and treatment of prostate cancer. This discovery was made by an international consortium, called The Pan Prostate Cancer Group, which involved researchers from the University of Oxford (Oxford, UK), who used artificial intelligence (AI) to make new discoveries about the evolution of prostate cancer. Cancer development, like human evolution, can be traced and studied through its evolutionary history. By examining the cancer’s evolutionary tree, valuable insights about the disease can be gained, potentially ...
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- March 5, 2024
CDC’s Advisory Committee Recommends Another Round of Covid-19 Shots for Seniors

Mike Hollan The agency updated its recommendations after a vote by the ACIP advisory committee. The Covid-19 shot isn’t done yet. The CDC is recommending that people over the age of 65 should get another injection of the COVID-19 vaccine. The recommendation comes after the CDC’s Advisory Committee on Immunization Practices (ACIP) voted on the matter, CNN reports.1 The committee voted 11 yes, one no, and one member abstained. According to the new recommendation, anyone over the age of 65 should get the latest version of any of the available COVID vaccines if it has been at least four months since their previous shot. According to CNN, CDC epidemiologist Dr. Ruth Link-Gelles said during a meeting with ACIP advisors, “[The vaccine] doesn’t protect absolutely,” she said. “What the vaccines are doing now is providing an incremental benefit or an extra benefit beyond whatever benefit someone has remaining from their past ...
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- March 5, 2024
Cancer Biotech Lands $145M for First-in-Class Drug to Block Elusive Tumor Target

FogPharma’s lead program is a peptide that blocks a difficult-to-drug pathway inside of cells. The new financing will go toward an ongoing Phase 1/2 study in advanced solid tumors and support development of pipeline programs for other elusive cancer targets. By FRANK VINLUAN FogPharma has reached early clinical development with a therapeutic candidate that takes a novel approach to treatment of solid tumors. The company now has $145 million to continue the drug’s clinical development and advance more programs in its pipeline. Cambridge, Massachusetts-based FogPharma discovers and develops peptides capable of entering cells to address targets that drive disease. Such targets haven’t been drugged before due to the difficulty of getting a drug to act within a cell. FogPharma says its peptide drugs, which it calls Helicon therapeutics, can get inside a cell to modulate protein-protein interactions as well as protein-DNA interactions. FogPharma’s lead program is FOG-001, a Helicon therapeutic ...
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- March 5, 2024
Biotheus’s PD-L1/VEGF dual antibody is planned to be included in breakthrough therapeutic category and has reached a licensing cooperation of over US$1 billion

Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
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- March 5, 2024
MHRA grants first approval via the new International Recognition Procedure in 30 days

A new formulation for XGEVA (denosumab), a treatment used in adults to prevent serious bone-related complications caused by bone metastasis and to treat giant cell tumour of bone in adults and adolescents, is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). The product was authorised in 30 days, providing UK patients with earlier access to this treatment thanks to international recognition. Launched in January this year, the IRP allows the MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process. As a result, medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, resulting in a more rapid, efficient, and cost-effective process for life sciences companies. Denosumab (XGEVA) was authorised on 29 February 2024 ...
- Source: drugdu
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- March 5, 2024
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
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- March 5, 2024
WuXi Biologics’ Irish Site Awarded Three Authoritative ISO International Standard System Certifications

Dundalk, Ireland, March 1, 2024 – WuXi Biologics (2269.HK), a leading global contract research, development and manufacturing (CRDMO) services company, announced that its Dundalk, Ireland site has recently been awarded three authoritative ISO (International Organization for Standardization) accreditations at the same time, including ISO 50001 Energy Management System, ISO 14001 Environmental Management System and ISO 45001 Occupational Health and Safety Management System. ISO 50001 Energy Management System Certification, ISO 14001 Environmental Management System Certification and ISO 45001 Occupational Health and Safety Management System Certification, fully demonstrating that WuXi Biologics has always been adhering to the ESG (Environmental, Social and Governance) development strategy, and has consistently adhered to international standards and achieved outstanding results in environmental protection, sustainable energy development and employee health and safety. As a model for WuXi Biologics’ future factory, the Ireland site has been actively optimizing energy use, improving efficiency and reducing waste emissions from operations, and ...
- Source: drugdu
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