Search Results for “EC” – Page 308 – media

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
- 131
- 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
- 82
- 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
- 85
- 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
- 130
- 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
- 96
- January 9, 2024
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
- 161
- 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
- 200
- 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
- 81
- 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
- 83
- 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
- 81
- January 9, 2024

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