Search Results for “EC” – Page 413 – media

AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval

After a postmarketing study of AstraZeneca’s bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.In the study, investigators tested Andexxa versus standard care in more than 450 patients with intracranial bleeding who have received blood thinners called factor Xa inhibitors. Those who received the AstraZeneca drug experienced superior hemostatic efficacy compared with the control arm, AZ said in a Monday release. Hemostatic efficacy is a measure of the body’s ability to stop the flow of life-threatening brain bleeds. “We are proud to offer the first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve haemostasis, providing an effective and reliable treatment when immediate care is required,” AZ’s executive vice president of biopharmaceuticals R&D, Mene Pangalos, Ph.D., said in a statement. Now, the company will look to convert Andexxa’s speedy approvals in ...
- Source: drugdu
- 117
- June 7, 2023
Johnson & Johnson’s Balversa tops chemotherapy in bladder cancer trial

Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy. The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology’s (ASCO’s) annual meeting in Chicago. “The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release. Balversa was approved on an accelerated basis in 2019, becoming the first ...
- Source: drugdu
- 168
- June 7, 2023
Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading

Moderna and Merck’s experimental cancer vaccine, used in combination with Merck’s Keytruda, reduced the risk of the most deadly form of skin cancer spreading to other parts of the body in a clinical trial, according to the midstage trial results published Monday. Moderna and Merck’s cancer vaccine reduced the risk of melanoma spreading to other parts of the body or death by 65% in patients with stage 3 or 4 of the disease compared with patients who received Merck’s immunotherapy treatment alone, the trial has found. Moderna and Merck will present the data at the American Society of Clinical Oncology’s annual conference in Chicago at 5 p.m. ET. The clinical trial has enrolled 157 patients who have had their cancer surgically removed. Patients in the treatment group receive 1 milligram injections of the vaccine every three weeks for nine total doses and 200 mg intravenous infusions of Keytruda every three ...
- Source: drugdu
- 123
- June 7, 2023
After selling Rubraca, Clovis Oncology unveils CRL for potential label expansion

Paul Schloesser Associate Editor Clovis Oncology is facing yet another setback with the FDA giving the battled company a complete response letter and rejecting a potential label expansion for its PARP inhibitor Rubraca. A new SEC filing Friday detailed how it received the CRL from the FDA on May 26, rejecting an sNDA for Rubraca as a first-line maintenance treatment for women with advanced ovarian cancer who are in complete or partial response to a first-line, platinum-based chemotherapy. FDA said that for the agency to reconsider the application, per the filing, Clovis would need to show results from an overall survival analysis that “do not demonstrate a potential OS detriment.” In the meantime, Clovis said that the FDA’s determination would impact the timing and achievability of milestone payments that Clovis is owed. The company sold rights to its PARP inhibitor to Swiss company pharma& Schweiz GmbH in an April deal ...
- Source: drugdu
- 195
- June 7, 2023
Dana-Farber research supports FDA approval of new therapy for metastatic breast cancer

Sacituzumab govitecan, a novel antibody drug-conjugate therapy was granted accelerated approval on February 3, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic HR+, HER2- breast cancer. The FDA action was based on the results of TROPICS-02, a study in which Dana-Farber Cancer Institute’s Sara Tolaney, MD, MPH, helped lead and which was presented at the European Society of Medical Oncology annual meeting in September 2022 as well as the American Society of Clinical Oncology meeting in June 2022. Researchers reported that the sacituzumab govitecan produced a statistically significant improvement in overall survival rates compared to chemotherapy. The overall survival rate for patients taking part in the global phase 3 study was 14.4 months for those who received sacituzumab govitecan and 11.2 for those given chemotherapy. The sacituzumab arm of the study also showed superior response rates as well as prolonged median progression free survival ...
- Source: drugdu
- 146
- June 6, 2023
Edelman

A new report by Edelman reveals an East-West divide in how people around the world view pharmaceutical businesses’ trustworthiness and their commitment “to do what is right.” Now in its second year, Edelman’s report found that people living in China, which is the world’s second largest and fastest growing pharma market, reported the highest level of trust in the industry (89%). China was closely followed by India, the world’s largest producer of generic medicines, where 86% of people trust the pharma industry. However, the numbers drop significantly in the West. In the U.K., 60% of people trust the pharma industry to do what is right, and the number dips to 55% in Germany and 52% in France. In the U.S., the world’s largest pharma market, 54% of people trust the pharma industry. The lowest ranking comes from Japan, home of Big Pharmas Eisai and Takeda, which registered a score of ...
- Source: drugdu
- 130
- June 6, 2023
After nabbing historic RSV shot approval, GSK looks to boost US vaccination rates

Rates of vaccination in the U.S. have dropped in recent years, with the COVID-19 pandemic hitting uptake. GSK, with a new vaccine to market, is looking to help turn this around.GSK is running a new “COiMMUNITY Initiative” that will add new funds, deeper data transparency and collaboration for all vaccine uptake across the country. On the money side, GSK said in a press release that it is “committing” up to $1 million in grant funding to support groups focused on adult immunization and health equity. On the data and collaboration side, GSK said it will continue to make adult vaccination claims data available through Vaccine Track platform, which publishes on a quarterly basis. The company also said it will “enhance the platform’s capabilities.” GSK is also looking to open the platform up to public and private stakeholders “to potentially integrate and host additional data and viewpoints on adult vaccination trends,” ...
- Source: drugdu
- 123
- June 6, 2023
FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage

The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in effort to ease an acute shortage of cancer drugs in the United States, according to an update posted to the agency’s website Friday. Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA permission to export the drug to the U.S. market weeks ago, a document shows. A letter dated May 24 from Qilu’s deputy general manager notified health care professionals of the approval. Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram cisplatin vials in the U.S. Health care providers can begin ordering the drug Tuesday through their wholesalers. Cisplatin is a generic drug that has been available for decades in the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to keep up with demand. Qilu’s version of cisplatin is not ...
- Source: drugdu
- 129
- June 6, 2023
Drug costs lead millions in the US to not take medications as prescribed, according to CDC

By Deidre McPhillips, CNN More than a third of adults in the US take at least three prescription medications and many are rationing them, according to a new CDC report. Owaki/Kulla/The Image Bank RF/Getty Images/FILE CNN — Millions of adults in the United States are not taking their medications as prescribed because of costs, according to a new report from the US Centers for Disease Control and Prevention. Most adults between the ages of 18 and 64 took at least one prescription medication in 2021. But more than 8% of them – about 9.2 million people – said they tried to save money by skipping doses, taking less than prescribed or delaying a prescription fill, according to the CDC data. Although average drug costs did not increase in 2021, the number of prescriptions did, and that raised spending. More than a third of adults took at least three prescription medications ...
- Source: drugdu
- 133
- June 5, 2023
Multi-cancer blood test shows real promise in NHS study

• IMAGE SOURCE,GETTY IMAGES By Michelle Roberts Digital health editor https://www.bbc.com/news/health-65775159 A blood test for more than 50 types of cancer has shown real promise in a major NHS trial, researchers say. The test correctly revealed two out of every three cancers among 5,000 people who had visited their GP with suspected symptoms, in England or Wales. In 85% of those positive cases, it also pinpointed the original site of cancer. The Galleri test looks for distinct changes in bits of genetic code that leak from different cancers. Spotting treatable cancer early can save lives. • What is the Galleri test? • NHS launches world first trial of blood test for 50 cancer types The test remains very much a “work in progress”, the researchers, from Oxford University, say, but could increase the number of cancers identified. Often, patients have symptoms, such as weight loss, with a range of possible ...
- Source: drugdu
- 119
- June 5, 2023

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