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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
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- 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
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- 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
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- June 6, 2023
Pfizer’s antibiotic combination shows promise in treating multi-drug resistant infections

Pfizer has announced positive phase 3 results supporting the safety and efficacy of its investigational antibiotic combination, aztreonam-avibactam (ATM-AVI), in treating serious infections caused by multi-drug resistant, gram-negative bacteria. Declared by the World Health Organization as one of the top ten threats to global health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases. Pfizer’s late-stage programme included a study which compared ATM-AVI and metronidazole with two older antibiotics – meropenem and colistin – for the treatment of complicated intra-abdominal infections, hospital-acquired pneumonia and ventilator-associated pneumonia. For patients with complicated intra-abdominal infections, the cure rate was 76.4% in the ATM-AVI plus metronidazole treatment group, versus 74% in the meropenem and colistin cohort. Additionally, for patients with hospital-acquired pneumonia and ventilator‐associated pneumonia, the cure rate ...
- Source: drugdu
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- 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
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- 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
- 138
- 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
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- June 5, 2023
ACNAP 2023 highlights the artistic and scientific dimensions of cardiovascular care

Hear from patients, nurses and allied health professionals about hot topics in cardiovascular disease at ACNAP 2023, a scientific congress of the European Society of Cardiology (ESC). The annual congress of the Association of Cardiovascular Nursing and Allied Professions (ACNAP), a branch of the ESC, takes place 23 and 24 June at the Edinburgh International Conference Centre (EICC), UK. Explore the scientific program. Novel findings will be presented in the scientific abstracts on a wide range of subjects. Including digital health, depression, anxiety and lifestyle behaviors such as exercise, diet and smoking. Scientific sessions cover contemporary issues in heart health from prevention to rehabilitation and encompassing areas such as climate change, diversity and advocacy. Does dog companionship improve heart health? Don’t miss the session on how pet ownership affects physical and psychological well-being, with a chance to meet working therapy dogs. Dr. Eleni Kletsiou, chair of the Congress Programme Committee, ...
- Source: drugdu
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- June 5, 2023
American College of Cardiology to host annual Care of the Athletic Heart course

The American College of Cardiology will host the annual Care of the Athletic Heart course on June 8-10, 2023, in Washington, including poster abstracts and educational sessions. The course is designed for all clinicians who provide cardiovascular care for the professional, occupational, tactical or recreational athlete. As the athletic population expands to all demographic groups, it is critical that there is a larger contingent of clinicians who understand the latest care and practice management for athletes at every level. Dermot Phelan, BAO, MBBCh, PhD, FACC, and Megan Wasfy, MD, FACC, will serve as the course chair and vice chair respectively. The course, which will be available both in-person and online, will feature top sports cardiology experts discussing the latest advances in sports cardiology, as well as fundamental cardiovascular diagnostic and management strategies and treatment options in the field. Can’t miss sessions:  Keynote: Can the Heart Get a Sports Injury? ...
- Source: drugdu
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- June 5, 2023
Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

About a month after GSK won the world’s first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should ACIP members put their support behind the vaccine. The FDA approved Abrysvo based on data from a phase 3 trial called RENOIR, which enrolled about 37,000 participants. In the study, the vaccine achieved 66.7% protection against RSV-associated lower ...
- Source: drugdu
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- June 5, 2023

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