Search Results for “EC” – Page 99 – media

Teleflex recall of separating vascular catheters labeled Class I event

Dive Brief Teleflex’s recall of its Arrow Endurance Extended Dwell Peripheral Catheter System was categorized by the U.S. Food and Drug Administration as a Class I event, the most severe type of recall. The company began the recall in May after receiving 83 complaints, including 18 reports of injuries. If the catheter separates while in a blood vessel, fragments could spread to other parts of the body and cause adverse events including heart attack and death, the FDA said in a notice. Hospitals should check if they have any of the 262,016 devices recalled in the U.S. and stop using the affected products. Teleflex is asking clinical staff overseeing patients who are currently using an affected product to weigh the risks and benefits of removing and replacing the device. Dive Insight Teleflex acquired Arrow International in 2007 to gain control of a portfolio of vascular access devices. That portfolio now ...
- Source: drugdu
- 135
- June 30, 2023
FDA rejection sets back Regeneron’s plan to defend top-selling eye drug

Dive Brief: Regeneron Pharmaceuticals is facing a delay for a much-anticipated new version of its best-selling eye medicine after failing to win U.S. approval on Tuesday because of a manufacturing issue. The Food and Drug Administration issued a complete response letter for the high-dose version of Eylea, citing inspection findings at a third-party facility that fills vials of the medication. Regeneron said it’s working with the FDA and the third party to resolve the issues “as quickly as possible.” Importantly, the FDA did not cite any issues with the drug’s safety or efficacy and isn’t asking for new clinical trials. The agency also did not find any issues with the labeling or manufacturing of the actual drug substance, Regeneron said. Dive Insight: While the issue sounds relatively minor, any delay is significant for Regeneron, and the company’s shares tumbled around 11% during trading sessions on Tuesday and Wednesday. Eylea is ...
- Source: drugdu
- 104
- June 30, 2023
Sanofi’s $1.4B Bet Pays Off with Promising Phase II Eczema Data

By Tristan Manalac https://www.biospace.com/ Pictured: Atopic dermatitis patient scratches their arm/iStock The company announced Tuesday that topline data from the Phase IIb STREAM-AD trial showed that Sanofi’s investigational antibody amlitelimab met the study’s primary outcome and strongly eased symptoms in patients with moderate-to-severe atopic dermatitis. After 16 weeks of treatment, patients in the amlitelimab group saw significant improvements in their average Eczema Area and Severity Index (EASI) scores compared to placebo. Amlitelimab retained its statistical edge over the placebo across all four studied doses. Sanofi’s candidate also cleared the study’s key secondary endpoints, including biomarker measurements, which suggested that amlitelimab had therapeutic effects on both type 2 and non-type 2 inflammatory pathways, according to the company’s news release. Improvements in primary and secondary measures persisted through 24 weeks of follow-up. These Phase IIb results support amlitelimab’s mechanism of action and indicate that “targeting OX40-Ligand has the potential to provide a ...
- Source: drugdu
- 155
- June 29, 2023
Light or moderate alcohol consumption does not protect against endocrine conditions

People who have just one or two drinks per day are not protected against endocrine conditions such as obesity and type 2 diabetes, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism. Alcohol consumption is a significant public health concern because it is related to many medical conditions such as diabetes, obesity, liver conditions and heart disease. While it is widely accepted that excessive alcohol consumption causes a wide range of health issues, whether modest alcohol consumption has beneficial health effects remains controversial. Tianyuan Lu, (Ph.D., McGill University in Québec, Canada) said, “Some research has indicated that moderate drinkers may be less likely to develop obesity or diabetes compared to non-drinkers and heavy drinkers. However, our study shows that even light-to-moderate alcohol consumption (no more than one standard drink per day) does not protect against obesity and type 2 diabetes in the general ...
- Source: drugdu
- 108
- June 29, 2023
Pfizer’s Litfulo approved by FDA as first treatment for adolescents with severe alopecia areata

Pfizer’s Litfulo (ritlecitinib) has been approved by the US Food and Drug Administration (FDA) as the first treatment option for patients aged 12 years and older with severe alopecia areata. Affecting almost seven million people in the US and approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body. The condition can develop at any age, with nearly 20% of patients diagnosed before the age of 18. Litfulo, which is a one-daily oral kinase inhibitor, is thought to work by blocking the activity of signalling molecules and immune cells believed to contribute to the loss of hair in patients with alopecia areata. Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, said: “Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options ...
- Source: drugdu
- 115
- June 29, 2023
Sanofi and Sobi’s haemophilia A treatment shows effective bleed protection in children

Sanofi and Sobi’s once-weekly haemophilia A treatment has demonstrated highly effective bleed protection in children with severe forms of the disease, according to late-stage data presented at the International Society on Thrombosis and Haemostasis (ISTH) annual meeting. The phase 3 XTEND-Kids study evaluated a once-weekly 50IU/kg dose of the factor VIII replacement therapy, Altuviiio, for 52 weeks in previously treated patients aged under 12 years. The oral presentation at ISTH detailed results from the study and confirmed that the therapy met the primary endpoint, with no inhibitor development to factor VIII detected. Key secondary endpoints were also met, including annualised bleeding rate and maintenance of factor VIII activity above pre-specified levels. Sanofi added that the therapy was well-tolerated and demonstrated a safety profile similar to the phase 3 XTEND-1 trial, confirming safety and efficacy in both adults and children. Haemophilia A is a rare, lifelong bleeding disorder in which a ...
- Source: drugdu
- 186
- June 29, 2023
Biogen Shareholders Elect Susan Langer to Board of Directors Despite Controversy

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock After a June 12 shakeup of Biogen’s board of directors that included three directors foregoing their re-election, the company announced Monday that shareholders elected Susan Langer, who currently serves as president of Souffle Therapeutics, to the board. Langer will serve on the board for a one-year term, according to the press release. She was nominated by Alex Denner, a former member of the board who did not stand for re-election. According to reporting by Endpoints News and STAT News, Langer is Denner’s romantic partner and the mother of his child. BioPharma Dive reported that during Monday’s annual meeting of stockholders, Biogen management was asked why the company didn’t disclose this potential conflict of interest. Caroline Dorsa, the new chair, replied that Langer’s “personal matters obviously are much less relevant than what she brings to this board.” Langer has previously worked at ...
- Source: drugdu
- 127
- June 28, 2023
AstraZeneca decries low kidney disease diagnosis rates, finds ‘urgent need’ for better screening

Chronic kidney disease (CKD) affects around 37 million Americans, but this disease, which does not get the attention other conditions often do, can go undetected for years, boosting the risks of organ failure and even death.AstraZeneca, maker of blockbuster diabetes drug Farxiga that recently nabbed an expanded label in CKD, wants more to be done to find those who have this disease. The pharma cited new, real-world evidence that shows the prevalence of undiagnosed stage 3—moderate—CKD is 85% to 97% across Australia, Brazil, Canada and Spain. The study was shared this month at the European Renal Association 2023 Congress in Milan, Italy. This is a “staggeringly low rate” of diagnosis in CKD, according to an accompanying release from AstraZeneca, with these data showing “that an urgent need exists for improved screening.” Improved screening can lead to earlier diagnosis and thus potentially better outcomes, given that once kidney damage sets in ...
- Source: drugdu
- 169
- June 28, 2023
Patients affected by depression more likely to stop taking their heart medications

Patients who feel low when having a cardiac device implanted are more likely to stop taking their heart medications than those without depression, according to research presented today at ACNAP 2023, a scientific congress of the European Society of Cardiology (ESC). Study author Mr. Ole Skov, a psychologist and PhD student in cardiac psychology at the University of Southern Denmark, Odense, Denmark said: “Medications help to control symptoms and prevent further heart problems so adherence is important. Patients with an implantable cardioverter defibrillator (ICD) who feel depressed or anxious should be encouraged to express their concerns, thoughts, and feelings and contact a health care professional who can screen them for distress to explore the best course of action. This could be referral to a psychologist or other measures.” An ICD implantation is recommended for people at high risk of a life-threatening arrhythmia and for those who have had a sudden ...
- Source: drugdu
- 102
- June 27, 2023
Using deep learning algorithm for automated detection of occlusal caries

A diagnostic study on the detection of occlusal caries from a clinical photograph using a deep learning algorithm will be presented at the 101st General Session of the IADR, which will be held in conjunction with the 9th Meeting of the Latin American Region and the 12th World Congress on Preventive Dentistry on June 21-24, 2023, in Bogotá, Colombia. The Interactive Talk presentation, “Automated Detection of Occlusal Caries Using Deep Learning Algorithm,” will take place on Saturday, June 24 at 4:25 p.m. Colombia Time (UTC-05:00) during the “Prevalence of Health Conditions and Risk Factors” session. The study by Chukwuebuka Elozona Ogwo of Temple University, Philadelphia, PA, USA sought to determine the accuracy, precision, and sensitivity of the YOLOv7 object detection algorithm in occlusal caries detection from clinical photographs and (2) develop software for occlusal caries detection. Only consenting adults (>=18 years old) with permanent dentition receiving care at the Temple ...
- Source: drugdu
- 123
- June 27, 2023

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