Attended by 200+ delegates with 13 case-presenters who drove 8.5 hours of scientific discussions each day, the end-objective of the Summit was to discuss best domestic and international practices in order to drive better patient care in venous domain in India To create awareness and enable knowledge-sharing around Venous diseases, in order to drive better patient care, BD (Becton, Dickinson, and Company) conducted roadshows across New Delhi, Mumbai and Bangalore recently. Venous disease is a condition where the veins in the body have difficulty returning blood to the heart, thereby resulting in blood clot forming in a vein, typically in the legs. If left untreated, these clots can break loose and travel to the lungs, causing serious complications. Delayed detection and intervention can lead to worsened clinical outcomes and a multitude of problems for both patients and healthcare professionals. The 3-day Venous Summit witnessed a series of Technology Innovation Forums ...
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI) Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). Nilesh Gupta, Managing Director, Lupin said, “We are pleased to receive the EIR with VAI status from the USFDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide.”
The MedCity INVEST conference is scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, The companies will offer a window into some of the promising treatments under development such as different types of cancers to muscular dystrophy. Space is limited so register today! By Stephanie Baum Biopharma companies are responsible for some of the most transformative, life-changing technologies in medicine from gene therapy to immunotherapy. At the MedCity INVEST conference scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, six biopharma companies will give attendees a window into some of the promising treatments under development. MedCity News Senior Biopharma Reporter Frank Vinluan will moderate the biopharma track of the startup contest Pitch Perfect. One judge confirmed for the track is Meredith Wilkerson, an investment principal with Plains Ventures who serves as the primary subject matter expert for evaluating life sciences and biotech investment opportunities. Wilkerson will also ...
The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
Don Tracy, Associate Editor Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.Pfizer announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) as a one-time gene therapy for adults with moderate to severe hemophilia B. The therapy is indicated for patients who currently use factor IX (FIX) prophylaxis therapy, have a history of severe hemorrhage, or experience frequent serious bleeding with no neutralizing antibodies to the adeno-associated virus serotype. In clinical trials, Beqvez was found to help patients to produce their own FIX, lowering the need for regular intravenous (IV) infusions. The approval was based on promising data from the Phase III open-label, single-arm BENEGENE-2 trial, which evaluated the efficacy and safety of Beqvez in 45 males aged 18 to 65 years with moderately severe to severe hemophilia B. All participants ...
It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. By Gretchen Zimmermann Body Mass Index (BMI) has long been regarded as a standard measure for assessing weight-related health risks and, more recently, determining eligibility for anti-obesity medications like GLP-1 receptor agonists semaglutide (Wegovy) and tirzepatide (Zepbound), according to the FDA. BMI, calculated from weight and height, offers a simplistic yet flawed assessment of health. It was initially designed for non-Hispanic white populations and overlooks nuances like muscle mass, fat distribution, and ethnic background, which can influence certain risk factors. It’s an antiquated measure that perpetuates inequities in healthcare and misses the mark for calculating cardiometabolic conditions. The perception that a “normal” BMI is ideal and an “overweight to obese” BMI is not ideal only exacerbates bias within the medical community and complicates our efforts to solve the obesity crisis. Individuals with an overweight to ...
Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
SHANGHAI, April 26, 2024 /PRNewswire/ — World Malaria Day is marked each year on April 25. World Health Organization (WHO) gave as the theme for World Malaria Day 2024 Accelerating the fight against malaria for a more equitable world. WHO stated that malaria not only continues to directly endanger health and cost lives, but it also perpetuates a vicious cycle of inequity. People living in the most vulnerable situations including pregnant women and children under 5 years of age continue to be disproportionately impacted. Artemisinin medicines developed with China’s scientific research efforts have become a ticket for China’s innovative medicines to go global. According to the WHO World Malaria Report 2023, globally in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths. Sub-Saharan Africa accounted for more than 95% of the global malaria cases and deaths. Globally, an estimated 11.7 million malaria deaths were averted in ...
According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver cancer, and deaths related to viral hepatitis, affecting hundreds of millions. Early detection plays a crucial role in initiating timely treatments that improve long-term health outcomes. The detection of the hepatitis B virus surface antigen (HBsAg) in serum or plasma is an early indicator of infection. HBsAg is the first serological marker to appear in the progression of the disease, emerging in the blood two to three weeks before symptoms become apparent. Traditional testing protocols typically require retesting and subsequent confirmatory tests for reactive samples. Now, two newly introduced hepatitis assays use advanced technology to elevate efficiency and confidence in hepatitis testing. Beckman Coulter Diagnostics (Brea, CA, USA) has extended the menu of DxI 9000 Immunoassay Analyzer assays with ...
Dive Brief Exo has made new artificial intelligence tools available on its Iris handheld ultrasound system, the company said Tuesday. The Food and Drug Administration cleared Exo’s AI tools for analyzing ultrasound images of the heart and lung last year. Exo sees the new capabilities as particularly beneficial for health systems and caregivers in rural and under-resourced settings because they simplify the collection and interpretation of images. Dive Insight Exo received a 510(k) nod for its original Iris device in 2021 and added imaging modes and indications to the clearance the following year. The clearances cover handheld portable diagnostic ultrasound systems, similar to Butterfly Network’s iQ, that enable healthcare professionals to measure body structures and fluids in adults and children. Users can view the images on smartphone screens. In 2023, Exo gained additional FDA clearances for AI products. One clearance covered software that uses machine learning to help quantify bladder ...
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