PharmaFocus Today – Page 171 – media

Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment

Dive Brief Edwards Lifesciences received approval from the Food and Drug Administration for its Evoque tricuspid valve replacement system, making it the first company to bring a transcatheter treatment for tricuspid regurgitation to the U.S. Tricuspid regurgitation is a condition where the valve between the two right heart chambers doesn’t close properly, allowing blood to leak backward. Edwards’ Evoque device is inserted through a minimally invasive surgery and is designed to replace the tricuspid valve. Competitor Abbott has submitted a device for FDA approval called TriClip, which clips together a portion of the leaflets of the tricuspid valve to prevent blood from leaking back. The FDA plans to hold an advisory panel on Feb. 13 to discuss the device. Dive Insight The approval for Evoque is a “meaningful milestone for [Edwards] as well as for the industry,” Shagun Singh, an RBC Capital Markets analyst, wrote in a research note. The ...
- Source: drugdu
- 91
- February 4, 2024
Roche’s Vabysmo Shows Sustained Improvements in Vision, Retinal Drying in Retinal Vein Occlusion

Davy James Vabysmo is the first bispecific antibody approved to treat ocular conditions such as diabetic macular edema and wet age-related macular degeneration. Findings from the global Phase III BALATON (NCT04740905) and COMINO (NCT04740931) trials show Roche’s Vabysmo (faricimab-svoa) produced sustained retinal drying and improved vision in patients with retinal vein occlusion (RVO).1 Vabysmo, the first bispecific antibody approved to treat ocular conditions, inhibits a pair of disease pathways involved in multiple vision-threatening retinal conditions by neutralizing angipoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).2 In February 2022, Vabysmo became the first and only FDA-approved injectable eye medicine for diabetic macular edema and wet age-related macular degeneration. “This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion,” Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global ...
- Source: drugdu
- 88
- February 4, 2024
Veracity Benefits, Levrx Technology Reveal New Digital Health Tech App

Don Tracy, Associate Editor App aims to leverage digital technology to significantly reduce pharmacy costs. Veracity Benefits and Levrx Technology have announced a strategic partnership with the launch of the Veracity Rx app. The app was developed with the goal of leveraging advanced digital technology to significantly reduce pharmacy costs by 40%-60% below the national average. According to a joint press release, the app provides members with efficient access to their pharmacy benefits and offers personalized, real-time data and insights for saving on medications. “Our collaboration with Levrx Technology is instrumental in streamlining our mission to digitize and promote pharmacy programs that yield optimal health outcomes and deliver financial results,” said James Davie, chief revenue officer, Veracity Benefits, in the press release. “The VeracityRx App is a testament to our commitment to providing cutting-edge solutions that benefit both employers and employees.” According to the companies, the primary features of the ...
- Source: drugdu
- 84
- February 4, 2024
Johnson & Johnson Seeks Approval for Darzalex Faspro Combo in Newly Diagnosed Multiple Myeloma

Pharmaceutical Executive Editorial Staff Darzalex Faspro has previously been approved by the FDA for eight indications in multiple myeloma. The FDA will evaluate Johnson & Johnson’s supplemental Biologics License Application (sBLA) for Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy and in combination with lenalidomide (D-R) for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1 Darzalex Faspro, a CD38-directed antibody, has previously been approved by the FDA for eight indications in multiple myeloma, with three in the frontline treatment of newly diagnosed patients who are transplant eligible or ineligible. “We are committed to changing the course of multiple myeloma through building combination regimens such as D-VRd with complementary mechanisms of action. The Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in the risk of progression or death for transplant-eligible, newly ...
- Source: drugdu
- 128
- February 2, 2024
Abbott Announces New High Protein Weight Loss Shake

Mike Hollan The shake is designed to work with regular dieters and those taking weight loss medications. Abbott announced the launch of a new brand of protein shakes named Protality. While there are plenty of protein shakes on the market, these particular shakes are designed to be used by people taking weight loss drugs. Over the past year, weigh loss or anti-obesity drugs have seen an increase in popularity and awareness. Often times, people using these medications will note a loss of appetite, which obviously goes hand-in-hand with weight loss. Unfortunately, not all of that weight loss is necessarily good. Typically, when people lose weight, they lose a combination of both muscle and fat. While fat burning is generally desired, muscle loss is not. According to Abbott’s press release, 11-50% of the weight lost by dieters can be made up of muscle. To avoid this, dieters should increase the amount ...
- Source: drugdu
- 121
- February 2, 2024
World’s First ‘Blood Matching’ Genetic Test to Better Pair People for Blood Transfusions

In the UK, there are about 17,000 individuals living with sickle cell disorder, and each year there are around 250 new cases. This condition, predominantly affecting people of black African and Caribbean descent, can lead to significant organ damage and intense pain. In contrast, the UK has around 800 patients with thalassaemia and less than 50 new cases annually. Thalassaemia patients struggle to produce sufficient hemoglobin, which, if untreated, can result in life-threatening anemia. This condition is most prevalent among people of Asian, Middle Eastern, and southern Mediterranean backgrounds. While life-saving blood transfusions are a common treatment for these inherited blood disorders, about 20% of patients develop antibodies against certain blood groups, causing delays in their treatment. Now, a groundbreaking ‘blood matching’ genetic test, the first of its kind in the world, is being made available to thousands of these patients in the UK to better pair people for blood ...
- Source: drugdu
- 111
- February 2, 2024
Innovative ‘Fragmentomics’ Approach to Enable Earlier Detection of Cancer Using Smaller Blood Draws

When cells die, they disintegrate, releasing part of their DNA material into the bloodstream. This cell-free DNA (cfDNA) contains cancer signals. The cfDNA from healthy cells breaks down into standard-sized fragments, whereas cancerous cfDNA fragments disintegrate at different locations, often in the genome’s repetitive regions. Instead of searching for specific DNA mutations, which is like finding a single misarranged letter in billions of letters, researchers have developed a novel machine-learning method. This method detects variations in fragmentation patterns between cancerous and normal cfDNA in these repetitive regions of cancer. This groundbreaking technique could potentially allow for earlier cancer detection in patients through smaller blood samples, as it requires approximately eight times less blood than what is needed for whole genome sequencing. The algorithm called Alu Profile Learning Using Sequencing (A-Plus) was developed by researchers at City of Hope (Duarte, CA, USA) and Translational Genomics Research Institute (TGen, Phoenix, AZ, USA). ...
- Source: drugdu
- 148
- February 2, 2024
Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

More than two years after Aduhelm’s controversial and ill-fated FDA accelerated approval, Biogen is discontinuing the Alzheimer’s disease therapy after walking a rocky path. Wednesday, Biogen said it’s pulling all efforts from the first-of-its-kind anti-amyloid beta therapy to focus on Leqembi, its Eisai-partnered newer medicine, and its pipeline candidates. The newer drug, Leqembi, won a full FDA approval early last year, making the partners’ marketing efforts on the therapy much simpler than was the case with Aduhelm. Biogen is taking a $60 million charge and is discontinuing all development and sales of Aduhelm, the company said. It’s terminating the ENVISION clinical study, which sought to confirm the benefit of the medicine as required under its 2021 accelerated approval. The decision follows Biogen’s move to launch a strategic review in early 2023 under new CEO Chris Viehbacher, the former Sanofi chief who joined the Massachusetts drugmaker in November 2022. During that ...
- Source: drugdu
- 197
- February 2, 2024
Daiichi Sankyo again dials up Enhertu sales forecast, advances 2nd AstraZeneca-partnered ADC

AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate. But this time, the rosier outlook reflects developments outside the U.S. Daiichi now expects Enhertu sales to come in at 383.9 billion Japanese yen (about $2.6 billion) for the 12 months ending March 31. The number includes profits from regions where AstraZeneca books Enhertu sales. Daiichi had already once dialed up its Enhertu forecast for its current fiscal year. The drugmaker’s projection was originally 320 billion yen back in April 2023, then Daiichi raised it to 381.7 billion yen in October. Despite rolling out the higher global forecast, Daichii actually reduced Enhertu’s 12-month sales estimate in the U.S. by $30 million to $1.58 billion. For the first nine months of the company’s fiscal year, Enhertu generated $1.14 billion in the U.S., an increase of ...
- Source: drugdu
- 131
- February 2, 2024
Hengrui’s new breakthrough! China’s first self-developed innovative opioid analgesic drug Tegelidine fumarate was approved for marketing

Recently, Hengrui Pharmaceutical received the “Drug Registration Certificate” approved and issued by the State Drug Administration, approving the launch of the company’s independently developed Tagelidine Fumarate Injection (Asut®) for the treatment of moderate to severe pain after abdominal surgery. This product is China’s first independently developed innovative Class 1 opioid analgesic drug and will provide new treatment options for patients suffering from postoperative pain. So far, Hengrui has got marketing approval for 16 innovative drugs. Postoperative pain is one of the most common forms of acute pain. It is reported that in China the prevalence of moderate to severe acute pain after surgery in patients is as high as 48.7%. At the same time, patients with moderate to severe pain are not satisfied with analgesic treatment, with 28.5% of patients expressing a need for more efficient analgesic therapy1. Taglidine Fumarate Injection is Hengrui’s key milestone product in the field of ...
- Source: drugdu
- 109
- February 2, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.