Search Results for “Clinical Trial” – Page 61 – media

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. By Frank Vinluan A primary immunodeficiency whose rarity means it can go undiagnosed or misdiagnosed in a patient for years now has its first drug. The FDA has approved a once-daily therapy that addresses the underlying genetic problem driving the inherited disorder, known as WHIM syndrome. The regulatory decision announced Monday for the X4 Pharmaceuticals drug covers WHIM patients age 12 and older. The daily capsule, known in development as mavorixafor, will be commercialized under the brand name Xolremdi (pronounced “zohl-REM-dee”). The name WHIM is an acronym for warts, hypogammaglobulinemia, infections, and myelokathexis, which are the four common clinical presentations of the disease. But the disease is not limited to those symptoms and it presents differently from one patient to another. There is no standard ...
- Source: https://medcitynews.com/author/fvinluan/
- 87
- May 4, 2024
AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...
- Source: https://www.expresspharma.in/astrazenecas-lynparza-to-dominate-parp-inhibitors-market-with-4-bn-in-sales-by-2027-globaldata/
- 162
- May 4, 2024
FDA approves X4 Pharmaceuticals’ WHIM syndrome drug

The US Food and Drug Administration (FDA) has approved X4 Pharmaceuticals‘ XOLREMDI (mavorixafor) capsules for patients aged 12 and above with warts, hypogammaglobulinemia, infections and myelokathexis (WHIM) syndrome. This marks a significant advancement in the treatment of WHIM syndrome, a rare combined primary immunodeficiency and chronic neutropenic disorder. XOLREMDI is a selective CXC chemokine receptor 4 (CXCR4) antagonist. It is the first drug specifically indicated to treat patients with WHIM syndrome. X4 Pharmaceuticals president and CEO Paula Ragan stated: “The approval of XOLREMDI is a transformational milestone both for X4 and, more importantly, for the WHIM syndrome community. “We are incredibly grateful to the people living with WHIM syndrome, their families, and the investigators who took part in our clinical programme, to US regulators for their continued focus on rare-disease treatment development, and to our dedicated employees for making this targeted breakthrough therapy a reality.” ...
- Source: https://www.pharmaceutical-technology.com/news/fda-x4-syndrome-drug/?cf-view
- 102
- May 3, 2024
Medtronic wins FDA approval for Inceptiv closed-loop spinal cord stimulator

Dive Brief Medtronic has received Food and Drug Administration approval for its Inceptiv closed-loop spinal cord stimulator (SCS) for the treatment of chronic pain, the company said Friday. The closed-loop system is meant to reduce overstimulation compared to the open-loop technology used by Medtronic’s rivals, such as Abbott, Boston Scientific and Nevro. Evercore ISI analysts think Medtronic has lost share to Abbott over the past two years, and the launch of Inceptiv could help the company regain ground in the coming quarters. Dive Insight Users of open-loop SCS receive a predetermined amount of stimulation, which is set when the physician programs the device, regardless of what the patient is doing. The fixed output can result in moments of overstimulation that are uncomfortable, potentially leading users to choose a lower, less effective level of stimulation. Open-loop efficacy may fall over time, too. Closed-loop systems, such as Medtronic’s Inceptiv device, adjust their ...
- Source: drugdu
- 73
- May 2, 2024
Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

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 ...
- Source: drugdu
- 70
- May 2, 2024
FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. By Frank Vinluan Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ. The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer. BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce an immune ...
- Source: https://medcitynews.com/author/fvinluan/
- 106
- May 2, 2024
FDA Approves Pfizer’s Beqvez for the Treatment of Adults with Moderate to Severe Hemophilia B

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 ...
- Source: drugdu
- 80
- May 1, 2024
Fosun Pharma’s Self-developed Artemisinin Medicines Inject New Impetus to Malaria Prevention and Treatment in Africa

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 ...
- Source: drugdu
- 70
- April 30, 2024
【EXPERT Q&A】What is the relationship between FDA registration and 510K registration for medical devices and what is the difference?

Drugdu.com expert’s response: The relationship between FDA registration and 510(k) clearance for medical devices involves overlap but also key distinctions. Relationship: 1.FDA Registration: This encompasses the process of submitting product information to the U.S. Food and Drug Administration (FDA) and obtaining FDA approval. It includes various types of registrations, such as 510(k) clearance, Premarket Approval (PMA), among others. 2.510(k) Clearance: This is a specific certification process within FDA’s regulatory framework, typically applicable to certain medical devices for which there are similar existing products on the market. In the 510(k) clearance process, manufacturers need to demonstrate that their product is substantially equivalent to an existing marketed device and does not pose an unreasonable risk to the user. Differences: 1.FDA registration is a broader concept encompassing various registration pathways, of which 510(k) clearance is one. 2.Within FDA registration, if a medical device can demonstrate substantial equivalence to a predicate device and meets ...
- Source: drugdu
- 164
- April 30, 2024
AI-Powered Digital Imaging System to Revolutionize Cancer Diagnosis

The process of biopsy is important for confirming the presence of cancer. In the conventional histopathology technique, tissue is excised, sliced, stained, mounted on slides, and examined under a microscope to identify cancerous markers. This lengthy procedure often results in patients waiting weeks or months for their results, causing treatment delays and heightened anxiety. Now, a breakthrough digital medical imaging system promises to transform cancer detection by offering instantaneous results, facilitating timely and effective treatment across all cancer types. The Photon Absorption Remote Sensing (PARS) system, an innovative, built-from-scratch technology developed by researchers at the University of Waterloo (Ontario, Canada), marks a radical departure from traditional cancer detection methods, promising diagnoses within minutes and enabling rapid surgical intervention. The system utilizes lasers to irradiate tissue samples, producing a comprehensive, high-resolution data set. This data is then processed by an artificial intelligence (AI) system that converts it into a conventional histopathology ...
- Source: drugdu
- 108
- April 29, 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.