Search Results for “FDA” – Page 12 – media

FDA Approves New Herceptin Biosimilar for the Treatment of Multiple HER2-Overexpressing Cancers

Don Tracy, Associate Editor Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers. Image Credit: Adobe Stock Images/Saiful52 Accord BioPharma announced that the FDA has approved Hercessi (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast and gastric cancers. The treatment is also approved for metastatic gastric or gastroesophageal junction adenocarcinoma. According to the company, the approval was based on promising data that showcased Hercessi’s biosimilarity to Herceptin when it came to efficacy, safety, and quality. This includes three studies, one being a Phase III clinical efficacy study, and the other two being Phase 1 PK equivalence studies. All trials displayed safety profiles on par with Herceptin.1 “The approval of Hercessi—our first biosimilar to be approved in the US—marks an important milestone for Accord BioPharma in our efforts ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 94
- May 4, 2024
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/
- 92
- May 4, 2024
Cardinal receives FDA warning letter over unapproved syringes

Dive Brief Cardinal Health marketed convenience kits that include piston syringes not authorized by the Food and Drug Administration, the agency said in an April 24 warning letter. The agency found the violations during an inspection of Cardinal’s facility in Waukegan, Illinois. Cardinal distributed syringes made by Jiangsu Shenli Medical Production with “substantially different technological characteristics” than those cleared by the FDA, according to the letter. Cardinal has come under scrutiny after the company recalled some of its disposable syringes last year because their dimensions had changed, making them incompatible with certain infusion pumps. The FDA has also taken steps to block plastic syringes made by Jiangsu Shenli from being imported. Dive Insight The warning letter focuses on Cardinal’s Monoject luer-lock tip syringes, which are intended to inject fluids into the body or withdraw fluids, and Monoject enteral feeding syringes, which deliver fluid, food or medications to ...
- Source: https://www.medtechdive.com/news/cardinal-warning-letter-unapproved-syringes/714934/
- 93
- May 4, 2024
Senseonics gets FDA clearance to pair CGM implant with insulin pumps

Dive Brief Senseonics has received an integrated continuous glucose monitoring (iCGM) designation from the Food and Drug Administration, the company said Tuesday. The designation, which the FDA granted via its de novo pathway, clears Senseonics to integrate its implantable CGM with pumps as part of automated insulin delivery systems. Senseonics’ sales are small compared to the CGM leaders Abbott and Dexcom, but BTIG analysts said the iCGM designation and planned one-year sensor could help the device appeal to a broader patient population. Dive Insight Senseonics’ Eversense device is a CGM implant that replaces fingerstick blood glucose measurements. The current device continually measures glucose levels for up to 180 days but requires daily calibrating with a fingerstick after day 21 and when symptoms do not match CGM information. Abbott and Dexcom sell shorter-lasting patches that dominate the CGM space. The iCGM designation allows Eversense to integrate with ...
- Source: https://www.medtechdive.com/news/senseonics-fda-clearance-integrated-cgm/714804/
- 80
- May 3, 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
- 106
- May 3, 2024
Lupin receives EIR from USFDA for its Aurangabad manufacturing facility

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.”
- Source: https://www.lupin.com/lupin-receives-eir-from-us-fda-for-its-aurangabad-manufacturing-facility/
- 97
- 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
- 76
- 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/
- 109
- 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
- 84
- May 1, 2024
Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose

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 ...
- Source: drugdu
- 86
- April 30, 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.