Search Results for “FDA” – Page 40 – media

Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis

Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS). The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population. A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. “Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS,” said Paul Lee, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. Tyruko, which is administered ...
- Source: drugdu
- 227
- August 30, 2023
FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri

By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
- Source: drugdu
- 108
- August 29, 2023
Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited immune condition Chaple disease. The disease, which is also known as CD55-deficient protein-losing enteropathy, has a global patient population of fewer than 100 people. In just the U.S., fewer than 10 patients have been diagnosed, Regeneron said in its Friday release. Chaple disease is caused by mutations of the complement regulator CD55 gene, which can lead the compliment system to attack the body’s own cells. Enter Veopoz, a fully human monoclonal antibody that targets a protein involved in complement system activation called compliment factor C5. It’s approved for patients 1 year of age and older and comes with a $34,615 price tag per single-use vial, a Regeneron spokesperson said in an emailed statement. The injection was tested in ...
- Source: drugdu
- 116
- August 22, 2023
Ipsen’s Sohonos gets FDA approval for fibrodysplasia ossificans progressive

Ipsen’s Sohonos (palovarotene), a drug treatment for fibrodysplasia ossificans progressive (FOP), has been approved by the US Food and Drug Administration (FDA). FOP is a rare muskuloskeletal condition that progressively transforms muscles and tendons into bone, affecting the movement of the body. As a rare disease, FOP is estimated to Impact around 900 people globally. Sohonos has been approved as a treatment for adults and paediatric patients with FOP – for females 8 years and older and for males 10 years and older – to mediate the interactions between the receptors, growth factors and proteins within the retinoid signaling pathway to reduce new abnormal bone formation. The drug has particular selectivity for the gamma subtype of retinoic-acid receptors, which are an important regulator of skeletal development and ectopic bone in the retinoid signaling pathway. “The first treatment for FOP has been proven to reduce the volume of new abnormal bone ...
- Source: drugdu
- 121
- August 22, 2023
FDA Approves Ipsen’s Palovarotene for Ultra-Rare Bone Disease

By Tristan Manalac Pictured: U.S. FDA headquarters in Maryland/iStock, Grandbrothers The FDA on Wednesday approved Ipsen’s palovarotene, now to be sold under the brand name Sohonos, for the treatment of fibrodysplasia ossificans progressiva. Sohonos is an oral medication indicated for the reduction of heterotrophic ossification in adults and children with fibrodysplasia ossificans progressiva (FOP). It is the first medicine authorized by the FDA to treat FOP. “For the first time, doctors have an approved medicine available to them, shown to reduce the formation of new, abnormal bone growth,” Ipsen R&D head Howard Mayer said in a statement. Afflicting approximately 400 patients in the U.S. and 900 globally, FOP is an ultra-rare genetic disease in which muscles and connective tissues are gradually replaced by bone. Patients with FOP often suffer from hindered movements and, in cases where joints are affected, lose their mobility. FOP also manifests as breathing problems and difficulties ...
- Source: drugdu
- 108
- August 21, 2023
FDA approves Talvey for heavily pre-treated multiple myeloma

US Food and Drug Administration (FDA) has approved Talvey (talquetamab-tgvs) for the treatment of refractory or relapsed multiple myeloma in adult patients who have received at least four prior lines of therapy. Talvey is a bispecific antibody targeting T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D) developed by Janssen. It received accelerated approval as a weekly or biweekly subcutaneous therapy. University of California multiple myeloma programme director Ajai Chari noted in a press release: “Patients at this stage of the disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.” The approval was based on meaningful overall response rates (ORR) demonstrated in the Phase II clinical trial data. However, continued approval for Talvey is contingent upon further confirmatory trials showing clinical benefit. To that end, Talvey is only available for use via a ...
- Source: drugdu
- 120
- August 21, 2023
FDA again slams Biocon’s troubled plant in Malaysia, citing 8 manufacturing shortfalls

Biocon’s troubled Malaysia manufacturing facility has been slammed once again by the FDA. After a recent inspection, the regulator cited the plant for eight observations. The latest citation follows an FDA visit to the site from July 10 to July 20. Afterward, the FDA wrote up its findings in a Form 483 filing that highlights inadequate corrective and “repeat” problems that it observed on previous visits. In a letter posted on the FDA’s website, Biocon was cited for a number of ongoing issues such as scissors stored in non-sterile holders being used to open “bags of sterile components,” improper blockage of air filters, insufficient cleaning of sterile machinery and numerous problems with batch testing and record-keeping. The filing, which contained numerous redactions, also cited Biocon’s failure to lay out detailed, written guidelines for some manufacturing operations. “Specifically, your firm has no written procedures on what corrective actions are to be ...
- Source: drugdu
- 164
- August 20, 2023
Medtronic’s dialysis device recall assigned to Class I by the FDA

Dive Brief Medtronic’s recall of hemodialysis catheters was categorized by the U.S. Food and Drug Administration as a Class I event, according to a Friday entry in the FDA’s database. The company contacted customers in June after routine manufacturing testing identified a blockage that could obstruct the catheter, potentially delaying treatment and leading to outcomes such as blood clots and the destruction of red blood cells. Healthcare providers with devices covered by the recall should immediately quarantine and stop use of the catheters. Medtronic has received no confirmed complaints related to the problem, and no reports of adverse events or deaths. Dive Insight The Medtronic recall affects specific lots of Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple Lumen Catheters. Medtronic’s Mahurkar Elite Catheters are unaffected by the recall. “Medtronic initiated a voluntary recall related to Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple ...
- Source: drugdu
- 141
- August 18, 2023
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection

By Tristan Manalac Pictured: Cancer cells growing on the liver/iStock, Rasi Bhadramani The FDA on Monday approved Delcath Systems’ Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma, capping a nearly decade-long effort to secure regulatory approval. Hepzato’s label covers metastatic uveal melanoma (mUM) patients with unresectable hepatic metastases that afflicts less than 50% of their liver and who do not show signs of extra-hepatic disease. Hepzato can also be used in cases of extra-hepatic spread, provided it is limited to the bone, lymph nodes, subcutaneous tissues or lungs. Monday’s approval makes Hepzato “the only liver-directed therapy that can treat the whole liver,” Delcath Chief Medical Officer Vojislav Vukovic said in a statement. The approved product comes with a boxed warning for severe peri-procedural complications, such as hemorrhage and hepatocellular injury, as well as myelosuppression. To manage these risks, the company will implement a Risk Evaluation ...
- Source: drugdu
- 108
- August 18, 2023
【EXPERT Q&A】For pharmaceutical exports to the United States, after obtaining FDA certification, is there still a need for an import permit from the U.S.?

Drugdu.com expert’s response: To export pharmaceuticals to the United States, in addition to obtaining FDA certification, one must also comply with other U.S. import regulations. After receiving FDA approval, the drug also needs to adhere to the import regulations set by the U.S. Customs and Border Protection (CBP). Sometimes, this may involve obtaining additional import permits or certificates, but the specific requirements can vary based on the type of product and specific circumstances. Before shipping the drug to the U.S., ensure that you are familiar with and compliant with all relevant regulations. Collaborating with local import/export agents might be helpful as they are typically knowledgeable about these regulations and can provide specific guidance.
- Source: drugdu
- 197
- August 17, 2023
FDA approval import permit

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