Search Results for “FDA” – Page 40 – media

Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday. “These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said. Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024. Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last ...
- Source: drugdu
- 167
- September 9, 2023
Sage Therapeutics Fires 40% Of Staff after FDA Rejected MDD Bid

Sage Therapeutics will reduce its workforce by 40% following the US Food and Drug Administration’s (FDA) rejection of its drug Zurzuvae (zuranolone) in adults with major depressive disorder (MDD). The US-based company will pause some undisclosed early-stage programs and focus instead on the refinement of its compounds SAGE-718 and SAGE-324, per the 31 August announcement. Sage’s leadership will also change with the departure of the current chief scientific officer (CSO) Al Robichaud and the chief development officer (CDO) Jim Doherty. The restructuring comes at a time when the company plans the commercial launch of Zurzuvae for treating postpartum depression which is expected in late 2023. On 4 August, the FDA approved Zurzuvae’s use in women with postpartum depression while simultaneously issuing a complete response letter (CRL) for the treatment’s use in MDD. The CRL stated that the drug’s application did not provide substantial evidence of effectiveness in MDD and that ...
- Source: drugdu
- 153
- September 5, 2023
Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA

Dive Brief Hamilton Medical’s recall of ventilators for a software problem was designated Class I by the U.S. Food and Drug Administration, the agency wrote in a Monday notice. Hamilton contacted customers in June after learning that its C1, C2, C3 and T1 ventilators switch to “ambient state” if used in neonates for more than 91 days without a restart. In ambient state, the device sounds an alarm and no active ventilation is provided to patients. In light of the fault, which has caused 80 complaints but no injuries or deaths, Hamilton is asking users of its ventilators to regularly restart their devices. Dive Insight Hamilton sells mechanical ventilators for use in adults, children and infants. The problem that caused the Class I recall happens when the devices “are used for long-term ventilation in neonatal group.” If the ventilation time exceeds 91 days, the devices enter ambient state, causing them ...
- Source: drugdu
- 130
- September 4, 2023
Amid shortage, FDA clears several generics of Takeda’s popular ADHD drug Vyvanse

After 16 years on the market, Takeda’s blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. The med, which is also approved for binge-eating disorder, has been in short supply since June due to a “manufacturing delay compounded by increased demand,” the company said in a statement earlier this summer. Now, generics may soon help ease the supply situation. On Aug. 25, the FDA cleared many copycats of the drug. The now-approved generics range in dosage from 10 mg to 70 mg and come in capsule and chewable forms. Manufacturers such as Teva, Sun Pharmaceutical, Actavis, Mylan, Hikma and others have cleared the agency’s regulatory bar with their generics. It’s not clear whether any of the companies have actually launched their copycats in the U.S. Takeda’s patents on its branded version expired Aug. 24. Whenever they debut, the generics will surely be welcomed by patients. A 100-day ...
- Source: drugdu
- 129
- September 1, 2023
FDA shuns Outlook Therapeutics with wet AMD drug BLA rejection

It is a bleak view for Outlook Therapeutics’ wet age-related macular degeneration (AMD) treatment plans after the US Food and Drug Administration (FDA) rejected a biologic licence application (BLA) for the company’s bevacizumab-vikg candidate. Shares in Outlook Therapeutics fell a hefty 80% when the market opened on 30 August. Prior to the FDA’s complete response letter (CRL), a GlobalData consensus estimated Outlook to potentially earn $989m in 2029 if the drug was approved. GlobalData is the parent company of Pharmaceutical Technology. Despite ONS-5010 (bevacizumab-vikg) demonstrating positive results in a trial – meeting safety and efficacy endpoints, the agency noted several manufacturing issues and the need for additional confirmatory clinical data. In a conference call on 30 August, Outlook Therapeutics’ CEO Russell Trenary said: “We are disappointed, and we were certainly not expecting to receive a CRL back from the FDA.” He added that the company believes the chemistry, manufacturing, and ...
- Source: drugdu
- 109
- September 1, 2023
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
- 232
- 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
- 112
- 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
- 121
- 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
- 126
- 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
- 115
- August 21, 2023

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.