Search Results for “FDA” – Page 38 – media

FDA Rejects ARS Pharmaceuticals’ Needle-Free EpiPen Alternative

Agency cites a need for more research to be completed. ARS Pharmaceuticals revealed in a company press release that the FDA issued a complete response letter (CRL) regarding its new drug application (NDA) for neffy, a potential nasal spray alternative to the EpiPen. According to the response, the agency stated that it needed more research before agreeing to approval. The denial comes amid an initial advisory committee vote to approve the treatment back in May. “We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote. In fact, multiple Committee members highlighted the favorable profile of neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response ...
- Source: drugdu
- 202
- September 22, 2023
FDA Rejects ARS’ Epinephrine Nasal Spray Despite Adcomm Support

By Tristan Manalac Pictured: FDA signage outside its office in Maryland/iStock, hapabapa The FDA on Tuesday turned down ARS Pharmaceuticals’ application for its epinephrine nasal spray neffy for the treatment of type I allergic reactions in adults and children weighing at least 30 kg. In its Complete Response Letter (CRL), the regulator asked ARS to conduct an additional pharmacokinetic and pharmacodynamic study that evaluates repeated neffy doses compared with repeat administrations of an epinephrine injection in participants with allergen-induced allergic rhinitis. According to the company’s announcement on Tuesday, the FDA is making this request despite aligning with ARS in August 2023 regarding the need to conduct this study as a post-marketing requirement. The regulator and the company have also already settled on the final physician’s labeling for the product. In May 2023, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16-6 that neffy’s risk-benefit profile was favorable in adults. The ...
- Source: drugdu
- 119
- September 22, 2023
Taysha Drops Gene Therapy Candidate as FDA Again Calls for Study Changes

By Connor Lynch Pictured: FDA sign in its headquarters/iStock, Grandbrothers Taysha Gene Therapies has decided to drop its lead experimental AAV-based gene therapy candidate after the FDA reiterated calls for the company to put the treatment through a randomized, double-blind placebo-controlled trial. The Dallas-based company announced on Tuesday that it would no longer be developing its TSHA-120 treatment for giant axonal neuropathy (GAN) based on the FDA’s Type C meeting feedback regarding the therapy’s potential pathway. “FDA continues to recommend a randomized, double-blind, placebo-controlled trial as the optimal path to demonstrate efficacy in TSHA-120,” the company said in a statement. Taysha noted in the announcement that the FDA “provided a potential path for a single-arm trial with an external control group matched with to-be treated patients by multiple prognostic factors and recommended longer term follow up to account for potential bias.” CEO Sean Nolan said in a statement that the ...
- Source: drugdu
- 189
- September 22, 2023
FDA finalizes breakthrough device changes to target health inequities

Dive Brief The Food and Drug Administration has finalized changes to its breakthrough devices guidance, adopting revisions that could accelerate development of products that address health inequities. Eleven months ago, the FDA proposed updating its breakthrough guidance to clarify that devices that improve accessibility, and thereby tackle health inequities, can qualify for the program. The proposals received broadly positive feedback, including from industry trade group AdvaMed, leading the FDA to finalize the changes with only minor revisions and schedule a webinar to discuss its new policy. Dive Insight The FDA designed the breakthrough program to support development of devices that could better treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. Originally, the guidance lacked a specific reference to accessibility as a way that devices can improve care. In October, the FDA proposed updating the guidance to explain that it considers the “totality of information regarding the proposed device, ...
- Source: drugdu
- 212
- September 20, 2023
Meridian Bioscience announces FDA clearance for innovative Curian® Shiga Toxin Assay

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) had granted clearance for the company’s new Curian® Shiga Toxin assay. This assay joins Curian HpSA® and Curian Campy as Meridian expands its Curian diagnostic platform to maintain leadership in the gastrointestinal disease testing market. Foodborne illness is a severe global public health problem that causes 48 million people to get sick yearly and 128,000 hospitalizations from common bacterial agents like Campylobacter and E. coli.1 Meridian is expanding its foodborne immunofluorescent testing capabilities beyond Campylobacter by adding Shiga toxin to the Curian platform. Speedy diagnosis is essential with patients suspected of having a Shiga toxin-producing E. coli infection because the use of antibiotics for treatment can increase Shiga toxin release, leading to hemolytic uremic syndrome (HUS), a potentially life-threatening complication. The Curian Shiga ...
- Source: drugdu
- 240
- September 20, 2023
FDA Approves GSK’s Momelotinib for Myelofibrosis Patients with Anemia

By Tristan Manalac Pictured: GSK building in Poland/iStock, Wirestock The FDA on Friday approved GSK’s oral drug momelotinib, now to be marketed under the brand name Ojjaara, for the treatment of myelofibrosis in adults with anemia. Myelofibrosis patients often develop anemia, which forces them to discontinue treatment and raise the need for transfusions. Ojjaara’s approval will help address this “significant medical need in the community” and lead to better outcomes in these patients, Nina Mojas, GSK senior vice president for oncology global product strategy, said in a statement. With Friday’s approval, Ojjaara becomes the first authorized treatment for both newly diagnosed and previously treated myelofibrosis patients with anemia that also targets the key symptoms of the condition, according to the company’s press release. The approval comes after a three-month delay in June 2023, which the FDA said was to give it more time to review additional data supporting the application. ...
- Source: drugdu
- 222
- September 20, 2023
FDA revises biosimilar guidelines for clearer drug labelling

The US Food and Drug Administration (FDA) released a draft guidance giving drug manufacturers recommendations for biosimilar and interchangeable biosimilar products, detailing tips for drafting label prescription information, on 15 September. In the “Labeling for Biosimilar and Interchangeable Biosimilar Products” document, the agency said that “the biosimilar or interchangeable biosimilar label should only be used in labelling text that is specific to the biosimilar or interchangeable biosimilar product or refers solely to it.” The FDA defines an interchangeable biosimilar as a “biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws.” The agency guided drug manufacturers to only include the drug product’s proprietary name in the following sections: indications and usage, dosage and administration, dosage forms and strengths, description and how supplied/storage and handling. The FDA also recommended its use in recommendations for preventing, monitoring, managing, or mitigating risks. ...
- Source: drugdu
- 108
- September 20, 2023
FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have been adapted to closely target the XBB.1.5. Omicron variant by including a monovalent component. Both companies’ mRNA vaccines are approved for use in individuals aged 12 years and older and authorised for emergency use in those aged six months to 11 years. The FDA has said that it is “confident in the safety and effectiveness” of the two updated vaccines and that its risk assessment demonstrated that the benefits of both vaccines for individuals aged six months and older outweighed the risks. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, director of the ...
- Source: drugdu
- 148
- September 20, 2023
FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class

Myelofibrosis can already be treated with several drugs from a class of medicines that address a pathway driving this type of blood cancer. A drug from GSK is now the latest entrant into the class, but with an additional component that specifically treats the anemia complication affecting myelofibrosis patients. FDA approval of GSK’s momelotinib covers the treatment of adult myelofibrosis patients regardless of whether or not they have been previously treated with another drug for the cancer. The regulatory decision announced late Friday marks the payoff for the pharmaceutical giant’s bet on a molecule it acquired in a $1.9 billion deal. The GSK drug, known in development as momelotinib, will be marketed under the brand name Ojjaara. In myelofibrosis, inflammation and scar tissue (fibrosis) impair the bone marrow’s ability to normally produce red blood cells. The disease leads to anemia, which must be treated with regular blood transfusions. Other complications ...
- Source: drugdu
- 181
- September 19, 2023
Iovance’s PDUFA date for lifileucel pushed due to FDA backlog

The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024. The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024. However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting. The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at ...
- Source: drugdu
- 102
- September 19, 2023

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