Search Results for “FDA” – Page 30 – media

Novartis’ Fabhalta approved by FDA as first oral monotherapy for rare blood disease PNH

Novartis’ Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first oral monotherapy for adults with paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disease affecting approximately ten to 20 people per million worldwide. PNH patients have an acquired mutation that causes them to produce red blood cells susceptible to premature destruction by the complement system, which can cause anaemia, thrombosis, fatigue and other symptoms that can impact quality of life. The disease has a significant unmet need, Novartis reports, with a large proportion of patients on anti-C5 treatment remaining anaemic and dependent on blood transfusions. Fabhalta is a factor B inhibitor of the immune system’s complement pathway and offers an alternative to therapies that need to be delivered by infusion or injection. Victor Bultó, president US, Novartis, described the approval as an “extraordinary moment” for the PNH community. “This new, effective oral medicine may ...
- Source: drugdu
- 105
- December 8, 2023
ImmunoGen’s ADC Elahere wins FDA priority review for ovarian cancer

The US Food and Drug Administration (FDA) has granted priority review for the full approval of the antibody drug conjugate, Elahere (mirvetuximab soravtansine-gynx) and has set a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024. Elahere was a central element in the $10.1bn ImmunoGen acquisition deal announced by AbbVie last week (30 November). AbbVie expects the acquisition to complete in mid-2024. Elahere is an antibody drug conjugate (ADC) that targets folate receptor alpha (FRα). In November 2022, it was granted accelerated approval as the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for patients who have received one to three prior systemic treatment regimens. The latest supplemental Biologics License Application (sBLA) for Elahere is supported by the data from the Phase III MIRASOL trial, which will allow for the accelerated approval to be converted to a full approval. ImmunoGen reported $105.2m in ...
- Source: drugdu
- 104
- December 7, 2023
Elli Lilly Cancer Drug Lands Its Second FDA Approval This Year

Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
- Source: drugdu
- 114
- December 6, 2023
Lilly’s Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing

As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
- Source: drugdu
- 99
- December 6, 2023
FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The US Food and Drug Administration (FDA) has announced its intention to investigate the safety of CAR-T therapies following reports that they could be linked to the development of T-cell cancers. Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that involves collecting and using patients’ own immune cells to treat conditions including lymphoma, leukaemia and multiple myeloma. T-cell malignancies have been seen in patients treated with several approved products in the class, including Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). Currently, the potential risk of developing secondary malignancies is labelled as ...
- Source: drugdu
- 106
- December 4, 2023
Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert

By Tristan Manalac Pictured: Sign outside the FDA’s office in Maryland The FDA has slapped Intas Pharmaceuticals with another warning letter over manufacturing violations, quality control lapses and compromised data integrity, this time at its plant in Gujarat, India. The regulator has also put the Indian facility on its import alert list, which allows the FDA’s field operatives to detain products from Intas without physical examination. In its Nov. 21 warning letter, the FDA pointed to four main issues found at the Gujarat plant over a 12-day site inspection in May 2023. According to the regulator, Intas failed to ensure that the drug products that it manufactures comply with ...
- Source: drugdu
- 114
- December 2, 2023
FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy in these patients RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date ...
- Source: drugdu
- 136
- December 2, 2023
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea

Dive Brief Vivos Therapeutics has received 510(k) clearance for the use of its oral devices in adults with severe obstructive sleep apnea (OSA). The Food and Drug Administration ruling, which comes 11 months after Vivos received clearance for an oral appliance in mild-to-moderate OSA, gives the green light to an application that was previously only possible off-label. The company’s trio of devices, called Complete Airway Repositioning and/or Expansion (CARE) oral appliances, include the DNA, mRNA and mmRNA products. Vivos’ share price increased nearly 834% to $41 when the market closed on Wednesday. The medtech company’s market capitalization was approximately $30.8 million even after the latest jump in its stock, according to Nasdaq. Dive Insight Vivos sells a set of airway repositioning and expansion devices for treating dentofacial abnormalities and OSA. The company has worked to add clearances to use more of the devices in the treatment of OSA, winning a ...
- Source: drugdu
- 96
- December 2, 2023
FDA Accepts New Drug Application for Karuna Therapeutics’ Novel Schizophrenia Drug

Pharmaceutical Executive Editorial Staff KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. The FDA has accepted a New Drug Application (NDA) for Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for schizophrenia in adult patients. The novel muscarinic antipsychotic is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia,” said Bill Meury, Karuna Therapeutics president and chief executive officer, said in a press release.1 Schizophrenia can be a disabling condition, potentially causing a combination of hallucinations, delusions, and extremely disordered thinking and behavior that has a negative impact on the ability to function in daily life. As such, patients with schizophrenia require lifelong ...
- Source: drugdu
- 101
- December 1, 2023
Intas on import alert as FDA flags data manipulation, management failures in warning letter

Drug manufacturer Intas Pharmaceuticals is no stranger to FDA scrutiny. Now, one of its plants has been placed on an import alert after a series of interactions with the agency. After a May inspection of Intas’ plant in Gujarat, India, the FDA published a warning letter that points a finger at management and labels products made at the site “adulterated” because of the company’s manufacturing deficiencies. Before this development, the FDA earlier this year slapped the site with a Form 483 filing outlining problems at the plant. Shortly after that, the company provided a response that proved to be “inadequate,” as the FDA described it. In the warning letter, the FDA blasted Intas for an “egregious pattern” of shortfalls that shows the company’s failure to carry out “basic responsibilities.” The agency tracked multiple instances of data manipulation going back to 2021. In these cases, visual inspectors manipulated particle and other ...
- Source: drugdu
- 104
- December 1, 2023

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