Search Results for “FDA” – Page 36 – media

Merck Touts Keytruda Phase III NSCLC Survival Data Ahead of FDA Decision  

By Kate Goodwin Pictured: Merck headquarters/iStock, JHVEPhoto Phase III results released Tuesday showed Merck’s anti-PD-1 therapy Keytruda is the first to improve overall survival when used as a neoadjuvant and adjuvant treatment versus pre-operative chemotherapy for patients with non-small cell lung cancer, according to the company’s announcement.  In the KEYNOTE-671 trial, Keytruda plus chemotherapy was given to patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) prior to surgery. After resection, Keytruda was administered as a single agent.   While the data was not provided in Tuesday’s announcement, Merck called the trial the first Phase III to “show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB” NSCLC.  The company said results from the analysis of KEYNOTE-671 will be presented later this month at the European Society for Medical Oncology (ESMO) Congress and shared with global regulatory authorities.  Previous interim results ...
- Source: drugdu
- 208
- October 12, 2023
Novartis Wins FDA Approval for Intravenous Cosentyx Formulation

By Tristan Manalac The FDA on Friday approved an intravenous formulation of Novartis’ IL-17A antagonist Cosentyx (secukinumab) for the treatment of rheumatic diseases. This latest approval covers existing indications of Cosentyx, including ankylosing spondylitis (AS), psoriatic arthritis (PsA) and non-radiographic axial spondyloarthritis (nr-axSpA). Previously, Cosentyx was only authorized as a subcutaneous treatment for these conditions. With Friday’s approval, Cosentyx has become the first intravenous (IV) treatment that specifically targets and inhibits IL-17A and currently the only non-TNF-α IV therapy for these indications, according to Novartis’ announcement. The IV route of administration will improve treatment access for “a significant portion of patients” with AS, PsA and nr-axSpA, who are not comfortable with self-injections or simply prefer to receive treatments in their healthcare provider’s office, according to Philip Mease, clinical professor at the University of Washington School of Medicine. “The approval of Cosentyx as an IV formulation is an important milestone for ...
- Source: drugdu
- 174
- October 11, 2023
FDA Blocks Alnylam’s Bid to Expand Onpattro Label

By Tristan Manalac Pictured: Alnylam headquarters in Cambridge, Massachusetts/iStock, hapabapa The FDA on Monday denied approval of Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis. In its Complete Response Letter (CRL), the regulator said that Alnylam had not provided enough evidence of the therapy’s benefit in the proposed indication. At the same time, the FDA did not flag any problems with patisiran’s clinical safety, drug quality, manufacturing processes or study conduct. “The CRL indicated that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established,” according to the company’s announcement. In light of the rejection, Alnylam will no long work toward an expanded label for Onpattro in the U.S. Monday’s CRL runs counter to the recommendations of the FDA’s own panel of external advisers. In September 2023, the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in ...
- Source: drugdu
- 107
- October 11, 2023
FDA Approves Novartis’ New Rheumatic Disease Treatment

Cosentyx is the first intravenous formulation interleukin-17A antagonist to focus on disease. Image Credit: Adobe Stock Images/Seventyfour Novartis officially announced that the FDA approved n intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Currently, Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. “At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience,” said Christy Siegel, ...
- Source: drugdu
- 108
- October 11, 2023
FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024. By FRANK VINLUAN An Alnylam Pharmaceuticals drug developed to treat a rare disease’s potentially fatal effects on the heart has fallen short in its bid for FDA approval, costing the company a chance to immediately challenge a Pfizer product that has become a blockbuster seller in the indication. But the biotech still has another chance with a different drug in late-stage development that could offer patients a better alternative. Alnylam was seeking approval of its drug, Onpattro, as a treatment for cardiomyopathy caused by hereditary transthyretin amyloidosis (hATTR). According to the Cambridge, Massachusetts-based company, the FDA’s complete response letter said ...
- Source: drugdu
- 210
- October 11, 2023
FDA wants more testing in Philips recall

BY SEAN WHOOLEY The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips (NYSE: PHG)+.The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.) Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga. FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming. “The FDA remains unsatisfied with the status of this recall, and we continue to ...
- Source: drugdu
- 109
- October 10, 2023
FDA panel says Amgen’s Phase III lung cancer KRAS drug data is unreliable

AUS Food and Drug Administration (FDA’s) Oncology Advisory Committee (AdCom) has raised questions about the upcoming decision to grant traditional approval of Amgen’s high-profile KRAS G12C inhibitor Lumakras (sotorasib). Lumakras was granted accelerated approval in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who had received at least one prior systemic therapy. This approval was based on the CodeBreaK 200 trial (NCT04303780) of sotorasib versus docetaxel. Lumakras generated $285m in sales last year worldwide, according to Amgen’s 2022 annual report to shareholders. The latest AdCom questioned the reliability of the data In the briefing document released by the FDA from the meeting, several features of the Codebreak trial were listed that were inconsistent with a sufficient well-controlled trial. The main issue noted was that too many patients were allowed to swap between the treatment and control arms ...
- Source: drugdu
- 170
- October 10, 2023
Amgen Fails to Secure FDA Adcomm Support for Full Lumakras Approval

By Tristan Manalac Pictured: Amgen’s office in Massachusetts/iStock, hapabapa The FDA’s Oncologic Drugs Advisory Committee on Thursday voted against Amgen, which is seeking to convert the accelerated approval of its oral G12C KRAS inhibitor Lumakras (sotorasib) to full approval in non-small cell lung cancer. In a 10-2 vote, the panel of external experts found that Amgen’s progression-free survival (PFS) data from the Phase III confirmatory CodeBreaK 200 study could not be reliably interpreted. In particular, the adcomm noted the high number of study dropouts, the small sample size and potentially biased behavior of the trial’s investigators. “No one expects a perfect [randomized controlled trial] but what we hope for is a small number of issues in trial conduct and an effect large enough to withstand the uncertainties caused by those issues,” committee member Mark Conaway, professor at the Division of Translational Research and Applied Statistics at the University of Virginia ...
- Source: drugdu
- 120
- October 9, 2023
‘Extremely concerning’ chemo shortage persists despite FDA’s efforts, national cancer group reports

While the White House recently touted the FDA’s efforts to mitigate the ongoing chemotherapy shortage in the U.S., a recent survey by the National Comprehensive Cancer Network (NCCN) shows that many treatment centers do not have enough supply of key medicines.、 NCCN surveyed 29 of its member institutions throughout the month of September and found that 72% of centers are still experiencing a carboplatin shortage, while 59% are short on cisplatin. The report is a follow-up to a June survey evaluating supply levels of the key platinum-based chemotherapies carboplatin and cisplatin. The June survey showed that 93% of centers were experiencing a carboplatin shortage, while 70% were low on cisplatin. “It is extremely concerning that this situation continues despite significant attention and effort over the past few months,” NCCN’s CEO Robert Carlson, M.D., said in a statement. “We need enduring solutions in order to safeguard people with cancer and address ...
- Source: drugdu
- 104
- October 9, 2023
FDA says Philips’ testing of recalled devices is inadequate

Dive Brief The Food and Drug Administration called for further testing by Philips to evaluate the risks of soundproofing foam used in its recalled sleep apnea machines and ventilators. “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Thursday statement that included more details on the recall and the agency’s actions. Philips has claimed use of the devices is “not expected to result in appreciable harm to health in patients,” but agreed with the FDA’s recommendations to run additional testing. Dive Insight Philips’ recall of sleep apnea devices and ventilators has continued since June 2021, when the company began an effort to repair or replace millions of devices that used polyester-based polyurethane (PE-PUR) foam for soundproofing. ...
- Source: drugdu
- 113
- October 8, 2023

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