Search Results for “FDA” – Page 35 – media

FDA clears next-gen image-guided therapy tech from GE HealthCare

BY SEAN WHOOLEY The Allia IGS Pulse system. [Image courtesy of GE HealthCare] GE HealthCare (Nasdaq:GEHC)+ announced today that the FDA granted 510(k) clearance to its Allia IGS Pulse system. The latest addition to GE HealthCare’s image-guided system (IGS) offerings features a new imaging chain. GE HealthCare says it engineered this feature to provide exceptional imaging at the right dose. This enables visible impact in complex cardiology interventions regardless of patient size. Allia IGS Pulse provides a personalized workspace to meet the operator’s specific needs and preferences. As part of the new image chain, the system features a monopolar X-ray tube used to capture images for interventional procedures. GE HealthCare says the tube — the first of its kind — provides powerful, yet quiet imaging capabilities. Its small footprint also helps clinicians reach steep angulation for better understanding of the coronary artery anatomy. More about the GE HealthCare Allia IGS ...
- Source: drugdu
- 169
- October 18, 2023
Pfizer announces FDA approval for Braftovi/Mektovi combination in lung cancer

Pfizer has announced that a new personalised treatment option, Braftovi (encorafenib) plus Mektovi (binimetinib), has been approved by the US Food and Drug Administration (FDA) for certain lung cancer patients. The regulator’s decision specifically applies to adults with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Lung cancer is the second most common type of cancer and NSCLC accounts for up to 85% of all lung cancers cases. Certain lung cancers are linked to acquired genetic abnormalities such as a BRAF V600E mutation, which occurs in approximately 2% of NSCLC cases. “BRAF V600E mutations identify a unique subtype of metastatic NSCLC that presents an actionable biomarker that precision medicines like Braftovi plus Mektovi combination therapy can help address,” explained Gregory Riely, an investigator in the ongoing mid-stage PHAROS trial that supported the FDA’s approval. The study, which is evaluating the combination ...
- Source: drugdu
- 117
- October 17, 2023
FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective. The FDA expects the new advisory committee will become fully operational in 2024. It will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. In addition, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, and cybersecurity. The committee will consist of a core nine voting members, including the chair. Members serve terms of up ...
- Source: drugdu
- 200
- October 17, 2023
FDA Approves Pfizer’s Ulcerative Colitis Drug, $6.7B Arena Buy Pays Off

By Connor Lynch Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis The FDA has greenlit Pfizer’s ulcerative colitis drug etrasimod, marketed as Velsipity, based on Phase III results published in The Lancet, the company announced Friday. Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, examined the safety and efficacy of a 2-mg daily dose of the oral medication for patients intolerant to or who had failed on trials of a conventional, biological, or Janus kinase inhibitor therapy. Both studies “achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of Velsipity,” Pfizer said in Friday’s announcement. In the Elevate 52 UC trial, 27% of patients achieved clinical remission, compared to 7% of patients receiving a placebo at week 12, and by week 52 it was 32% versus 7%. In the Elevate 12 UC ...
- Source: drugdu
- 104
- October 17, 2023
FDA Clears Pfizer’s Braftovi + Mektovi for Non-Small Cell Lung Cancer Treatment

Treatment indicated for patients with BRAF V600E-mutant metastatic form of disease. Image Credit: Adobe Stock Images/Tex vector Pfizer revealed that the FDA has approved Braftoni (encorafenib) + Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Previously, the medication was approved for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. “Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, chief oncology research and development officer, EVP, Pfizer. “Since its initial FDA approval in 2018, Braftovi + Mektovi combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant ...
- Source: drugdu
- 107
- October 17, 2023
FDA quells Care Access misconduct concern in Pfizer’s Lyme disease vaccine trial

The US Food and Drug Administration (FDA) has found no misconduct by contract research organisation (CRO) Care Access in Pfizer and French partner Valneva’s Lyme disease vaccine trial. The FDA did not issue a Form 483 – a document sent to a company indicating violations after an inspection. The outcome comes after a nine-day for-cause FDA Good Clinical Practices (GCP) inspection into sites managed by Care Access in Pfizer’s VALOR trial. The inspection reviewed Care Access’s contributions to the trial, including GCP requirements, patient safety and data integrity, the CRO said in an 11 October statement. Care Access CEO Ahmad Namvargolian said in a company statement: “We’re very glad to have had the opportunity finally to undergo this independent, searching review by an FDA expert, which confirmed what we’ve always said about our performance on the VALOR trial and beyond.” In February 2023, Pfizer and Valneva announced it was halting ...
- Source: drugdu
- 201
- October 16, 2023
After FDA snub, Lilly’s mirikizumab looks to regain momentum with phase 3 Crohn’s win

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 Crohn’s disease study. The interleukin-23p19 antagonist achieved both primary endpoints and all of its major secondary endpoints in the VIVID-1 study, Lilly said in a Thursday release. The trial results will serve as the basis of regulatory submissions in the disease next year, the company added. In the study, Lilly’s drug helped 54.1% of participants achieve clinical remission at week 52, compared with 19.6% for those on placebo. However, the drug couldn’t prove superiority in the endoscopic response measure when pitted against Johnson & Johnson’s star immunosuppressant Stelara (ustekinumab). Still, mirikizumab’s results were “numerically higher” than its J&J counterpart, Lilly said. Lilly will pursue approval in Crohn’s in 2024, when it will submit a marketing application ...
- Source: drugdu
- 113
- October 13, 2023
FDA Clears IND for Kyverna Therapeutics’ Scleroderma Treatment

KYV-101 designed as a CD19 CAR T-cell therapy. Image Credit: Adobe Stock Images/Trsakaoe Kyverna Therapeutics revealed in a company press release that FDA has approved an investigational new drug (IND) application for KYV-101 for the treatment of scleroderma. It marks the third IND clearance for the drug candidate. Reportedly, this will result in a multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma). “We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,” said Peter Maag, PhD, CEO, Kyverna Therapeutics. “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their ...
- Source: drugdu
- 109
- October 13, 2023
Merck’s Keytruda hits overall survival goal in early lung cancer as FDA decision nears

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda. Using Keytruda both before and after surgery significantly extended the lives of patients with stage 2 to 3b NSCLC in a phase 3 trial, Merck said Tuesday. The Keytruda regimen was pitted against presurgical chemo alone, while Keytruda recipients also received chemotherapy before surgery. The Keynote-671 trial marks the first time an immunotherapy has shown a statistically significant overall survival benefit for certain patients with early-stage NSCLC, Marjorie Green, M.D., head of late-stage oncology development at Merck Research Laboratories, said in a statement. The positive readout comes right before the FDA is expected to decide—by Monday—on Keytruda’s perioperative use as a continuous neoadjuvant-plus-adjuvant therapy in early-stage NSCLC. The trial previously met its other dual primary endpoint, showing Keytruda could reduce ...
- Source: drugdu
- 118
- October 12, 2023
J&J’s DePuy Synthes wins FDA clearance for TriAltis tech

BY SEAN WHOOLEY [Image courtesy of DePuy Synthes] Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology. DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use. The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies. DePuy Synthes built its TriAltis system on what it calls a legacy of thoracolumbar solutions and expertise. It features a “hyperfocus” on performance and ...
- Source: drugdu
- 108
- October 12, 2023

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