Search Results for “FDA” – Page 37 – media

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
- 112
- 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
- 173
- 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
- 126
- 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
- 106
- 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
- 116
- October 8, 2023
backAgomab’s FSCD therapy gains fast track designation from US FDA

Agomab Therapeutics has received the US Food and Drug Administration (FDA)’s fast track designation for AGMB-129 to treat fibrostenosing Crohn’s disease (FSCD). Designed to inhibit ALK5 in the gastrointestinal (GI) tract, AGMB-129 is an oral, small molecule GI-restricted ALK5 (TGF-βRI) inhibitor currently in clinical development. The single and multiple-dose AGMB-129 was well-tolerated at all doses in a Phase I study in healthy participants. The company has also announced the commencement of the STENOVA Phase IIa clinical study to assess AGMB-129 for patients with symptomatic FSCD. This global, placebo-controlled, multi-centre, double-blind study will assess 36 patients with symptomatic FSCD at investigational sites in Europe, Canada and the US. Subjects will be randomised to receive one of two doses of AGMB-129 or a placebo for a period of 12 weeks. Tolerability and safety of AGMB-129 in FSCD patients are the primary endpoints of the trial. The pharmacokinetics and target engagement at the ...
- Source: drugdu
- 105
- October 7, 2023
FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots

A Novavax Covid-19 vaccine developed for the fall vaccination season now has the FDA green light, bringing an alternative to the messenger RNA shots that are already rolling out to pharmacies, doctor’s offices, and other locations throughout the country. The FDA decision announced Tuesday afternoon is not an approval. Last year’s emergency authorization for the Novavax vaccine is now amended to include an updated formula, which reflects currently circulating variants. The initial Novavax vaccine was authorized for those 18 and older. For the updated shot, the FDA expanded the age range to 12 and older. The regulatory decision for the latest version of the Novavax vaccine means the company’s initial vaccine, developed for the original SARS-CoV-2 strain, is no longer authorized for use in the U.S. Gaithersburg, Maryland-based Novavax makes its protein-based vaccines with nanoparticle technology that engineers proteins that mimic antigens found on natural pathogens. For its Covid-19 vaccine, ...
- Source: drugdu
- 129
- October 4, 2023
FDA expands total product life cycle program to cover neurological devices

Dive Brief The Food and Drug Administration is expanding a program for accelerating device development to cover neurological and physical medicine technologies. Initially, the voluntary total product life cycle advisory program (TAP) pilot was limited to cardiovascular devices. This week, the FDA Office of Neurological and Physical Medicine Devices also began accepting enrollment requests. Expanding the program to cover cardiovascular, neurological and physical medicine devices is part of a scaling up of the pilot, which enrolled 12 products in its first year. The FDA could enroll up to 45 additional devices over the coming year. Dive Insight The FDA and industry agreed to the TAP pilot in MDUFA V. While the industry initially opposed the advisory program, the FDA secured a chance to show it can “spur more rapid development and more rapid and widespread patient access” by facilitating early engagement and coordination with external stakeholders. A year ago, the ...
- Source: drugdu
- 197
- October 4, 2023
FDA clears Krystal Biotech’s IND for Type 1 AATD treatment KB408

The US Food and Drug Administration has approved Krystal Biotech’s Investigational New Drug (IND) for a Phase I clinical trial of the investigational alpha-1 antitrypsin deficiency (AATD) treatment KB408. Earlier this month, the FDA granted orphan-drug status for KB408 in AATD. The first patient in the planned Phase I trial is expected to receive treatment in Q1 2024. The Phase I trial, involving adult patients with AATD and the PI*ZZ genotype, will assess the safety, tolerability, and efficacy at three planned dose levels. AATD is a rare genetic disorder that occurs when there is insufficient production or impaired functionality of the alpha-1 antitrypsin (AAT) protein. Low AAT levels result in damage to lung tissue, leading to chronic obstructive pulmonary disorder (COPD). KB408 is a gene therapy consisting of a modified herpes simplex virus 1 (HSV-1) derived vector, which delivers two full-length copies of the SERPINA1 gene to enable AAT expression. ...
- Source: drugdu
- 143
- October 4, 2023
FDA Releases Draft Guidance for Regulatory Considerations for Prescription Drug-Use-Related Software

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use. Pharmaceutical companies are embracing new technologies that could potentially assist patients with taking medication in a safe and effective manner. In 2018, FDA began soliciting comments for a possible regulatory framework based around these technologies. In September 2023, the agency issued its draft guidance on the subject, explaining how drug sponsors should describe their software both in FDA required labeling and promotional labeling. For the required labeling, which includes prescribing information, the sponsor can submit evidence to FDA that the software results in a meaningful improvement in a clinical outcome as compared to when the patient takes the drug without using the software. If the evidence supports this, the label should include relevant information about the software and its use. If the software does not have a meaningful outcome on the use ...
- Source: drugdu
- 102
- September 28, 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.