media – Page 230 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Manufacturing Issues Block Astellas From a First-in-Class Cancer Drug Approval

Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.1, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this this target include AstraZeneca and Bristol Myers Squibb. By FRANK VINLUAN Astellas Pharma’s path to winning the first drug approval for a particular promising gastrointestinal cancer target has hit a detour. The FDA turned down the drugmaker’s application, citing manufacturing issues for the therapy, zolbetuximab. Astellas announced the FDA action earlier this week. The company did not go into detail about the problems spotted by the regulator, but described them as “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab.” Astellas added that the agency did not raise any concerns about the safety or efficacy of the drug, nor is it asking for additional clinical data. Zolbetuximab was developed as a treatment for patients with locally ...
- Source: drugdu
- 253
- January 16, 2024
CAR-T drug launches pay-per-therapeutic-value program with up to 600,000 yuan drug rebate

On January 11, Fosun Kate and Chenshi Health, a health management and comprehensive patient service platform under Sinopharm Holdings, jointly launched the first lymphoma pay-per-therapeutic value plan for Ekeda in China. Eligible patients who fail to achieve complete remission (CR) after treatment with Ekeda, a CAR-T treatment that originally cost $1.2 million, will receive a rebate of up to RMB600,000. The program will be China’s first innovative payment model for lymphoma drugs paid by the value of efficacy, and Ekeda will be China’s first bioinnovative drug paid by the value of efficacy. “If the complete remission indicator is not reached at three months, even if there is efficacy but the efficacy is not as good as complete remission, half of their out-of-pocket drug purchase price will still be refunded under the program. If this patient’s medication is completely self-funded, then the maximum return is 600,000 RMB for the medication. If ...
- Source: drugdu
- 220
- January 16, 2024
Rehabilitation New Drug Fund Incubatees Featured at J.P. Morgan Healthcare Conference

The 42nd Annual J.P. Morgan Healthcare Conference (hereinafter referred to as “JPM Conference”) was held on January 8-11, 2024 in San Francisco, California, USA. The conference invited “big names” from the pharmaceutical industry and the international investment and financing community to discuss cutting-edge advances in the industry and new trends for future development. Three companies incubated by Rehabilitation Capital’s New Drug Innovation Fund, namely, StarMed Unigene, StarNucleus Disease, and StarOptoVision, attended the JPM conference and delivered speeches in the biotechnology session, which gained great response. The company deeply participated in the international exchange of global biopharmaceuticals, laying the foundation for future innovation cooperation and exploring sustainable cooperation opportunities. JPM Conference has been held for 41 years since 1983, is the largest and most informative healthcare investment seminar in the global biomedical health field, which connects nearly 10,000 industry leaders, representatives of innovative enterprises, technology developers and investors worldwide, and is ...
- Source: drugdu
- 162
- January 16, 2024
FDA yet to find link between suicidal risk and GLP-1RA use

The US Food and Drug Administration (FDA) released an update on its evaluation of suicidal risk related to glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The agency did not find a clear link to suicidal risk through a review of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System agency (FAERS) and a meta-analysis of GLP-1 RA clinical trials. Looking at FAERS data, regulators found that reported incidents were often limited in the information provided and did not offer enough evidence to determine a clear relationship with GLP-1 RA use. Furthermore, the large outcome studies and observational studies showed no association between suicidal thoughts or actions and the use of the drug class. Despite this, the agency said that due to the small number of suicidal ideation cases, it would not yet definitively rule out a potential link with GLP-1RA use. The FDA will share its ...
- Source: drugdu
- 171
- January 16, 2024
FDA’s early review finds no evidence linking Novo, Lilly weight-loss drugs to suicidal thoughts

A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said. Over the last several months, the agency has been looking into reports of suicidal thoughts or actions from users of the GLP-1 treatments gathered through its FDA Adverse Event Reporting System (FAERS), it said. “Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of (GLP-1s),” the FDA wrote. The agency said its reviews of clinical trials and observational studies found no association between the treatments and suicidal thoughts. Ten days ago, the FDA drew attention when it included the trendy therapies on a list of medicines it said it was monitoring for side ...
- Source: drugdu
- 95
- January 16, 2024
BioMarin’s commercial chief Jeffrey Ajer hits the exit as new CEO looks to boost launch of Voxzogo, Roctavian

Rare disease specialist BioMarin has a new CEO in Alexander Hardy and he appears to be shaking up his commercial team as the company announced its lead Jeffrey Ajer will leave the company by July. The disclosure, made via a short SEC filing, said the 18-year company veteran Ajer would “step down” as the company’s executive vice president and chief commercial officer (CCO) in July and that the termination was “without cause.” There was, unusually, no accompanying press release, quotes from Hardy or Ajer, and no details on plans for a new CCO. Ajer has been at BioMarin since 2005 and was promoted to his current position back in 2012. A BioMarin spokesperson told Fierce Pharma Marketing that it “has begun a search for his successor and Jeff will continue to lead the organization in the interim.” The spokesperson added that Ajer held a “pivotal role” over his very long ...
- Source: drugdu
- 177
- January 16, 2024
Appeals court allows unique argument in Gilead’s legal battle over HIV meds

When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm. But in Gilead’s years-long court battle over its tenofivor-based HIV meds, patients have put a unique twist on that norm with their argument that the company delayed development of a safer drug. By doing so, the company was negligent, according to the plaintiffs, despite the earlier med’s effectiveness. Now, in a decision that could raise uncertainty for manufacturers across several industries, a California appeals court determined that the plaintiff’s negligence claim can stand. The allegations date back to 2001, when Gilead launched its tenofovir disoproxil fumarate- (TDF) based HIV med. While effective in HIV treatment, users of TDF risked adverse events such as skeletal and kidney damage. Around the same time, the company discovered a similar but safer candidate called tenofovir alafenamide fumarate (TAF), according to the plaintiffs. After ...
- Source: drugdu
- 87
- January 16, 2024
Menopause Startup Launches AI-Powered Hot Flash Care Product

Loewen Cavill, co-founder and CEO of Amira, never expected to work in the menopause space. But then her aunt was unexpectedly hospitalized due to severe menopause symptoms. “She was waking up five times a night for four years [because of hot flashes],” Cavill said in an interview. “Her sleep deprivation got so bad that she had to quit her job, that she would get sick all of the time, that she was no longer herself anymore, that she spent over $10,000 on doctors, naturopaths, and products. One of the things she tried sent her to the hospital with side effects.” Cavill thought her aunt’s experience had to be niche. But after digging deeper and speaking with hundreds of women, she learned that it was actually very common (in fact, three-quarters of women will battle sleep disruptions from hot flashes). This led Cavill to start Amira in 2021. The startup is ...
- Source: drugdu
- 190
- January 15, 2024
FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced by other factors, the FDA said. Consequently, the agency said it determined the reports did not demonstrate a clear relationship with GLP-1 drugs. This finding is preliminary. “However, because of the small number of suicidal thoughts or actions observed in both people ...
- Source: drugdu
- 177
- January 15, 2024
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace

Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
- Source: drugdu
- 155
- January 15, 2024

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.