Search Results for “FDA” – Page 92 – media

What effect does X-ray inspection have on pharma products?

Mike Pipe, Head of Global Sales, Mettler-Toledo Mettler-Toledo Safeline X-rayX-ray technology is an effective way of inspecting pharmaceutical products for a range of factors, among them being certain kinds of contaminants, fill levels, damaged or missing components, and damaged packaging. Without a doubt, the pharma sector is waking up to how useful X-ray inspection can be, and how it can improve matters of cost, efficiency and waste. The European Medicines Agency (EMA) has issued rules regulating the exposure of drugs to X-rays, in its document “The Use of Ionising Radiation in the Manufacture of Medicinal Products” (3AQ4a). This guidance advises that irradiation may be used for microbial decontamination, sterilisation or other treatments in the manufacture of medicinal products and that manufacturers doing so should refer to the Guide to Good Manufacturing Practice (Volume IV of “The Rules Governing Medicinal Products in the European Union”) and in particular to Annex 12, ...
- Source: drugdu
- 67
- August 10, 2024
ImmunityBio Launches Study to Evaluate Combination of Anktiva, AdHER2DC Cancer Vaccine for Endometrial Cancer

By Don Tracy, Associate Editor The study aims to explore Anktiva as a potential cornerstone of future immunotherapy treatments for endometrial cancer and other forms of the disease. ImmunityBio has initiated a clinical trial to evaluate the combination of Anktiva, their IL-15 superagonist, with the investigational AdHER2DC cancer vaccine, a product of the National Cancer Institute (NCI), as a potential treatment for endometrial cancer. According to the company, the purpose of the trial is to assess the safety and efficacy of this combination therapy in patients with HER2-positive endometrial cancer. The trial comes amid Anktiva’s recent FDA approval for treating BCG-unresponsive non-muscle invasive bladder cancer.1,2 “We are pleased to partner with the NCI on this important cancer control study involving Anktiva, which has demonstrated in clinical trials that activation of memory T cells may help deliver long-duration response well beyond that of checkpoint inhibitors alone,” said Patrick Soon-Shiong, MD, executive ...
- Source: drugdu
- 63
- August 10, 2024
Chinese CAR-T Pioneer Legend Biotech in Profile

Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the company has remained uniquely focused on CAR-T cells targeting the BCMA protein. Humble Beginnings and a Breakthrough Approval Back in 2014, a team of Chinese scientists began investigating cell therapies for cancer under the banner of the “Legend Project,” operating in what the company calls “a room the size of a freight elevator.” After making the decision to focus its research solely on chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein in 2015, Legend began conducting its first clinical trials in 2016. The pioneering biotech landed its first major vote of confidence from the global life sciences community in 2017, ...
- Source: drugdu
- 69
- August 9, 2024
New AI Protocol Instantaneously Detects Cancer Genomic Biomarkers Directly from Tumor Biopsy Slides

The late 90s marked the beginning of the era of precision oncology, yet recent studies in the U.S. indicate that most cancer patients are not receiving FDA-approved precision therapies. Factors such as high costs, extensive tissue requirements, and lengthy processing times have hampered the broader adoption of precision oncology, often leading to treatments that are not only suboptimal but potentially harmful. A significant barrier is the lack of testing; many cancer patients endure critical delays waiting for standard genomic tests following an initial tumor diagnosis, which can be life-threatening. Now, a groundbreaking advancement has been made with the development of a new generation of artificial intelligence (AI) tools that enable the rapid and cost-effective detection of clinically actionable genomic alterations directly from tumor biopsy slides. This innovation could cut weeks and save thousands of dollars in clinical oncology treatment workflows for diseases like breast and ovarian cancers. The new AI ...
- Source: drugdu
- 83
- August 7, 2024
Bayer Looks to Expand Kerendia’s Label to Heart Failure After Phase 3 Win

Bayer reported a Phase 3 test of Kerendia in heart failure led to statistically significant reductions in cardiovascular death and hospitalizations. Detailed results will be presented during the European Society of Cardiology annual meeting in September. By Frank Vinluan Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure. Kerendia is a small ...
- Source: drugdu
- 64
- August 7, 2024
KOREA PHARM & BIO

Organiser：KOREA PHARM & BIO Time：April 22nd – 25th, 2025 address：217-59 Kintekseu-ro, Daehwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, Korea Exhibition hall：KINTEX Product range: Pharmaceuticals: Pharmaceutical Raw Materials, Active Pharmaceutical Ingredients (APIs), Pharmaceutical Fine Chemicals, Intermediates, Pharmaceutical Additives, Pharmaceutical Dosage Forms, Natural Extracts, Biotechnology, Pharmaceutical Outsourcing and Services, Laboratory Equipment, Pharmaceutical Manufacturing Equipment, etc. Chemicals: Chemical Raw Materials, Chemical Equipment, Instrumentation, Automation Control Technology, Heat Exchangers, Crystallization, Gas Absorption, Drying, Filtration, Centrifugal Separators, Dust Collection, Chemical Reactors, Crushers, Mixers, etc. Cosmetics: Cosmetic Raw Materials, Cosmetic Additives, Functional Materials, Natural Extracts, etc. About KOREA PHARM & BIO： KOREA PHARM & BIO is one of the most influential pharmaceutical and biotechnology exhibitions in Korea and Asia. It is jointly organized by the Korea Food and Drug Administration (KFDA), Korea Pharmaceutical Manufacturers Association (KPMA), and Kyungyon Exhibition Company in Korea.
- Source: drugdu
- 111
- August 7, 2024
Jade Bio’s Launch, Brenig’s Debut, Confo’s Cash & More

Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
- Source: drugdu
- 82
- August 6, 2024
Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. By Frank VinluanOtsuka Pharmaceutical is broadening its scope in rare disease, striking a deal to acquire Jnana Therapeutics and its lead drug candidate, a small molecule on track for pivotal testing in a metabolic disorder with few treatments. Per deal terms announced Thursday, Otsuka is paying $800 million up front to buy Boston-based Jnana. The Japanese pharma company could shell out up to $325 million more if the lead drug candidate of privately held Jnana achieves development and regulatory milestones. Jnana’s lead program, JNT-517, is in development for phenylketonuria (PKU), an inherited disorder that leads to deficiency of an enzyme needed to break down phenylalanine, an amino acid found in certain foods. Buildup of phenylalanine in ...
- Source: drugdu
- 79
- August 5, 2024
Tirzepatide Shows Statistically Significant Improvements in Reducing Heart Failure Risk, Enhanced Symptoms

By Don Tracy, Associate Editor Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses. Results from the SUMMIT Phase III clinical trial found that Eli Lilly’s tirzepatide, tested at doses of 5 mg, 10 mg, and 15 mg, showed statistically significant improvements in reducing heart failure with preserved ejection fraction (HFpEF) and obesity, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS), compared to placebo. According to the company, tirzepatide also demonstrated improved exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and a noteworthy mean body weight reduction at 52 weeks.1 “HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity.1,2 Despite ...
- Source: drugdu
- 68
- August 5, 2024
Adaptimmune’s Tecelra gains accelerated approval for synovial sarcoma

Oxford-based cell therapy company Adaptimmune Therapeutics has received accelerated approval from the US Food and Drug Administration (FDA) for Tecelra (afamitresgene autoleucel) for treatment of synovial sarcoma. Tecelra is the first engineered cell therapy for solid tumours approved in the US, and represents the first therapy option against synovial sarcoma in more than a decade. It is indicated to treat adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, and whose tumours express the MAGE-A4 antigen. Additionally, the tumours need to have a certain HLA type— HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive. The approval was granted based on results from the Phase II SPEARHEAD-1 trial (NCT04044768). Amongst 44 patients with synovial sarcoma, the overall response rate (ORR) to treatment was 43% with a median duration of response of six months (95% CI: 4.6, not reached). Continued approval remains subject to verification of clinical benefit in further trials. ...
- Source: drugdu
- 62
- August 5, 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.