Search Results for “Clinical Trial” – Page 73 – media

Rezzayo approved to treat adult patients with invasive candidiasis

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat a fungal infection called invasive candidiasis. Invasive candidiasis is an infection caused by a yeast called Candida. While some common Candida infections (such as thrush) are easily treatable and do not pose a serious risk to health, invasive candidiasis is a severe infection that can affect the blood, heart, brain, eyes and bones and other parts of the body. Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review. The treatment is administered once a week by a drip into the ...
- Source: drugdu
- 156
- February 1, 2024
EMA Grants Bersiporocin Orphan Drug Designation

Mike Hollan The agency recognized the medication as a significant advancement for the treatment of IPF. Daewoong Pharmaceuticals The European Medicines Agency (EMA) granted its orphan drug designation to bersiporocin, a medication developed by Daewoong Pharmaceuticals. The drug earned the title for its treatment of idiopathic pulmonary fibrosis (IPF). Daewoong Pharmaceuticals describes the drug as the world’s first PRS inhibitor for IPF. In a press release, Daewoong Pharmaceutical CEO Seng-ho Jeon said, “With Bersiporocin’s global recognition and its clinical advancements, we are more committed than ever to delivering this promising treatment to IPF patients, potentially transforming the landscape of this challenging disease.” IPF is a rare disease and only has about 13 cases per 100,000 people across the entire planet. It is a serious condition and the 5-year survival rate is about 40%. Patients with the condition suffer from a reduction of lung function due to a build-up of ...
- Source: https://www.pharmexec.com/authors/mike-hollan
- 101
- January 31, 2024
Asieris Presents for the First Time Interim Analysis Data of Oral APL-1202 in Combination with PD-1 Inhibitor Tislelizumab for Neoadjuvant Treatment of Muscle-Invasive Bladder Cancer at 2024 ASCO-GU

Shanghai, China – January 28,2024- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the first-time release of interim analysis data for the Phase II clinical trial of oral APL-1202 in combination with the PD-1 inhibitor tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC). Release of the interim analysis data was made in the form of a rapid oral presentation abstract (Abstract No:632）at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). Patient enrollment of the trial was recently completed. Primary objective of the Phase II clinical trial is to evaluate the safety and efficacy of APL-1202 in combination with tislelizumab compared to tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The trial population includes patients with newly diagnosed MIBC for whom radical cystectomy (RC) is planned, ...
- Source: drugdu
- 93
- January 30, 2024
Key Trends from the 2024 J.P. Morgan Healthcare Conference

Key trends such as the resilience of the emerging biopharma space, the complexities of Medicare, and the revolutionary role of data and AI are shaping the future of the industry. By SUJAY JADHAV Beneath the Californian sunshine (and a few showers) at JP Morgan, a revolution simmers. Not a political one, but a healthcare revolution propelled by necessity and fueled by innovation. Imagine a future where groundbreaking therapies reach patients years sooner, personalized treatments offer hope for chronic diseases, and healthcare costs become more manageable for everyone. This isn’t science fiction; it’s the promise of the cutting-edge trends made at the annual J.P. Morgan Healthcare Conference earlier this month. For those that attended JPM in early 2023, you may recall it was quite gloomy coming off of a soft 2022 and an interest rate burdened 2023. JPM 2024 had an air of optimism. Emerging biopharma space: Challenges and innovations One ...
- Source: drugdu
- 86
- January 27, 2024
IASO Bio’s IND application for new autoimmune indication of Equecabtagene Autoleucel Injection approved

January 25, 2024, Nanjing, Shanghai, China, and San Jose, California, USA – IASO Bio, a biopharmaceutical company dedicated to the development, production and sales of innovative cell-based drugs, announced the National Medical Products Administration (NMPA) Review Center (CDE) has officially approved its fully human BCMA-targeted chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel Injection, R&D code: CT103A) for the new expanded indication of refractory generalized myasthenia gravis (Myasthenia gravis, MG). ) clinical trial application (IND) (acceptance number: CXSL2300759). Equecabtagene Autoleucel Injection (trade name: Equecabtagene Autoleucel®) has been approved for marketing by the State Food and Drug Administration on June 30, 2023, for the treatment of relapsed and refractory multiple myeloma. The approval of this IND for myasthenia gravis further expands This is the second autoimmune indication approved for IND after Neuromyelitis Optica Spectrum Disease (NMOSD). IASO Bio is the first company in China to use CAR-T products for autoimmune ...
- Source: drugdu
- 86
- January 27, 2024
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 96
- January 26, 2024
Eli Lilly Sounds Off as Early Data Show How Gene Therapy Can Restore Hearing

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy. By FRANK VINLUAN Gene therapy made its first breakthroughs slowing vision loss from inherited eye disorders. Eli Lilly is making the ear this therapeutic modality’s next proving ground, and the pharmaceutical giant now has some encouraging early clinical trial results showing it can work. An 11-year-old boy with profound hearing loss experienced restored hearing within 30 days of receiving the gene therapy, AK-OTOF, Lilly announced Tuesday. These are results for just one patient—the first in a clinical trial that could enroll up to 150 participants. But this early result is a promising sign for the therapy, which Lilly gained in 2022 through the $487 million acquisition of its developer, Akouos. ...
- Source: drugdu
- 84
- January 26, 2024
Major update of the SME user guide

The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development, and has become a reference source of information for SME and academic developers, supporting them to navigate the system of medicine regulation in the EU. The new release incorporates significant updates to reflect major changes in the EU’s legal and regulatory framework for human and veterinary medicines: Veterinary Regulation: the document has been fully revised to align with the veterinary regulation Clinical Trials Regulation (new section 4.4): provides an overview of the clinical trial regulation and Clinical Trials Information System (CTIS) Medical Devices Regulation (new section 4.8): offers insights into the medical devices regulation for human medicines Other important new sections/subsections include: IT Systems (section 1.3): An overview of common platforms, systems, and databases ...
- Source: drugdu
- 82
- January 26, 2024
Gilead’s Tecartus gets revised safety demand amid FDA’s push for CAR-T boxed warnings

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, the agency has adjusted the wording of a proposed boxed warning. In a revised letter (PDF) dated Jan. 23, the FDA is still pressing Gilead’s cell therapy unit Kite Pharma to include new language about the risk of T-cell malignancies in the black-box warning section of Tecartus’ label. But unlike its proposed boxed warning for other commercial CAR-T therapies, the FDA’s updated letter for Tecartus no longer names Tecartus patients specifically as having experienced T-cell malignancies. The FDA apparently took some time before uploading the new letter after taking down the original one, dated Jan. 19. The missing letter for Tecartus caused a brief period of confusion because the FDA says in all letters to ...
- Source: drugdu
- 87
- January 26, 2024
FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply. By FRANK VINLUAN Post a comment / at 7:04 PM Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers. The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the drugmakers last Friday instruct them to add additional language to the boxed warning stating that T cell malignancies have occurred following the treatment of ...
- Source: drugdu
- 89
- January 25, 2024

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