Search Results for “EC” – Page 41 – media

YolTech Therapeutics to Participate in 2024 Cell & Gene Meeting on the Mediterranean

SHANGHAI, March 27, 2024 /PRNewswire/ — YolTech Therapeutics, a trailblazing biopharmaceutical company specializing in gene editing, is delighted to announce its participation in 2024 Cell & Gene Meeting on the Mediterranean. The event will take place from April 9th to 11th, 2024, at the esteemed Rome Cavalieri, A Waldorf Astoria Hotel, situated at Via Alberto Cadlolo, 101, 00136 Roma RM, Italy. The Cell & Gene Meeting on the Mediterranean stands as the premier conference uniting the ATMP (Advanced Therapy Medicinal Products) community from Europe and beyond. Covering an extensive array of commercialization topics spanning market access, regulatory issues, manufacturing, and financing within the sector, this program boasts expert-led panels, extensive one-on-one partnering capabilities, exclusive networking opportunities, and over 60 dedicated presentations by leading publicly traded and privately held companies in the space. YolTech is poised to make a significant impact at this event, showcasing its pioneering advancements in in vivo ...
- Source: drugdu
- 88
- April 4, 2024
A step towards global harmonisation of GMP inspection protocols

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’ US FDA’s ‘Observed Inspection Program‘ involves interaction between the USFDA India office and State Drug Control Authorities, with the former inviting the latter as observers during inspections. As the letter indicates, ‘FDA has shared best practices and inspectional protocols in regulatory forums with several states.’ It is logical that the US FDA would now turn to replicate these efforts in other states, especially those with many FDA-registered facilities, like Maharashtra, for instance, and explore the possibility of adding to this ...
- Source: drugdu
- 95
- April 3, 2024
Alebund’s Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SHANGHAI, March 29, 2024 /PRNewswire/ — Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). “We are very excited that AP303 has been granted Orphan Drug Designation by the FDA”, Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented. “It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.” AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model. AP303 has completed its first-in-human study in healthy ...
- Source: drugdu
- 86
- April 3, 2024
IASO Bio Announces NMPA’s IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma

SHANGHAI and NANJING, China and SAN JOSE, Calif., March 29, 2024 /PRNewswire/ — IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the ...
- Source: drugdu
- 86
- April 3, 2024
FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

Don Tracy, Associate Editor Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy. The FDA has approved an expanded indication for Gilead’s Vemlidy (tenofovir alafenamide), to treat chronic hepatitis B virus (HBV) infection in pediatric patients aged six years and older who weigh at least 25 kg and have compensated liver disease. In 2016, the medication was initially approved for adults with chronic HBV and compensated liver disease, with an extended use approved in 2022 for children aged 12 years and above. Approval for the expanded indication was based on positive results stemming from Gilead’s Phase II clinical trial (Trial 1092) after 96 weeks, showing safety and efficacy in younger children. According to the study data, participants experienced progressive increases in the rates of virological suppression compared to those administered a placebo.1 “Chronic hepatitis B ...
- Source: drugdu
- 86
- April 2, 2024
Innovative Blood Collection Device Overcomes Common Obstacles Related to Phlebotomy

The discomfort associated with traditional blood draws leads to a significant issue: approximately 30% of diagnostic tests prescribed by physicians are never completed by patients. This avoidance is often due to the fear of pain from needle sticks and a reluctance to visit medical facilities where there’s a perceived risk of encountering illness. Now, a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system solves the problem of the physical pain of a traditional blood draw, making it easier, cheaper, and faster to potentially receive a diagnosis. RedDrop Dx’s (Fort Collins, CO, USA) innovative blood collection device, RedDrop One, aims to enhance blood collection technology and patient care practices. With its user-centric design, RedDrop One eliminates many of the drawbacks associated with traditional blood collection methods, allowing for the collection of larger blood volumes more efficiently and with significantly less discomfort for the patient. This device is ...
- Source: drugdu
- 88
- April 2, 2024
Roche wins FDA approval for first molecular malaria blood donor screening test

Dive Brief Roche has received Food and Drug Administration approval for the first molecular test to screen U.S. blood donors for malaria, the company said Tuesday. In 2022, the FDA recommended preventing people from giving blood for a time after they return from an area with malaria because there was no licensed test to screen donors. Other countries including Australia, England and France use antibody testing to avoid excluding potential donors. Roche’s Cobas malaria molecular test screens whole blood samples for the five main species of parasites that cause infections. The company is pitching the test as a way to improve the safety and availability of blood. Dive Insight Around 2,000 people are diagnosed with the mosquito-borne disease in the U.S. each year, typically after traveling to a country where malaria transmission occurs. The potential for donors to unknowingly pass the parasite on to recipients of their donations led the ...
- Source: drugdu
- 134
- April 1, 2024
Strand Therapeutics develops new class of mRNA molecules for cancer

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases Strand Therapeutics, a Massachusetts Institute of Technology (MIT) spinout, has developed a new class of advanced mRNA molecules for more targeted and powerful treatments for cancer. The new class of mRNA molecules is designed to sense what type of cells they encounter in the body and express therapeutic proteins once they have entered diseased cells. Most next-generation cancer immunotherapies are based on recombinant proteins, which are challenging to deliver to specific targets in the body and do not remain active for long enough to create a durable response. Strand has developed the world’s first mRNA programming language to improve mRNA molecules’ ability to sense their environment and generate targeted responses where needed most, allowing the company to specify the tissues its mRNAs express proteins in. In addition, the company uses techniques such as ...
- Source: drugdu
- 77
- April 1, 2024
BioDuro-Sundia’s Partner, DigmBio Announced IND Clearance from Korea MFDS for its Selective PARP1 Inhibitor DM5167

SHANGHAI, March 26, 2024 /PRNewswire/ — BioDuro-Sundia’s partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application. Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, “We are pleased to receive official approval from the Food and Drug Safety Department without the need for any ...
- Source: drugdu
- 77
- April 1, 2024
Researchers discover a safer and more efficient technique for testing new drugs

McGill researchers have discovered a safer and more efficient technique for testing new drugs while they are in development. “Because this approach is so much more streamlined, it could help accelerate this step in the drug development process and make it less dangerous, since probing the distribution and fate of a drug in the body is required for any pharmaceutical candidate to be approved,” says Bruce A. Arndtsen, a James McGill Professor who teaches in the Department of Chemistry at McGill and is the senior author on the paper describing the new process, published recently in Nature Chemistry. “This research replaces what can be a days’ long, dangerous and costly process with a simple and safe one requiring only a few hours,” adds José Zgheib, a PhD candidate in the Arndtsen Group at McGill University who worked on the project. Making sure medication reaches its target Before a drug makes ...
- Source: drugdu
- 140
- March 30, 2024

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