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FDA hits Renovo with warning letter over reprocessed medical devices

Dive Brief Renovo received a warning letter in October for supplying reprocessed medical devices without seeking 510(k) clearance from the Food and Drug Administration. The letter, which the FDA published Tuesday, accuses Renovo of providing reprocessed models other than the ones covered by its 510(k) clearances. Renovo failed to evaluate how cleaning and re-sterilization of the additional models could affect performance and reliability. FDA inspectors also identified problems with Renovo’s approach to air particulate sampling that prompted warnings about the failure to establish control procedures. Dive Insight Renovo cleans medical devices that have been used in procedures such as the ablation of soft tissue for reuse. Renovo has multiple 510(k) clearances that permit the company to supply reprocessed versions of devices such as Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. The problem, according to the FDA, is that Renovo has reprocessed models that are outside of the scope of ...
- Source: drugdu
- 137
- April 1, 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
- 148
- 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
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- April 1, 2024
University of Liverpool to lead £125m research facility supported by UKRI investment

Set to open in 2032, the RUEDI facility is funded by the UKRI’s recent infrastructure fund worth £388m The University of Liverpool has announced that it will be leading a national research facility worth £125m to drive scientific discovery and advance technologies as part of the UK Research and Innovation’s (UKRI) infrastructure fund worth £388m. The Relativistic Ultrafast Electron Diffraction and Imaging (RUEDI) facility will benefit areas of research including quantum technologies and personalised medicine. The UKRI recently announced five new infrastructure projects with new funding to equip the UK’s research and innovation bases, with an additional £85m for the UKRI’s Digital Research Infrastructure Programme. In collaboration with the University of Liverpool’s Science and Technology Facilities Council and the Rosalind Franklin Institute, the new facility will allow researchers to explore changes in living cells as they happen to develop more personalised treatments for patients in a more renewable and sustainable ...
- Source: drugdu
- 91
- 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
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- April 1, 2024
Innovent Dosed First Participant in Phase 3 Clinical Study (Neoshot) of IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab for MSI-H/dMMR Colon Cancer Neoadjuvant Therapy

ROCKVILLE, Md. and SUZHOU, China, March 27, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy. Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant ...
- Source: drugdu
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- April 1, 2024
Agile, responsive regulation helps early breast cancer patients to benefit from a study to potentially improve survival outcomes

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. Data published between 2016 to 2018 suggests that close to 56,000 new cases of breast cancer are diagnosed in the UK, mostly affecting females, and with 86% presenting with early disease. Most breast cancers have proteins (receptors). These include oestrogen receptor-positive (ER+), where breast cancers have receptors for the hormone oestrogen, and HER2-negative, where the protein is absent – human epidermal growth factor 2. Hormones, particularly oestrogen, can attach to these receptors and encourage the cells to grow. A pathologist can identify the receptors during biopsy or surgery, helping to determine treatment. Recent research has led to the development of new candidate drugs known as SERDS (selective oestrogen receptor degraders). These drugs are designed to attach to and disrupt these oestrogen receptors, preventing the growth of cancer. A new SERD molecular entity, ...
- Source: drugdu
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- April 1, 2024
FDA Approves Akebia’s Vafseo for Anemia in Adults with Chronic Kidney Disease on Dialysis

Don Tracy, Associate Editor Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.Akebia Therapeutics announced that the FDA has approved Vafsen (vadadustat) for the treatment of anemia in adults with chronic kidney disease (CKD) who are on dialysis. According to a company press release, the once-daily, oral tablet works as a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, activating the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. In other words, it copies the body’s response to low oxygen levels. The FDA based the approval was on positive outcomes from the INNO2VATE program and additional safety data from its use in Japan, where it was launched in August 2020. Now approved in 37 countries, Akebia stated that Vafsen has the potential to improve overall outcomes for patients struggling with ...
- Source: drugdu
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- March 30, 2024
Boundless Bio’s ‘BOLD’ IPO Reels In $100M for a New Kind of Cancer Drug

Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year. By FRANK VINLUAN Targeted therapies and immunotherapies offer new treatment options for more types of cancer, but these drugs are less helpful when tumors produce multiple copies of a gene. This gene amplification contributes to drug resistance. Boundless Bio’s research into the what drives this phenomenon has yielded new understanding of cancer biology. The company now has $100 million in IPO cash to support two programs in early clinical development and more in its pipeline. Boundless Bio late Wednesday priced its offering of 6.25 million shares at $16 each, which was the midpoint of the preliminary $15 to $17 price range the San Diego-based company set last week. Those shares will trade on the Nasdaq under ...
- Source: drugdu
- 174
- March 30, 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
- 149
- March 30, 2024

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