Search Results for “Clinical Trial” – Page 64 – media

Touchlight joins forces with University of Liverpool for NSCLC vaccine

UK-based CDMO Touchlight has teamed up with the University of Liverpool, UK, to utilise its doggybone DNA (dbDNA) technology in for developing a personalised DNA vaccine for patients with non-small cell lung cancer (NSCLC), which will be assessed in a clinical trial. Touchlight’s dbDNA is a small, closed loop of DNA that is made in a lab using enzymes. This technique can speed up the drug development process by amplifying long and complex DNA sequences without traditional methods like bacterial fermentation. The term doggybone DNA refers to the structure of the synthesised DNA molecule, which resembles a bone with two loops at each end. The approach offers a way to make vaccines very quickly, especially for personalised treatments. In March 2023, Touchlight received a £14m ($17.7m) grant from the UK government for commercial scale manufacturing of the technology. A team at the University of Liverpool will use Touchlight’s dbDNA technology ...
- Source: drugdu
- 81
- April 9, 2024
Amylyx Withdraws ALS Drug From Market; Restructuring Will Slash 70% of Staff

The voluntary removal of ALS drug Relyvrio from the market comes with a corporate restructuring that turns Amylyx Pharmaceuticals’ focus to other neurodegenerative diseases. But the company also has another ALS drug candidate set to begin clinical testing this year.Amylyx Pharmaceuticals is withdrawing its drug for amyotrophic lateral sclerosis from the market, a decision that comes a month after post-marketing clinical trial results showed the medication was no better than a placebo at treating the fatal neuromuscular disease. Starting Thursday, Relyvrio (known as Albrioza in Canada) will no longer be available for new patients, Amylyx said. But patients currently receiving the drug in the U.S. and Canada who, in consultation with their physicians, wish to stay on treatment may transition to a program that will provide the drug for free. The withdrawal of Relyvrio is voluntary. The drug received full FDA approval in 2022 based on results from a small ...
- Source: drugdu
- 89
- April 8, 2024
myTomorrows and brainstrust partner to support patients living with brain cancer

myTomorrows has announced a new partnership with a UK-based charity, brainstrust, to support individuals living with brain cancer. The partnership will help equip patients with knowledge of relevant treatment options, participation in clinical trials and access to pre-approved drugs, while supporting clinicians when recruiting patients to relevant clinical trials. Brain tumours affect around 80,000 people in England, with only 12% of patients surviving beyond five years of their diagnosis. As part of the agreement, the charity will provide its patient network with timely, up-to-date and useful information surrounding credible and accessible clinical trials, along with myTomorrow’s expertise and support. In addition, myTomorrow’s trained patient navigators will play a key role as a single point of contact to help guide patients with brain tumours and their loved ones, as well as healthcare professionals, through medical care and help them make the best decisions during their treatment journey. Using a GDPR-compliant ISO ...
- Source: drugdu
- 105
- April 8, 2024
RemeGen’s Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren’s Syndrome

YANTAI, China, April 3, 2024 /PRNewswire/ — RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), independently developed by RemeGen for the treatment of patients with primary Sjögren’s syndrome (pSS). The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs. Primary Sjögren’s syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator ...
- Source: drugdu
- 112
- April 8, 2024
【EXPERT Q&A】What is the basic process of Class II medical device registration certificate application?

Drugdu.com expert’s response: The basic process for applying for the registration certificate of Class II medical devices is as follows: 1.Document Preparation: Prepare all necessary documents for the application, including technical documentation for the product, clinical trial reports, quality management system documents, etc. 2.Application Submission: Submit the application documents to the National Medical Products Administration (NMPA) or relevant local drug regulatory authority. The application documents should include company information, product information, technical documentation, clinical trial reports, etc. 3.Preliminary Review: The drug regulatory authority conducts a preliminary review of the submitted application documents to ensure completeness and compliance with requirements. 4.Acceptance: After the preliminary review, the drug regulatory authority formally accepts the application and issues an acceptance notice. 5.Technical Review: Conduct a technical review of the application documents to assess the safety, efficacy, and quality control system of the product. 6.Clinical Evaluation: If necessary, conduct a clinical evaluation of the product ...
- Source: drugdu
- 133
- April 8, 2024
Cellenkos links with Mount Sinai to explore CK0804 for myelofibrosis

Cellenkos has signed a sponsored research agreement with the Icahn School of Medicine at Mount Sinai Hospital, New York, US, to investigate the use of CK0804, a T-regulatory cell therapy for myelofibrosis. The collaboration aims to explore the therapeutic potential of CK0804, an allogeneic, cord blood-derived T-regulatory cell product enriched with C-X-C chemokine receptor type 4. The research will be led by Ronald Hoffman, director of the Myeloproliferative Disorders Research Program at the Tisch Cancer Institute, Mount Sinai. CK0804 uses Cellenkos’ CRANE technology to create disease-specific cell therapy products. This approach allows CK0804 cells to preferentially target inflamed bone marrow. Cellenkos chief operating officer Tara Sadeghi stated: “We are very excited by our collaboration with Mount Sinai and eagerly anticipate gaining a deeper understanding of [how] mechanisms of CK0804 Tregs work in myelofibrosis, especially to decrease inflammation. “CK0804 is already in a Phase I clinical trial to examine its safety ...
- Source: drugdu
- 72
- April 5, 2024
FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. By FRANK VINLUAN A software app that modifies behavior through a series of lessons and exercises has received FDA clearance for treating patients with major depressive disorder, making it the first prescription digital therapeutic for this indication. The product, known as CT-152 during its development by partners Otsuka Pharmaceutical and Click Therapeutics, will be commercialized under the brand name Rejoyn. Rejoyn is an alternative way to offer cognitive behavioral therapy, a type of talk therapy in which a patient works with a clinician in a series of in-person sessions. In Rejoyn, the cognitive behavioral therapy lessons, exercises, and reminders are digitized. The treatment is intended for use ...
- Source: drugdu
- 119
- April 4, 2024
Alexion’s Voydeya gains FDA approval for extravascular haemolysis

Alexion, AstraZeneca Rare Disease has received approval from the US Food and Drug Administration (FDA) for Voydeya (danicopan) as an add-on therapy to treat extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). A first-in-class, oral Factor D inhibitor, Voydeya has been developed for patients who continue to suffer from EVH despite treatment with C5 inhibitors such as Ultomiris (ravulizumab) or Soliris (eculizumab). The FDA’s decision is grounded in the positive outcomes of the ALPHA Phase III trial, which demonstrated that Voydeya met its primary endpoint of haemoglobin change from baseline to week 12, alongside all key secondary endpoints. The drug was generally well-tolerated with no new safety concerns. As part of the ALPHA double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo apart from their ongoing Soliris or Ultomiris therapy over 12 weeks. It aimed to assess the superiority of Voydeya as an ...
- Source: drugdu
- 126
- April 4, 2024
Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
- Source: drugdu
- 93
- April 3, 2024
Labcorp’s $237M Tuck-In Deal Brings Lab Testing Assets From BioReference Health

Labcorp is buying the clinical diagnostics and reproductive women’s health businesses of BioReference Health, excluding those assets in New York and New Jersey. Labcorp has returned to being fully focused on lab testing after last year’s spinoff of Fortrea, its former clinical trial services business. By FRANK VINLUANLabcorp’s testing capabilities are getting a little broader with the $237.5 million acquisition of certain laboratory assets from BioReference Health, a subsidiary of Opko Health. The BioReference assets going to Labcorp span clinical diagnostics and reproductive women’s health across the U.S. and account for about $100 million in annual revenue. The deal announced Thursday excludes those assets in New York and New Jersey, where BioReference will continue to maintain its full operations. BioReference will also continue to offer oncology and urology diagnostic services nationwide. Burlington, North Carolina-based Labcorp was founded as a laboratory testing company in 1969. In 2015, it entered drug development ...
- Source: drugdu
- 127
- April 2, 2024

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