Search Results for “Clinical Trial” – Page 72 – media

Regeneron’s linvoseltamab application accepted for review

Regeneron Pharmaceuticals marketing authorisation application (MAA) for linvoseltamab has received acceptance for review from the European Medicines Agency (EMA) to treat adults with r/r MM. Linvoseltamab is a bispecific antibody designed to target and destroy cancer cells by bridging the B cell maturation antigen on MM cells with CD3 (cluster of differentiation 3, a protein complex)-expressing T cells. The MAA submission is based on findings from the Phase I/II LINKER-MM1 clinical trial of linvoseltamab in r/r MM patients. The open-label, multicentre, dose-escalation and dose-expansion study is designed to evaluate the investigational drug in patients who have undergone multiple prior treatments. All 282 enrolled trial subjects had received a minimum of three lines of therapy or were considered triple refractory. They subsequently received linvoseltamab through an initial step-up dosing regimen, followed by a full dose. The completed Phase I portion of the trial evaluated the tolerability, safety ...
- Source: https://www.echnology.com/news/regeneron-linvoseltamab-application-review/
- 91
- February 11, 2024
Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities

Pfizer announced a partnership with the American Cancer Society aimed at reducing disparities in cancer treatment. As part of the initiative, Pfizer is providing $15 million in funding. This money will go towards improving the health outcomes of cancer patients from underrepresented communities in the United States. This will include working to improve access to cancer screenings, clinical trial opportunities, and patient care. In a press release, Pfizer’s chief oncology officer and executive vice president Chris Boshoff said, “Cancer doesn’t discriminate–and neither should cancer care. Everyone should have the same opportunity to access the latest advances in care, regardless of their background or where they live. We’re proud to partner with the American Cancer Society on a broad, community-focused initiative to reach people living with cancer where they are, with urgency, and connect them to resources to receive the care they deserve.” The partnership will work under the banner of ...
- Source: drugdu
- 74
- February 8, 2024
【EXPERT Q&A】What are the steps in the FDA’s drug approval process?

Drugdu.com expert’s response: The drug approval process by the FDA is quite standardized and rigorous. Here’s a detailed breakdown of the entire process: Preclinical Studies: This is the first step in the drug approval process, involving pharmacological and toxicological studies to assess the drug’s safety and efficacy. These studies are usually conducted in laboratories or animal models. Submission of an Investigational New Drug Application (IND): Once preclinical studies indicate that the drug might be safe, pharmaceutical companies submit an Investigational New Drug application (IND). The IND includes preclinical study data, manufacturing information, and clinical trial protocols. Clinical Trials: This is the core part of the drug approval process and mainly consists of three phases. Phase I primarily tests the drug’s safety and dosage in humans; Phase II focuses on the drug’s efficacy and side effects; Phase III further confirms efficacy, monitors side effects, and compares the drug with existing treatments. ...
- Source: drugdu
- 146
- February 8, 2024
Valneva sells Ixchiq priority voucher for $103m to fuel R&D

Valneva has sold its US Food and Drug Administration (FDA) priority review voucher for €95m ($103m) to an undisclosed party. The French company received the priority review voucher when its chikungunya vaccine, Ixchiq, got FDA approval in November 2023.Valneva plans to use the funds from the voucher sale to advance its research and development (R&D) efforts, as per a 5 February press release. The voucher sale price is in line with the company’s previous projections of gaining €90m-€110m with such a sale. One of the projects that the company plans to use its proceeds for is the Lyme disease vaccine, VLA15. Valneva is co-developing the vaccine in partnership with Pfizer. VLA15 is an experimental multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. The vaccine is being evaluated in a placebo-controlled Phase III trial (NCT05477524). The trial suffered a delay when both companies paused patient ...
- Source: drugdu
- 90
- February 7, 2024
FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing shows. External experts invited by the FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal ...
- Source: drugdu
- 95
- February 6, 2024
Neuro Biotech Alto Adds $128M in IPO Cash for Biomarker-Based Psych Drugs

Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development. By FRANK VINLUAN Matching a drug to a patient’s biology is not a new idea, but it hasn’t caught on in neuropsychiatric disorders, which have high failure rates in drug studies. The technology of Alto Neuroscience brings precision medicine to psychiatric drug research and its IPO has raised $128.6 million to see if this approach can yield better clinical trial results. Alto priced its IPO late Thursday, offering more than 8 million shares for $16 apiece. The Los Altos, California-based company was able to raise more than planned. When Alto set preliminary financial terms earlier this week, it projected offering 6.7 million shares in the range of $14 and $16 each, which would have raised $100.5 million at ...
- Source: drugdu
- 83
- February 5, 2024
CSPC Pharmaceutical Group’s SYS6002’s first human study unveiled at ASCO-GU

From January 25th to 27th local time, the 2024 American Society of Clinical Oncology Urogenital Oncology Branch (ASCO-GU) annual meeting was grandly held in San Francisco. ASCO GU is an academic event in the field of urogenital tumors. The conference will showcase the most innovative scientific progress in this field and discuss the future treatment directions of urogenital tumors. The first human study of SYS6002, a collaboration between CSPC and Fudan University Cancer Hospital’s Professor Ye Dingwei’s team and Professor Zhang Jian’s team – “Evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6002 in patients with advanced solid tumors “An open, single-arm, multi-center phase I clinical trial” – phased research results were presented at the conference in the form of a poster (number B622). Research methods This study is a single-arm, open, multi-center phase I study. Aims to evaluate the safety, tolerability and PK characteristics of SYS6002 in ...
- Source: drugdu
- 133
- February 5, 2024
Innovative ‘Fragmentomics’ Approach to Enable Earlier Detection of Cancer Using Smaller Blood Draws

When cells die, they disintegrate, releasing part of their DNA material into the bloodstream. This cell-free DNA (cfDNA) contains cancer signals. The cfDNA from healthy cells breaks down into standard-sized fragments, whereas cancerous cfDNA fragments disintegrate at different locations, often in the genome’s repetitive regions. Instead of searching for specific DNA mutations, which is like finding a single misarranged letter in billions of letters, researchers have developed a novel machine-learning method. This method detects variations in fragmentation patterns between cancerous and normal cfDNA in these repetitive regions of cancer. This groundbreaking technique could potentially allow for earlier cancer detection in patients through smaller blood samples, as it requires approximately eight times less blood than what is needed for whole genome sequencing. The algorithm called Alu Profile Learning Using Sequencing (A-Plus) was developed by researchers at City of Hope (Duarte, CA, USA) and Translational Genomics Research Institute (TGen, Phoenix, AZ, USA). ...
- Source: drugdu
- 147
- February 2, 2024
Hengrui’s new breakthrough! China’s first self-developed innovative opioid analgesic drug Tegelidine fumarate was approved for marketing

Recently, Hengrui Pharmaceutical received the “Drug Registration Certificate” approved and issued by the State Drug Administration, approving the launch of the company’s independently developed Tagelidine Fumarate Injection (Asut®) for the treatment of moderate to severe pain after abdominal surgery. This product is China’s first independently developed innovative Class 1 opioid analgesic drug and will provide new treatment options for patients suffering from postoperative pain. So far, Hengrui has got marketing approval for 16 innovative drugs. Postoperative pain is one of the most common forms of acute pain. It is reported that in China the prevalence of moderate to severe acute pain after surgery in patients is as high as 48.7%. At the same time, patients with moderate to severe pain are not satisfied with analgesic treatment, with 28.5% of patients expressing a need for more efficient analgesic therapy1. Taglidine Fumarate Injection is Hengrui’s key milestone product in the field of ...
- Source: drugdu
- 106
- February 2, 2024
HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 30, 2024: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE® (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). ELUNATE® is a selective oral inhibitor of vascular endothelial growth factor (“VEGF”) receptors -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. This marks the first medicine to be approved under the new mechanism for registration of new drugs (“1+” mechanism) announced by the Government of the Hong Kong Special Administrative Region (“SAR”) in October last year. The mechanism officially commenced on November 1, 2023. It allows drugs which are beneficial for treatment of life-threatening or severely debilitating diseases to apply for registration for use in Hong Kong, if they have supporting local clinical data and recognition ...
- Source: drugdu
- 106
- February 1, 2024

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