Search Results for “Clinical Trial” – Page 84 – media

Novel and emerging therapies offer new hope for patients with inflammatory bowel disease

Ulcerative colitis (UC) and Crohn’s disease (CD) are chronic inflammatory bowel diseases (IBD) that affect the gastrointestinal tract. In recent decades, there have been significant advances in the understanding of IBD pathophysiology and the development of new treatments. The International Organisation for the Study of Inflammatory Bowel Diseases (IOIBD) developed the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) programs, which recommend specific treatment goals for UC and CD in children and adults. These goals include clinical response and remission, endoscopic healing, normalization of C-reactive protein/erythrocyte sedimentation rate and fecal calprotectin, prevention of disability, restoration of quality of life, and normal growth in children. The current mainstay treatments for IBD include immunomodulators, biologics (anti-tumor necrosis factor alpha (TNF-α) agents being the most commonly used), and other monoclonal antibodies such as anti-integrins and anti-interleukins (IL-12/23). However, primary and secondary loss of response to these therapies is a major recurring issue, with ...
- Source: drugdu
- 89
- November 9, 2023
New UK research institute launched for motor neurone disease

A new research institute in London has been launched aimed at discovering a cure and new treatments for motor neurone disease (MND). The UK Motor Neuron Disease Research Institute (UK MND RI) will bring together a virtual network of MND labs, clinical centres and researchers to carry out MND research across the UK. Affecting one in every 300 people in the UK, MND is a neurodegenerative disease which affects the nerve cells in the brain and spinal cord. Around one-third of patients with MND die within one year of diagnosis, and more than half within two years. Currently, Sanofi’s Rilutek (riluzole) is the only licenced drug for MND in the UK. Collaboratively, doctors, clinicians, scientists and people living with MND, along with funders and charities, will work to speed up drug discovery and drug development and aim to test potential treatments in clinical trials. LifeArc, the MND Association, MND Scotland, ...
- Source: drugdu
- 92
- November 9, 2023
Apellis parries Astellas’ long-term Izervay data with 3-year results on its rival GA med Syfovre

After this summer’s FDA approval of Iveric Bio’s Izervay—the drug at the center of the $5.9 billion buyout by Japanese pharma Astellas—the battle for the geographic atrophy (GA) crown is on in the U.S. Now, Apellis Pharmaceuticals, which boasts embedded eye disease sales leader Syfovre, is putting up long-term data in a bid to outdo its new rival. Touting data from its GALE extension study, Apellis on Saturday said Syfovre yielded increasing treatment effects year over year and helped patients achieve more than a 40% reduction in non-subfoveal lesion growth at the study’s three-year mark. Apellis rolled out the latest GALE results as part of a presentation at this year’s meeting of the American Academy of Ophthalmology (AAO) in San Francisco. The timing coincides with the release of two-year data on Astellas and Iveric’s GA drug Izervay—also at AAO—which suggest the rival drug’s treatment benefit emerged in as few as ...
- Source: drugdu
- 110
- November 8, 2023
Candel announces promising results for immunotherapy candidate in pancreatic cancer

Candel Therapeutics has announced positive results from a mid-stage trial of its viral immunotherapy candidate in non-metastatic pancreatic cancer. The ongoing phase 2 trial has been evaluating the candidate CAN-2409 plus valacyclovir together with standard of care (SoC) chemo-radiation followed by resection in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). Interim results demonstrated an estimated survival rate of 71.4% at months 24 and 36 months in patients who received the CAN-2409 regimen prior to surgery, compared to 16.7% in those receiving SoC chemo-radiation alone. Five out of seven patients who received CAN-2409 were still alive at the time of the data cut-off, with two patients surviving more than 45 months from enrolment, while only one patient randomised to control SoC chemotherapy remained alive at the data cut-off. A “consistent and robust activation of immune response” was also observed after dosing with CAN-2409, the company said, and that the candidate ...
- Source: drugdu
- 97
- November 8, 2023
Daiichi Sankyo, Merck Set to Collaborate on Three DXd Antibody-Drug Conjugates

Image Credit: Adobe Stock Images/huenstructurebio.com Daiichi Sankyo and Merck announced that they have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). Reportedly, the companies will jointly develop and potentially commercialize the candidates globally, except for Japan where Daiichi Sankyo will maintain exclusive rights. “The promising results from clinical trials of patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan continue to demonstrate the broad applicability of Daiichi Sankyo’s DXd ADC technology across multiple targets, with each of these medicines having the potential to change clinical practice as has been already seen with Enherti,” said Sunao Manabe, representative director, executive chairperson, CEO, Daiichi Sankyo Company, Limited. “As Daiichi Sankyo continues its transformation into a global oncology leader by increasingly building our infrastructure and talent, we recognize that a collaboration with Merck, a company ...
- Source: drugdu
- 129
- October 27, 2023
Mirum’s plans to expand Livmarli’s market get hit as FDA pushes approval date

The US Food and Drug Administration (FDA) has announced an extended review of the Supplemental New Drug Application (sNDA) for Mirum Pharmaceutical’s Livmarli (maralixibat) to treat patients with cholestatic pruritus in progressive familial intrahepatic cholestasis (PFIC). The company announced that the FDA extended the prescription drug user fee act (PDUFA) date to allow time for a full review of a submission provided in response to an FDA information request, which is deemed to be a major amendment. The date has been pushed from 13 December to 13 March, 2024. The news was announced after markets closed on 17 October. Earlier today, Mirum’s stock opened more than 4% lower than the previous day. Mirum submitted the sNDA in February of this year based on the Phase III MARCH trial. The study was the largest randomised trial conducted for patients with PFIC. A statistically significant difference in efficacy was reported between the ...
- Source: drugdu
- 155
- October 20, 2023
After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti

As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they’ve occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call. Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership. Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to ...
- Source: drugdu
- 108
- October 20, 2023
Novo Nordisk to buy KBP’s hypertension drug ocedurenone for up to $1.3bn

Novo Nordisk has agreed to acquire ocedurenone, a drug for uncontrolled hypertension, from KBP Biosciences in a deal worth up to $1.3bn. Ocedurenone, an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist, is currently being evaluated in the late-stage CLARION-CKD trial as a treatment option for patients with uncontrolled hypertension as well as for those with advanced chronic kidney disease (CKD). Uncontrolled hypertension is when a person’s blood pressure remains high despite taking two or more blood pressure-lowering treatments. An estimated 1.28 billion adults aged 30 to 79 years worldwide have hypertension and only about 21% have it under control, marking a significant unmet need in the treatment of the condition. Martin Holst Lange, executive vice president and head of development at Novo, said: “Hypertension is a leading risk factor for cardiovascular events, heart failure, CKD and premature death. “With its expected benefit-risk profile, ocedurenone has best-in-class potential in treating ...
- Source: drugdu
- 157
- October 19, 2023
FDA establishes new advisory committee to provide expertise on digital health

The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring. The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”. The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December. Jeff Shuren, director of the FDA’s Center for Devices ...
- Source: drugdu
- 202
- October 18, 2023
Merck’s Keytruda receives approval greenlight from EU CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed a positive recommendation for Merck’s Keytruda (pembrolizumab) as part of a first-line treatment for advanced gastric and gastroesophageal junction cancer (GEJ). Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, would be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The intravenously administered drug is designed to improve the immune system’s anti-tumour response by inhibiting the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating tumor-fighting T-cells. Keytruda is also being studied as a treatment for hepatobiliary, oesophageal, pancreatic, and colorectal cancers. The EU CHMP’s positive recommendation was based on results from the Phase III KEYNOTE-859 (NCT03675737) study, a randomised, double-blind clinical trial evaluating the efficacy of Keytruda plus chemotherapy as a first-line treatment for human epidermal growth factor receptor-2 (HER2) negative, unresectable or ...
- Source: drugdu
- 170
- October 18, 2023

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