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Yet another clinical hold for Gilead’s magrolimab trials

Gilead Sciences had paused enrolment in the magrolimab solid tumour trials, with the FDA requesting a partial clinical hold on these studies. Earlier this month, the US regulatory agency placed a full clinical hold on all the clinical trials of magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). “Gilead will likely decide to deprioritise the magrolimab programme entirely,” said Sakis Paliouras, associate director for oncology research and analysis at GlobalData. Adding: “it is less likely, but still possible, that the company will come back from the clinical hold and continue the programme.” The latest partial clinical hold affects the Phase II trials of magrolimabin multiple solid tumour conditions such as head and neck squamous cell carcinoma (NCT04854499), triple-negative breast cancer (NCT04958785), and colorectal cancer (NCT05330429). In addition to Gilead-sponsored trials, the partial clinical also applies to Investigator Sponsored Studies with magrolimab in solid tumours. Paliouras said the blood ...
- Source: drugdu
- 155
- February 21, 2024
Health Executives Are Implementing Digital Health, But Aren’t Seeing ROI Yet

Following the Covid-19 pandemic, there has been a boom in the digital health space. But health executives aren’t seeing the financial benefits just yet, according to a recent survey from EY, a consulting firm. The online survey received responses from 101 healthcare executives in the U.S. It found that while 86% of health executives say that digital health solutions have the potential to reduce costs, 70% said they haven’t seen a return on investment so far. In addition, 50% of healthcare organizations say that “siloed tracking metrics” make it hard to follow tech’s initial cost value. “I think we’re still in the early innings of this digital transformation. The Covid episode introduced to the world of U.S. healthcare that, yes, I can interact with my physician remotely and so forth. … We got this first initial wave of incredible excitement and value, but there’s so much work to be done ...
- Source: drugdu
- 139
- February 20, 2024
Astellas’s CAR Tech Deals Speed Up Its Pursuit of In Vivo Cancer Cell Therapies

Astellas Pharma is working with Kelonia Therapeutics, a startup that develops in vivo CAR T-therapies with technology that precisely delivers genetic cargo to cells. The collaboration combines this tech with a platform from Xyphos Biosciences, a cell therapy developer that Astellas acquired in 2019. By FRANK VINLUAN Cell therapy’s next breakthrough could be the engineering of these cells inside the patient. Two deals more than four years apart put Astellas Pharma in position to ramp up its work developing these in vivo treatments. Under the more recent agreement announced late Thursday, Astellas is collaborating with Kelonia Therapeutics, a startup that has developed technology for precisely delivering genetic cargo to target cells in the body in order to make those cells into in vivo CAR T-therapies. Kelonia calls its technology in vivo gene placement system, or iGPS. The genetic payload delivered to a cell gets it to express a receptor that ...
- Source: drugdu
- 138
- February 20, 2024
Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients

Davy James Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above. The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the first medication indicated to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with immunoglobulin E (IgE)-mediated food allergy. Xolair is a monoclonal antibody that binds to and inhibits IgE, which is involved in the pathophysiology of the allergic inflammation characteristic of asthma. Through this mechanism of action, IgE down-regulates the immune response to help gain control over allergy-driven inflammation. “Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result. Today’s ...
- Source: drugdu
- 170
- February 20, 2024
Jacobio Announces China CDE Clearance for Phase III Clinical Trial of SHP2 Inhibitor Plus KRAS G12C Inhibitor

BEIJING and SHANGHAI and BOSTON, Feb. 18, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312. JAB-3312 is the first SHP2 inhibitor entered into phase III study globally in combination with KRAS G12C inhibitor. This approved study in China is a randomized active controlled phase III trial design to evaluate the efficacy and safety of JAB-3312 in combination with glecirasib for first-line non-small cell lung cancer patients with KRAS G12C mutations. The control arm is the current standard treatment for first-line non-small cell lung cancer, which is the combination therapy of PD-1 antibody and chemotherapy. Jacobio initiated clinical trials of SHP2 inhibitors in 2018. Data presented by Jacobio in an oral presentation at the 2023 European Society for ...
- Source: drugdu
- 95
- February 20, 2024
Xyphos and Kelonia link for immuno-oncology drug development

Astellas subsidiary Xyphos Biosciences has entered a research partnership and licence agreement with Kelonia Therapeutics aimed at developing new immuno-oncology therapeutics in an $875m deal. The alliance will merge Xyphos’ ACCEL technology with Kelonia’s in vivo gene placement system to develop universal, off-the-shelf in vivo chimeric antigen receptor (CAR) T-cell therapies for up to two programmes. Kelonia focuses on genetic medicine innovation and utilises its in vivo gene placement system to precisely deliver genetic material to the target cells within the patient’s body. This system employs lentiviral particles for efficient delivery. Xyphos’ ACCEL technology platform features the convertible CAR used on immune cells. Xyphos will oversee the development and marketing of the products resulting from the joint research. Kelonia is entitled to an upfront payment of $40m for the first programme. If Xyphos opts for the second programme, an additional $35m will be paid to Kelonia. The deal also includes ...
- Source: drugdu
- 109
- February 20, 2024
GSK concludes Aiolos Bio acquisition for $1.4bn

GSK has successfully concluded the acquisition of Aiolos Bio in a deal that could reach $1.4bn, marking a significant expansion of GSK’s respiratory biologics portfolio. The agreement, signed last month, includes an upfront payment of $1bn and $400m in regulatory milestone payments. The acquisition introduces AIO-001, a long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, into GSK’s pipeline. The antibody is ready to enter Phase II clinical development. It targets adults with asthma and has the potential for extended dosing intervals, possibly every six months, due to its extended half-life and high potency. AIO-001 operates by attaching to the TSLP ligand, a key player in asthma inflammation, to hinder its signalling pathway. The acquisition significantly benefits the estimated 40% of severe asthma patients who suffer from low Type 2 (T2) inflammation. GSK’s commitment to respiratory diseases is further solidified with the addition of AIO-001, potentially redefining standard care for asthma patients. ...
- Source: drugdu
- 166
- February 20, 2024
Sanofi’s investigational frexalimab shows promise in relapsing forms of MS

Sanofi has announced that its investigational anti-CD40L antibody frexalimab has shown potential as a “high-efficacy therapy” for relapsing multiple sclerosis (MS), according to mid-stage results published in The New England Journal of Medicine. Affecting approximately 2.8 million people worldwide, MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Sanofi frexalimab has “a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion,” the company said. The phase 2 study of the candidate randomised ...
- Source: drugdu
- 103
- February 20, 2024
Hengrui’s anti-IL-17A Vunakizumab marketing application for ankylosing spondylitis indications accepted

Recently, Suzhou Shengdia Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Pharmaceuticals, received the “Notice of Acceptance” issued by the National Medical Products Administration. The company submitted the Class 1 new drug Vunakizumab Injection (SHR-1314) The drug marketing authorization application was accepted by the NMPA. This product is used for adult patients with active ankylosing spondylitis whose conventional treatment is not effective. This application for marketing is based on a multi-center, randomized, double-blind, placebo-controlled adaptive seamless phase II/III clinical trial (SHR-1314-302). Research shows that Vunakizumab injection provides statistically significant and clinically meaningful improvements in active ankylosing spondylitis compared with placebo. At the same time, SHR-1314 injection is safe and well tolerated in the long-term treatment of patients with active ankylosing spondylitis. About SHR-1314-302 Research In November 2023, the main research endpoint of the Phase III clinical trial (SHR-1314-302) of SHR-1314 injection for the treatment of active ankylosing spondylitis in subjects with ...
- Source: drugdu
- 180
- February 20, 2024
MHRA launches second phase of genetic biobank for stroke prevention medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its Yellow Card Biobank will begin investigating a new group of medicines to prevent strokes. First launched in partnership with Genomics England in June 2023, the Yellow Card Biobank will help to improve understandings of how genetic makeup can impact the safety of medicines and to improve personalised medicine approaches. Accumulated genetic data and patient samples will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse drug reactions (ADRs), which involve medicines and medical devices. In total, ADRs account for one in 16 hospital admissions in the UK and continue to be a significant burden on the NHS. In its second phase, the genetic biobank will begin investigating direct oral anticoagulants, such as apixaban, dabigatran, edoxaban and rivaroxaban. A stroke, responsible for more than 100,000 cases in the UK every year, occurs when the ...
- Source: drugdu
- 96
- February 20, 2024

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