PharmaFocus Today – Page 162 – media

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
- 181
- 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
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- February 20, 2024
New Protein Biomarker to Help Develop Blood-Based Tests for Aggressive Neuroendocrine Carcinomas

Neuroendocrine carcinomas, such as neuroendocrine prostate cancer and small-cell lung cancer, originate in hormone-releasing cells and can develop in various organs, including the prostate and lungs. While they are not the most prevalent cancer type in these organs, they often have a poor prognosis and limited therapeutic options. Current treatments for these cancers include chemotherapy, radiation, and immunotherapy combinations. Neuroblastoma, predominantly found in young children, develops from immature nerve cells, often in the adrenal glands or nerve tissue along the spine, chest, abdomen, or pelvis. Despite treatment efforts, these therapies only extend survival by a few months, underscoring the need for better therapeutic targets and less invasive diagnostic approaches for these malignancies. Investigators from the UCLA Health Jonsson Comprehensive Cancer Center (Los Angeles, CA, USA) have identified UCHL1, a protein found in aggressive neuroendocrine carcinomas and neuroblastoma, as a potential molecular biomarker for diagnosing these cancers and predicting and monitoring ...
- Source: drugdu
- 114
- February 19, 2024
Study Advances Blood Tests for Psychiatric and Neurological Disorders

The lack of non-invasive methods for monitoring brain status is a significant challenge in psychiatric care. Using genetic material from human blood and lab-grown brain cells, researchers have now made advances in developing a blood test to detect brain-related changes associated with postpartum depression and other psychiatric and neurological disorders. The research by investigators at Johns Hopkins Medicine (Baltimore, MD, USA) focused on tracing brain cell-derived mRNAs in the bloodstream. These extracellular vesicles (EVs), which are tiny sacs containing genetic material, are crucial for cell communication and carry messenger RNA (mRNA) from the brain. This method allows for the detection of changes in gene activity within the brain. The team’s interest in this area grew from an earlier study that found altered EV communication in pregnant women who developed postpartum depression after childbirth. The latest study used the human placenta as a model to identify 26 placental mRNAs in maternal ...
- Source: drugdu
- 140
- February 19, 2024
FDA grants orphan drug status to Ionis’ olezarsen for FCS treatment

The US Food and Drug Administration (FDA) has granted orphan drug designation to Ionis Pharmaceuticals’ olezarsen, an investigational ligand conjugated antisense medicine for familial chylomicronemia syndrome (FCS). This rare genetic disease is characterised by extremely high triglyceride levels and can lead to recurrent acute pancreatitis (AP). Olezarsen is an RNA-targeted therapy aimed at reducing the production of apolipoprotein C-III (ApoC-III), a protein that regulates triglyceride metabolism. It is currently undergoing evaluation for individuals at risk of diseases caused by elevated triglyceride levels, including FCS. In January 2023, the US regulator awarded fast track designation to olezarsen for FCS. Ionis is also investigating its potential to treat severe hypertriglyceridemia (sHTG) in Phase III clinical trials. FCS patients experience triglyceride levels that are significantly higher than normal, leading to life-threatening conditions such as AP and potential damage to vital organs. No currently FDA-approved therapies exist for FCS, and standard treatments for lowering ...
- Source: drugdu
- 132
- February 19, 2024

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