Search Results for “Sanofi” – Page 10 – media

Insmed’s Trial Results Pave Way for FDA Filing in a Lung Disease With No Approved Therapies

Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders. By Frank VinluanAn Insmed drug developed for a serious chronic lung disorder with no FDA-approved therapies handily beat a placebo in a pivotal clinical trial, preliminary results that set the stage for a regulatory submission planned for later this year. It could be the first of several. The drug is also in development for other inflammatory conditions, giving the drug multiple opportunities to achieve its blockbuster potential. The first disease target of the Insmed drug is non-cystic fibrosis bronchiectasis (NCFB), a chronic lung disease characterized by excess production of sputum that’s persistently coughed up from the respiratory tract. Patients who have NCFB also experience frequent respiratory infections. There’s no ...
- Source: drugdu
- 98
- May 30, 2024
Amgen and AstraZeneca ponder label expansion for Tezspire in COPD

Amgen and AstraZeneca have highlighted the potential of Tezspire (tezepelumab) in chronic obstructive pulmonary disease (COPD) in a subgroup of patients in a Phase IIb study even though the trial missed the primary endpoint. The therapy failed to show a significant reduction in the annual rate of moderate to severe exacerbations compared to the placebo, the trial’s primary endpoint. The data from the placebo-controlled Phase IIa COURSE trial (NCT04039113) was presented at the American Thoracic Society (ATS) International Conference taking place in San Diego, US, from 16 to 21 May. However, a pre-determined subgroup analysis of COPD patients based on the levels of eosinophils, measured as baseline eosinophil count (BEC), showed significant reductions in COPD exacerbations. The therapy also demonstrated a 48% reduction in severe exacerbations compared to the placebo. Patients who received Tezspire while having a BEC of 150 cells/μL or more, which is associated with increased COPD-related emergency ...
- Source: drugdu
- 71
- May 22, 2024
Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi.Immunology and inflammation continues to be one of the hottest areas for research, and investment firm Blackstone is joining in with the launch of Uniquity Bio, a new startup whose lead asset from Merck addresses a clinically validated target that puts it in direct competition with some big pharmaceutical companies. Uniquity is backed by up to $300 million in financing from Blackstone Life Sciences, the firm’s biotechnology investment division. The in-licensed Merck drug, solrikitug, is ready to begin Phase 2 development in its lead indications, chronic obstructive pulmonary disease (COPD) and asthma. The Uniquity pipeline includes a third undisclosed gastrointestinal indication. Solrikitug is a monoclonal antibody designed to block thymic stromal lymphoprotein ...
- Source: drugdu
- 77
- May 17, 2024
FDA Grants Priority Review Biologics License Application to Dupixent Add-On Maintenance for the Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis

Don Tracy, Associate Editor Dupixent has previously been approved for adults with chronic rhinosinusitis with nasal polyposis whose condition is inadequately controlled. Regeneron and Sanofi announced that the FDA has granted Priority Review to their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years who have chronic rhinosinusitis with nasal polyposis (CRSwNP) and whose condition is inadequately controlled. With the treatment already approved for adults with CRSwNP, the FDA is expected to make a final decision on the sBLA for the expanded indication by September 15, 2024.1 According to the companies, the application is supported by efficacy data from SINUS-24 and SINUS-52, two trials that showed major improvements in nasal congestion/obstruction severity, nasal polyp size, sense of smell, and a reduction in the need for systemic corticosteroids or surgery. In 2019, Regeneron first released the results of both trials, ...
- Source: drugdu
- 83
- May 15, 2024
A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. By Frank VinluanWhen it comes to evaluating the health of a patient, each therapeutic area has its own data-gathering tools. Think glucose monitors in diabetes and heart monitors for cardiovascular disease. But in mental health, a clinician relies on what a patient says. Self-reporting is incomplete and lacks objectivity, says George Eleftheriou, CEO and co-founder of Feel Therapeutics. Feel is trying to bring more complete and objective data collection to the field of mental health. The San Francisco-based startup does it with wearable technology that continuously collects data and provides recommendations. “One of the things we hear is how poor storytellers people are and [how they] cannot truly depict what happened over the past ...
- Source: drugdu
- 132
- April 16, 2024
Precision Medicine Startup Mirador Unveils $400M for R&D of New I&I Drugs

Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year. By FRANK VINLUAN Nearly a year ago, Merck struck a $10.8 billion deal to acquire Prometheus Biosciences, a clinical-stage company whose technology platform analyzed genetics and biology data to discover new drugs. The executive who led Prometheus to that buyout is now back with a new immunology startup supported by $400 million. Mirador Therapeutics launched Thursday, aiming to take the precision medicine approaches that have led to advances in cancer drugs and apply them to the research of new therapies for immunology and inflammation. It’s a similar strategy to the one taken by Prometheus under the helm of Mark McKenna, now the CEO of San Diego-based Mirador. There’s a plethora of immunology drugs on the ...
- Source: drugdu
- 117
- March 25, 2024
Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein. By FRANK VINLUANCancer immunotherapy comes in several forms, and one area of growing research interest is a type of drug called a T cell engager. These drugs bind to a cancer cell and a T cell simultaneously, bringing both of them together to spark a therapeutic effect. Robert Ross, CEO of Clasp Therapeutics, likens T cell engagers to the chaperone at a middle school dance who grabs a boy and a girl in each hand, getting them to dance together. But in cancer drugs, just as in school dances, sometimes the pairing just isn’t right. The wrong pairing in cancer happens when a drug that’s targeted to a tumor also hits healthy cells, causing toxic effects. Clasp is developing ...
- Source: drugdu
- 88
- March 22, 2024
Dupixent® Receives Another FDA Priority Review for Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation

Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of Dupixent (dupliximab) for a sixth potential indication as a supplemental biologic. Sanofi announced today that the U.S. Food and Drug Administration (FDA) has granted priority review of the Supplemental Biologics License Application (SBLA) for the sixth potential indication for dabigatran (duplizumab), an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The FDA approval is expected on June 27, 2024. China has also submitted a marketing authorization application and received acceptance from the Center for Drug Evaluation (CDE) of the State Drug Administration (SDA). Data from two Phase III clinical trials (BOREAS and NOTUS) supporting this SBLA and other applications globally evaluated the efficacy and safety of Dupixent in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation who are smokers or have a history of ...
- Source: drugdu
- 176
- February 27, 2024
Adverse Event Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule. By FRANK VINLUAN Rapt Therapeutics aim to bring patients oral alternatives to injectable or infused immunology medications has hit a setback. A Rapt drug candidate in mid-stage clinical development in atopic dermatitis and asthma has been placed under an FDA clinical hold after a serious adverse event reported in a study participant, the company announced Tuesday. The patient, a participant in the atopic dermatitis study, experienced liver failure. According to Rapt, the cause of the liver failure is unknown but has been characterized as potentially related to the company’s experimental drug, zelnecirnon. South San Francisco-based Rapt said the FDA verbally notified the ...
- Source: drugdu
- 157
- February 22, 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

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