Search Results for “Pfizer” – Page 19 – media

Replimune kickstarts Phase III melanoma trial studying RP1 immunotherapy

Replimune has announced the first patient in the Phase III melanoma trial with its lead immunotherapy RP1 or vusolimogene oderparepvec has been dosed and randomised. The IGNYTE-3 study (NCT06264180) will investigate the use of RP1 plus Bristol Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) for patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are ineligible for anti-CTLA-4 therapy. Massachusetts-based biotech Replimune’s CMO Kostas Xynos stated that the trial will serve to, “advance of our planned BLA submission of RP1 in advanced melanoma later this year”. In spite of slowing research, the wider oncolytic virus-based market has been projected to grow from $114mn in 2023 to $2.4bn in 2029 according to GlobalData analyst Kevin Marcaida. Marcaida expects that within this period, Replimune’s RP1 could claim a 74% market share. The IGNYTE-3 trial comes as Replimune continues a downward financial trend. Despite announcing $100m in private placement ...
- Source: drugdu
- 66
- August 16, 2024
Study suggests COVID-19 vaccination lowers incidence of arterial thromboses

Researchers from the Universities of Cambridge, Bristol and Edinburgh have suggested that COVID-19 vaccinations could lower the incidence of arterial thromboses. The study, published in Nature Communications, was supported by the British Heart Foundation (BHF) Data Science Centre at Health Data Research UK. Researchers analysed the de-identified health records of 46 million adults from GP practices, hospital admissions and death records in England between December 2020 and January 2022, provided by NHS England. The team compared the incidence of cardiovascular diseases (CVDs) following COVID-19 vaccination with the incidence before or without vaccination during the first two years of the vaccination programme. CVD affects around seven million people in the UK and is a significant cause of disability and death. Overall, the study revealed that the incidence of arterial thromboses, such as heart attacks and strokes, which affect 200,000 people in the UK every year combined, was up to 10% lower ...
- Source: drugdu
- 64
- August 14, 2024
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
- Source: drugdu
- 92
- August 14, 2024
Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. By Frank VinluanOtsuka Pharmaceutical is broadening its scope in rare disease, striking a deal to acquire Jnana Therapeutics and its lead drug candidate, a small molecule on track for pivotal testing in a metabolic disorder with few treatments. Per deal terms announced Thursday, Otsuka is paying $800 million up front to buy Boston-based Jnana. The Japanese pharma company could shell out up to $325 million more if the lead drug candidate of privately held Jnana achieves development and regulatory milestones. Jnana’s lead program, JNT-517, is in development for phenylketonuria (PKU), an inherited disorder that leads to deficiency of an enzyme needed to break down phenylalanine, an amino acid found in certain foods. Buildup of phenylalanine in ...
- Source: drugdu
- 93
- August 5, 2024
GSK, Flagship Pioneering Commit $150M to Start R&D Pact for Novel Drugs and Vaccines

Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced it is pursuing novel obesity treatments. By Frank VinluanGSK already has a strong presence in respiratory disease and immunology, two of its core therapeutic areas. The pharmaceutical giant is now teaming up with Flagship Pioneering in an alliance intended to discover novel medicines to bolster its pipelines in both disease categories. The deal announced Monday calls for the partners to fund up to $150 million up front for an exploration phase intended to identify concepts that can leverage the technologies of Flagship’s portfolio companies. Flagship forms and incubates startups, each one based on a platform technology that focuses on some aspect of biology. The research stemming from these platforms informs the discovery and development of novel medicines. The best known of these “bioplatform” companies ...
- Source: drugdu
- 111
- July 31, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
- 120
- July 29, 2024
+ Study finds pain gene affects success of chronic pain medicine in women

A study led by the University of Edinburgh in collaboration with the University of Oxford has found that a pain gene carried by women with chronic pelvic pain makes them more likely to respond well to Pfizer’s painkilling drug, Neurontin (gabapentin). Published in the journal iScience, the study found that women carrying a naturally occurring variation of the gene called Neuregulin 3 in their DNA were more likely to experience relief after taking Neurontin. Chronic pelvic pain is a persistent, disabling pain that affects around one in four women globally. Often prescribed for chronic pain, Neurontin is designed to target the central nervous system to reduce the heightened pain sensitivity that affects people living with long-standing conditions. After studying the genetic make-up of 71 women living with chronic pelvic pain who had received Neurontin, researchers found that 29 women responded to the medication, while 42 saw no improvement. The team ...
- Source: drugdu
- 83
- July 24, 2024
Roche Weighs In With Encouraging Early Clinical Data for Oral GLP-1 Drug

Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year. By Frank VinluanRoche is a relative latecomer to GLP-1 metabolic disorder drugs, but an oral drug candidate that came as part of a $2.7 billion acquisition last year now has preliminary early-stage clinical data that keep the pharmaceutical giant in contention to bring patients a pill to tap into this increasingly popular mechanism for weight loss. The results reported Wednesday are from a Phase 1 test of CT-996, a once-daily pill designed to activate the GLP-1 receptor to treat type 2 diabetes and obesity. Roche said treatment of patients who are obese and do not have type 2 diabetes lost a placebo-adjusted average of 6.1% of body weight within ...
- Source: drugdu
- 97
- July 19, 2024
NICE recommends Ebglyss for atopic dermatitis patients

England’s National Institute for Health and Care Excellence (Nice) has recommended Almirall’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer, Eli Lilly, and AbbVie, respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of ...
- Source: drugdu
- 63
- July 12, 2024
NeuroSense Therapeutics shares positive results of lead candidate in ALS

The neurodegenerative disease currently affects more than 200,000 people worldwide NeuroSense Therapeutics has announced positive mid-stage results of its lead drug candidate, PrimeC, in people living with amyotrophic lateral sclerosis (ALS). The phase 2b PARADIGM study has been evaluating PrimeC, a fixed-dose combination of two US Food and Drug Administration (FDA)-approved drugs, Bayer’s ciprofloxacin, a well-known antibiotic, and Pfizer’s Celebrex (celecoxib), a COX inhibitor used to treat inflammation, in 68 people living with the neurodegenerative disease in Canada, Italy and Israel. Affecting more than 200,000 people globally, ALS is a neurological disorder that affects the motor neurons, the nerve cells in the brain and the spinal cord that control voluntary muscle movement and breathing. Previously granted Orphan Drug Designation by the FDA and the European Medicines Agency, PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic ...
- Source: drugdu
- 77
- July 9, 2024

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