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GSK Pulls Ahead of Pfizer in RSV Vaccine Market as Arexvy Nears Blockbuster Status

By Tristan Manalac Pictured: GSK building in Poznan, Poland/iStock, Wirestock GSK CEO Emma Walmsley on Thursday touted the smooth launch of its respiratory syncytial virus vaccine Arexvy and its strong potential for growth in the coming years. In an interview with Reuters, Walmsley said the British biopharma is “delighted” with the progress it has made in the RSV vaccine race with Pfizer. “We are delighted with the start of our RSV vaccine,” Walmsley said, adding that the company expects Arexvy “will be more than £1 billion in its first year, (it) has lots of headroom for growth.” GSK is positioning Arexvy to be its next blockbuster asset. The U.S. launch of the vaccine has so far reached three million of the more than 80 million adults over 60 at risk from RSV, according to Walmsley. Arexvy became the first FDA-approved RSV shot in May 2023 and is authorized for use ...
- Source: drugdu
- 28
- December 5, 2023
Pfizer Nixes Twice-Daily Oral GLP-1 Candidate After High Rates of Side Effects

By Tyler Patchen Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer on Friday said it is scrapping an investigational twice-daily oral Glucagon-like peptide-1 receptor agonist candidate after topline data from a Phase IIb trial of obese patients without type 2 diabetes showed high rates of adverse events. While the trial did reach the primary endpoint of a statistically significant change in body weight, there were high rates of adverse events. According to Pfizer, the adverse events in the obesity trial for the twice-daily dosing of GLP-1 danuglipron were mild and included gastrointestinal symptoms that were “consistent with the mechanism” of the candidate. However, the company noted high rates of these side effects. Up to 73% of patients experienced ...
- Source: drugdu
- 30
- December 5, 2023
Rising Cost of New Medications, Will the People Who Need Them Most be able to Afford them?

Americans can’t afford their medications. About 25% leave prescriptions unfilled, split pills, or skip doses. Seniors face challenges covering non-Medicare services, including prescriptions. Even those with commercial health insurance are not immune. One-third of insured adults worry about affording their premiums, and 44% must meet increasingly high deductibles before insurance even kicks in. As a result, 41% of adults carry substantial medical debt. At the same time, FDA approvals for therapeutics targeting rare diseases are on the rise, including those for cancer, Alzheimer’s, and many previously untreatable diseases. In fact, 54% of 2022’s novel drug approvals targeted rare diseases. They encompass groundbreaking therapies like the first acid sphingomyelinase deficiency treatment, a prurigo nodularis remedy, and an obstructive hypertrophic cardiomyopathy therapy. In 2023, the first enzyme replacement therapy for non-neurological alpha-mannosidosis effects gained early approval. Breakthroughs, though welcome, are staggeringly expensive. In fact, Hemgenix, a new treatment for hemophilia, is officially ...
- Source: drugdu
- 22
- December 5, 2023
3 Trends Employers Should Watch Out for in 2024

The top three areas of concern for employers in 2024 include rising healthcare costs, mental health challenges and cancer care, according to a recent report from Business Group on Health. By MARISSA PLESCIA There are several challenges and trends employers should keep tabs on in 2024, with rising healthcare costs topping the list, according to a report the Business Group on Health released on Tuesday. Washington, D.C.-based Business Group on Health is a non-profit organization representing large employers on health benefits and health policy issues. Here are the three top healthcare trends for employers in 2024: 1. Rising healthcare costs: Healthcare costs are expected to continue to climb in 2024 due to inflation, provider shortages, growing mental health challenges and missed preventive screenings that led to more costly health conditions. Other major cost drivers include expensive cell and gene therapies and GLP-1s. “A confluence of factors are creating a fever ...
- Source: drugdu
- 23
- December 5, 2023
Bright Uro Snags $23M To Make Urology Diagnostics Easier for Providers & Patients

Bright Uro raised $23 million in Series A funds to help achieve FDA clearance for its urodynamics system and launch the product in the U.S. Should it be cleared, the system will become the first product on the market able perform urodynamic monitoring wirelessly and without a catheter, the company’s CEO said. By KATIE ADAMS Bright Uro, a Irvine, California-based startup founded in 2021, is on a mission to make urodynamic testing more accurate for clinicians, more comfortable for patients, and more efficient for clinics. On Thursday, the company announced it has raised $23 million to help it get closer to achieving those goals — the Series A funding round was led by Laborie Medical Technologies, a provider of urology diagnostic and therapeutic products. The round reflects the total amount of equity investment Bright Uro has raised since its founding, said CEO Derek Herrera. The startup also received a $2 ...
- Source: drugdu
- 23
- December 5, 2023
GlobalData

As gene therapies ramp up in spinal muscular atrophy and hemophilia, it may soon be the turn of Gaucher disease patients to realize the latent potential of this type of treatment. That’s according to analysts at GlobalData, which spoke to key opinion leaders (KOLs) during the recent International Gaucher Disease Awareness Month to gauge their thoughts of gene therapy in this space. GlobalData said in an accompanying report that these KOLs believe pipeline gene therapies “will significantly impact the Gaucher disease landscape,” given that it has the curative potential to provide patients with a healthy GBA1 copy, disrupting the Gaucher drug market. However, much “groundwork remains to be covered,” the analysts cautioned. Gaucher disease is a rare inherited metabolic disorder caused by defects in the GBA1 gene and comes with three distinct types of the disease with varying severity. The rare condition is typically characterized by the accumulation of fatty ...
- Source: drugdu
- 23
- December 5, 2023
Phenomic scores two deals in two days with Boehringer and Astellas

Canada-based Phenomic AI has landed two strategic collaborations this week with Boehringer Ingelheim and Astellas-owned cell therapy biotech Xyphos Biosciences to develop cancer therapies. Phenomic and Boehringer have teamed up on a target identification collaboration, announced on 29 November. Under the deal, Phenomic will receive an upfront payment of $9m and may be entitled to up to $500m in research funding and milestones. The Canadian company hasn’t disclosed the financial terms of the deal with Astellas, but the companies aim to develop cell therapies with an antibody directed at a novel target of the tumour stroma, utilising Phenomic’s scTx platform. The company singled out colorectal and pancreatic cancers as being stroma-rich, which would be amenable to being targeted by Phenomic’s platform. These developments mark the first deals announced by Phenomic in three years since the company launched in 2020 with $6m in seed funding. Phenomic’s scTx is a single-cell RNA ...
- Source: drugdu
- 23
- December 5, 2023
NHS to offer stem cell transplants to patients living with rare blood disorder

The NHS has announced that it will offer stem cell transplants that could cure patients living with thalassaemia, a severe and life-limiting inherited blood disorder. Funded for the first time by the NHS, curative stem cell transplants will be eligible for patients living with the condition following new guidance from NHS England’s Clinical Advisory Group. Thalassaemia is a rare disorder that affects the haemoglobin in the blood and requires patients to have blood transfusions every two to four weeks. Across the UK, more than 600 adults are estimated to be living with transfusion-dependant thalassaemia. The procedure, known as allogeneic haematopoietic stem cell transplant (Allo-HSCT), involves replacing the bone marrow stem cells of patients with ones from a matched sibling donor. The procedure was previously only used as a treatment for children due to the potential risk of complications among adults. However, thanks to new advances in transplant treatment, including better ...
- Source: drugdu
- 21
- December 5, 2023
Eli Lilly and PRISM BioLab enter drug discovery collaboration worth over $660m

Eli Lilly has entered into a licence and collaboration agreement with PRISM BioLab aimed at discovering oral inhibitors of a protein-protein interaction (PPI) target, with the deal worth over $660m. The partnership centres around PRISM’s proprietary PepMetics technology, which the Japanese biotech says has the potential to “expand the field of drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules and by generating oral small molecule alternatives for injectable biologics”. Despite PPI dysfunction being implicated in a broad range of diseases, including cancer, fibrosis and autoimmune disorders, only a small proportion of PPIs are targeted by approved drugs. Lilly, which will select the first PPI target, has the option to add another two to the collaboration and will be responsible for the clinical development and commercialisation of any resulting products. In exchange, PRISM will receive undisclosed upfront payments from Lilly and will be eligible to ...
- Source: drugdu
- 22
- December 5, 2023
【EXPERT Q&A】What are the differences between the MDR and IVDR regulations?

Drugdu.com expert’s response: Although the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) share a common purpose, they apply to different categories of products, with specific differences in the following aspects: Scope of Application: MDR is a regulation for medical devices: It applies to all medical devices not used for in vitro diagnostics, including surgical tools, medical equipment, implants, etc. IVDR is a regulation for in vitro diagnostic medical devices: It specifically applies to in vitro diagnostic devices, such as reagent kits and equipment used for blood analysis. Classification System: MDR: Implements a new risk-based classification system, detailing medical devices into different levels more comprehensively. IVDR: Introduces a new risk classification rule, which is a significant change for the in vitro diagnostic device industry, especially increasing the scrutiny requirements for high-risk IVD products. Clinical Requirements: MDR: Strengthens the requirements for clinical evidence, demanding manufacturers to conduct clinical assessments and ...
- Source: drugdu
- 29
- December 4, 2023

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