Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
Sanna Uskela et al., at North Karelia Central Hospital-Heart Center, Finland, conducted a retrospective single-center registry study that focused on the use of drug-coated balloon (DCB)-only strategy for treating de novo left main coronary artery disease. This study is significant as it addresses a treatment approach that has not been extensively studied before, particularly in the context of high bleeding risk (HBR) patients. The study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using the DCB-only strategy between August 2011 and December 2018. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups based on whether the lesion preparation was done according to the international consensus group guidelines. Key findings from the study include: (1) The study included 66 patients with a ...
Following Johnson & Johnson’s (J&J) recent US Food and Drug Administration (FDA) fast track designation of nipocalimab for the reduction of foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in pregnant adults, Rallybio has announced a collaboration with the pharma giant to advance complementary therapeutic solutions for the rare disorder. The collaboration will see the development of therapeutic approaches that comprehensively address FNAIT, as J&J aims to treat patients who have already alloimmunised while Rallybio focuses on preventing alloimmunisation altogether, Dr. Steve Uden, Rallybio’s CEO, told Pharmaceutical Technology in an exclusive interview. “They are very much complementary and not competitive approaches; and both are needed,” said Uden. As per the 10 April press release, the clinical-stage biotech received an equity investment of $6.6m from J&J, with eligibility for future milestone payments. The funds will be deployed to support a FNAIT natural history study that will be conducted across North America and ...
Prostate cancer is responsible for around 12,000 deaths a year in the UK and is the second biggest cause of death for men Researchers from the Universities of Bristol, Oxford and Cambridge have revealed that a prostate-specific antigen (PSA) blood test for prostate cancer has a small impact on reducing deaths and can lead to overdiagnosis and missed early detection of aggressive forms of cancer. Published in the Journal of the American Medical Association and funded by Cancer Research UK (CRUK), the CAP trial studied over 400,000 men aged 50 to 69 years from 570 GP practices in the UK. Currently the second biggest cause of death for men in the UK, responsible for around 12,000 deaths a year, prostate cancer is a disease that occurs when malignant cells grow in the prostate gland. Widely used for diagnosis, a PSA blood test measures the amount of PSA, a protein made ...
Dive Brief Steris has agreed to sell its dental business to investment firm Peak Rock Capital for $787.5 million in cash, the companies said on Thursday. The sale will allow Steris to focus on its core markets of healthcare, pharma and medtech, CEO Dan Carestio said in a statement. The Mentor, Ohio-based company provides sterilizers and washers, surgical tables and other equipment. Steris decided to divest the dental segment “after a thorough review of strategic alternatives,” Carestio said. The business reported $407 million in revenue and $86 million in operating income during the 12-month period ending Dec. 31, 2023. Dive Insight Steris acquired the dental business in 2021 when it bought Cantel for $4.6 billion. The purchase was expected to complement Steris’ existing business, adding infection control products for endoscopy and providing an entry into the dental market. Now, the company is looking to sell the segment. Peak Rock Capital ...
Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant.Novartis, whose presence in prostate cancer is mainly through the radiopharmaceutical Pluvicto, is expanding its prospects in the disease, striking a deal that brings a Phase 3-ready small molecule in the emerging therapeutic modality called targeted protein degradation. The drug, ARV-766, was developed by New Haven, Connecticut-based Arvinas. The deal announced Thursday calls for Novartis to pay $150 million up front. The Swiss pharmaceutical giant could shell out up to $1 billion more if the molecule achieves development, regulatory, and commercial milestones. Targeted protein degradation involves using a small molecule to target a disease-causing protein, marking it for disposal by the cell’s built-in system for eliminating old or damaged proteins. Arvinas specializes in protein degrader drugs, and the company’s pipeline ...
Don Tracy, Associate Editor New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube. SK Life Science announced that the FDA has approved two new ingestion methods for Xcorpi (cenobamate tablets) CV, an antiseizure medication. As of today, the medication can be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. These new methods of administration were approved as a result of the results of an open-label, randomized, single-center, three-period, six-sequence, crossover study showing biochemical similarity between three administration routes, including the aforementioned methods.1 “The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole,” said Louis Ferrari, BS, RPh, MBA, VP, medical affairs, SK Life Science, in ...
Don Tracy, Associate Editor Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis. Lonza and NeuroSense Therapeutics have announced a collaboration focused on evaluating biological markers in neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS). According to both companies, the joint venture intends to utilize Lonza’s expertise in extracellular vesicles in combination with NeuroSense’s experience in biomarker utilization for neurodegenerative diseases. The overall goal of this partnership is to enhance development of neurodegenerative disease treatments. This deal comes amid NeuroSense revealing positive results from the Phase IIb PARADIGM trial for PrimeC, focused on treating adults living with ALS. Under terms of the agreement, Lonza will focus on utilizing neuron-derived exosomes (NDEs) for assimilation into the development of PrimeC.1 “We believe this collaboration could be a game-changer for the ALS and neurodegeneration field, as findings in such biomarkers may advance early diagnosis and treatment, ...
Bio-Rad Laboratories and Alleghany Health Network (AHN) have partnered to advance clinical evidence for monitoring solid tumour cancers using Bio-Rad’s Droplet Digital PCR (ddPCR) technology. The collaboration will use ddPCR technology for molecular residual disease (MRD) monitoring of patients across a range of solid tumour types. Accounting for approximately 90% of all adult human cancers and half of childhood malignancies, solid tumour cancers can develop in many parts of the body, including the breast, lung, prostate and colon. Used to provide a critical indication of both remission and potential relapse in patients, MRD testing has been widely adopted for monitoring haematological malignancies and is now being implemented for solid tumour diseases. As part of the agreement, the collaboration will combine Bio-Rad’s digital PCR technology and expertise in molecular oncology, assay design and development with AHN’s cancer-care expertise, clinical data and patient samples collected via its Cancer Institute’s Moonshot programme, which ...
A clinical trial led by researchers from University College London (UCL) and University College London Hospitals NHS Trust Foundation (UCLH) has revealed that removing a step from a three-part MRI scan could make prostate cancer diagnosis quicker, cheaper and more accessible. The PRIME study was funded by Prostate Cancer UK and the John Black Charitable Foundation. Currently the most common form of cancer in men, prostate cancer is responsible for around 52,000 new cases and 12,000 deaths every year in the UK. In the UK, a three-part multiparametric MRI of the prostate is the current standard of care for patients suspected of having prostate cancer, which includes a dye injection as its third step to identify abnormalities to be seen on the MRI scan. In the study, cancer experts from 22 hospitals from 12 different countries recruited 555 patients and performed full-three-part multiparametric scans on them. Radiologists then assessed the ...
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