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UK’s NICE recommends AbbVie’s Aquipta to treat migraines

The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
- Source: drugdu
- 169
- April 13, 2024
Rallybio and J&J collaborate to tackle maternal-foetal blood disorder

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 ...
- Source: drugdu
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- April 13, 2024
Researchers call to reduce repeat antibiotic prescriptions for respiratory tract infections

RTIs account for around 60% of global antibiotic prescribing and are a key driver of AMR Researchers from the Universities of Bristol, Bath, King’s College London and the University Medical Center Utrecht have called for a reduction in the use of repeat antibiotic prescriptions in primary care for the same respiratory tract infection (RTI) episode, based on findings from a study. Published in the Journal of Infection, the study found high rates of repeat within-episode prescriptions for RTI in primary care in England, despite evidence of little benefit. Accounting for around 60% of antibiotic prescribing in primary care globally, RTIs are caused by viruses and are one of the key drivers of antimicrobial resistance. The study analysed over 900,000 RTI episodes from clinical records across 530 English general practices. Researchers found that nearly 30% of adults and 10% of children had received a second course of antibiotics within the same ...
- Source: drugdu
- 127
- April 13, 2024
UK study finds screening with a PSA test in prostate cancer can lead to overdiagnosis

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 ...
- Source: drugdu
- 144
- April 13, 2024
Steris to sell dental segment for $787.5M

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 ...
- Source: drugdu
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- April 13, 2024
Blood-Based Machine Learning Assay Noninvasively Detects Ovarian Cancer

Ovarian cancer is one of the most common causes of cancer deaths among women and has a five-year survival rate of around 50%. The disease is particularly lethal because it often doesn’t cause symptoms in its early stages. The absence of effective screening tools and the disease’s asymptomatic nature contribute to its diagnoses during the later stages when treatment options are less effective. A cost-effective, accessible detection method could revolutionize the clinical approach to ovarian cancer screening and potentially save lives. Although liquid biopsy technologies, which analyze blood for tumor-derived DNA, have been explored for noninvasive cancer detection, their utility in ovarian cancer has been limited. Now, a retrospective study presented at AACR 2024 has demonstrated that a blood-based machine learning assay, which combines cell-free DNA (cfDNA) fragment patterns with levels of the proteins CA125 and HE4, can effectively distinguish patients with ovarian cancer from healthy controls or patients with ...
- Source: drugdu
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- April 13, 2024
Novartis Pays $150M to Nab a Phase 3-Ready Protein Degrader for Prostate Cancer

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 ...
- Source: drugdu
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- April 13, 2024
FDA Approves New Administration Methods for SK Life Science’s Xcorpi for Adults with Partial-Onset Seizures

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 ...
- Source: drugdu
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- April 13, 2024
PureTech Startup Gets $100M to Try For Success Where Sage & Others Fall Short in Depression

Seaport Therapeutics’ drug candidates are delivered through the lymphatic system, an approach that could overcome some limitations of neuropsychiatric medicines, including products from Sage Therapeutics. The startup stems from the research of PureTech Health.Even when depression drugs address known and validated targets, their commercial potential can be constrained by dosing or safety limitations. Seaport Therapeutics’ drugs use a novel delivery approach to overcome those limitations. The startup launched on Tuesday, backed by $100 million in financing. Boston-based Seaport was formed by PureTech Health, a company that creates startups, typically around a platform technology. One notable example is neuropsychiatric drugs developer Karuna Therapeutics, which grew and eventually spun out of PureTech as a publicly traded company with a lead drug taking a novel approach to schizophrenia. Bristol Myers Squibb last year struck a $14 billion deal to acquire Karuna, whose schizophrenia drug is currently under FDA review. Former Karuna CEO Steven ...
- Source: drugdu
- 154
- April 12, 2024
Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases

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, ...
- Source: drugdu
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- April 12, 2024

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