PharmaFocus Today – Page 361 – media

Hansa Biopharma enters into collaboration with Genethon

Swedish biotech company Hansa Biopharma has entered a research and development collaboration with Genethon. The partnership will assess the efficacy and safety of imlifidase, Hansa Biopharma’s antibody cleaving enzyme, in a clinical trial. Imlifidase will be developed as a pre-treatment for patients with Crigler-Najjar syndrome and pre-existing neutralising antibodies (NAbs) to adeno-associated virus serotype 8 (AAV8), before administering GNT-0003, Genethon’s gene therapy product candidate. The company stated that patients with circulating NAbs will be excluded from the clinical trial of potentially curative gene therapies as well as from access to approved gene therapies. Hansa Biopharma president and CEO Søren Tulstrup said: “Genethon is a pioneer at the cutting-edge of research and development of gene therapies for rare diseases and we are thrilled to be collaborating with them. “This research collaboration further validates Hansa’s commitment in gene therapy and underscores the important role that our antibody-cleaving ...
- Source: drugdu
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Stablix, Vertex partner to develop targeted protein stabilisation therapies

Biopharmaceutical company Stablix and Vertex Pharmaceuticals have joined forces to discover and develop targeted protein stabilisation (TPS) therapies. Under the terms of the deal, Stablix will use its platform to discover new heterobifunctional small molecule drug candidates (RESTORACs) against specified targets which are involved in several diseases. Vertex will get an exclusive licence to certain molecules, which will be identified under the collaboration. Additionally, the company will handle the development and commercialisation along with research costs associated with the collaboration. As per the terms of the agreement, Stablix will get an upfront payment including a convertible note investment. The company is also eligible to receive research, development, regulatory and commercial milestones, along with the tiered royalties on future net sales of any products that are resulted from the partnership. Stablix CEO Tony Kingsley said: “We’re thrilled to partner with the outstanding scientists and ...
- Source: drugdu
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Statins Tied to Lower Stroke Risk in Atrial Fibrillation

Daniel M. Keller, PhD Among patients with atrial fibrillation (AF), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows. Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications. Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen Hospital, Shenzhen, China, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AF. “The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said. The results were presented in a moderated poster session at the European Heart Rhythm Association (EHRA) 2023 in Barcelona and are available online. Widely Prescribed Anticoagulant ...
- Source: drugdu
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AbbVie weathers first months of biosimilar challenge to top-selling Humira

Ned PagliaruloLead Editor Dive Brief: AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January. U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes. Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker ...
- Source: drugdu
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Positive CHMP opinion for UCB’s bimekizumab

by John Pinching Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis UCB has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted marketing authorisation for bimekizumab in the EU. It concerns the treatment of adults with active axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). AxSpA is an indication that covers both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) – also known as radiographic axSpA (r-axSpA). In active PsA, the CHMP recommended approval of bimekizumab alone or in addition to methotrexate, for the treatment of adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs. Furthermore, in active axSpA, the CHMP recommended approval of bimekizumab for treating adults with active nr-axSpA with objective signs of inflammation. Throughout all four relevant studies – BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2 ...
- Source: drugdu
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FDA clears Pfizer’s pneumococcal vaccine for infants and children

Delilah AlvaradoAssociate Editor A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England. Dan Kitwood via Getty Images Dive Brief: Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. Dive Insight: While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the ...
- Source: drugdu
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Exploring Doggybone ™ DNA Technology

By Michael Greenwood, M.Sc.Reviewed by Danielle Ellis, B.Sc. Doggybone DNA ™ (dbDNA) is a technology developed by biotech company Touchlight, which is a form of linear plasmid with applications in genetic engineering and therapeutics. Plasmids are small circular double-stranded DNA molecules naturally generated by bacterial cells, some eukaryotes, and archaea and separate from chromosomal DNA. Plasmids can self-replicate by using host enzymes, and each carries at least one gene, most of which are beneficial to the host. The gene(s) carried by the plasmid may then be incorporated into the genome for expression. For example, a plasmid may encode a gene that produces a protein with antiphage functionality, allowing viral resistance to be incorporated into the bacterial chromosome. Plasmids are transferred between bacterial cells via pili; thus, beneficial genes carried by plasmids can be disseminated and incorporated into the chromosomal DNA of neighboring cells. Owing to the natural function of plasmids, they can be ...
- Source: drugdu
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In Rare Move, CMS Fines 2 Hospitals for Price Transparency Violations

The Centers for Medicare & Medicaid Services appears to be enforcing its price transparency rule more seriously. The agency recently fined two hospitals for alleged violations of the rule. Last week, CMS issued fines to Frisbie Memorial Hospital in Rochester, New Hampshire and Kell West Regional Hospital in Wichita Falls, Texas. The former was fined $102,660, and the latter received a $117,260 fine. These fines are only the third and fourth penalties issued by CMS since its price transparency rule took effect on January 1, 2021. The other two came nearly a year ago, in June 2022 — Northside Hospital in Atlanta was fined $883,180 and Northside Hospital Cherokee in Canton, Georgia was fined $214,320. CMS’ rule aims to make hospitals’ pricing data more accessible to patients so they can compare costs and make more informed decisions about the healthcare services they choose. The law requires all hospitals to post their gross charges, payer-specific negotiated charges, de-identified minimum negotiated charges, de-identified maximum negotiated charges and cash prices on their ...
- Source: drugdu
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Quest Expands in Cancer Testing With $300M Haystack Oncology Acquisition

Quest Diagnostics is boosting its capabilities in cancer, paying $300 million to acquire a Johns Hopkins University spinout whose technology identifies cancer cells in order to guide treatment decisions. The Secaucus, New Jersey-based diagnostics giant on Thursday announced the cash acquisition of Haystack Oncology. The Baltimore-based startup is part of a growing area in cancer testing called liquid biopsies, tests that detect cancer by finding circulating tumor DNA in a patient’s blood sample. Grail and Guardant Health are among the companies that market tests that detect early signs of cancer, enabling clinicians to intervene sooner. Haystack’s focus is minimal residual disease—detecting cancer cells that remain following initial treatment with surgery or a drug. Test results help clinicians assess how well the initial treatment worked and whether additional treatment, called an adjuvant, is necessary to kill any lingering cancer cells. That’s important because additional treatment, often a chemotherapy, introduces a wide ...
- Source: drugdu
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Do ketogenic diets elevate low-density lipoprotein cholesterol levels?

In a recent study published in the American Journal of Preventive Cardiology, researchers explored the impact of ketogenic dieting on low-density lipoprotein (LDL) cholesterol levels. Background Due to the escalating obesity levels, the ketogenic (keto) diet has been studied as a potential remedy for overweight patients’ deteriorating weight gain, cardiovascular outcomes, and insulin resistance. Though popular as a comparatively safe, non-pharmaceutical therapy, the long-term effects of the keto diet for weight loss are not fully understood, and most professional medical societies do not advise this regimen. Some individuals on a ketogenic diet may experience a significant rise in low-density lipoprotein (LDL) cholesterol levels due to its high saturated fatty acid content. About the study In the present study, researchers described a cohort of patients whose LDL-cholesterol levels rose to an unprecedented level after beginning a ketogenic diet. The team evaluated medical records of patients who ...
- Source: drugdu
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