PharmaFocus Today – Page 334 – media

Study reveals first genetic locus for voice pitch

In a paper published in Science Advances, an international team led by deCODE genetics, a subsidiary of Amgen, reveals the discovery of sequence variants in the gene ABCC9 that influence the pitch of voices. Speaking is one of the most characteristic human behaviors, and yet the genetic underpinnings of voice and speech are largely unknown. In the first study of its kind, the scientists combined speech recordings from almost 13,000 Icelanders with data, in the sequence of the genome, to search for common variants in ABCC9 that are associated with a higher-pitched voice. The scientists found that ABCC9 variants associate with higher voice pitch in both men and women. The same sequence variants are also linked to higher pulse pressure, a cardiovascular risk factor, highlighting links between voice pitch and health-related traits. In addition to voice pitch, the study investigated the genetics of vowel acoustics. While vowel sounds such as ...
- Source: drugdu
- 109
- June 11, 2023
Sanofi, AstraZeneca’s RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.Thursday, experts on the FDA’s Antimicrobial Drugs Advisory Committee voted 21 to 0 that nirsevimab boasts a favorable benefit-risk profile to protect against RSV-associated lower respiratory disease in infants born during or entering their first RSV season. On a separate question of whether the drug has a favorable benefit-risk profile in children up to 24 months of age who remain vulnerable through their second RSV season, the vote was 19 to 2 in favor of the drug. “Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Sanofi’s executive vice president of vaccines, Thomas Triomphe, said in a Thursday statement. “We are encouraged by the Advisory Committee’s positive ...
- Source: drugdu
- 166
- June 10, 2023
’ Seagen CEO talks about his next stop, Pfizer deal and the ADC landscape

David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
- Source: drugdu
- 187
- June 10, 2023
Axol and StrataStem link up for Alzheimer’s disease trial

Companies will incorporate cells and technology to create a ‘clinical trial in a dish’ Axol Bioscience – a stem cell technology provider – has reached an agreement with StrataStem to access and commercialise its collection of Alzheimer’s disease (AD) patient samples. Under the terms, Axol will reprogramme the samples into ‘induced pluripotent stem cells’ (iPSCs) that can subsequently be separated into an extensive range of brain cells. These include neurons and neuroinflammatory cells. Formed in vitro, the cells can provide patient-specific human brain models from a cohort of AD patients, ultimately creating a ‘clinical trial in a dish’. The research concentrates on sporadic AD (sAD) – the most prevalent form of the disease, accounting for over 95% of all cases. sAD has no specific family link and is triggered by a combination of genetics, the environment and an individual’s lifestyle. Meanwhile, StrataStem’s collection of donor materials, including blood samples and ...
- Source: drugdu
- 127
- June 10, 2023
Janssen shares positive phase 3 results for erdafitinib in bladder cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has shared positive results from a late-stage study of erdafitinib in urothelial carcinoma, the most common type of bladder cancer. Urothelial carcinoma accounts for approximately 90% of bladder cancer cases, and up to 20% of patients diagnosed with metastatic urothelial carcinoma have an FGFR genetic alteration. Despite most urothelial carcinomas being diagnosed at an early stage, rates of recurrence and disease progression are high and a significant proportion of patients who undergo radical surgery will experience disease recurrence. Martin Vogel, EMEA therapeutic area lead oncology, Janssen-Cilag GmbH, said: “Bladder cancer, of which urothelial carcinoma is the most common form, carries a high burden of disease for patients… Patients with advanced urothelial carcinomas, including FGFR-driven tumours who have exhausted standard treatment options, can face a particularly poor prognosis.” Results from an interim analysis of cohort 1 in the phase 3 THOR trial, ...
- Source: drugdu
- 118
- June 10, 2023
New devices could help Penumbra take market share, according to physician survey

Dive Brief Penumbra is expected to retain and take market share in the peripheral vascular market over the next 6 to 18 months, according to a survey of physicians by J.P. Morgan analysts. The firm surveyed 25 vascular surgeons, who forecast that Penumbra will take share as the broader peripheral market is expected to grow. “New products should drive share capture across both arterial and venous,” J.P. Morgan analyst Robbie Marcus wrote in a Thursday research note, although the majority of doctors surveyed expect to continue using devices from multiple manufacturers even when targeting the same vessels. Dive Insight Alameda, Calif.-based Penumbra recently launched two new thrombectomy devices: Lightning Bolt 7, which is designed to remove clots from the arteries, and Lightning Flash, which is designed for the veins and pulmonary arteries. The surgeons’ reception to both devices was “broadly positive,” Marcus wrote, with the majority saying they expected Lightning ...
- Source: drugdu
- 229
- June 10, 2023
Study may help advance data on oncolytic adenovirus mediated double suicide-gene therapy for high-grade brain tumors

Researchers in the Hermelin Brain Tumor Center at Henry Ford Health are leading a Phase I clinical trial studying the maximum tolerated dose of an oncolytic adenovirus, a mutated virus engineered to selectively replicate in and destroy cancer tissue, in combination with fractionated stereotactic radiosurgery among patients who are undergoing resection of a recurrent high-grade astrocytoma brain tumor. Tobias Walbert (M.D., Ph.D., principal investigator of the study and co-director of the Hermelin Brain Tumor Center at Henry Ford Health) said, “The participants in this study have progressive high-grade astrocytoma as well as glioblastoma, and are scheduled to undergo repeat surgery. After the removal of as much tumor tissue as possible, a modified oncolytic adenovirus is injected into the wall of the resection cavity and any residual tumor tissue. The goal of this study is to determine the maximum tolerated dose of the injected adenovirus, which is engineered to selectively replicate ...
- Source: drugdu
- 108
- June 10, 2023
FDA Indicates Potential Full Approval for Eisai & Biogen’s Leqembi Ahead of Adcomm

By Rosemary Scott Pictured: Three side-by-side scans of a human brain/iStock, semnic The FDA released briefing documents Wednesday that signal it is likely to grant Eisai and Biogen’s Leqembi (lecanemab) full approval to treat Alzheimer’s disease on its decision date in July. The documents come just two days before an advisory committee is scheduled to vote on whether to recommend the drug’s approval. The FDA has asked the six members of the advisory committee to answer the following question: Do the results of a pivotal trial dubbed Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? But it appears the agency may have already decided for itself. Both the briefing documents and the committee’s decision will be based on the Study 301results. In the documents, the FDA stated that the data from the trial showed “consistently favorable results for the primary and secondary endpoints,” ...
- Source: drugdu
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- June 10, 2023
FDA advisers endorse antibody to protect against RSV in infants and some young toddlers

By Jamie Gumbrecht, CNN CNN — Advisers to the US Food and Drug Administration voted Thursday to endorse a monoclonal antibody designed to protect infants and some young toddlers from RSV. Members of the agency’s Antimicrobial Drugs Advisory Committee voted 21-0 that the benefit-risk profile of nirsevimab was favorable in infants and 19-2 that it was favorable in children up to 24 months who are vulnerable to severe respiratory syncytial virus. Next, the FDA will consider the advice of the advisers and decide whether to approve the treatment. The monoclonal antibody, nirsevimab, was developed by AstraZeneca and Sanofi. It’s designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable. If approved, it will be the first single-dose preventative treatment for all ...
- Source: drugdu
- 120
- June 10, 2023
Neurotic people are more likely to suffer from mood swings, study finds

In everyday life, our emotions often change from moment to moment, and people experience these fluctuations to varying degrees. Psychologists at Leipzig University have studied the relationship between the personality trait neuroticism—a potential risk factor for mental health—and emotional experiences. They found that neurotic people experience negative emotions not only more intensely, but also with more mood swings than others. They have just published their findings in the Proceedings of the National Academy of Sciences (PNAS). “Previous studies are in agreement that neurotic people experience stronger negative emotions in everyday life. Because of new, contradictory studies, there has been disagreement about whether this is also associated with increased variability in emotional experiences, i.e., mood swings,” says the study’s first author, Nina Mader from the Wilhelm Wundt Institute of Psychology at Leipzig University. Personality psychologists at Leipzig University have developed a new approach to modeling data that solves previous methodological problems. ...
- Source: drugdu
- 143
- June 9, 2023

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