Universal Influenza Vaccine

Study shows promise for a universal influenza vaccine - Scientists validate theory using 1918 flu virus: New research led by Oregon Health & Science University reveals a promising approach to developing a universal influenza vaccine—a so-called "one and done" vaccine that confers lifetime immunity against an evolving virus.

The study, published today in the journal?Nature Communications, tested an OHSU-developed vaccine platform against the virus considered most likely to trigger the next pandemic.Researchers reported the vaccine generated a robust immune response in?nonhuman primates?that were exposed to the avian H5N1 influenza virus. But the vaccine wasn't based on the contemporary H5N1 virus; instead, the primates were inoculated against the influenza virus of 1918 that killed millions of people worldwide. Read

In Other News

The National Institute for Health and Care Excellence (NICE) has recommended Accord’s oral hormone therapy, Orgovyx (relugolix), for use in advanced prostate cancer patients. The androgen deprivation therapy (ADT), which has been specifically recommended for those with hormone-sensitive cases of the disease, is now the first oral treatment of its kind to be approved by the agency. Read

The US Food and Drug Administration (FDA) has announced plans to establish a new innovative hub aimed at improving treatment options for rare disease patients. The Rare Disease Innovation Hub will leverage cross-agency expertise to expedite the development and approval of safe and effective drugs and biologics.More than 30 million people in the US are affected by a rare disease, many of which are life-threatening and without approved treatments. Read

Glasgow scientists develop first bone marrow model to support human stem cells: Scientists from the University of Glasgow have developed the first bioengineered bone marrow model that supports human stem cells, which are crucial for bone marrow transplants and in vitro study work. Read

Exploring how astrocytes respond to spinal cord injury or stroke-induced tissue damage: Astrocytes are star-shaped glial cells known to have a range of functions, ranging from clearing neurotransmitters to promoting the formation of synapses in healthy brains to responding to injury and disease. While the proliferation of reactive astrocytes around damaged CNS tissue is well-documented, the unique features of these cells and their contributions to wound repair have not yet been uncovered. Better understanding of astrocytes around lesion borders could inform the development of more effective and targeted therapeutic strategies to promote recovery after injuries or strokes. Read

Roche’s subcutaneous (SC) formulation of its Ocrevus (ocrelizumab) has been approved by the Medicines and Healthcare products Agency (MHRA) to treat adults with relapsing and primary progressive multiple sclerosis (MS) .The new ten-minute injection maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, providing an additional treatment option for patients and enabling them to spend less time in hospital. Read

A drug has increased the lifespans of laboratory animals by nearly 25% , in a discovery scientists hope can slow human ageing too.The treated mice were known as "supermodel grannies" in the lab because of their youthful appearance.They were healthier, stronger and developed fewer cancers than their unmedicated peers.The drug is already being tested in people, but whether it would have the same anti-ageing effect is unknown. Read

Researchers from the University of Cambridge’s department of psychology have revealed that their artificial intelligence tool for predicting early Alzheimer’s disease (AD) more accurately detected the condition compared to current clinical tests. Published in?eClinical Medicine, the machine learning model was able to predict whether and how fast an individual with mild memory and thinking problems will go on to develop the neurological disease. Read

Vertex Pharmaceuticals and Genomics have extended and expanded their collaboration to accelerate the discovery and development of precision medicines using human genetics and machine learning. The partners have been working together since 2018 to support Vertex’s efforts to develop medicines for serious diseases, with the collaboration now set to run until 2026. Read

US study reveals Co-STAR receptor cells show promise in treating cancers: Researchers from Johns Hopkins Kimmel Cancer Center and its Ludwig Center, along with the Lustgarten Laboratory and the Bloomberg-Kimmel Institute for Cancer Immunotherapy, have designed a novel type of cell called co-stimulatory synthetic T-cell receptor and antigen receptor (Co-STAR), which has shown potential when treating cancer. In the study published in?Science Translational Medicine,?researchers tested Co-STAR against human cancer cells growing in test tubes and in mice. Read

Bayer and Orion’s darolutamide has demonstrated significant survival benefits as part of a combination treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to new late-stage results shared by the companies. The phase 3 ARANOTE trial randomised more than 660 patients to receive 600mg of darolutamide twice daily or matching placebo, both in addition to androgen deprivation therapy (ADT). Read

Roche?said on Wednesday a second drug candidate from its purchase of Carmot Therapeutics yielded positive results in an early-stage trial, as the Swiss drugmaker asserted itself as a late contender in the race to develop obesity drugs. Roche's experimental once-daily pill CT-996 resulted in a placebo-adjusted average weight loss of 6.1% within four weeks in obese patients without diabetes in a Phase I trial, Roche said in a statement.Roche's experimental pill, which could appeal to patients averse to injections, was well tolerated with mostly mild or moderate gastrointestinal side effects similar to those seen in other weight-loss drugs, according to the statement. Read

Tempus AI , Inc., a leader in artificial intelligence and precision medicine, announced that its multimodal immune profile score (IPS) algorithmic test is now available for research use only (RUO). IPS is the first in a series of immunotherapy-based diagnostics being developed by Tempus to advance algorithmic diagnostics in immuno-oncology. Tempus is also partnering with institutions like the Cleveland Clinic to expand this portfolio, utilizing clinical, laboratory, genomic, and transcriptomic data to identify patients likely to respond to immunotherapy. Read

Lexeo Therapeutics’ investigational gene therapy has shown promise as a treatment for Friedreich’s ataxia (FA) cardiomyopathy , according to new phase 1/2 data shared by the company.Affecting approximately one in every 40,000 people, FA is a neurodegenerative movement disorder and the most common form of inherited ataxia. Read

Scientists exploring potential new treatments for glioblastoma: A new approach to treating the most malignant type of brain cancer - glioblastoma - has shown strong promise in pre-clinical settings, raising hopes of increasing current average survival rates beyond 18 months.Targeted alpha therapy (TAT) is emerging as a potential additional treatment for glioblastoma (GB), a disease which has confounded oncologists for decades due to its aggressive nature and strong resistance to existing therapies. GBs are problematic because they grow very quickly and spread beyond the visible tumor into normal brain tissue, making it difficult for oncologists to deliver the optimal dosage of radiation needed to kill the cancer. Animal studies demonstrate that only a few targeting agents can effectively cross the blood brain barrier (BBB) to reach cancerous tissue, and those that do cause unwanted side effects in surrounding healthy tissue. Read

Pfizer has announced that it will be advancing a once-daily formulation of its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron. The drugmaker said it plans to conduct dose optimisation studies of the candidate in the second half of 2024, following “encouraging” data from an ongoing pharmacokinetic study.Danuglipron is intended to keep blood sugar at healthy levels by increasing the amount of insulin released.Additional potential effects of the investigational medicine include slowing down food digestion and increasing the feeling of fullness after eating, which may be associated with weight loss. Read

AbbVie?is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib) .The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis . Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis,?ankylosing spondylitis, axial spondylarthritis,?Crohn’s disease,?psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Read

BridgeBio, based in California, is currently testing its late-stage drug infigratinib for the treatment of achondroplasia, the most common form of dwarfism affecting approximately one in every 40,000 children, and hypochondroplasia, a milder variant of the condition. Most achondroplasia cases are caused by a sudden mutation in the FGFR3 gene (fibroblast growth factor receptor 3), which impedes bone growth, resulting in shortened limbs, poor muscle tone, and sometimes kyphosis, a condition where a curved spine causes the upper back to appear rounded. Read

Novo Nordisk’s semaglutide has been associated with a lower risk of cognitive problems , according to new research conducted by a team from the University of Oxford.The observational study suggests that people with diabetes receiving the glucagon-likepeptide-1 (GLP-1) receptor agonist, which is marketed under brand names including Ozempic and Wegovy, experienced cognitive benefits as well as lower nicotine dependence.The analysis, published in?The Lancet’s eClinicalMedicine?journal, used records from more than 100 million patients in the US, including over 20,000 who were taking semaglutide.The team found that the drug was not associated with an increased risk of neurological and psychiatric conditions, such as dementia, depression or anxiety, compared to other common anti-diabetic medications, challenging recent safety concerns surrounding the treatment. Read

Upcoming Events & Webinars

Discovering Business Value with Quantum-Aided Drug Design [JUL 30]: Join

5th Clinical Trial Agreements, Philadelphia, USA [AUG 21 -22] : Join * Save 15% off with discount code PHARMEMED

Med Dev day (Medical Devices)[07 - 08 October 2024]: Join

Regulatory Careers Live 2024 [11 September 2024]: Join

Digital Healthcare & Innovation Conference [SEP 12]: Join

How RTU Solutions Can Meet? GMP Annex 1 Requirements [SEP 19]: Join

NPL Summit - [SEP 24 - 26]: Join

Cleaning Validation Summit 2024 [OCT 01 - 2]: Join

Pharmaceutical Technology for Non-Biotechnologists [OCT 09-10]: Join

Pharma & Patient USA 2024 - Boston - [OCT 15-16]: Join

Pharma Customer Engagement USA 2024 [OCT 22-23]: Join

Cancer Biology and Therapeutics - Paris - [NOV 18-19]: Join

GMP for Vaccine Manufacturers, Hamburg, Germany [NOV 19-20]: Join

BioHealth 2024 - Copenhagen - [NOV 20 -21]: Join

Data Briefing: How the Pharma Industry is Strategizing for Gen AI: Access

Company Spotlight

TEMPUS AI

Tempus AI is a leading technology company specializing in precision medicine through the application of artificial intelligence in healthcare. Founded in 2015 by Eric Lefkofsky, Tempus has developed one of the world's largest libraries of multimodal data and an operating system designed to make that data accessible and useful for personalized patient care.

Tempus AI offers a variety of solutions aimed at improving patient outcomes. These include AI-enabled clinical assistants, tools to identify gaps in care, and multimodal real-world data analysis. Notably, Tempus has received FDA 510(k) clearance for its Tempus ECG-AF device, which uses AI to help identify patients at increased risk of atrial fibrillation. This is a significant advancement in cardiovascular diagnostics, enabling earlier detection and intervention for at-risk patients.

The company's technology is widely adopted, with connections to about 65% of all academic medical centers in the US and partnerships with over 95% of the top 20 pharmaceutical oncology companies. Tempus's platform is used by more than 50% of US oncologists and includes data from over 30,000 patients identified for potential clinical trial enrollment.

Tempus AI continues to expand its capabilities and offerings, including the recent launch of Tempus One, an AI-enabled clinical assistant designed to provide real-time insights to clinicians. Additionally, Tempus is advancing its research and development efforts with innovative tests and solutions in the fields of oncology, cardiology, and beyond.

Visit Tempus AI to learn more.