The EU has established a €100m fund to support research and development into medical countermeasures that could tackle public health threats, including antimicrobial resistance and pathogens with “high pandemic potential”. The European Commission (EC) and the European Investment Bank (EIB) announced the creation of the HERA Invest fund, a top-up to the InvestEU programme that aims to give an additional boost to investment, innovation, and job creation in Europe. The fund will be run by the European Health Emergency Preparedness and Response Authority (HERA), which was established in 2021 to help prevent, detect, and rapidly respond to future health emergencies. “Currently, European companies find it difficult to access sufficient public and private funding for the development and scaling up of cutting-edge solutions in health and life sciences,” the EC and EIB explained in a joint statement. The HERA Invest funding is specifically geared towards small ...
Researchers have found a possible explanation as to why higher breast density and older age increase the risk of breast cancer. In an innovative study, researchers at the Turku Bioscience Centre, InFLAMES Flagship of the University of Turku, and Turku University Hospital, Finland, have made an extraordinary discovery that turns conventional wisdom on its head. Their findings reveal that healthy fat cells in the breast, also known as adipocytes, secrete a potent factor called IGFBP2, which acts as a barrier against invasive breast cancer progression. Dr. Emilia Peuhu (Study Key Collaborator) said, “Adipocytes generally get a bad rap for promoting cancer progression, but this study demonstrates that healthy breast fat can play a protective role in the maintenance of tissue homeostasis and cancer containment. It’s time to re-evaluate our assumptions and recognize the important role of these unsung heroes.” Breast cancer patients who experience the transition ...
For the first time, Alzheimer’s patients in the U.S. have a treatment that has shown the ability to modify the disease in some patients. But experts have called Leqembi—developed by Eisai and Biogen—a “modest win” and a “first step” in the fight against Alzheimer’s disease. The next step could lie in untangling the correlation between amyloid and tau proteins—and defining what it means for drug development. The predominant theory is that Alzheimer’s is caused by the accumulation of two proteins—amyloid-beta and tau—in the brain. The anti-amyloid hypothesis received regulatory validation in June 2021 when the FDA approved Aduhelm (aducanemab) based on clinical data showing that the drug’s reduction of amyloid-beta plaques was reasonably likely to predict clinical benefit. A more solid endorsement arrived last week with the traditional approval of Leqembi (lecanemab). Leqembi and Aduhelm—along with and Eli Lilly‘s donanemab, which the company is expected to submit for regulatory approval soon—are anti-amyloid antibodies. All of these therapies have secondary ...
Roche has announced positive results from a late-stage study of Ocrevus (ocrelizumab) as a twice-yearly subcutaneous injection in patients with relapsing forms of multiple sclerosis (MS) or primary progressive MS. Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves, disrupting communication between the brain and the rest of the body. Relapsing-remitting MS accounts for approximately 85% of MS cases and is characterised by episodes of new or worsening signs or symptoms followed by periods of recovery, while primary progressive MS affects about 15% of patients and is marked by steadily worsening symptoms. Roche’s Ocrevus is a humanised monoclonal antibody designed to target a type of immune cell thought to be a key contributor to myelin and axonal damage, which can lead to disability in people with ...
CureVac is adding fuel to its COVID-19 vaccine patent fire by asserting more claims against Pfizer and BioNTech in both its U.S. and German cases. The German mRNA specialist put a tenth patent on the table in its U.S. litigation and three more to its five in Germany, expanding the scope of the disputes. CureVac went after BioNTech in Germany last summer, starting off with four claims and adding a fifth in May. The original patents it claimed its fellow German mRNA maker stepped on related to inventions considered “essential to the design and development” of BioNTech and Pfizer’s Comirnaty, including sequence modifications and mRNA vaccine formulations, the company noted in a statement at the time. Its lawsuit doesn’t aim to stop the production and distribution of the shot but wants recognition and royalties from past and future sales. That likely puts $500 million on the line, Berenberg Capital Markets analyst Zhiqiang ...
A new research perspective was published in Oncoscience (Volume 10) on May 27, 2023, entitled, “Think outside the box – atypical infections in chronic sinusitis.” Inflammations of the paranasal sinuses represent a common clinical picture. The annual prevalence of chronic sinusitis in Europe is up to 10%. Sinusitis can be divided into acute and chronic forms. In particular, the chronic forms (>12 weeks duration) are often challenging in the context of therapy. Generally, all ventilation disorders of the paranasal sinuses (concha bullosa, nasal septal deviations, etc.,) represent risk factors for the development of any form of sinusitis. In addition, an immune deficiency or systemic diseases relevant to the immune system predispose to infections with atypical pathogens. Most sinusitis are caused by viruses, sometimes bacteria and, in rare cases, fungal infections. Furthermore, sinusitis can be differentiated with regard to the affected paranasal sinuses. In addition to conservative ...
Food insecurity is associated with slightly faster memory decline in middle- to older-aged U.S. adults, according to a study published online July 3 in JAMA Network Open. Peiyi Lu, Ph.D., from Columbia University in New York City, and colleagues examined whether exposure to food insecurity is associated with changes in memory function among 12,609 middle- to older-aged U.S. adults (11,951 food-secure and 658 food-insecure) followed for 18 years (1998 to 2016). The researchers found that over time, the memory function of the food-secure respondents decreased by 0.045 standard deviation units annually (β for time, −0.045), with a faster memory decline rate among food-insecure respondents than food-secure respondents. However, the magnitude of the coefficient was small (β for food insecurity × time, −0.0030), yielding an estimated 0.67 additional (i.e., excess) years of memory aging over a 10-year period for food-insecure respondents compared with food-secure respondents. “The study noted a longitudinal association between food insecurity and memory ...
Clinical-stage biotech Recursion continues to go from strength to strength. After its recent acquisition of Cyclica and Valence, the company announced a partnership with—and $50 million investment from—NVIDIA on Wednesday. Under the agreement, the tech giant is giving Recursion a $50 million private investment in public equity. The two companies are looking to accelerate the development of Recursion’s AI foundation models to help the biopharma industry create improved patient therapies more quickly. “With our powerful dataset and NVIDIA’s accelerated computing capabilities, we intend to create groundbreaking foundation models in biology and chemistry at a scale unlike anything that has ever been released in the biological space,” Recursion CEO Chris Gibson said in a statement. Recursion has built a massive biological and chemical database via its Recursion OS, which exceeds 23 petabytes and has three trillion searchable compound and gene relationships. The company has been training machine-learning algorithms on this dataset to tackle the complex ...
Dive Brief Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries, the agency said in a Tuesday notice. Megadyne contacted customers last month after receiving reports of burns linked to its reusable electrode pads. The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths. The Class I recall covers 21,200 MEGA 2000 and MEGA Soft reusable electrodes sold in the U.S. In an emailed statement, a spokesperson for J&J wrote that the notification was not a product removal, and Mega Soft pads may continue to be used. Dive Insight Megadyne is a subsidiary of Johnson & Johnson’s Ethicon segment that makes tools used in electrosurgery, procedures that involve the use of electric current to heat or cut tissue or to stop bleeding. The ...
With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. Swedish drugmaker Xspray has received an FDA complete response letter on its application for its first product Dasynoc. In issuing the rejection, the FDA requested additional information on the drug’s dosing plus greater clarity around a third-party manufacturing facility. Xspray is seeking an FDA nod for Dasynoc to treat chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Despite issuing the rejection, Xspray said the FDA signed off on “critical aspects” of the application and did not identify any deficiencies pertaining to the drug’s stability or clinical data, the company said in a release Tuesday. Xspray is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back ...
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