Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%. By FRANK VINLUAN Longboard Pharmaceuticals is chasing much bigger companies already in the market with therapies for rare forms of epilepsy. The biotech has gone from saying its drug could be differentiated to claiming it has best-in-class potential. Longboard now has some early clinical data to help build that case. Longboard drug bexicaserin, formerly known as LP352, was tested in a placebo-controlled Phase 1b/2a study whose main goal is measuring the change in seizure frequency. Preliminary results released Tuesday show the bexicaserin group achieved a median 53.3% reduction in seizure frequency in the 75-day treatment period compared to a 20.8% median decrease in seizure frequency in ...
On January 2, 2024, AstraZeneca and Sanofi announced that the long-acting monoclonal antibody Beyfortus® (Nirsevimab/nisevizumab) has been officially approved for marketing by the State Drug Administration of China (SDA) for the prevention of Lower Respiratory Tract Infections (LRTIs) caused by Respiratory Syncytial Virus (RSV) in newborns and infants. The drug is indicated for newborns and infants who are entering or born during the first season of RSV infection. Nisevizumab is expected to be available in China during the 2024-2025 RSV infection season. Nisevizumab is the first and only* approved prophylaxis in China to protect the broader infant population against RSV infection, covering healthy term infants, preterm infants, and infants vulnerable to serious RSV infection due to specific health conditions. Nisevizumab was approved in China based on the results of three pivotal clinical trials and the Chinese clinical development program. For all clinical trial endpoints, a single injection of nisevizumab demonstrated ...
Vaccine immunization has dramatically reduced the morbidity and mortality of invasive bacterial infectious diseases such as bloodstream infections. Although a large number of studies have demonstrated that immune protection requires vaccine-induced antibody production, human beings still lack a clear understanding of the cellular and molecular mechanisms of how vaccines provide immune protection. The current international consensus is that vaccines provide immune protection by activating phagocytes in the spleen and blood circulation to remove pathogens that invade the bloodstream. Recently, Jingren Zhang’s group and Linqi Zhang’s group at Tsinghua University School of Medicine, together with Haifa Zheng’s group at Beijing Minhai Biotechnology Co., Ltd, published a paper in Science Translational Medicine titled “Liver macrophages and sinusoidal endothelial cells The research paper, entitled Liver macrophages and sinusoidal endothelial cells execute vaccine-elicited capture of invasive bacteria, reveals that the liver is the main organ that executes vaccine-elicited immunoprotection, and elucidates the molecular mechanism ...
Suzhou, China, January 2, 2024 – Suzhou MediLink Therapeutics (“MediLink”) announced today that it has reached a global cooperation and licensing agreement with Roche. The two parties will collaborate to develop a next-generation antibody-drug conjugate product candidate YL211 (“c-MET ADC”) targeting mesenchymal epidermal transforming factor (c-MET) for the treatment of solid tumors. Under the terms of the agreement, Roche will obtain exclusive rights to the global development, manufacturing and commercialization of YL211. MediLink will work with the China Innovation Center of Roche (CICoR) to promote the YL211 project into phase I clinical trials, and Roche will be responsible for further development and commercialization work on a global scale. Roche will pay MediLink an upfront payment and near-term milestone payments of US$50 million, in addition to nearly US$1 billion in potential milestone payments for development, registration and commercialization, as well as future gradient royalties based on global annual net sales. About ...
The World Health Organization (WHO) has said it has added a new malaria vaccine to its list of prequalified vaccines, marking a “significant milestone” in the prevention of the mosquito-borne disease. R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, is now the second malaria vaccine to be prequalified by the organisation following its prequalification of the RTS,S/AS01 vaccine in July 2022. Malaria places a particularly high burden on the African Region, where nearly half a million children die from the disease every year. Despite high demand, WHO outlined that the available supply of RTS,S has been limited and expects the addition of R21 to result in sufficient vaccine supply for children living in areas where malaria is a significant public health risk. Dr Kate O’Brien, director of WHO’s department of immunisation, vaccines and biologicals, said the decision marked “a huge stride in global health”. “This ...
In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
AbbVie is entering 2024 with a foothold in the antibody-drug conjugate (ADC) field thanks to its late-2023 buyout of ImmunoGen worth more than $10 billion. But according to a new securities filing, AbbVie didn’t pursue the cancer drugmaker until other suitors were already at the negotiating table. ImmunoGen’s recent round of M&A deliberations began in April, according to the filing, when a company only identified as “Party A” reached out to CEO Mark Enyedy expressing interest in a potential transaction. Before that, ImmunoGen had been routinely evaluating potential opportunities for deals of various types, but the interest from Party A struck up a round of talks that ultimately led to the sale. However, Party A’s note of interest came without a proposed purchase price, a move that the company’s advisors at Goldman Sachs and Lazard called “unusual but not unprecedented.” Before the talks moved along, ImmunoGen presented its first-quarter earnings ...
Over half of maternal deaths occurring in hospitals are attributed to sepsis, a critical condition where an infection spreads beyond local tissue containment, leading to organ failure. Maternal or perinatal sepsis is a significant health concern globally, affecting more than 20 million women and resulting in approximately 17,000 deaths each year. Identifying the infectious agents responsible for these cases is often a complex task. While blood cultures are the preferred diagnostic method, they frequently yield low positive results. Other specimens like vaginal swabs have limited clinical usefulness, and obtaining microbiological cultures from the uterine cavity for antimicrobial guidance is typically challenging. Now, a new study of microbiology specimens used to investigate maternal sepsis has demonstrated that placental swabs could play a vital role in informing antimicrobial therapy decisions. The study performed by researchers from the University of Limerick (Limerick, Ireland) involved the analysis of nearly 2,000 specimens collected over five ...
Millions of people across the world are diagnosed with colorectal cancer and endometrial cancer each year. A significant number of patients with these cancers exhibit mismatch repair deficiency, a genetic anomaly characterized by errors in DNA due to the absence of specific repair proteins. This deficiency hampers DNA repair capabilities, potentially leading to various cancer types. Prior studies have indicated that patients with this condition often show positive responses to immunotherapy, which leverages the body’s immune system to combat cancer. Now, a new study has broadened the scope of patients who might benefit from this treatment approach. A research team from Brigham and Women’s Hospital (Boston, MA, USA) conducted an analysis involving 1,655 patients with either colorectal or endometrial cancer. These patients underwent both immunohistochemistry, the prevailing standard test for this genetic state, and next-generation sequencing tests. Immunohistochemistry detects mutations impacting the antigen, while next-generation sequencing provides a more comprehensive ...
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