Australian biotech QBiotics has won an orphan drug designation for a drug based on a chemical obtained from the blushwood tree, which is being investigated as a treatment for a rare group of cancers called soft tissue sarcoma. Qbiotics will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, the potential for seven years of market exclusivity for the given indication. A veterinary formulation of the drug, tigilanol tiglate, is already approved for use in the US, UK, and Australia under the trade name Stelfonta. QBiotics started life as EcoBiotics, which was established in 2000 to discover potential drugs from Queensland’s tropical rainforest. QBiotics itself was founded in 2004 as a subsidiary of EcoBiotics, and the two groups merged in 2017. The company has signed several biodiscovery agreements covering the rainforest areas in the country in the past decade. The company has ...
BHF data reveals early heart disease deaths rise to highest level In 2022, over 39,000 people in England died prematurely of cardiovascular conditions The British Heart Foundation (BHF) has revealed new data showing that early heart disease deaths in England have risen to the highest level seen since 2008. New figures show that over 39,000 people in England died prematurely of cardiovascular conditions, including heart attacks, coronary heart disease and stroke, in 2022. Cardiovascular disease is a general term for conditions that affect the heart or blood vessels in the body. In the UK, there are currently around 7.6 million people living with heart and circulatory diseases. Before 2012, the number and rate of deaths from these types of conditions among people under the age of 75 were falling. However, recent statistics have shown that the rate of premature deaths from cardiovascular disease has increased in England for three years. ...
Around one million adults in the UK visit their GP every year due to chest pain Researchers from Keele University have identified the key risk factors of people with unattributed chest pain developing heart and circulatory diseases. The study, published in the European Journal of Preventative Cardiology, was funded by the British Heart Foundation (BHF). Every year, around one million adults in the UK visit their GP due to chest pain and many will not receive a diagnosis, with only a few receiving preventative treatments. Previous research has shown that people living with unattributed chest pain have a higher risk of experiencing future heart health problems compared to those without. Researchers developed risk calculators to identify people at a high risk of developing future heart and circulatory diseases, and to pinpoint the key factors that influence that risk. The team used anonymised information from the health records of over 600,000 ...
In a letter to the US Departments of Treasury, Defense, and Commerce, four lawmakers have expressed their concerns regarding biotech WuXi AppTec and its subsidiary WuXi Biologics’ supposed ties to the Chinese military. The 12 February letter from Chairman Mike Gallagher (R-WI), Senator Bill Hagerty (R-TN), Ranking Member Raja Krishnamoorthi (D-IL), and Senator Gary Peters (D-MI) asked that the administration add Wuxi to US government control lists given the biotech’s alleged ties to the Chinese Communist Party (CCP) and involvement in the CCP genocide of Uyghurs in Xinjiang, Reuters first reported. In addition, the letter alleges that the biotech is “closely affiliated” with the People’s Liberation Army (PLA), claiming that the biotech’s chairman and CEO Dr. Li has “personally commended CCP branch work in the company and has called on Party branches and members to play an active role in the company.” Lawmakers also claim that CEO Chen Zhisheng of ...
The aggressive brain cancer is responsible for over 3,000 cases in the UK every year Researchers from King’s College London (KCL) have developed an artificial intelligence (AI)-based model that can predict adult brain cancer patients’ rates of survival after receiving radiotherapy treatment. Published in Neuro-Oncology, researchers applied deep learning to predict whether glioblastoma patients would survive eight months. Responsible for around 3,200 cases every year in the UK, glioblastoma is a very aggressive and difficult-to-treat cancer, with just one in four patients surviving over one year after diagnosis. Currently, patients are regularly and routinely tested to see whether chemotherapy is effective or not. However, some patients can suffer from harmful side effects as a result of chemotherapy. Instead, by giving patients an instantaneous and accurate prediction from a single routine MRI scan, the AI will allow doctors to identify patients who would not benefit from chemotherapy and try a different ...
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
Davy James Vabysmo is the first bispecific antibody approved to treat ocular conditions such as diabetic macular edema and wet age-related macular degeneration. Findings from the global Phase III BALATON (NCT04740905) and COMINO (NCT04740931) trials show Roche’s Vabysmo (faricimab-svoa) produced sustained retinal drying and improved vision in patients with retinal vein occlusion (RVO).1 Vabysmo, the first bispecific antibody approved to treat ocular conditions, inhibits a pair of disease pathways involved in multiple vision-threatening retinal conditions by neutralizing angipoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).2 In February 2022, Vabysmo became the first and only FDA-approved injectable eye medicine for diabetic macular edema and wet age-related macular degeneration. “This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion,” Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global ...
In the UK, there are about 17,000 individuals living with sickle cell disorder, and each year there are around 250 new cases. This condition, predominantly affecting people of black African and Caribbean descent, can lead to significant organ damage and intense pain. In contrast, the UK has around 800 patients with thalassaemia and less than 50 new cases annually. Thalassaemia patients struggle to produce sufficient hemoglobin, which, if untreated, can result in life-threatening anemia. This condition is most prevalent among people of Asian, Middle Eastern, and southern Mediterranean backgrounds. While life-saving blood transfusions are a common treatment for these inherited blood disorders, about 20% of patients develop antibodies against certain blood groups, causing delays in their treatment. Now, a groundbreaking ‘blood matching’ genetic test, the first of its kind in the world, is being made available to thousands of these patients in the UK to better pair people for blood ...
More than two years after Aduhelm’s controversial and ill-fated FDA accelerated approval, Biogen is discontinuing the Alzheimer’s disease therapy after walking a rocky path. Wednesday, Biogen said it’s pulling all efforts from the first-of-its-kind anti-amyloid beta therapy to focus on Leqembi, its Eisai-partnered newer medicine, and its pipeline candidates. The newer drug, Leqembi, won a full FDA approval early last year, making the partners’ marketing efforts on the therapy much simpler than was the case with Aduhelm. Biogen is taking a $60 million charge and is discontinuing all development and sales of Aduhelm, the company said. It’s terminating the ENVISION clinical study, which sought to confirm the benefit of the medicine as required under its 2021 accelerated approval. The decision follows Biogen’s move to launch a strategic review in early 2023 under new CEO Chris Viehbacher, the former Sanofi chief who joined the Massachusetts drugmaker in November 2022. During that ...
AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate. But this time, the rosier outlook reflects developments outside the U.S. Daiichi now expects Enhertu sales to come in at 383.9 billion Japanese yen (about $2.6 billion) for the 12 months ending March 31. The number includes profits from regions where AstraZeneca books Enhertu sales. Daiichi had already once dialed up its Enhertu forecast for its current fiscal year. The drugmaker’s projection was originally 320 billion yen back in April 2023, then Daiichi raised it to 381.7 billion yen in October. Despite rolling out the higher global forecast, Daichii actually reduced Enhertu’s 12-month sales estimate in the U.S. by $30 million to $1.58 billion. For the first nine months of the company’s fiscal year, Enhertu generated $1.14 billion in the U.S., an increase of ...
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