EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. Every year, EMA issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization (WHO) which are informed by regular monitoring activities on the prevalence and characteristics of different influenza viruses worldwide. Based on this data EMA’s Emergency Task Force (ETF) has issued a statement recommending a transition from quadrivalent to trivalent vaccines that do not include the B/Yamagata component. Currently, most authorised influenza vaccines are quadrivalent, which means that they are formulated to protect against the four main strains of influenza responsible for seasonal flu, A(H1N1)pdm09 and A(H3N2), B/Victoria and B/Yamagata. However, the B/Yamagata strain of the influenza B virus has not been detected in circulation since March 2020. This is thought to be due ...
Recently, the innovative biologic drug Efbemalenograstim alfa Injection (Chinese trade name “Ryzneuta”), independently developed by Evive Biotech and for which Chia Tai Tianqing has exclusive commercialization rights in China, received the “COMMISSION IMPLEMENTING DECISION” issued by the European Commission, approved for sale in the EU. The decision is based on a positive review by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). So far, Efbemalenograstim alfa Injection has become the first domestic innovative biological drug that has been approved for marketing in China, the United States and the European Union. It has also become the first innovative drug approved by the European Union by a Chinese pharmaceutical company in 2024. Previously, Chia Tai Tianqing had signed a commercial cooperation agreement with Evive Biotech and obtained all intellectual property rights and exclusive commercialization rights of Yilisu® in China. Efbemalenograstim alfa Injection is currently the only G-CSF ...
On March 22nd, Yi Li Shu® (Efbemalenograstim Alfa Injection), an innovative biopharmaceutical product developed by EVIVE and exclusively commercialized in China by Chiatai Tianqing, received the “COMMISSION IMPLEMENTATION DECISION” from the European Commission approving its marketing and sales in the European Union. The decision is based on the positive review opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Thus, Efbemalenograstim Alfa Injection has become the first innovative biopharmaceutical in China that has been approved for marketing in China, the United States and the European Union, as well as the first innovative drug approved by a Chinese pharmaceutical company in the European Union in the year 2024. Previously, Chiatai Tianqing has signed a commercialization cooperation agreement with EVIVE to obtain all intellectual property rights and exclusive commercialization rights of Yi Li Shu® in China. Efbemalenograstim Alfa Injection is the only drug among ...
Pharmacy solutions and pharmacy benefit managers perform several functions, including administrative tasks, handling benefit processing claims and negotiating with the supply chain. However, the problem is that many of them are performing these tasks on outdated technology. “All of those things, to do them well, require a foundation of technology capabilities to enable our people to operate at the top of their license. … The majority of the industry is using 30 to 40-year-old technology to do all of this work,” said Mostafa Kamal, president and CEO of pharmacy benefit manager Prime Therapeutics, in an interview. That’s why Prime Therapeutics has formed a strategic alliance with Capital Rx, which is also a PBM, the companies announced last week. Through the alliance, Prime Therapeutics will be the only PBM — aside from Capital Rx — to use Capital Rx’s JUDI platform. JUDI is a pharmacy benefits administration platform that puts all ...
Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections, including neutropenic sepsis—a potentially fatal reaction to infection and a severe complication of chemotherapy. Identifying the signs of neutropenic sepsis can be challenging, leading to a stressful and expensive treatment process. Consequently, all chemotherapy patients feeling ill are advised to seek emergency care to check for neutropenic sepsis. Unfortunately, half of these patients do not receive antibiotics quickly enough, while the other half, not at risk of neutropenic sepsis, unnecessarily visit the emergency department. 52North Health Ltd. (Cambridge UK) has developed NeutroCheck, a groundbreaking approach aimed at enhancing the safety and well-being of cancer patients. This innovation combines a finger-prick blood test with an AI-powered digital platform, allowing patients to evaluate their neutropenic sepsis risk at home. This affordable, ...
In 2021, neurological conditions, including Alzheimer’s disease, affected approximately 3.4 billion people globally In a new study funded by the Bill & Melinda Gates Foundation, results published in the Lancet Neurology have determined that neurological conditions are currently the leading cause of ill health worldwide. Results showed that the biggest contributors to neurological health loss globally were stroke, neonatal encephalopathy, migraine, Alzheimer’s disease and other dementias, and diabetic neuropathy. Affecting 3.4 billion people globally in 2021, neurological conditions are any conditions that affect the brain, spinal cord and nerves, which can affect anyone at any age. The study revealed that the number of people globally living with or dying from neurological conditions has drastically risen in the past three decades, partially due to ageing societies. Worldwide, the analysis suggests that the total amount of disability, illness and premature death caused by neurological conditions increased by 18% between 1990 and 2021. ...
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run. During the first meeting of the MSP advisory group that officially kicks-off the platform, María Jesús Lamas, director of the Spanish agency of medicines and medical products, who is regulatory co-chair of the group, said: “The establishment of the multi-stakeholder platform is an important milestone for ACT EU. Our collaborative efforts will drive progress towards more streamlined and efficient clinical trials and allow patients and citizens to benefit from clinical research in Europe.” The launch of the MSP fosters collaboration and promotes open dialogue around the challenges and opportunities represented by ...
Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
Contineum Therapeutics, which emerged from a Verant Ventures startup creation engine, has filed paperwork for an IPO. The biotech’s clinical-stage pipeline spans multiple sclerosis, idiopathic pulmonary fibrosis, and depression. By FRANK VINLUAN Jhnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO. Contineum, which traces its origins to a startup creation engine of venture capital firm Versant Ventures, filed its IPO paperwork with the Securities and Exchange Commission late Friday. The company has not yet set any financial terms for its planned stock market debut, but IPO research firm Renaissance Capital said the offering could reach up to $150 million. The San Diego-based biotech has applied for a Nasdaq listing under the ...
Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” said Peter Marks, M.D., Ph.D., director of ...
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