AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, the companies announced. The US Food and Drug Administration’s (FDA) decision makes the long-acting antibody the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The approval, which also applies to children aged up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, was based on results from the Beyfortus clinical development programme spanning three pivotal late-stage clinical trials and follows a unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of the drug. Across all clinical endpoints, a single dose of Beyfortus ...
At the World Health Organization’s (WHO) sixth meeting of the Intergovernmental Negotiating Body in Geneva, the WHO director-general Dr Tedros Adhanom Ghebreyesus has called out critics of the organisation’s planned pandemic accords at the opening remarks of Intergovernmental Negotiating Body’s sixth meeting. “20 years ago, the tobacco industry tried to undermine negotiations on the WHO Framework Convention on Tobacco Control. The same thing is happening now. Groups with vested interests are claiming falsely that the accord is a power grab by WHO, and that it will stymie innovation and research,” he said in his opening remarks on 19 July. The “Pandemic prevention, preparedness and response accord” is an agreement between the WHO member states to “draft and negotiate a convention, agreement or other international instrument under the Constitution of the World Health Organization to strengthen pandemic prevention, preparedness and response”. Member states began developing the pandemic accords in February 2022 ...
While vaccines for COVID-19 have certainly enjoyed the spotlight in recent years, rates of uptake for other shots have sharply declined.That’s the finding of a new analysis funded by GSK in collaboration with the IQVIA Institute for Human Data Science and the Global Coalition on Aging (GCOA). All told, about 100 million fewer doses than anticipated of some adult vaccines, other than those targeting COVID-19, were administered between 2021 and 2022, the team found. To reach this number, the group weighed vaccine use in the last two years versus trends in global vaccine adoption from 2013 to 2020. In fact, just 16.2 doses of some vaccines were doled out globally per 100 adults in 2022. Meanwhile, COVID-19 vaccines saw overwhelming success with 132 doses delivered for every 100 adults in the same year, according to the report. “While significant strides in vaccine development have delivered vaccines to ...
Pfizer is looking to enrich its pipeline with up to 10 new innovative medicines by partnering with startup creator Flagship Pioneering, the companies announced Tuesday. Under the terms of the agreement, Pfizer and Flagship will each contribute an upfront investment of $50 million. The collaboration will leverage Flagship’s rich ecosystem of biotechnology platforms and more than 40 human health companies. Pfizer and Flagship will explore up to 10 single-asset programs, which Pfizer will fund and have the option to acquire. Flagship and its companies will be eligible to receive up to $700 million in milestones and royalties for each program that hits the market, giving Tuesday’s deal a maximum potential value of $7 billion. This partnership will bring together expertise from Pfizer and Flagship “to maximize discovery and development potential from inception to impact,” Paul Biondi, executive partner at Flagship and president of Pioneering Medicines, said in a statement. ...
Bioengineers have found a way to program the size and shape of virus particles by combining viral protein building blocks and templates made from DNA. The resulting nanostructures could have applications in vaccine development and transporting drugs inside the body. Virus capsid proteins-;the proteins that shield the genome of a virus-;can be used to build precisely structured protein assemblies. Their shapes and geometry, however, depend largely on the virus strain. Reprogramming these assemblies, no matter the original viral blueprint, is an intriguing possibility for drug delivery and vaccine development. Scientists tackled the challenge by generating a “structured genome” template on which capsid proteins can assemble. To avoid deforming the flexible genome and creating unintended shapes, they used rigid DNA origami structures. These structures are only tens to hundreds of nanometres in length, but entirely made of DNA, which is folded accurately into the desired template shape. ...
GSK has announced that eligible endometrial cancer patients in the UK will be granted early access to its anti-PD-1 therapy Jemperli (dostarlimab) in combination with platinum-containing chemotherapy via the Early Access to Medicines Scheme (EAMS). The EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The combination has been specifically indicated to treat adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. Endometrial cancer is the most common gynaecological cancer in the UK, with approximately 10,000 new cases reported each year. While it often has a better prognosis than other womb cancers if diagnosed early, patients with advanced or recurrent disease face limited treatment options and a poor prognosis. The positive scientific opinion from the Medicines and ...
Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech.Seeking damages from Pfizer and BioNTech for alleged infringement, Moderna has lodged new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, European intellectual property outlet Juve Patent reported Tuesday. The Irish court, where Moderna is claiming infringement by Pfizer-BioNTech on a pair of Spikevax patents, is set to hear the case in early 2024, according to the publication. Less is known about the status of Moderna’s Belgian lawsuit, Juve points out. A spokesperson for Moderna didn’t immediately respond to a request for comment. The new lawsuits add to a complex web of ongoing mRNA patent litigation. The legal melee began last August when Moderna filed patent infringement lawsuits in the U.S. and Germany. Separately, Moderna has also sued Pfizer and its German partner BioNTech in the Netherlands, plus ...
Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases. The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE. “The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he ...
Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will “be exclusively for the Chinese people” and won’t “be exported,” a Moderna spokesperson told CNBC. Chinese media outlet Yicai first reported on Tuesday that Moderna was slated to make its first investment in China that could be worth around $1 billion, citing unnamed sources. The outlet also reported that Moderna CEO Stéphane Bancel was visiting Shanghai. The Moderna spokesperson did not confirm the report or comment on the size of the deal. “These agreements are focused on strengthening health security by targeting unmet needs and contributing to the ecosystem of medical solutions available to patients in China,” the spokesperson said. ...
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled a new corporate plan that aims to create a faster and more predictable regulatory environment. The plan assigns the agency’s agenda to four key strategic priorities, which are further split into multiple milestones over a three-year span. This includes a focus on public trust, improved access to safe and effective products and the pursuit of new strategic partnerships, based on the 4 July announcement. As part of the corporate plan, the MHRA plans to create faster risk-proportionate regulatory pathways that will support innovation in areas such as artificial intelligence, cell therapy and vaccines, per a document detailing the plan. In the first year, the MHRA aims to launch an improved regulatory management system that will streamline its services and increase the use of self-service. The agency also seeks to optimise service delivery times in priority areas in the second ...
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