PharmaFocus Today – Page 376 – media

Novavax surges after biotech company unveils job cuts, positive vaccine data

Novavax’s stock jumped around 30% on Tuesday after the biotech company unveiled promising new vaccine data and a broad cost-cutting push that includes major layoffs. The announcements are a sign of hope for investors after last quarter, when the company raised doubts about its ability to stay in business and decided not to provide full-year guidance. Novavax’s stock closed Tuesday at $9.52. The company’s share price is down more than 7% so far this year, giving it a market value of nearly $821 million. Novavax is now betting on its cost controls and new vaccines to help it stay afloat, forecasting 2023 sales of $1.4 billion to $1.6 billion, according to its first-quarter earnings report. The Gaithersburg, Maryland-based company said its combination vaccine targeting Covid and the flu produced a strong immune response against the viruses and was well tolerated in a phase two trial. Novavax shared similar trial results ...
- Source: drugdu
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- May 11, 2023
Chatbots are infiltrating healthcare. What now?

Lisette Hilton | Healthcare practices are already using chatbots to help with administrative tasks like scheduling appointments or requests for prescription refills. And while users say the current generative artificial intelligence (AI) technology falls short for safely treating patients, a recent survey of healthcare practices suggests 77% of users predict chatbots will be able to treat patients within the next decade. According to Software Advice’s 2023 Medical Chatbot Survey of 65 healthcare providers or practice owners who use live chatbots on their websites, which was conducted in March 2023, more than three quarters of those surveyed are extremely or somewhat confident in chatbots’ ability to assess patients’ symptoms. Chris R. Alabiad, MD, professor of clinical ophthalmology and ophthalmology residency program director at Bascom Palmer Eye Institute, Miami, FL, has tested the use of ChatGPT (Open AI) in the academic and clinical settings. He piloted the use of ChatGPT at Bascom ...
- Source: drugdu
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- May 11, 2023
Most effective treatment for excessive daytime sleepiness found

McMaster University researchers Dena Zeraatkar and Tyler Pitre have found that the drug solriamfetol is the most effective treatment for excessive daytime sleepiness (EDS) for people with obstructive sleep apnea (OSA). The standard treatment for OSA is a positive airway pressure (PAP) mask that uses compressed air to support lung airways during sleep. However, some people with OSA still experience EDS and may benefit from anti-fatigue medication. Zeraatkar and Pitre published their results in the Annals of Internal Medicine. “The most important thing that people with OSA should do is use their PAP machine, but if they are still sleepy there are options in the form of medications that can reduce their tiredness.” Tyler Pitre, first author, resident physician in internal medicine at McMaster University and incoming respirology fellow at the University of Toronto “Fifteen to 30 per cent of people in North America have a diagnosis ...
- Source: drugdu
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Spikevax approved for use in children aged 6 months to 5 years

Spikevax, the COVID-19 vaccine from Moderna, has today been authorized for use in children aged 6 months to 5 years. The vaccine has been authorized in this new age group after it has been found to meet our standards of safety, quality and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence. This is the second COVID-19 vaccine to be authorized in this age group; the Pfizer/BioNTech vaccine (Comirnaty), was authorized in Great Britain for infants and children aged 6 months to 4 years on 6 December 2022. For this age group, the vaccine is given as a primary series of two 25-microgram injections in the upper arm or in the thigh, approximately one month apart. In reaching their decision, the MHRA’s experts carefully reviewed data from an ongoing clinical trial involving 6,388 children aged 6 months to ...
- Source: drugdu
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Life Bio, Forge to develop gene therapies for aging-linked diseases

Life Biosciences has announced a cGMP manufacturing collaboration with Forge Biologics for advancing the development of new gene therapies to treat aging-related diseases. This partnership aims to help advance the company’s partial epigenetic reprogramming platform for aging-related diseases, such as its lead programme that targets the ophthalmic indications. Through the alliance, Forge Biologics will provide cGMP manufacturing, toxicology, adeno-associated virus (AAV) process development, and analytical services to Life Biosciences. Life Biosciences will use the platform processes of Forge Biologics, including the HEK293 suspension Ignition Cells and per adenovirus helper plasmid. The company stated that all the development and AAV manufacturing works will take place at Forge Biologics’ 200,000ft2 gene therapy facility, called Hearth, located in Columbus, Ohio, US. Life Biosciences CEO Jerry McLaughlin said: “We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched. “We believe we’re on the cusp of revolutionising ...
- Source: drugdu
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Lifesaving solution dramatically reduces severe bleeding after childbirth

A new solution, known as E-MOTIVE, could provide a major breakthrough in reducing deaths from childbirth-related bleeding, according to a landmark study published today (May 9) in the New England Journal of Medicine by researchers from the World Health Organization (WHO) and the University of Birmingham. Postpartum hemorrhage (PPH)—defined as the loss of more than 500 mL of blood within 24 hours after birth—is the leading cause of maternal mortality worldwide. It affects an estimated 14 million women each year and results in around 70,000 deaths, mostly in low and middle-income countries, equivalent to one death every six minutes. “Postpartum hemorrhage is scary, not always predictable, but absolutely treatable. Nonetheless, its impacts around the world are tragic,” said Dr. Pascale Allotey, Director of Sexual and Reproductive Health and Research at WHO and head of the United Nations’ Special Program of Research, Development and Research Training in Human Reproduction (HRP). ...
- Source: drugdu
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Novel Rutgers COVID vaccine may provide long-lasting protection

Animal studies indicate that a new COVID-19 vaccine developed at Rutgers may provide more durable protection against SARS-CoV-2 and its emerging variants than existing vaccines. “We need a better vaccine, one that provides years of robust protection with fewer booster shots against a variety of SARS-CoV-2 strains. Our data suggest this vaccine candidate might be able to do that,” said Stephen Anderson, associate professor of Molecular Biology and Biochemistry in SAS, resident member of the Rutgers Center for Advanced Biotechnology and Medicine and senior author of the paper in Vaccines. Existing COVID vaccines often provide some protection against serious disease and death. However, these vaccines typically elicit temporary bursts of protective antibodies that rapidly wane, even after booster doses, leaving most individuals vulnerable to potentially dangerous repeat infections. This new vaccine, dubbed MT-001, might provide longer-lasting protection against many COVID-19 varieties. “Thankfully, the current vaccines saved many lives, but they’re ...
- Source: drugdu
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- May 10, 2023
EQRx resets strategy, abandoning plans to disrupt drug pricing

EQRx, a high-profile startup that attempted to build a new pharmaceutical business model, will lay off a large portion of its staff and discard much of its drug pipeline in a large-scale reset announced Monday. Launched by veteran biotech venture capitalist Alexis Borisy, EQRx started up in early 2020 with grand plans to reimagine how prescription drugs are developed and priced. The company claimed it could invent or license similar, but more effective competitors to top-selling specialty medicines, such as those for cancer, and sell them for less — a vision EQRx executives used to raise more than $2 billion in funding. EQRx made some progress, licensing several cancer drugs from Chinese companies and advancing them into late-stage clinical testing. But its near-term plans were thrown into disarray by the Food and Drug Administration, which set out stricter approval standards for drugs developed and tested in China. EQRx pivoted ...
- Source: drugdu
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As COVID vaccine sales plummet, BioNTech looks for new growth opportunities

After raking in billions with its Pfizer-partnered vaccine, BioNTech is turning to new ventures as its revenues plummet. BioNTech reported first-quarter revenues of €1.27 billion (1.4 billion), a far cry from 2022’s first-quarter haul of €6.37 billion ($7.03 billion). Despite the downturn, the quarter went “fully to our expectations,” CFO Jens Holstein said on a conference call. Sales-wise, the current quarter should be the weakest of 2023, Holstein said. The company’s COVID-19 vaccine revenue guidance for 2023 stands at €5 billion ($5.4 billion), which is “something we can live with,” the CFO added. Meanwhile, BioNTech believes the United States’ transition to a commercial COVID-19 vaccine market could provide new growth opportunities. But as its pandemic-related business struggles, BioNTech is busy advancing its pipeline as it looks for its next big growth driver. The company’s pipeline includes multiple oncology ventures, including an HER2-targeted antibody-drug conjugate (ADC) that it’s working on with ...
- Source: drugdu
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- May 10, 2023
FDA completes inspection of Nexus’ manufacturing facility in US

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards. Equipped with advanced isolator technology, the Pleasant Prairie facility adheres to the highest current good manufacturing practice (CGMP) standards. It is designed to manufacture a broad range of injectable medications and will provide hospitals and clinicians access to affordable, safe, and critical-need medicines. Nexus Pharmaceuticals President and CEO Usman Ahmed said: “We are thrilled to receive the EIR for our Pleasant Prairie facility. “This is a major milestone for our company and reflects our commitments to reshoring sterile pharmaceutical manufacturing to the US. “We are proud of our team’s hard work and focus on achieving a ...
- Source: drugdu
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- May 10, 2023

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