PharmaFocus Today – Page 352 – media

Gilead notches trial win in high-stakes HIV patent case against US government

It’s extremely unusual for the U.S. government to go after a pharmaceutical company for alleged patent infringement, much less take the case to trial. But in the government’s case against Gilead Sciences, the California drugmaker has come out on top.After years of litigation, Gilead prevailed following the trial in a Delaware federal court. The jury found the patents at issue were invalid, The New York Times reports.With that, the company doesn’t have to pay the more than $1 billion that the government sought with its patent infringement case. The company is “pleased” with the decision, Gilead’s executive vice president of corporate affairs and general counsel Deb Telman said in an emailed statement. “Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” Telman said. “Gilead will continue to champion collaborations, including our efforts with the ...
- Source: drugdu
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- May 11, 2023
Most antidepressants prescribed for chronic pain lack reliable evidence of efficacy or safety, scientists warn

Most antidepressants used for chronic pain are being prescribed with “insufficient” evidence of their effectiveness, scientists have warned. A major investigation into medications used to manage long-term pain has found that harms of many of the commonly recommended drugs have not been well studied. Published in the Cochrane Database of Systematic Reviews, the study led by scientists from several UK universities including Southampton and Newcastle, examined 176 trials consisting of nearly 30,000 patients involved in assessments which prescribed antidepressants for chronic pain. Among the drugs studied were amitriptyline, fluoxetine, citalopram, paroxetine, sertraline, and duloxetine—with only the latter showing reliable evidence for pain relief. One third of people globally are living with chronic pain, World Health Organization data shows, with many prescribed antidepressants for relieving symptoms. Lead author Professor Tamar Pincus from the University of Southampton said, “This is a global public health concern. Chronic pain is a problem for millions ...
- Source: drugdu
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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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- May 11, 2023
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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- May 11, 2023
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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- May 10, 2023

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