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US appeal in high-stakes Gilead patent case garners support from patient advocates

Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal. In a letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, more than 30 organizations said they “commend the decision” by the Department of Justice (DOJ) to keep fighting in the case. After the recent trial went in Gilead’s favor on May 9, the DOJ is seeking a new trial, according to the letter. The groups said they “strongly support HHS’s and DOJ’s decision to contest the surprising verdict,” arguing that the government’s case remains “fundamentally strong.” The U.S. first sued Gilead in 2019, saying that taxpayers funded research in the early 2000s that eventually went into the company’s lucrative HIV prevention medicines. U.S. officials said they sought to license the patented technology to Gilead for many years ...
- Source: drugdu
- 165
- June 2, 2023
Amgen reports positive results for Otezla in psoriatic arthritis

Amgen has announced positive new research evaluating the use of its inflammatory disease medication Otezla (apremilast) in psoriatic arthritis. Psoriatic arthritis is a chronic, inflammatory form of arthritis estimated to affect nearly 38 million people worldwide. The condition can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. Otezla regulates inflammation by inhibiting an enzyme known as phosphodiesterase 4. This enzyme controls much of the inflammatory action within cells, which can affect the level of inflammation associated with psoriatic disease. The new data for the drug, being presented at the 2023 European Congress of Rheumatology (EULAR), includes results from the phase 4 MOSAIC study, which evaluated its effect on joint inflammation and structural progression of psoriatic arthritis using MRI. Results showed that patients treated with Otezla had improvements in both clinical and MRI measures of inflammation up to week 48, ...
- Source: drugdu
- 178
- June 2, 2023
FDA warns about compounded semaglutide-based drugs

Tyler Patchen The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness. The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective. Novo Nordisk’s Ozempic and Wegovy, both of which contain semaglutide, are approved to treat type 2 diabetes and obesity, and demand for the drugs has soared over the last two years, given the ability of both therapies to help people lose weight. That demand has created a supply crunch, with both medications on the FDA’s shortages list. Though compounding medications is legal when drug shortages occur, the compounded versions ...
- Source: drugdu
- 121
- June 2, 2023
FDA’s cancer chief weighs in on common chemo shortages — report

Tyler Patchen Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity. In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage. The shortages are causing oncologists across the US to ration platinum-based drugs, according to The Cancer Letter. To restore the supply of cisplatin, the FDA is ...
- Source: drugdu
- 122
- June 2, 2023
MEDICAL FAIR THAILAND

MEDICAL FAIR THAILAND - Hospital, Diagnostic, pharmaceutical, Medical and Rehabilitation Equipment Exhibition, MEDICAL FAIR THAILAND, was first held in Bangkok, Thailand in 2003. Since then, the exhibition has become an important platform for the medical industry in Thailand and Southeast Asia.
- Source: drugdu
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- June 1, 2023
CPhI Worldwide Europe

CPhI Worldwide Europe is a famous brand exhibition in the field of international pharmaceutical raw materials, as well as a professional exhibition in the field of pharmaceutical raw materials and intermediates. The show travels annually between France, Germany and Spain.CPhI World pharmaceutical raw materials, P-MEC pharmaceutical machinery, InnoPack pharmaceutical packaging materials and ICSE contract customization will be held at the same time, realizing four exhibitions in one, becoming a great gathering of the global pharmaceutical industry, in addition to zero distance to understand the latest technology application and product information, the development direction of the pharmaceutical industry, but also play a role in the weather.
- Source: drugdu
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- June 1, 2023
FIME 2023

FIME is the largest medical specialty show in the southeastern United States. The feature of the exhibition is both regional and international. In addition to exhibitors and professional buyers mainly from Florida, the exhibition has attracted a large number of exhibitors and professional buyers from Latin American countries by taking advantage of the advantageous geographical location of the exhibition city adjacent to the Caribbean Sea. A large number of products and equipment are re-exported to Caribbean countries and markets through Florida.
- Source: drugdu
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- June 1, 2023
Cats can play a role in transmitting COVID-19, finds new study

Cats can play a role in the transmission of SARS-CoV-2 and their contaminated environment (pens in this study) can be infectious, according to new research. The study is published in Microbiology Spectrum. “In practice, after the introduction of SARS-CoV-2 in our household, we should see our cat as part of the family regarding virus transmission,” said study co-author Wim van der Poel DVM, Ph.D., Professor of Emerging and Zoonotic Viruses, Wageningen University and Research, in the Netherlands. Dr. van der Poel and colleagues conducted the study to gain better insight into the risk of COVID-19 infection that could arise from cats infected with SARS-CoV-2. In the study, 16 cats were either directly exposed to SARS-CoV-2 virus obtained from a naturally infected human patient, exposed indirectly from a directly exposed cat, or exposed from the pen in which an infected cat was housed. All cats were regularly sampled during the whole ...
- Source: drugdu
- 138
- June 1, 2023
More depressed patients than previously estimated could have increased activation of their immune system

New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London has used an assessment of gene expression involved in the immune response to show that there could be more patients with major depressive disorder (MDD) with activated immune systems than research has previously estimated. By identifying the molecular mechanisms involved in this association, the research could pave the way to better identify those patients with an immune component to their depression which would potentially help to provide more personalized approaches to treatment and management of MDD. The research, published in Translational Psychiatry builds on previous findings that there is an activated immune response in many people with MDD. However, most of the research in this area has focused on the levels of inflammation related proteins like C-reactive protein (CRP). Studies using CRP have found that about 21 to 27 % of people with depression have ...
- Source: drugdu
- 126
- June 1, 2023
Titan licenses robotic surgery intellectual property to Intuitive after failing to find buyer

Dive Brief Intuitive Surgical has paid $7.5 million for a nonexclusive license to most of Titan Medical’s intellectual property. The deal gives Intuitive access to patents related to the enhancement of robotic-assisted surgery, including ways to enter the body through a single access point. Titan licensed the patents after failing to find a company willing to buy its business. The failure of the search for a buyer led Titan to further reduce its headcount to lower its operating costs. Dive Insight Titan has been struggling for years. In 2019, cash constraints forced it to rethink its timeline for seeking 510(k) clearance for its single-port robotic surgical system. After further delays, the company started to look for strategic alternatives such as the sale of some or all of its business late last year. Titan contacted “over 55 potential counterparties,” it said in a statement. None of the parties expressed an interest ...
- Source: drugdu
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- June 1, 2023

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