PharmaFocus Today – Page 379 – media

Newly merged manufacturers Meridian, Kindeva invest $100M in Missouri site

Five months after merging, manufacturers Kindeva Drug Delivery and Meridian Medical Technologies are expanding their capabilities in Missouri. In a $100 million investment over four years, Meridian plans to convert its newly purchased building in Bridgeton to increase production of drug-device combination products with added fill-finish capability, the companies said. Since adding 300 jobs since the start of 2022, Meridian now employs more than 900 people in the St. Louis area, the companies said. Financial incentives from state and local municipalities are helping this investment, which was announced in a press release that included quotes from seven different government officials. “Meridian brings a strong history of specific expertise to support critical manufacturing capabilities for complex products—addressing a manufacturing shortage we have seen increase over the last several years,” Milton Boyer, Meridian’s CEO who now heads up both companies, said in the release. Reference: https://www.manufacturingchemist.com/news/article_page/Meridian_set_for_100m_sterile_fill-finish_expansion_in_US/208133
- Source: drugdu
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Moderna nabs a win in Arbutus patent case as appeals court upholds prior invalidation

While Arbutus Biopharma is busy scrapping with Moderna and Pfizer over COVID-19 vaccine patents, Moderna has chalked up a win in a separate case. Back in 2018, Moderna challenged one of Arbutus’ lipid nanoparticle (LNP) technology patents at the U.S. Patent and Trademark office (PTO)’s Patent Trial and Appeal Board (PTAB). The patent, known as the ‘127 patent, was invalidated by the board the following year on the grounds that the company had already stated the invention in a prior patent (the ‘069 patent). Now, after an appeal attempt by Arbutus, the U.S. Court of Appeals for the Federal Circuit has upheld the decision. Moderna has “persuasively shown” that one or more formulations disclosed in the ‘069 patent are “the same or essentially the same” as formulations listed in the ‘127 patent, the appeals court said. Reference: https://www.fiercepharma.com/pharma/moderna-prevails-again-over-arbutus-appeals-court-upholds-2018-decision-strike-arbutus
- Source: drugdu
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Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US

By Jacqueline Howard, CNN Updated 2:41 PM EDT, Wed April 12, 2023 The White House has declared that the powerful synthetic opioid fentanyl combined with xylazine – an animal tranquilizer that’s increasingly being used in illicit drugs – is an “emerging threat” facing the United States due to its role in the ongoing opioid crisis. Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine. The move, announced Wednesday, marks the first time in history that any administration has declared a substance to be an emerging threat to the country, said Dr. Rahul Gupta, director of the Office of National Drug Control Policy. The SUPPORT Act of 2018 established that the office has authority to declare such “emerging threats,” and no administration has used it until now. Last year, Congress declared methamphetamine an emerging drug threat but none have been declared by an administration previously. Under other agencies or in separate circumstances, concerns such as bioterrorism, ...
- Source: drugdu
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- April 13, 2023
EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment

By Brenda Goodman, CNN Updated 2:49 PM EDT, Tue April 11, 2023 The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices. The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk. Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas. In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process. The EPA issued the report on the new risks without issuing a news release, as ...
- Source: drugdu
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FDA, citing safety concerns, places partial hold on Merck KGaA’s MS drug

Dive Brief: The Food and Drug Administration told Merck KGaA not to give an experimental drug for multiple sclerosis to new patients and to pause treatment for study participants who have been on it for less than 70 days amid concerns about possible liver damage. Regulators acted after laboratory tests suggested the livers of two patients might have been adversely affected by the drug, known as evobrutinib. However, neither patient exhibited symptoms and their liver enzyme levels returned to normal after they stopped taking the medicine, Merck KGaA said Wednesday. The German drugmaker had already fully enrolled a Phase 3 study known as Evolution, and that program will continue as planned because all the patients have already had received the medication for at least 70 days. Results are still expected in the fourth quarter. Dive Insight: Evobrutinib is part of a class of drugs known as BTK ...
- Source: drugdu
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ImmuneBridge raises funds to advance new cell-based immunotherapies

Biotechnology company ImmuneBridge has raised $12m seed financing to advance new natural killer (NK) cell-based immunotherapies. Co-led by global investors Insight Partners and M Ventures, the financing round has also seen participation from Gaingels and One Way Ventures. ImmuneBridge is developing allogeneic NK cell-based immunotherapies to treat solid tumours and hematologic malignancies. According to the company, NK cells represent a platform for allogeneic immunotherapy as they are potent cancer killers, with less risk profile. The company’s orthogonal approach leverages an expansion technology and a diverse clinic-ready source for accelerating the discovery and translation of potent cell therapies. Its expansion technology expands hematopoietic stem cells (HSCs), which are natural NK cells precursors. ImmuneBridge CEO and co-founder Peretz Partensky said: “Cell therapy is a new pillar of medicine and is inextricably human. Cell therapy developers fear donor-to-donor variability, yet we humans are unapologetically diverse in our innate ...
- Source: drugdu
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Mediterranean diet may lower heart disease risk in women by nearly 25%, study finds

Closely following a Mediterranean diet may cut a woman’s risk of heart disease and death by nearly 25%, according to a new analysis of 16 studies. “This study adds to what is already known about the cardiovascular benefits of a Mediterranean diet but further reiterates that it can be equally as beneficial in women as it is known to be in men,” said lead author Sarah Zaman, associate professor at the Westmead Applied Research Centre at the University of Sydney, in an email. Heart disease is the number one killer of women and men worldwide, according to the World Health Organization. Coronary artery disease kills more than twice as many women as breast cancer in the United Kingdom, while in 2020, one in five deaths among women in the United States was because of heart disease. Yet few studies on the heart have looked specifically at women, ...
- Source: drugdu
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The virological characteristics of XBB.1.16

In a recent study posted to the bioRxiv* preprint server, researchers perform extensive multiscale investigations to explore virological characteristics of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron XBB subvariant, XBB.1.16. Background The SARS-CoV-2 XBB.1.16 variant is associated with a 1.27- and 1.17-fold higher effective reproductive number (Re) as compared to the XBB.1 and XBB.1.5 subvariants, respectively, thus indicating the ability of this novel Omicron variant to disseminate quickly. As a result of this increased transmissibility, the World Health Organization (WHO) began monitoring XBB.1.16 on March 30, 2023, following its detection in several countries, including India. Earlier, the SARS-CoV-2 Omicron XBB subvariants with the F486P substitution in their spike (S) protein, which include XBB.1.5 and XBB.1.9, were widely circulating worldwide. Study findings The current analyses showed that as compared to its predecessor mutant strains, XBB.1.16 had two S substitutions, including E180V and T478R in the N-terminal domain (NTD) ...
- Source: drugdu
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Dietary supplement helps combat resistance in breast cancer, finds study

Many cancer therapies do not produce the hoped-for results. A common reason for this is that the tumors develop resistance to the medications. This is the case, for example, with alpelisib, a drug that has been approved for use in Switzerland for the past few years as a treatment for advanced breast cancer. A research group at the Department of Biomedicine of the University of Basel has now discovered that the loss of the neurofibromin 1 (NF1) gene leads to a reduced response to alpelisib. The researchers also found that the dietary supplement N-acetylcysteine restores the sensitivity of cancer cells to this treatment. The findings have been published in the journal Cell Reports Medicine on April 11. Loss of gene triggers resistance At the moment, patients with advanced and metastatic breast cancer lack effective treatment options. The PI3K signaling pathway is often overactive in breast cancer due to mutations promoting tumor ...
- Source: drugdu
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- April 12, 2023
STDs are on the rise. This morning-after-style pill may help

US health officials released data Tuesday showing how chlamydia, gonorrhea and syphilis cases have been accelerating, but doctors are hoping an old drug will help fight the sexually transmitted infections. Experts believe STDs have been rising because of declining condom use, inadequate sex education and reduced testing during the COVID-19 pandemic. Millions of Americans are infected each year. Rates are highest in men who have sex with men, and among Black and Hispanic Americans and Native Americans. “Sexually transmitted infections are an enormous, low-priority public health problem. And they’ve been a low-priority problem for decades, in spite of the fact that they are the most commonly reported kind of infectious disease,” said Dr. John M. Douglas Jr., a retired health official who lectures at the Colorado School of Public Health. To try to turn the tide, many doctors see promise in doxycycline, a cheap antibiotic that has been sold for more than ...
- Source: drugdu
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- April 12, 2023

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