Search Results for “EC” – Page 426 – media

Moderna hits back at Alnylam’s ‘baseless’ patent infringement claims

The United States’ COVID-19 health emergency might be over, but vaccine-related lawsuits are moving forward in full force. After Alnylam levied patent infringement claims against Moderna last year, the mRNA specialist is hitting back. In a pair of countersuits, Moderna claims Alnylam “baselessly seeks to profit” from Moderna’s inventions. Alnylam first sued Moderna in March 2022, claiming patent infringement on its so-called ‘933 patent. The patent covers delivery technology that Alnylam says is infringed by Moderna’s popular vaccine Spikevax. Alnylam later claimed violations on another patent that it received in July. The company did not seek to stop sales of the lucrative mRNA vaccine but instead requested damages and royalties. But Moderna isn’t having it. “Alnylam played no role in Moderna’s significant accomplishments,” the company said in a pair of countersuits, filed last week. The Spikevax maker says that it had been pioneering mRNA technologies for a decade before the ...
- Source: drugdu
- 107
- May 18, 2023
FTC sues to block Amgen’s $28B Horizon buy in alarming sign for biopharma M&A

Just as biopharma’s M&A prospects seemed to be improving, the U.S. antitrust watchdog is putting a damper on dealmaking. The U.S. Federal Trade Commission has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, the agency said Tuesday. By a unanimous vote among the three Democrat commissioners, the agency is seeking a temporary restraining order and preliminary injunction to prevent the transaction from closing. In an alarming sign for biopharma M&A scrutiny to come, the FTC argues Amgen could leverage its existing product portfolio to “entrench the monopoly positions” of Horizon meds for thyroid eye disease and chronic gout. The antitrust challenge marks the first time that the FTC has reached beyond specific product overlaps in its reviews and instead focused on companies’ past behaviors around drug pricing. It’s an approach that the agency has threatened to implement since 2021 but has only now reared its ...
- Source: drugdu
- 122
- May 18, 2023
Vegan mothers’ breastmilk contains two important nutrients, study finds

A vegan diet does not affect maternal breastmilk concentrations of vitamin B2 and carnitine, nutrients essential for the developing infant. These are the results of an Amsterdam UMC study, presented today at the 55th Annual Meeting of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Research has found that lactating mothers following a vegan diet compared to mothers with an omnivorous diet showed no difference in the human milk concentrations of vitamin B2 or carnitine, despite these nutrients being found in highest concentrations in animal products. Using a technique that separates a sample into its individual parts and analyses their mass, this study challenges assumptions that vegan diets may not be nutritionally complete and that breastfed infants of vegan mothers may be at an increased risk of developing vitamin B2 or carnitine deficiency. In the last four years, the number of vegans in Europe alone has doubled. Lead ...
- Source: drugdu
- 124
- May 18, 2023
`FDA advisory committee backs Sarepta’s Duchenne muscular dystrophy gene therapy

A US Food and Drug Administration’s (FDA) panel of experts has recommended Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) investigational gene therapy for accelerated approval. The Cellular, Tissue and Gene Therapies advisory committee voted eight to six in support of SRP-9001 (delandistrogene moxeparvovec) as a treatment for ambulatory DMD patients with a confirmed mutation in the DMD gene. DMD is a rare and inherited X-chromosome-linked disease that results in the lack of dystrophin protein, which is required to strengthen and protect muscles. Over time, this causes progressive loss of muscle strength, with most patients requiring full-time use of a wheelchair by their early teens. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The disease almost exclusively affects males, occurring in approximately one in every 3,500-5,000 newborn males worldwide. SRP-9001 is designed to address the underlying cause of DMD ...
- Source: drugdu
- 107
- May 18, 2023
Rapid spread of antibiotic-resistant E. coli across Europe raises concerns

In a recent study published in the journal Eurosurveillance, researchers performed whole genome sequencing (WGS) on 874 Escherichia coli (E. coli) isolates carrying the bla NDM-5 gene, which encodes New Delhi metallo-β-lactamase (NDM)-5. They retrieved the study sample set from 13 European Union (EU)/European Economic Area (EEA) countries between 2012 and June 2022. Background In a survey of carbapenem- and/or colistin-resistant Enterobacterales (CCRE survey) performed across 36 European countries in 2019, researchers detected 62 of 201 carbapenemase-producing E. coli isolates carrying NDM-5 encoding gene ‘blaNDM-5’ in 15 countries. Additionally, they observed that some of these 62 E. coli isolates belonged to high-risk sequence types (STs), which increased the risk of extraintestinal infections. Since these findings were concerning, the European Centre for Disease Prevention and Control (ECDC) requested further investigation into the matter. About the study In the present study, researchers initiated the collection of WGS and epidemiological data on bla ...
- Source: drugdu
- 130
- May 17, 2023
After Hemgenix approvals, uniQure cashes out some of its royalty rights for $375M-plus

Months after the U.S. and European approvals of its CSL-partnered hemophilia A gene therapy Hemgenix, uniQure is selling some royalty rights for up to $400 million. In a deal with HealthCare Royalty (HCRx) and Sagard Healthcare, uniQure agreed to part ways with a portion of its Hemgenix royalty rights. The company previously licensed the drug to Australia’s CSL Behring, and it’s entitled to milestone and royalty payments as the launch progresses. Now, though, it’s trading some of those royalty rights for a quick payday. Under the new deal with HCRx and Sagard Healthcare, uniQure will get $375 million upfront and another $25 million if an undisclosed sales threshold is achieved. The cash lets uniQure “continue to invest” in its adeno-associated virus vector gene therapy pipeline, CEO Matt Kapusta said a statement. The pipeline includes a Huntington’s disease prospect, a refractory temporal lobe epilepsy candidate and an SOD-1 amyotrophic lateral sclerosis ...
- Source: drugdu
- 115
- May 17, 2023
Occasional cannabis use during pregnancy may be enough to impact fetal growth significantly

As more people use cannabis for recreational purposes, attitudes towards the drug have changed. For example, research has shown that dispensaries often recommend cannabis—also referred to as marijuana—to pregnant women to ease pregnancy symptoms, especially morning sickness. There is a growing body of literature attesting to poor child outcomes if cannabinoids are consumed during pregnancy. The exact effects on the developing fetus, however, remain unclear. Researchers in the US have now examined how timing of cannabis exposure during pregnancy impacts fetal development. “We show that even when marijuana use occurred only in the first trimester of pregnancy, birth weight was significant reduced, by more than 150g on average,” said Dr. Beth Bailey, professor and director of population health research at Central Michigan University and senior author of the study published in Frontiers in Pediatrics. “If that use continued into the second trimester, newborn head circumference was significantly decreased as well.” ...
- Source: drugdu
- 106
- May 17, 2023
Novartis brings on 8 business vets for Sandoz’s new board, including 4 women

Novartis has taken another step toward spinning off its generics and biosimilars business Sandoz, identifying eight of its new board of directors.The group includes Nestle chief financial officer Francois-Xavier Roger and former Eli Lilly chief information and digital officer Aarti Shah, Ph.D. They are among eight approved by Novartis after being recommended by Gilbert Ghostine, who was designated as Sandoz’s chairman of the board three months ago. Ghostine been the CEO of Swiss perfume and taste company Firmenich since 2014. Other new members of the board—which will begin prep work for the spinoff—include Urs Riedener, formerly the CEO of Swiss dairy company Emmi; Remco Steenburgen, the CFO at Deutsche Lufthansa AG; and Yannis Skoufalos, a former executive at Proctor & Gamble. In addition to Shah, the board will have three other women including Shamiram Feinglass, M.D., formerly the VP of medical affairs and policy at Danaher; Maria Varsellona, J.D., the ...
- Source: drugdu
- 121
- May 17, 2023
Hyperbaric Oxygen May Improve Heart Function in Long COVID

Marilynn Larkin Editor’s note: Find the latest long COVID news and guidance in Medscape’s Long COVID Resource Center. Hyperbaric oxygen therapy (HBOT) increased markers of heart function in a small randomized, controlled trial of patients with long COVID. Patients with reduced left ventricular global longitudinal strain (GLS) at baseline who received HBOT had a significant increase in GLS compared with those who received sham treatment. GLS is a measure of systolic function that is thought to be a predictor of heart failure-related outcomes. The study also showed that global work efficiency (GWE) and the global work index (GWI) increased in HBOT-treated patients, though not significantly. “HBOT is an effective treatment for diabetic foot ulcers, decompression sickness in divers, and other conditions, such as cognitive impairment after stroke,” Marina Leitman, MD, of the Sackler School of Medicine, Tel Aviv, Israel, told theheart.org | Medscape Cardiology. Her team also studied HBOT in ...
- Source: drugdu
- 111
- May 17, 2023
Cervical Cancer Screenings Double With Mailed DIY Kits

WebMD Health News Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. The self-sampling kits, which detect human papilloma virus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online Thursday in the journal Lancet Public Health. Experts writing in a commentary published with the study said it “provides the required evidence that … self-collected samples can be an effective strategy for hard-to-reach populations.” The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More ...
- Source: drugdu
- 111
- May 17, 2023

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