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Reduction in neighborhood-related stress leads to improvement in kids’ asthma symptoms

Children whose families participated in a program that helped them move from distressed neighborhoods to areas with lower rates of poverty and better public resources like schools and parks experienced significant improvements in severe asthma episodes, according to a new study led by a researcher at Dell Medical School at The University of Texas at Austin. The study, published today in the Journal of the American Medical Association, involved 123 children, ages 5 to 17, with persistent asthma whose families took part in a six-year housing mobility program in Baltimore. Before moving, for every 100 children, there were approximately 88 severe asthma attacks per year. After moving, there were approximately 40 severe attacks per year, a reduction of more than 50%. In fact, researchers found that the reduction in neighborhood-related stress was responsible for between 20% and 35% of the improvement in asthma exacerbations and symptoms. The number of symptom ...
- Source: drugdu
- 125
- May 18, 2023
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
- 109
- 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
- 126
- 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
- 125
- 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
- 109
- May 18, 2023
Melinta, Xediton partner to commercialise anti-infective products in Canada

Melinta Therapeutics and Xediton Pharmaceuticals have entered an exclusive commercialisation and licensing agreement for four novel anti-infective products. The products include Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Kimyrsa (oritavancin). Under the terms of the deal, Xediton Pharmaceuticals will handle the registration and commercialisation works of these products in Canada. Melinta Therapeutics president and CEO Christine Ann Miller said: “Xediton shares our commitment to ensure that all patients who need our life-saving therapies can get them. “We are confident that Xediton brings the right amount of energy and experience to effectively bring our novel anti-infective portfolio to market throughout this region.” Baxdela is indicated to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), which is caused by designated susceptible bacteria in adult patients. Vabomere will be used to treat complicated urinary tract infections (cUTI), including pyelonephritis, that are caused by the susceptible ...
- Source: drugdu
- 100
- May 18, 2023
Pfizer’s maternal RSV vaccine effective at preventing severe infections in newborns, FDA says, but flags potential risk of preterm birth

By Brenda Goodman, CNN CNN — Pfizer’s vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators. Many parents have been eagerly anticipating this news, particularly after last year’s long and severe RSV season. RSV is a major cause of hospitalization in infants and the elderly each year, and it typically hits hardest during the winter months. Scientists have been working on an effective RSV for young children for roughly 60 years, so there’s plenty of excitement around the prospect of having a candidate get so close to the finish line. But the news isn’t all rosy. Safety data published in an agency analysis Tuesday also showed ...
- Source: drugdu
- 132
- May 18, 2023
Universal flu vaccine based on mRNA tech to be tested by National Institutes of Health

Patients are now enrolling in an early stage clinical trial to test a universal flu vaccine based on messenger RNA technology, the National Institutes of Health announced Monday. Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year. Messenger RNA, or mRNA, is the technology behind Moderna ’s and Pfizer ’s widely used Covid vaccines. NIH played a crucial role in developing the mRNA platform used by Moderna. “A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic,” Dr. Hugh Auchincloss, acting director of National Institute of Allergy and Infectious Diseases, said in a statement Monday. The universal flu vaccine trial will enroll up to 50 healthy people ages 18 through 49 to test whether the experimental shot is safe and produces ...
- Source: drugdu
- 117
- May 17, 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
- 133
- 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
- 118
- May 17, 2023

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