PharmaFocus Today – Page 346 – media

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
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- 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 ...
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- 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 ...
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- 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 ...
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- 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 ...
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- 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 ...
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- 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 ...
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- 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 ...
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- 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.” ...
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- 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
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- May 17, 2023

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