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Spherix

U.S. neurologists are “cautiously optimistic” about using Eisai’s Leqembi in Alzheimer’s disease as concerns about safety and the need for the FDA’s full green light for the drug remain high barriers to uptake. That’s according to a new survey and report out by drug launch analyst Spherix Global Insights, which in March asked 73 neurologists working in the U.S. about their use and receptivity of Leqembi, which was partially approved by the FDA at the start of the year. Now launched, the drug finds itself at a strange junction. It still does not have a full FDA approval; that isn’t set to come until early July. While there is another new drug on the market for Alzheimer’s—namely Aduhelm, which Eisai helped create with Biogen—that drug is commercially dead in the water. The Centers for Medicare & Medicaid Services (CMS) refused to cover payments of Aduhelm, which was ...
- Source: drugdu
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- April 14, 2023
These 3D-printed masks could greatly help pediatric burn patients

April 11, 2023 By Jim Hammerand Leave a Comment FacebookTwitterLinkedIn分享 Burn patients wear the masks on their face to heal scars and prevent complications. “I almost prefer to have the mask on,” said patient Laura Weibel (pictured on the left). [Photo courtesy of Formlabs] 3D-printed masks are removing a traumatic part of treatment for children recovering from severe burns. At Romans Ferrari pediatric rehabilitation center in France, a child with facial burns previously would need to sit motionless for a plaster cast of their face to make a mask for treatment. The masks compress the skin to help scars heal without complications, but the heat from warm plaster bandages can make young burn victims uncomfortable — or worse. “It required the patients to be motionless for the duration of the plaster cast that lasts about half an hour, which can be difficult, especially for children, and could reactivate symptoms of post-traumatic stress ...
- Source: drugdu
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- April 14, 2023
This technology could enable time-released drug delivery

April 13, 2023 By Sean Whooley Leave a Comment FacebookTwitterLinkedIn分享 Rice University Ph.D. student Tyler Graf holds a microscope slide. It holds an array of more than 300 tiny biodegradable particles. These can be used for time-released drug delivery. (Photo by Brandon Martin/Rice University) Bioengineers at Rice University developed a new technology for delivering drugs in a time-releasing manner. Kevin McHugh, corresponding author of a study about the technology, believes this could make missing doses of medicines and vaccines a thing of the past. McHugh and the Rice team saw their work published online in Advanced Materials. According to McHugh and graduate student Tyler Graf, encapsulating medicine in microparticles that dissolve and release drugs over time isn’t new. However, they believe their method — using 21st century methods to develop next-level encapsulation technology —offers more versatility in medication delivery. “This is a huge problem in the treatment of chronic disease,” McHugh said in a post ...
- Source: drugdu
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- April 14, 2023
Appeals court rules abortion drug can stay on market — but limits access

A three-judge panel decided mifepristone’s FDA approval shouldn’t be revoked, but its decision could still make the drug much harder to obtain. An appellate court has blocked a ruling that would have suspended the approval of a decades-old abortion pill, but decided the medicine should only stay on the market with strict limitations. The 2-1 decision from the U.S. Court of Appeals for the 5th Circuit upholds the Food and Drug Administration’s 2000 approval of mifepristone, a medicine used in more than half of all U.S. abortions and to treat miscarriages. But the panel also unwound long-running efforts by the regulator to expand access to mifepristone in recent years. Since 2016, the FDA has enabled the drug to be used through ten weeks of gestation, instead of seven. The agency has also allowed the medication to be delivered by mail and prescribed through a teleheath visit, rather than ...
- Source: drugdu
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- April 14, 2023
Chiesi Farmaceutici acquires biopharmaceutical firm Amryt Pharma

Chiesi Farmaceutici has completed the previously announced acquisition of global, commercial-stage biopharmaceutical company Amryt Pharma. The definitive agreement between the companies was initially signed in January this year. The total deal value at close is nearly $1.2bn in upfront consideration and contingent value rights (CVRs) representing an additional potential consideration of around $225m. Chiesi Global Rare Diseases head Giacomo Chiesi said: “Amryt has unique and clinically differentiated products and additional promising drugs in its pipeline, and, as a benefit corporation certified B Corp, Chiesi has a patient-centric and sustainable model in place to make these treatments available to even more patients who need them.” With this acquisition, Chiesi will be able to expand patient access to approved treatments and also advance efforts for the development of new treatments for individuals with rare diseases. Chiesi Group CEO Giuseppe Accogli said: “This acquisition reflects Chiesi Group’s commitment towards patients. ...
- Source: drugdu
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- April 14, 2023
Engineers find cancer cells have remarkable ability to penetrate deep into their environment

In the 1835 Hans Christian Andersen fairy tale “The Princess and the Pea,” a princess is deemed authentic because of her sensitivity to a pea placed under 20 mattresses on her bed. New research from the McKelvey School of Engineering at Washington University in St. Louis has found that like the fabled princess, cancer cells can sense a layer of cells beneath the top collagen layer on which they normally travel, while normal cells cannot. Amit Pathak, an associate professor of mechanical engineering and materials science, and Christopher Walter, a postdoctoral research associate in Pathak’s lab, found that cancer cells have what they term “depth mechanosensing,” or the ability to sense the properties of the distant environments underneath their immediate extracellular matrix. This could mean that the mechanical properties of extracellular matrices located away from the cells could regulate cell migration. Results of their research were published online in Cell Reports on April 5. Pathak ...
- Source: drugdu
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- April 13, 2023
Identifying ‘hallmark’ Parkinson’s disease protein buildup could aid early detection, improved diagnosis and treatment

A technique that identifies the build-up of abnormal protein deposits linked to Parkinson’s disease could aid in early detection and play a key role in the disease’s clinical diagnosis and characterization, according to research published in The Lancet Neurology journal. Findings from the study confirm that the technique—known as α-synuclein seed amplification assay (αSyn-SAA)—can accurately detect people with the neurodegenerative disease and suggest it can identify at-risk individuals and those with early, non-motor symptoms prior to diagnosis. The presence of misfolded α-synuclein protein aggregates in the brain is the pathological hallmark of Parkinson’s disease. Co-lead author Professor Andrew Siderowf, of the University of Pennsylvania Perelman School of Medicine (U.S.) and Parkinson Progression Marker Initiative (PPMI) investigator, says, “Recognizing heterogeneity in underlying pathology among patients with Parkinson’s disease has been a major challenge. Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially ...
- Source: drugdu
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- April 13, 2023
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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- April 13, 2023
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

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