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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
- 128
- 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
- 106
- 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
- 189
- 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
- 110
- 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
- 131
- 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
- 108
- April 13, 2023
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
- 116
- 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
- 178
- April 13, 2023
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
- 198
- April 13, 2023
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
- 111
- April 13, 2023

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