PharmaFocus Today – Page 356 – media

Formus Labs’ Hip Surgery Planning Software Expands with FDA Clearance

In order to carry out a seamless joint replacement, surgeons must create a customized preoperative plan for each patient. However, surgeons having to perform multiple operations per day are often too busy to dedicate adequate time to this step. Formus Labs, a New Zealand-based medical technology startup, is on a mission to make the preoperative planning process much quicker. On Wednesday, the company received 510(k) clearance from the FDA for Formus Hip, its fully automated 3D software for hip replacement preoperative planning. The company announced its plans to expand into the U.S. last year. Wednesday’s FDA clearance represents a major milestone, as Formus can now begin to sell its product to surgeons and healthcare providers across the country. Founded in 2017, Formus seeks to solve the problem of patient dissatisfaction and unsustainable costs in joint replacement surgery, said CEO Ju Zhang in a recent interview. “Our approach to solving this ...
- Source: drugdu
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- May 7, 2023
Researchers find possible link between self-perceived cognitive deficits and symptomatic long COVID

People who perceived that they had cognitive difficulties such as memory problems during COVID were more likely to have lingering physical manifestations of the disease than people who did not report cognitive issues, new UCLA research suggests. More than one in three people experiencing long COVID symptoms perceived such cognitive deficits, which have been found to be related to anxiety and depression. The findings indicate that psychological issues such as anxiety or depressive disorders may play a part in some people who are experiencing long COVID, technically known as post-COVID-19 condition, or PCC. “This perception of cognitive deficits suggests that affective issues—in this case anxiety and depression—appear to carry over into the long COVID period,” said senior author Dr. Neil Wenger, professor of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at UCLA. “This is not to say ...
- Source: drugdu
- 135
- May 7, 2023
WHO declares end to Covid-19 global public health emergency

The spread of Covid-19 is no longer a global public health emergency, the World Health Organization declared Friday. “For more than a year, the pandemic has been on a downward trend with population immunity increasing from vaccination and infection, mortality decreasing, and the pressure on health systems easing,” WHO Director-General Tedros Adhanom Ghebreyesus said at a news conference in Geneva. “This trend has allowed most countries to return to life as we knew it before Covid-19,” Tedros said. “It’s therefore with great hope that I declared Covid-19 over as a global health emergency.” Nearly 7 million people have died from the virus worldwide since the WHO first declared the emergency on Jan. 30, 2020, according to the U.N. organization’s official data. Tedros said the true death toll is at least 20 million. The WHO’s decision comes as the U.S. is set to end its national public health emergency on ...
- Source: drugdu
- 97
- May 7, 2023
Researchers use skull-implantable ultrasound to help deliver chemotherapy to the brain

By Sean Whooley Leave a Comment [Screenshot from video provided by Nortwestern Medicine] Northwestern Medicine shared results from a first-in-human clinical trial for a skull-implantable ultrasound device that supports chemotherapy delivery. The device opened the blood-brain barrier to repeatedly permeate large, critical regions of the human brain. This enabled the delivery of chemotherapy injected intravenously. With the patient awake, a four-minute procedure opens the blood-brain barrier and patients go home after a few hours. Results from the Northwestern study demonstrated both a safe and well-tolerated treatment. Some patients even reached up to six cycles of chemotherapy treatment. The paper published on May 2 in The Lancet Oncology. More about the chemotherapy study The researchers say this marks the first study to successfully quantify the effect of ultrasound-based blood-brain barrier opening on the concentrations of chemotherapy in the human brain. Opening the blood-brain barrier led to approximately a four-to-six-fold increase in drug concentrations ...
- Source: drugdu
- 113
- May 7, 2023
NIH researchers gain new insights on rare immune deficiency

In an 11-year study, researchers at the National Institutes of Health have further characterized idiopathic CD4 lymphocytopenia (ICL), a rare immune deficiency that leaves people vulnerable to infectious diseases, autoimmune diseases and cancers. Researchers observed that people with the most severe cases of ICL had the highest risk of acquiring or developing several of the diseases associated with this immune deficiency. This study, published in the New England Journal of Medicine, was led by Irini Sereti M.D., M.H.S. and Andrea Lisco, M.D., Ph.D. of the HIV Pathogenesis Section in the Laboratory of Immunoregulation at the National Institute of Allergy and Infectious diseases (NIAID), part of NIH, and conducted at the NIH Clinical Center. ICL is a condition marked by too few CD4+ T-cells, which are a type of white blood cell. The clinical definition of ICL is a CD4+ T-cell count of less than 300 cells per cubic ...
- Source: drugdu
- 158
- May 6, 2023
Janssen signs $245m deal with Cellular Biomedicine for pair of CAR T-cell therapies

Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into a worldwide collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) for a pair of CAR T-cell therapy candidates. Under the terms of the agreement, Janssen will pay CBMG an upfront fee of $245m, with the Chinese biotech also eligible for certain milestone payments, as well as tiered royalties. In exchange, CBMG will grant Janssen a worldwide licence to develop and commercialise the CAR-T assets, except in Greater China, with the companies set to negotiate an option for the pharma to commercialise the products in the China territory. The investigational CAR-Ts have shown promising early-stage results in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL), the companies said, with the majority of patients in the studies having diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of aggressive lymphoma, accounting for approximately one-third of ...
- Source: drugdu
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- May 6, 2023
Membrane lipid remodeling alters key enzyme involved in Alzheimer’s

Adding long-chain fatty acids can thicken cell membranes and alter the activity of a key enzyme, as LMU scientists have demonstrated in cell cultures. A characteristic feature of Alzheimer’s disease are deposits of the amyloid-β protein, which clumps together to form plaques in the brain. The amyloid-β protein is produced by an enzyme which resides in cellular membranes. A team lead by Prof. Harald Steiner and Dr. Edgar Dawkins from the Biomedical Center Munich at LMU has now shown that the production of amyloid-β is influenced by the membrane thickness. Cellular membranes consist of lipid bilayers. By externally adding further lipids, they can be thickened, which alters their properties. In earlier studies, Steiner’s team had already demonstrated in cell-free model systems that such changes affect the production of amyloid-β. This effect arises because the key enzyme for the production of amyloid-β, the so-called γ-secretase, is localized inside ...
- Source: drugdu
- 119
- May 6, 2023
Acelyrin follows Kenvue with largest IPO for a biotech startup since 2021

Acelyrin has raised $540 million in an initial public offering, the largest for a biotechnology startup since early 2021 and one of only a handful by young drugmakers this year. The company said Thursday it sold 30 million shares at $18 apiece, exceeding the projections it set earlier this week. It will start trading Friday on the Nasdaq under the ticker symbol “SLRN.” The pace of biotech IPOs has slowed considerably since 2021, when a record 104 startups flooded Wall Street, according to data compiled by BioPharma Dive. The following year, the number of new stock offerings fell by about 80%. Until this week, only five companies had priced a new offering in 2023, the sector’s slowest start in at least five years. The value of those offerings has also trended downwards. Prior to Acelyrin’s offering, nine of the last 15 biotech startups that went public raised $15 million or ...
- Source: drugdu
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- May 6, 2023
Psychiatric disorders in children

Some types of epilepsy medicine taken during pregnancy are associated with an increased risk of severe psychiatric disorders in children. This is the conclusion of a comprehensive study of 38,000 children of mothers with epilepsy by researchers from Aarhus University. The research is published in the journal JAMA Neurology. While it has long been known that some forms of epilepsy medicine used during pregnancy are associated with a risk of birth defects, this new study is the most comprehensive study of children’s mental health so far. Among other things, the researchers found a worrying link between the antiseizure medication valproat and the child’s risk of developing a number of different psychiatric disorders. “Our study shows that four out of ten children born to mothers with epilepsy who had used valproat during pregnancy were diagnosed with a psychiatric disorder before the age of 18, and that the drug was particularly associated with an ...
- Source: drugdu
- 120
- May 6, 2023
FDA issues new draft guidance on decentralised clinical trials

The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional investigation sites. This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects’ will play an important role in addressing public health needs’. ‘By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,’ the FDA said in a statement. The guidance covers recommendations on topics such as DCT design, the use of digital health technologies for remote patient monitoring, ...
- Source: drugdu
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- May 6, 2023

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