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Study identifies new genes associated with heart attack risk largely affecting younger women

Research led by the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC) and Universite Paris Cite, and supported by worldwide partners in Canada, the USA and Australia, has identified new genes that are associated with an increased risk of a type of heart attack primarily affecting young to middle-aged women. The results are published in Nature Genetics today, 29 May 2023. SCAD – or Spontaneous Coronary Artery Dissection – is when a bruise or bleed occurs in the wall of a coronary artery, cutting off the blood to part of the heart. This leads to a heart attack. Unlike other types of heart attack, SCAD is most common in women under the age of 60 and is a leading cause of heart attacks around the time of pregnancy. Furthermore, people who have had a SCAD tend to be generally healthy and SCAD can sometimes happen ...
- Source: drugdu
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FDA decisions that could be delayed if the U.S. defaults on its debt

As lawmakers trudge through debt ceiling negotiations, the possibility that the U.S. will default on its loan obligations in the coming days looms like a dark cloud over Washington. Should government coffers run dry on June 1, as Treasury Secretary Janet Yellen has warned they could, federal workers will go unpaid and agencies like the FDA could see operations come to a screeching halt. Just last week, FDA Commissioner Robert Califf said that without a bipartisan bill to raise the debt limit by June, the regulator wouldn’t have the money to pay staff and scientific reviewers, potentially delaying upcoming drug approval decisions, advisory committee meetings and regulations. And with President Joe Biden and House Speaker Kevin McCarthy scrambling to finish negotiations — while haggling over where to cut federal spending in future budget packages — it’s unclear when a deal might be struck, or how long a potential default could ...
- Source: drugdu
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【EXPERT Q&A】How to ace the process of drug registration?

Drugdu.com expert’s response: Drug registration is a complex task that involves multiple steps. To do it well, you need to follow these steps: 1. Understand regulations and guidelines: Firstly, understand the related laws, guidelines, and policies of drug registration to ensure your product complies with the requirements of the country or region where it’s being registered. These laws and guidelines usually cover requirements for drug quality, safety, and efficacy. 2. Prepare registration materials: Prepare relevant registration materials according to the drug registration requirements of the country or region. These materials usually include the chemical, biological, and pharmacological properties of the drug, the drug development process, production technology, quality control, clinical trial data, drug labels, and instructions. Ensure the materials you submit are complete, accurate, and easy to understand. 3. Conduct clinical trials: In some cases, you may need to conduct clinical trials to prove the safety and effectiveness of the ...
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【EXPERT Q&A】How to improve the response rate of emails for international trade development?

Drugdu.com expert’s response: Email marketing, as one of the essential tools for medical trade marketing, can significantly influence customer responses and even determine the success of your orders. Therefore, editing emails requires attention to detail and technique, as a small detail might prompt a customer to reply to your email. So, how can you write high-response-rate emails that make customers eager to reply? Deduo Medical Trade Network shares four essential email editing tips: Five times more people read email subject lines than the email body Readers usually judge whether to continue reading an email based on the subject line’s appeal, especially for customers who receive many emails every day. If your email subject line can grab the customer’s attention, you are already halfway successful. To increase the chances of customers opening your email, consider these three subject line patterns (use with caution as they may risk being marked as spam): 1.Imitate ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】What exactly is the difference between intermediates and active pharmaceutical ingredients?

Drugdu.com expert’s response: Both intermediates and active pharmaceutical ingredients (APIs) are chemical substances used in the pharmaceutical manufacturing process, but they serve different roles and purposes. An API refers to a chemical substance used to manufacture pharmaceutical products, typically obtained through chemical synthesis or natural extraction. APIs are the foundation of pharmaceutical manufacturing and are a crucial factor in determining the quality and efficacy of the drugs. APIs usually have specified chemical structures and purity requirements, therefore, the quality control and standard requirements for APIs are relatively high. Intermediates, on the other hand, are chemical substances used in the synthesis of APIs during the pharmaceutical manufacturing process. They are typically intermediate products obtained through multiple chemical reaction steps. Although intermediates themselves usually do not possess pharmacological activity, they play a significant role in pharmaceutical manufacturing, influencing the synthesis efficiency, quality, and cost of APIs, among other factors. Intermediates generally need ...
- Source: drugdu
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【EXPERT Q&A】What are the market access requirements for medical devices entering the Ecuadorian market?

Drugdu.com expert’s response: The following are the market access requirements for medical devices entering the Ecuadorian market: Registration requirements: All medical devices must be registered with the National Agency for Regulation, Control, and Health Surveillance of Ecuador (ARCSA). Registration requirements include product technical documents, manufacturing license, quality management system, labels, instructions, and samples. License requirements: All medical devices require a medical device license in Ecuador to be sold in the market. The license application requirements include a registration certificate, manufacturing license, product instructions, and other relevant documents. Customs requirements: All imports of medical devices must comply with Ecuador’s customs regulations, including providing product information, product pricing, and the identity of the importer. Labeling requirements: All medical devices must have information such as the product name, usage, manufacturing date, expiration date, and the name and address of the manufacturer marked on the packaging. Ecuador’s medical device classification rules are based on ...
- Source: drugdu
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Study maps immune responses produced by COVID-19 vaccination in First Nations population

Published in Nature Immunology and Nature Briefing, the research is the first of its kind to decisively map immune responses produced by a COVID-19 vaccination in any First Nations populations. In partnership with Menzies School of Health Research, researchers at the Peter Doherty Institute for Infection and Immunity (Doherty Institute) evaluated immune responses in Aboriginal and Torres Strait Islander peoples and non-Indigenous individuals after receiving the mRNA COVID-19 vaccine. Lead author of the study and PhD candidate at the Doherty Institute, University of Melbourne’s Wuji Zhang, said the research provides strong evidence that COVID-19 vaccination triggers effective immune responses against the virus in First Nations peoples. “We found excellent antibody and T cell responses against SARS-CoV-2 in Australian First Nations peoples following COVID-19 vaccination. We saw high levels of antibodies binding to the virus following two vaccine doses,” Mr Zhang said. “T cells against the spike protein, which often recognize ...
- Source: drugdu
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77.4% ORR! Abbisko to present the updated clinical phase Ib data of Pimicotinib (ABSK021) at the 2023 ASCO Annual Meeting

SHANGHAI, May 28, 2023 /PRNewswire/ — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be released at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting to be held in Chicago, USA from June 2 to June 6, 2023. The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of “EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE” in a poster presentation with the poster Bd# of “493”. Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% ...
- Source: drugdu
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US and Mexico sound alarm over cosmetic surgery-linked fungal outbreak

IMAGE SOURCE,ABRAHAM PINEDA Image caption, Mexican authorities shut one of two clinics linked to the fungal outbreak By Laura Gozzi BBC News US and Mexican authorities are urging the World Health Organization (WHO) to declare a public health emergency over a fungal outbreak linked to cosmetic operations in Mexico. The Centers for Disease Control and Prevention (CDC) said two people who got surgeries involving epidural anaesthesia have died of meningitis. Almost 400 people in the US and Mexico are being monitored. Two cosmetic clinics in the Mexican city of Matamoros have been shut. Authorities in both the US and Mexico have urged people who had surgeries involving epidural anaesthesia at either the River Side Surgical Center or Clinica K-3 since January to get evaluated, even if they are currently asymptomatic. The CDC said it had already identified 25 people in the US with “suspected” or “probable” cases of fungal meningitis. ...
- Source: drugdu
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- May 31, 2023
Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension. This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. ZTALMY may be continued in those patients who are aged 18 years and more. A serious and rare genetic disorder, CDKL5 deficiency disorder (CDD) is characterised by early‑onset, difficult‑to‑control seizures besides severe neuro‑developmental impairment. Marinus chairman and CEO Scott Braunstein said: “The CHMP’s positive opinion reinforces the safety and efficacy profile of ZTALMY and is a testament to the tireless efforts and dedication of our team and the CDD community. “This recommendation brings us one step closer to addressing a significant unmet need for CDD patients with treatment-resistant seizures ...
- Source: drugdu
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- May 31, 2023

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