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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
- 297
- May 31, 2023
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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- May 31, 2023
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
- 133
- May 31, 2023
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
- 106
- 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
While Pfizer, BioNTech agree to cut COVID vaccine supply to Europe, Moderna sets up shop in China

With demand plummeting for COVID-19 vaccinations, the EU has cut a deal with Pfizer and BioNTech to alter their contract, reducing purchases of the companies’ Comirnaty vaccine by roughly 35%, EU sources told Bloomberg. The companies provided little information on the adjusted contract, calling it a “rephrasing of delivery doses annually through 2026,” in a release. “The agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States,” the companies wrote. “The EC [European Commission] will maintain access to future adapted COVID-19 vaccines and the ability to donate doses.” Some member states opted out of the deal, according to a statement from the EU. Meanwhile, the world’s other premier producer of COVID-19 vaccines, Moderna, is looking to advance sales of its mRNA shot in China, as it has established a unit called Moderna Biotech Ltd. in Shanghai, Reuters reports. Moderna CEO Stephane Bancel visited Shanghai last month, according ...
- Source: drugdu
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- May 31, 2023
Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case

Right before opening arguments were set to begin in Gilead Sciences and Teva’s HIV antitrust trial, the two came to a last-minute settlement with some of the plaintiff groups. Both companies settled with the pharmacy plaintiffs, a group that includes CVS Pharmacy, Rite Aid and Walgreens, while Gilead made a deal with the direct purchasers. Now, indirect purchasers and others involved in the suit can take their claims to a California federal jury. Gilead and Teva confirmed the settlements, and Gilead noted that the lawsuit with the other parties is ongoing. “The claims against Gilead in this lawsuit lack merit, do not accurately reflect antitrust laws, and ignore Gilead’s history of innovation and scientific advancements to help address the pressing challenges of the HIV epidemic,” a Gilead spokesperson said over email. The deals mark an eleventh hour end to a sprawling case that dates back to 2019, when plaintiffs including ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】May I know if a registration certificate is required for the export of pharmaceuticals to the Democratic Republic of the Congo?

Drugdu.com expert’s response: Yes, a registration certificate is required for exporting pharmaceuticals to the Democratic Republic of the Congo. Congolese laws and regulations stipulate that the import of all pharmaceuticals must be authorized and registered by the local health authorities. The registration certificate for the pharmaceutical is a necessary document for entry into the country’s market. Therefore, if you wish to export pharmaceuticals to the Democratic Republic of the Congo, you need to obtain approval and a registration certificate from the Congolese health authorities. Additionally, the Democratic Republic of the Congo has stringent requirements for the quality and specifications of pharmaceuticals. The exported pharmaceuticals must meet local pharmaceutical laws and quality standards. If you are unfamiliar with the pharmaceutical regulations and registration requirements in the Democratic Republic of the Congo, it’s recommended that you consult local legal and trade professionals to ensure your export complies with local requirements and regulations. ...
- Source: drugdu
- 327
- May 30, 2023
What is the process for obtaining FDA certification in the United States?

Drugdu.com expert’s response: 1.Pre-Submission Consultation: This initial step often involves a formal or informal consultation with the FDA to discuss the product’s classification, the type of application needed, and data requirements. 2.Preparing Documentation: Following consultation, you’ll need to prepare all necessary documentation, which usually includes preclinical and clinical data, product information, manufacturing details, labeling, and more. The exact documentation needed will depend on the product classification and type of application. 3.Submission of Application: The next step is to submit your application or registration to the FDA. The type of application may include a Premarket Notification (510(k)), Premarket Approval (PMA), Investigational Device Exemption (IDE), or others, based on the product classification. 4.FDA Review: Once the FDA receives your application, they will conduct a review. This involves an assessment of all submitted materials and may include inspections, additional data requests, and more. 5.FDA Decision: After the review process, ...
- Source: drugdu
- 314
- May 30, 2023
【EXPERT Q&A】What steps does the initiation of a drug development project go through?

Drugdu.com expert’s response: The initiation of a drug development project is a complex process, often involving multiple stages and steps. Here is a general flow for reference: 1.Research background and objectives: Determine the background and objectives of the research, including the type of drug to be developed, therapeutic area, and target patient population, etc. 2.Demand assessment: Assess the market demand, business prospects, and potential risks of developing the drug. 3.Preliminary research: Carry out preliminary research and development work, such as drug molecule design, synthesis, screening, and preliminary in vitro experiments, etc. 4.Development plan: Develop a detailed plan for drug development based on the results of preliminary research, including subsequent experimental design, animal experiments, clinical trials, etc. 5.Project application: Write the project application and submit it to the relevant departments for approval. 6.Project evaluation: Experts and review committees evaluate the project application, including the feasibility and scientific aspects of the development plan. ...
- Source: drugdu
- 261
- May 30, 2023

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