Search Results for “EU” – Page 41 – media

Edelman

A new report by Edelman reveals an East-West divide in how people around the world view pharmaceutical businesses’ trustworthiness and their commitment “to do what is right.” Now in its second year, Edelman’s report found that people living in China, which is the world’s second largest and fastest growing pharma market, reported the highest level of trust in the industry (89%). China was closely followed by India, the world’s largest producer of generic medicines, where 86% of people trust the pharma industry. However, the numbers drop significantly in the West. In the U.K., 60% of people trust the pharma industry to do what is right, and the number dips to 55% in Germany and 52% in France. In the U.S., the world’s largest pharma market, 54% of people trust the pharma industry. The lowest ranking comes from Japan, home of Big Pharmas Eisai and Takeda, which registered a score of ...
- Source: drugdu
- 137
- June 6, 2023
EULAR announces the launch of new survey targeted directly at RMD patients

The European Alliance of Associations for Rheumatology (EULAR) has announced the launch of the EULAR Impact of RMDs Survey, an online questionnaire targeted directly at RMD patients. The data collected through this survey will be an important resource for researchers, healthcare professionals, and patients alike, providing a comprehensive database of patient-reported outcomes on their healthcare situation, and how the illness affects their social and occupational lives. By collecting and analysing data from a large number of patients with RMDs on a recurring basis, the survey will provide valuable insights into the burden of disease and help improve the overall care for people living with these conditions. “EULAR is committed to improving the lives of people with rheumatic diseases,” said Dr Anna Molto, chair of the EULAR Research sub-committee of epidemiology and public health and lead of the project. “The launch of this survey is a significant step forward in our ...
- Source: drugdu
- 107
- June 3, 2023
MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

Dive Brief MedTech Europe has set out its vision for cybersecurity in the medical technology ecosystem in a paper that argues for industry-specific legislation. The trade group outlines three areas of discussion, starting with its belief that medtech security should be regulated under sectoral legislation such as the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Other parts of the paper address MedTech Europe’s preferred approach for tackling ransomware and support for actions to improve digital literacy in general and cybersecurity skills in particular. Dive Insight More connected medical devices have increased the risk that hackers will access confidential data or gain the ability to modify technologies in ways that put patients at risk. As the risks increase, medical device manufacturers “continue to invest significant resources in guaranteeing state of the art cybersecurity for all their products and services,” the trade group wrote. Other groups including ...
- Source: drugdu
- 151
- June 2, 2023
CPhI Worldwide Europe

CPhI Worldwide Europe is a famous brand exhibition in the field of international pharmaceutical raw materials, as well as a professional exhibition in the field of pharmaceutical raw materials and intermediates. The show travels annually between France, Germany and Spain.CPhI World pharmaceutical raw materials, P-MEC pharmaceutical machinery, InnoPack pharmaceutical packaging materials and ICSE contract customization will be held at the same time, realizing four exhibitions in one, becoming a great gathering of the global pharmaceutical industry, in addition to zero distance to understand the latest technology application and product information, the development direction of the pharmaceutical industry, but also play a role in the weather.
- Source: drugdu
- 1,054
- June 1, 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
- 298
- 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
- 109
- 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
- 141
- 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
- 325
- May 30, 2023
European Commission to receive fewer Pfizer-BioNTech vaccine doses under amended contract

Nicole DeFeudis Editor The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.” The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third. Some member states have opted out of the amendment, and “will continue to be bound by current contractual obligations,” the Commission said. The news comes weeks after the World Health Organization ended its three-year global health emergency for Covid-19, while warning that “the virus is ...
- Source: drugdu
- 121
- May 30, 2023
EU regulators recommend yanking authorization for Novartis’ sickle cell med Adakveo after phase 3 miss

After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended snatching back Novartis’ approval after concluding that the med’s benefits did not outweigh the risks. The decision was based on the results of the phase 3 STAND trial, where the drug didn’t outperform placebo. Specifically, Adakveo (crizanlizumab) couldn’t reduce the number of painful crises leading to a healthcare visit. Adakveo-treated patients saw an average of 2.5 painful crises resulting in a healthcare visit over their first year of treatment, while patients in the placebo group had an average of 2.3. Another nail in the coffin was the average number of crises requiring a home healthcare visit or treatment, which ...
- Source: drugdu
- 162
- May 30, 2023

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