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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
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- 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
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- 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
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- May 30, 2023
【EXPERT Q&A】How to find overseas customers for veterinary raw materials?

Drugdu.com expert’s response: Finding overseas customers for veterinary active pharmaceutical ingredients requires certain market research and marketing strategies. Here are some possible methods: 1. Participate in international trade shows: Attending international trade shows in the veterinary industry can enhance brand visibility, establish an international business network, and provide an opportunity to interact directly with overseas customers to understand their needs and feedback. 2.Use internet search engines: You can find potential overseas customers for related veterinary products and ingredients via search engines, particularly popular ones like Google and Bing. You can then proactively reach out to them. 3.Leverage B2B platforms: B2B platforms such as Alibaba are professional industry websites that provide international trade information for veterinary products and raw materials. You can register and post product information to attract the attention of overseas customers. 4.Seek local agents: Consider finding local veterinary drug agents or traders to contact overseas customers and establish long-term ...
- Source: drugdu
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- May 30, 2023
Type 2 diabetes patients who were physically active in the afternoon have greater reductions in blood sugar

Over 37 million Americans have diabetes, and 90-95% of that population are diagnosed with type 2 diabetes. Lifestyle interventions, such as a healthy diet and a regular physical activity program, are methods to manage diabetes. A new study from a collaboration of investigators at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, and Joslin Diabetes Center, part of Beth Israel Lahey Health, uses data from the Look AHEAD (Action for Health in Diabetes) study, a randomized controlled trial that compared an intensive lifestyle intervention with diabetes support and education in patients diagnosed with type 2 diabetes and overweight or obesity to track the development of cardiovascular disease over time. In the current study, the research team assessed whether physical activity at certain times of day was associated with greater improvement in blood glucose control. Their findings suggest patients with type 2 diabetes who were ...
- Source: drugdu
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- May 30, 2023
Restoring thought-controlled movement after spinal cord injury using a brain-computer interface

ONWARD Medical N.V., the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces a publication in Nature showing that a wireless brain-computer interface (BCI) can use thought to modulate ARC Therapy. Researchers reported that when paired with ARC Therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved his paralyzed legs. Dave Marver (CEO of ONWARD) said, “This publication shows the remarkable potential of ARC Therapy to be enhanced with the introduction of a BCI, facilitating more natural movement based on the thoughts of a person living with paralysis. We have positioned ONWARD as a leader in the BCI field with our unique understanding of spinal cord stimulation for people with SCI.” As a neuroscientist and professor, EPFL, and Co-author of the Nature Paper, Grégoire Courtine said, “The ...
- Source: drugdu
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- May 30, 2023
Social vulnerability tied to higher assault-related firearm death rates for youth

States with restrictive gun laws have lower rates of assault-related firearm deaths among youths, but youths from socially vulnerable communities are disproportionately impacted across the spectrum of state gun laws, according to a study published online May 24 in JAMA Network Open. Eustina G. Kwon, M.D., M.P.H., from Seattle Children’s Hospital, and colleagues assessed the rate of death due to assault-related firearm injury by community-level social vulnerability and state-level gun laws. The Gun Violence Archive was used to identify all 5,813 assault-related firearm deaths among U.S. youths (aged 10 to 19 years) between Jan. 1, 2020, and June 30, 2022. The researchers found that the death rate in the low social vulnerability index (SVI) cohort was 1.2 per 100,000 person-years versus 2.5 in the moderate SVI cohort, 5.2 in the high SVI cohort, and 13.3 in the very high SVI cohort. Comparing the very high to the low SVI cohort, ...
- Source: drugdu
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- 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
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- May 30, 2023

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