Search Results for “EC” – Page 297 – media

World’s First ‘Blood Matching’ Genetic Test to Better Pair People for Blood Transfusions

In the UK, there are about 17,000 individuals living with sickle cell disorder, and each year there are around 250 new cases. This condition, predominantly affecting people of black African and Caribbean descent, can lead to significant organ damage and intense pain. In contrast, the UK has around 800 patients with thalassaemia and less than 50 new cases annually. Thalassaemia patients struggle to produce sufficient hemoglobin, which, if untreated, can result in life-threatening anemia. This condition is most prevalent among people of Asian, Middle Eastern, and southern Mediterranean backgrounds. While life-saving blood transfusions are a common treatment for these inherited blood disorders, about 20% of patients develop antibodies against certain blood groups, causing delays in their treatment. Now, a groundbreaking ‘blood matching’ genetic test, the first of its kind in the world, is being made available to thousands of these patients in the UK to better pair people for blood ...
- Source: drugdu
- 109
- February 2, 2024
Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

More than two years after Aduhelm’s controversial and ill-fated FDA accelerated approval, Biogen is discontinuing the Alzheimer’s disease therapy after walking a rocky path. Wednesday, Biogen said it’s pulling all efforts from the first-of-its-kind anti-amyloid beta therapy to focus on Leqembi, its Eisai-partnered newer medicine, and its pipeline candidates. The newer drug, Leqembi, won a full FDA approval early last year, making the partners’ marketing efforts on the therapy much simpler than was the case with Aduhelm. Biogen is taking a $60 million charge and is discontinuing all development and sales of Aduhelm, the company said. It’s terminating the ENVISION clinical study, which sought to confirm the benefit of the medicine as required under its 2021 accelerated approval. The decision follows Biogen’s move to launch a strategic review in early 2023 under new CEO Chris Viehbacher, the former Sanofi chief who joined the Massachusetts drugmaker in November 2022. During that ...
- Source: drugdu
- 188
- February 2, 2024
Hengrui’s new breakthrough! China’s first self-developed innovative opioid analgesic drug Tegelidine fumarate was approved for marketing

Recently, Hengrui Pharmaceutical received the “Drug Registration Certificate” approved and issued by the State Drug Administration, approving the launch of the company’s independently developed Tagelidine Fumarate Injection (Asut®) for the treatment of moderate to severe pain after abdominal surgery. This product is China’s first independently developed innovative Class 1 opioid analgesic drug and will provide new treatment options for patients suffering from postoperative pain. So far, Hengrui has got marketing approval for 16 innovative drugs. Postoperative pain is one of the most common forms of acute pain. It is reported that in China the prevalence of moderate to severe acute pain after surgery in patients is as high as 48.7%. At the same time, patients with moderate to severe pain are not satisfied with analgesic treatment, with 28.5% of patients expressing a need for more efficient analgesic therapy1. Taglidine Fumarate Injection is Hengrui’s key milestone product in the field of ...
- Source: drugdu
- 106
- February 2, 2024
MHRA announces two new UK Approved Bodies to certify medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public. LNE-GMED UK and Scarlet NB UK join the seven current UK Approved Bodies, increasing capacity for the certification of medical devices in the UK. LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD). This comes after two of the existing UK Approved Bodies had their scope expanded, with UL International UK now designated to assess and certify general medical devices (in addition to in-vitro devices), and TÜV SÜD now designated to assess and certify ...
- Source: drugdu
- 90
- February 2, 2024
WuXi Biologics Successfully Completes First 1,6000L Manufacturing Run in Ireland

DUNDALK, Ireland, Jan. 31, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has successfully completed the first manufacturing run at its drug substance facility MFG7, paving the way for large-scale commercial manufacturing projects at this Ireland site. The manufacturing run reached 16,000-liter scale by combining four 4,000-liter single-use bioreactors. This pioneering paradigm marks not only the first successful manufacturing run for the MFG7 facility, but also the largest manufacturing scale for WuXi Biologics to date. The Cost of Goods (COGS) from this run is comparable to that of a 16,000-liter traditional stainless-steel bioreactor, reinforcing the comparable cost seen in over 100 runs at 12,000-liter scale single-use bioreactors (6×2,000-liter in MFG2 and MFG5 facilities; 3×4,000-liter in MFG5 and MFG8 facilities) compared with a traditional 12,000-liter stainless steel bioreactor. Dr. Chris Chen, CEO of WuXi Biologics, commented, “We ...
- Source: drugdu
- 153
- February 2, 2024
Rezzayo approved to treat adult patients with invasive candidiasis

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat a fungal infection called invasive candidiasis. Invasive candidiasis is an infection caused by a yeast called Candida. While some common Candida infections (such as thrush) are easily treatable and do not pose a serious risk to health, invasive candidiasis is a severe infection that can affect the blood, heart, brain, eyes and bones and other parts of the body. Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review. The treatment is administered once a week by a drip into the ...
- Source: drugdu
- 156
- February 1, 2024
【EXPERT Q&A】What documents and certifications are needed, and what are the main processes for exporting pharmaceuticals to Canada?

Drugdu.com expert’s response: Exporting pharmaceuticals to Canada requires adherence to specific processes and regulations. Here are the key steps for exporting pharmaceuticals to Canada: Understanding Canadian Regulations: Before exporting, familiarize yourself with the pharmaceutical regulations and regulatory requirements of Canada. Health Canada is the regulatory authority responsible for formulating and enforcing policies on drug imports. Familiarity with these regulations is essential to ensure that the exported pharmaceuticals comply with Canadian standards. Registration and Approval: Pharmaceuticals must be registered and approved by Health Canada before export. Depending on the type of drug, different application forms and materials may be required. Specific requirements can be found on Health Canada’s official website: https://www.canada.ca/en/health-canada.html Quality Management in Drug Production: Ensure that exported pharmaceuticals meet Canadian Good Manufacturing Practices (GMP). Exporting companies should regularly conduct internal audits to ensure compliance with GMP standards. Product Labeling and Instructions: Pharmaceutical labels and instructions must be prepared according ...
- Source: drugdu
- 190
- February 1, 2024
Grifols files lawsuit against hedge fund for making ‘false and misleading statements’

Spanish plasma medicines producer Grifols is clapping back at Gotham City Research, filing a lawsuit that accuses the New York hedge fund of “knowingly making false and misleading statements” about the company “to manipulate the value of Grifols’ stock for their own monetary gain.” The complaint, filed in federal court in the Southern District of New York, comes in response to a report from Gotham on Jan. 9 which accused Grifols of wrongful accounting practices.Gotham called Grifols shares “uninvestable,” and over the next several days the report triggered a drop in Grifols shares of more than 30% and a freefall of its market cap from $7.6 billion to $4.6 billion. In reaction to the Gotham report, in a regulatory filing to Spain’s stock market watchdog CNMV, Grifols called it “false information” and “speculation.” The accounting questions raised by Gotham surround Grifols’ 2018 acquisitions of Haema AG and Biotest though its subsidiary Scranton Enterprises. In essence, Gotham said Grifols has underreported ...
- Source: drugdu
- 178
- January 31, 2024
Hengrui Medicine’s immunosuppressant tacrolimus sustained-release capsules were approved for marketing in the United States

Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company’s tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022. Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and ...
- Source: drugdu
- 112
- January 31, 2024
EMA to support establishment of the African Medicines Agency

EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors. The European Commission’s Directorate-General for International Partnerships has signed an agreement with EMA marking the official launch of the project.AMA will be a specialised agency of the African Union (AU) dedicated to improving equitable access to quality, safe and effective medical products in Africa. To date, 27 countries have ratified the AMA treaty, and more AU members are expected to complete the process in the coming months. The creation of AMA is a unique opportunity to facilitate the regulation and oversight of key medicines at continental level, promoting collaboration among African countries and regions. Cooperation and collaboration are in the DNA of the European medicines ...
- Source: drugdu
- 87
- January 31, 2024

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