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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
- 94
- 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
- 156
- February 2, 2024
Chip Monitors Cancer Cells in Blood Samples to Assess Treatment Effectiveness

Approximately only half of cancer patients see a positive response to treatments, with the remaining experiencing inadequate outcomes. The high costs and potential adverse reactions of treatments make it crucial for clinicians to quickly determine their effectiveness, or if an alternative therapy is more suitable. Presently, it can take weeks or months to fully gauge the success of cancer treatment, typically using CT scans to measure significant size changes in tumors. While tumor biopsies offer more precise data, their infrequency limits the ability to provide ongoing updates. As a solution, many clinicians are now resorting to liquid biopsies, which involve testing for cancer indicators in a patient’s blood, like tumor-shed cancer cells. However, these tests require sufficiently high cell levels for detection. This is particularly challenging in lung cancer, where some FDA-approved methods for detecting blood-borne cancer cells are ineffective, often due to targeting a single, less common protein in ...
- Source: drugdu
- 146
- February 1, 2024
AI-Based Blood Test Detects Ovarian Cancer With 93% Accuracy

Ovarian cancer, often termed the silent killer, typically presents no symptoms in its initial stages, leading to late detection when treatment becomes challenging. The stark contrast in survival rates highlights the urgent need for early diagnosis: while late-stage ovarian cancer patients have a five-year survival rate of around 31% post-treatment, early detection and treatment can raise this rate to over 90%. Despite over three decades of research, developing an accurate early diagnostic test for ovarian cancer has proved challenging. This difficulty stems from the disease’s molecular origins, where multiple pathways can lead to the same cancer type. Scientists at the Georgia Tech Integrated Cancer Research Center (ICRC, Atlanta, GA, USA) have now made a breakthrough by integrating machine learning with blood metabolite information, developing a test that can detect ovarian cancer with 93% accuracy in their study group. This test outperforms existing detection methods, especially in identifying early-stage ovarian disease ...
- Source: drugdu
- 110
- February 1, 2024
HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 30, 2024: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE® (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). ELUNATE® is a selective oral inhibitor of vascular endothelial growth factor (“VEGF”) receptors -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. This marks the first medicine to be approved under the new mechanism for registration of new drugs (“1+” mechanism) announced by the Government of the Hong Kong Special Administrative Region (“SAR”) in October last year. The mechanism officially commenced on November 1, 2023. It allows drugs which are beneficial for treatment of life-threatening or severely debilitating diseases to apply for registration for use in Hong Kong, if they have supporting local clinical data and recognition ...
- Source: drugdu
- 117
- February 1, 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
- 161
- February 1, 2024
FDA rejects Defender Pharma’s motion sickness nasal gel candidate

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter (CRL) to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion. Barry Feinberg, M.D., the CEO of Defender, a privately held St. Louis company, said in a release that the firm will schedule a meeting with the FDA so it can “understand the issues raised in the CRL so we can develop and implement a comprehensive action plan.” “We remain confident that our intranasal scopolamine is a safe and effective therapy,” Feinberg added. In 2012, the NASA teamed with Irvine, California-based Epiomed Therapeutics to develop a nasal spray version of scopolamine. Astronauts often experience motion sickness in space. Two years later, Defender purchased Epiomed, according to the St. Louis Post-Dispatch. Also working to develop the treatment has ...
- Source: drugdu
- 113
- February 1, 2024
As AstraZeneca gears up for courtroom showdown over IRA, Novo’s case faces separate HHS rebuke

When the Biden administration welcomed the passing of the Inflation Reduction Act (IRA) in August 2022, it marked a rare defeat for the pharmaceutical industry in Washington, D.C. Naturally, drugmakers didn’t lie down without a fight on the controversial topic of Medicare price negotiations. Now, new developments show that the Biden administration is willing to go to the mat in defense of the IRA negotiations. Wednesday, lawyers for AstraZeneca are set to engage in oral arguments against the U.S. Department of Justice in a federal court, according to a September court order and a new report from Bloomberg Law. The British drugmaker aims to challenge the legality of the drug pricing provisions put in place under the IRA, which will allow Medicare to haggle over the prices of some of the costliest drugs it covers starting in 2026. AstraZeneca’s diabetes blockbuster Farxiga ranks among the 10 drugs that were selected ...
- Source: drugdu
- 93
- February 1, 2024
CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13i) Receives Phase III Clinical Trial Summary Report

Recently, CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as “PCV13i”) has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population. CanSinoBio’s PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory. At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines. In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal ...
- Source: drugdu
- 169
- February 1, 2024
Dual-carrier 13-valent Pneumococcal Conjugate Vaccine Receives Overseas Orders, Signs Sales Contract with Indonesian Partner, and Will Soon Realize First Batch of Exports

Recently, BIOKANGTAI’s wholly-owned subsidiary, Beijing Minhai Biotechnology, has signed a sales contract with its Indonesian partner, in which a detailed agreement was made on the quantity, unit price, total amount of the order, and shipment date of the world’s first dual-carrier 13-valent pneumococcal conjugate vaccine developed and produced by BIOKANGTAI to be exported to Indonesia. In October 2023, Minhai Biotech obtained the Marketing License for 13-valent Pneumococcal Polysaccharide Conjugate Vaccine issued by the Indonesian Food and Drug Administration, marking that the vaccine has the basic conditions for sale in the local market in Indonesia. The signing of this contract indicates that after years of market expansion, Kangtai’s 13-valent pneumococcal vaccine has formally opened for overseas sales, and as the relevant work continues to progress, this variety will bring new growth points for the company’s 2024 annual results. Dr. Lucia Rizka Andalusia, Acting Head of Indonesia’s Food and Drug Regulatory Agency ...
- Source: drugdu
- 93
- February 1, 2024

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