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Reuters

After Novartis reportedly backed out of late-stage talks to acquire Cytokinetics earlier this year, the company appears to still be on the M&A prowl.Novartis is in advanced talks to acquire German cancer drug maker MorphoSys, Reuters reports, citing two people familiar with the matter. The anonymous sources stayed mum on details about the bid and a potential acquisition price, according to the news service. Also involved in the MorphoSys M&A talks is Incyte, according to Reuters.As a “matter of policy,” Novartis does not comment on “market rumors/speculations,” a company spokesperson said over email. Incyte and MorphoSys did not immediately respond to Fierce Pharma’s requests for comment. Both known bidders have preexisting ties to the company, with Novartis taking over a MorphoSys preclinical cancer program in 2022 and Incyte partnering on MorphoSys’ sole commercial product, the lymphoma med Monjuvi.Monjuvi garnered $92 million in U.S. sales last year, and MorphoSys expects 2024 sales of between $80 million and $95 million. The Novartis ...
- Source: drugdu
- 107
- February 9, 2024
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace

Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
- Source: drugdu
- 82
- February 6, 2024
FDA clears stereotactic guidance system from ClearPoint Neuro

ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices in neurological procedures. It helps during the planning and operation processes of these procedures, performed in conjunction with using a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placements and electrode introduction. ClearPoint Neuro’s ClearPointer works with SmartFrame OR and a compatible stereotactic optical navigation system. It helps with patient registration and navigation. SmartFrame OR can be used with or without available bone screw fiducials. ClearPoint Neuro plans to begin a limited market release of the system in the first half of 2024. It earmarked the second ...
- Source: drugdu
- 85
- February 6, 2024
Neural Network Recognizes Breast Cancer on Histological Samples With 100% Accuracy

The likelihood of a favorable outcome for a breast cancer patient is greatly influenced by the stage at which the cancer is diagnosed. Histological examination is the benchmark for diagnosis, but its reliability can be affected by subjective interpretations and the quality of the tissue sample. Inaccuracies in these examinations can lead to incorrect diagnoses. Now, a team of mathematicians has developed a machine learning model that significantly enhances the accuracy of identifying cancer in histological images. The highlight of this model is the incorporation of an additional module that boosts the neural network’s “attention” capability, enabling it to achieve near-perfect accuracy. The mathematicians at RUDN University (Moscow, Russia) conducted tests on several convolutional neural networks and supplemented them with two convolutional attention modules. These modules are crucial for detecting objects within images. The model underwent training and testing using the BreakHis dataset, which comprises nearly 10,000 histological images at ...
- Source: drugdu
- 87
- February 5, 2024
Neuro Biotech Alto Adds $128M in IPO Cash for Biomarker-Based Psych Drugs

Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development. By FRANK VINLUAN Matching a drug to a patient’s biology is not a new idea, but it hasn’t caught on in neuropsychiatric disorders, which have high failure rates in drug studies. The technology of Alto Neuroscience brings precision medicine to psychiatric drug research and its IPO has raised $128.6 million to see if this approach can yield better clinical trial results. Alto priced its IPO late Thursday, offering more than 8 million shares for $16 apiece. The Los Altos, California-based company was able to raise more than planned. When Alto set preliminary financial terms earlier this week, it projected offering 6.7 million shares in the range of $14 and $16 each, which would have raised $100.5 million at ...
- Source: drugdu
- 87
- February 5, 2024
CSPC Pharmaceutical Group’s SYS6002’s first human study unveiled at ASCO-GU

From January 25th to 27th local time, the 2024 American Society of Clinical Oncology Urogenital Oncology Branch (ASCO-GU) annual meeting was grandly held in San Francisco. ASCO GU is an academic event in the field of urogenital tumors. The conference will showcase the most innovative scientific progress in this field and discuss the future treatment directions of urogenital tumors. The first human study of SYS6002, a collaboration between CSPC and Fudan University Cancer Hospital’s Professor Ye Dingwei’s team and Professor Zhang Jian’s team – “Evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6002 in patients with advanced solid tumors “An open, single-arm, multi-center phase I clinical trial” – phased research results were presented at the conference in the form of a poster (number B622). Research methods This study is a single-arm, open, multi-center phase I study. Aims to evaluate the safety, tolerability and PK characteristics of SYS6002 in ...
- Source: drugdu
- 137
- February 5, 2024
【EXPERT Q&A】What are the classifications of pharmaceutical intermediates?

Drugdu.com expert’s response: Pharmaceutical intermediates are one or more chemical substances generated during the drug synthesis process, playing a crucial role in the production of the final Active Pharmaceutical Ingredient (API). The variety of pharmaceutical intermediates depends on the chemical structure and synthesis pathway of the target drug. Here are some common types of pharmaceutical intermediates: Benzene Ring Intermediates: Many drugs, especially anticancer and cardiovascular drugs, are based on the benzene ring structure. Heterocyclic Compounds: Such as pyridine, thiophene, imidazole, etc., commonly used in pharmaceutical manufacturing. Amino Acids and Peptides: They are the foundation of many bioactive molecules and drugs, like insulin. Carboxylic Acids and Their Derivatives: Often used in the synthesis of anti-inflammatory drugs and antibiotics. Esters and Ethers: Utilized in the synthesis of various drugs, including painkillers and sedatives. Sulfur Compounds and Thioethers: Play an important role in the synthesis of certain special drugs. Aldehydes and Ketones: Key intermediates ...
- Source: drugdu
- 140
- February 5, 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
- 164
- 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
- 91
- 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
- 200
- February 1, 2024

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