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Merck plans €300m investment at new German research centre

Merck KGaA (Merck) has announced an investment of more than €300m ($320.8m) in a new Life Science Research Center at its global headquarters in Darmstadt, Germany. Set to open in 2027, the centre will be a hub for developing biopharmaceuticals, including antibodies and messenger ribonucleic acid applications. The investment is part of Merck’s broader €1.5bn commitment to the Darmstadt site by 2025. Covering an area of 18,000m², the Advanced Research Center will consolidate efforts on key life science technologies such as the production of antibodies, recombinant proteins, and viral vectors. It allows collaboration across departments of the company in an open, modern work environment. The facility will also focus on the advancement of cell culture media, pharmaceutical formulation, purification aids, and analytical chromatography. Merck said the new centre will support both European and global customers in addressing significant medical challenges. Merck CEO and executive board chair Belén Garijo said: “With ...
- Source: drugdu
- 102
- April 29, 2024
Chiatai Tianqing’s Class 1 Innovative Drug TQA3038 (siRNA) Completes Phase I Clinical Study

Recently, Chiatai Tianqing Pharmaceutical Group’s self-developed Class 1 innovative drug TQA3038 (siRNA) successfully completed Phase I clinical study. The company will start the follow-up clinical study of TQA3038 injection in patients with chronic hepatitis B in the near future. TQA3038 injection is a small interfering RNA (siRNA) drug independently developed by Chiatai Tianqing to target hepatitis B virus (HBV), with the indication of chronic hepatitis B. TQA3038, as an N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, can be enriched in the liver, degrade the targeted RNA, inhibit translation of the relevant proteins, thus blocking the replication of hepatitis B virus. TQA3038 adopts a nucleic acid sequence with independent intellectual property rights and has strong in vitro and in vivo antiviral activity. The “randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic profile of TQA3038 in healthy adult subjects” initiated by the Company has been successfully completed recently. The ...
- Source: drugdu
- 138
- April 29, 2024
Nestlé India and Dr Reddy’s announces joint venture

The partnership will bring together the global range of nutritional health solutions as well as vitamin, minerals, herbals and supplements of Nestlé Health Science (NHSc) with the commercial strengths of Dr. Reddy’s in India Nestlé India and Dr. Reddy’s Laboratories both together referred as “JV Partners”, today announced that they have entered into a definitive agreement to form a joint venture (“JV Company”) to bring innovative nutraceutical brands to consumers in India and other agreed territories. The partnership will bring together the global range of nutritional health solutions as well as vitamin, minerals, herbals and supplements of Nestlé Health Science (NHSc) with the commercial strengths of Dr. Reddy’s in India. The joint venture will help JV Partners combine their strengths and grow their complementary nutraceuticals portfolios in categories such as metabolic, hospital nutrition, general wellness , women’s health and child nutrition for consumers across India. The JV Company will be ...
- Source: drugdu
- 115
- April 29, 2024
Parexel partners with Palantir to accelerate clinical data delivery

Under the collaboration, Parexel will leverage Palantir’s Foundry and Artificial Intelligence Platform (AIP) to further power its clinical data platform, focused on driving clinical trial efficiency while maintaining the safety and regulatory rigor Parexel and Palantir Technologies has announced a multi-year strategic partnership to leverage AI to help enhance and accelerate the delivery of safe and effective clinical trials for the world’s biopharma customers. Under the collaboration, Parexel will leverage Palantir’s Foundry and Artificial Intelligence Platform (AIP) to further power its clinical data platform, focused on driving clinical trial efficiency while maintaining the safety and regulatory rigor. Parexel is the first CRO working with Palantir in this capacity, building on the companies’ existing collaboration over the past year. Jonathan Shough, Chief Information Officer for Parexel said, “We’re thrilled to expand our collaboration with Palantir — a leader in artificial intelligence technology — as we build on our application of AI ...
- Source: drugdu
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- April 29, 2024
【EXPERT Q&A】What is the specific process of ce certification for medical devices?

Drugdu.com expert’s response: The specific process of CE certification for medical devices typically includes the following steps: 1.Preparation of Application: Manufacturers first need to prepare comprehensive application materials, including technical documentation, product specifications, quality management system documents, etc. 2.Selection of Certification Body: Choose an appropriate certification body for CE certification, ensuring that it is accredited and recognized. 3.Evaluation and Testing: The certification body will conduct evaluation and testing of the product to ensure compliance with the relevant European Union Medical Device Directives. 4.Compilation of Technical Documentation: Manufacturers need to compile complete technical documentation, including product descriptions, design files, test reports, etc. 5.Conducting Audit: The certification body will audit the manufacturer’s technical documentation to ensure its completeness and compliance with requirements. 6.Issuance of Certificate: If the product passes the audit and meets the requirements, the certification body will issue a CE certification certificate, confirming that the product complies with relevant standards ...
- Source: drugdu
- 128
- April 29, 2024
Pharma Asia 2024

Organiser: Ecommerce Gateway Pakistan Time:20 – 22 August 2024 address：University Rd, Gulshan-e-Iqbal, Karachi- Pakistan Exhibition hall: Karachi Expo Center Product range: Medical Products exhibition area: Medical diagnostic equipment and supplies, electronic medical equipment and instruments, rescue equipment, medical reagents and equipment, etc Hospital supplies exhibition area: catheters, interventional materials, surgical hygiene products, disposable medical consumables, surgical tools, medical clothing and bedding, first aid equipment, maternal and child care equipment, disinfection equipment, etc Experimental equipment exhibition area: laboratory instruments and equipment, optical instruments and equipment, image analysis and processing system, test instruments and devices, laboratory update and transformation technology, consumables and related software, etc Medicine exhibition area: all kinds of new special medicine, proprietary Chinese medicine, Western medicine, traditional Chinese medicine health products, nutritional food, etc. Traditional medicine: Chinese medicine, herbal medicine, etc Pharmaceutical equipment exhibition area: drug production equipment and technology, drug packaging equipment, drug packaging materials, drug production, cleaning, ...
- Source: drugdu
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- April 29, 2024
Exo adds FDA-cleared AI tools to handheld ultrasound system

Dive Brief Exo has made new artificial intelligence tools available on its Iris handheld ultrasound system, the company said Tuesday. The Food and Drug Administration cleared Exo’s AI tools for analyzing ultrasound images of the heart and lung last year. Exo sees the new capabilities as particularly beneficial for health systems and caregivers in rural and under-resourced settings because they simplify the collection and interpretation of images. Dive Insight Exo received a 510(k) nod for its original Iris device in 2021 and added imaging modes and indications to the clearance the following year. The clearances cover handheld portable diagnostic ultrasound systems, similar to Butterfly Network’s iQ, that enable healthcare professionals to measure body structures and fluids in adults and children. Users can view the images on smartphone screens. In 2023, Exo gained additional FDA clearances for AI products. One clearance covered software that uses machine learning to help quantify bladder ...
- Source: drugdu
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- April 28, 2024
Judge approves settlement of more than $500M from Philips recall

Dive Brief District Judge Joy Flowers Conti approved a settlement on Thursday that will provide more than $500 million to people who purchased, leased or rented recalled Philips devices. Philips must put at least $467.5 million into a settlement fund for users who bought a recalled device and for devices returned to the company. The company must also set aside $34 million into a payer settlement fund. Flowers is a judge for the U.S. District Court for the Western District of Pennsylvania. The agreement does not include personal injury and medical monitoring claims, which the plaintiffs’ attorneys are pursuing separately. Dive Insight The settlement is related to Philips’ ongoing recall of sleep apnea devices and ventilators. Philips started recalling the devices in June 2021 because foam used to soundproof the machines could break down and be inhaled by patients, posing potential health risks. The majority of the funds will go ...
- Source: drugdu
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- April 28, 2024
How Will Walgreens’ Expansion into Specialty Pharmacy Affect the Industry?

Walgreens announced that it is expanding its specialty pharmacy offerings. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry. By Katie Adams on April 25, 2024 Walgreens announced this week that it is expanding its specialty pharmacy offerings to include cell and gene therapy services. The move could allow Walgreens to play a bigger role in a growing market — research shows that specialty medications now account for more than half of the country’s prescription drug spend, despite making up a small percentage of total prescriptions. With the announcement, the pharmacy giant introduced a newly integrated business unit called Walgreens Specialty Pharmacy. The unit encompasses most of Walgreens’ assets in the specialty pharmacy space, including specialty pharmacy subsidiary ...
- Source: drugdu
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- April 28, 2024
FDA Approves Utility Therapeutics’ Pivya to Treat Uncomplicated Urinary Tract Infections in Adult Females

Don Tracy, Associate Editor Pivya has shown efficacy against bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA announced that it has approved Pivya (pivmecillinam), for the treatment of uncomplicated urinary tract infections (UTIs) in adult females. According to the agency, the approval supports a communal health issue, with close to half of all women experiencing at least one UTI in their lifetime. Before reaching approval, Pivya, which is now available, was given Priority Review and Qualified Infectious Disease Product designations. As part of its support against UTIs, Pivya was designed to fight specific bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA based their approval on positive results from three different clinical trials comparing various Pivya dosing regimens to placebo, a different oral antibacterial drug, and ibuprofen. In all three trials, Pivya demonstrated a higher level of effectiveness in treating UTIs ...
- Source: drugdu
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- April 28, 2024

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