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I.R. Tubes Pvt Ltd, a leading supplier of specialty chemicals in India, today announced the expansion of its product line to better serve the rising demand in pharmaceutical, medical device, and industrial manufacturing sectors. The company’s latest initiatives are aligned with India’s "Make in India" vision, aiming to deliver advanced chemical solutions that meet global regulatory and ...
Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. The MAA is complicated by the need to consider both European economic integration and the independence of individual member states. As a specialist in regulatory matters, Proregulations has ...
The EU Active Substance Master File (ASMF) is a technical document containing confidential information on an API that is submitted by the manufacturer of the API to the EMA or the medicines regulatory authority of an EU member state. As a form of DMF in the EU, the ASMF is used to support MAA or MAV by manufacturers of pharmaceutical preparations for human or veterinary use. The ASMF applies to ...
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness in terms of intended use, design, ...
The FDA regulates cosmetics and their ingredients on the U.S. cosmetics market. Strict adherence to FDA regulations and standards is essential for the smooth entry and successful operation of cosmetic products on the US market. At Proregulations, a company that specializes in assisting with regulatory compliance, we offer U.S. Cosmetics Registration services designed to ensure that cosmetics meet ...
An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but ...
Biopharma PEG, a key provider of premium polyethylene glycol (PEG) derivatives, is thrilled to announce a substantial expansion of its large-scale Good Manufacturing Practice (GMP) production capabilities. This strategic move is aimed at addressing the rising global demand for Lipid Nanoparticles (LNPs), which are vital for nucleic acid drug delivery, especially in mRNA-based therapies and ...
Biopharma PEG, a leader in PEG derivatives, is excited to announce the expansion of its high-purity Multi-Arm PEG linker product line, catering to the evolving needs of the medical and bioorganic fields. These advanced PEG linkers are available in various functional groups and molecular weights ranging from 1k to 40k, offering unmatched versatility and performance for research and development in ...
CanaQuest Medical Corp (“CanaQuest” or the “Company”) (OTC: CANQF), is pleased to announce strategic additions to its executive team with expertise in conducting clinical trials and US FDA drug approval success. The team plans to effectively navigate the regulatory approval process for Drug Candidate, CQ-001 (cannabidiol + proprietary API composition), to treat rare ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the launch of its new Force Degradation Services to help pharmaceutical and medical device companies evaluate the stability of their drug candidates and finished products under a variety of stress conditions, ensuring their safety and efficacy throughout their shelf life. Forced ...
BySTEMart
The multi-target research and development partnership will focus on severe skin diseases The collaboration leverages etherna’s proprietary mRNA and lipid nanoparticle (LNP) technology with Almirall’s expertise in the dermatology space In addition to upfront and technology access payments, etherna is eligible to receive €300 million in development and commercial ...
ByeTheRNA
Amerigo Scientific, a distributor focused on providing critical products and services to biomedical and life science communities, unveils the addition of the reliable Daptomycin ReadyMade™ Solution to its growing portfolio of innovative products to power up spectrum and microbiology applications. Daptomycin is an essential antibiotic used in the treatment of serious bacterial infections, ...
Efficient leadership plays a huge role in bringing a clinical trial to fruition. Pharmaceutical companies are not immune to making mistakes and facing failures. Lack of funding, safety issues, and patient dropouts are some of the struggles clinical development teams face. Some problems you as a leader may face may not always be in your control, e.g., lack of funding. Other ...
Europe-wide aid project for the protection of people with paraplegia Cologne, 28/05/2020 – COVID-19 can be particularly dangerous for people with severe spinal cord injuries. That is why FARCO-PHARMA supports the European Spinal Cord Injury Federation (ESCIF) and the Association of Paraplegics in Germany e.V. (FGQ) with the supply of free protective masks for the caregivers of this ...
ViGeneron GmbH, a gene therapy company, announced the closing of its series A financing round led by WuXi AppTec and Sequoia Capital China. The proceeds will enable ViGeneron to accelerate its proprietary viral vector-based gene therapy platforms and drive product development in its two lead ophthalmic gene therapy programs. Funds will advance development of ViGeneron’s next-generation ...
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced API Impurity Identification services for clients in the medical device, pharmaceutical product, and consumer product industries using a variety of techniques under standard guidance. Impurities are chemical species that differ from the chemical compositions of desired ...
BySTEMart
Dr. Walid Abi-Saab has decided to retire from the company as Chief Medical Officer and member of the Executive Committee, effective 31 December 2022. He will stay with Galapagos until 31 May 2023 to ensure a smooth transition. The company also announces the retirement of André Hoekema who joined Galapagos in 2005 as Chief Business Officer and member of the Executive Committee. Dr. Paul ...
Portal Instruments is pleased to announce the appointment of Dr. Veena Rao, PhD, as Chief Business Officer, effective December 5th, 2022. Dr. Rao will lead the identification, evaluation, and negotiation of partnership opportunities for Portal. In addition, Dr. Rao, in close collaboration with the CEO and cross-functional team, will guide the company’s short and long-term commercial ...
Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for severe lung disease, announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Zephyr® Endobronchial Valve for treating severe COPD/emphysema patients following a positive recommendation by Pharmaceuticals and Medical Devices Agency (PMDA). ...
Shanghai, China and Rapperswil, Switzerland) Shanghai Fosun Pharma (Group) Co. (“Fosun Pharma”, stock code : 600196.SH; 02196.HK) announced that Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. (“Fosun Pharmaceutical Industry”), a controlled subsidiary, signed an exclusive sales agency and development agreement with Switzerland ’s Neovii Pharmaceuticals ...