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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 ...
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 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 applications for new active substances, pharmacopeial active substances (included in the EP) and existing active substances (excluded from the EP). ...
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 ...
Our service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. Our featured services include but are not limited to FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, New Dietary ...
Our service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. Our featured services include but are not limited to FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, New Dietary ...
By facilitating the development of cutting-edge therapies, our products support advancements in various medical fields, including gene therapy, vaccine creation, and oncology treatments. “At Biopharma PEG, we are dedicated to providing innovative, high-performance PEG products tailored for the pharmaceutical and biotech sectors,” stated Brenda, ...
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 ...
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 ...
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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 ...
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Amerigo Scientific, as a reliable product and service distributor for research institutions and enterprises in the biological, chemical, pharmaceutical, medical, and other industries, recognizes the increasing need for reliable and ready-to-use solutions that can optimize lab workflows and ensure consistent results. ...
Efficient leadership plays a huge role in bringing a clinical trial to fruition. Pharmaceutical companies are not immune to making mistakes and facing failures. ...
The organization aims to supply the people affected in 28 European countries with free medical mouth-nose-protection for their caregivers as a form of external protection. ...
ViGeneron’s pipeline in gene therapy addresses ophthalmic diseases with high unmet medical need, including two programs in development for undisclosed indications where no approved treatment options are currently available. ...
-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. ...
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Walid Abi-Saab has decided to retire from the company as Chief Medical Officer and member of the Executive Committee, effective 31 December 2022. ...
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 ...
--(BUSINESS WIRE)--Sep. 20, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the European Commission (EC) has granted marketing authorization for AMVUTTRA® (vutrisiran), an RNAi therapeutic for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 ...