drug production News
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Lonza to Establish Drug Product Manufacturing Services in Guangzhou, China
As part of Lonza's continued investment in China, a new drug product fill and finish manufacturing line will be installed at its Guangzhou (CN) site The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services The introduction of drug product manufacturing ...
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Lonza to Establish Drug Product Manufacturing Services in Guangzhou, China
As part of Lonza's continued investment in China, a new drug product fill and finish manufacturing line will be installed at its Guangzhou (CN) site The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services The introduction of drug product manufacturing ...
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Evotec Biologics awarded contract from U.S. Department of Defense under accelerated antibodies program
Evotec SE have announced that the U.S. Department of Defense (“DOD”) has awarded Evotec’s Seattle-based subsidiary, Just – Evotec Biologics, Inc. a contract valued up to $ 49.9 m for the rapid development of monoclonal antibody (“mAb”)-based drug product prototypes targeting plague. Plague, an infectious disease caused by the bacterium... READ MORE ...
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Microviable will be attending Pharmabiotics Event 2022
Our CEO Claudio Hidalgo will be attending the Pharmabiotics Event 2022 taking place on April 20th-21st at Lyon. The Pharmabiotics Conference brings together players from academia and industry and it is an incredible opportunity to meet stakeholders and discuss the further innovation in microbiome-based drug products and regulatory affairs. Reach out to us if you want to meet during the ...
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Lupin and Axantia Enter into a License, Supply and Technology Sharing Agreement for Pegfilgrastim in the Middle East and North Africa
Global pharma major, Lupin Limited (Lupin) announced today that they have entered into a License, Supply and Technology Sharing agreement with Axantia Holding (Axantia), a leading pharmaceutical company in the region operating through its pharmaceutical subsidiaries; Pharma International Company and Med City Pharmaceutical Industries. Under the terms of Agreement, Axantia will register, ...
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FDA issues Anticounterfeiting Guidance
The U.S. Food and Drug Administration (FDA) posted on itswebsite a draft document for comment entitled “Guidance for Industry, Incorporation ofPhysical-Chemical Identifiers into Solid Oral Dosage Form Drug Products forAnticounterfeiting.”1 This memorandum summarizes the Guidance. FDA states in the introduction to the Guidance that it was prompted by actionsbeing taken and/or considered by ...
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Online Sales of Prescription Drugs via Donation
Many public services, e.g. the public school system, make up resource deficits by soliciting or accepting private charitable donations. This strategy does not work for prescription drug donations as they require a medical order for sale to a private customer; a prospective donor can’t simply walk into Walgreens and buy epinephrine, heparin, insulin, Zofran, Dilaudid or ketamine. Emergency ...
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FDA Will Hold NanoDay Virtual Research Symposium on October 9
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA. The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product ...
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Scandinavian Biopharma welcomes Anna Sumic to the position as Drug Substance and Drug Product Manufacturing Specialist
Scandinavian Biopharma continues to strengthen its organization in manufacturing and is pleased to welcome Anna Sumic as our new DS & DP Manufacturing Specialist. Anna has a Master of Science in Chemistry and Chemical Engineering from KTH, Royal Institute of Technology, with 15 years of experience within the pharmaceutical industry. She is joining us from AFRY, a consulting company, where ...
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Aurobindo Pharma receives USFDA Approval for Bivalirudin Injection
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bivalirudin injection, 250 mg/vial. The approved ANDA is a generic equivalent to the reference listed drug (RLD) product Angiomax® Injection of The Medicines Company. The estimated market size Bivalirudin injection is US$ 101 ...
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Lumosa One of the Finalists for Clinical Advance of the Year Award in Scrip Awards 2022
We are delighted to announce that Lumosa's LT3001 (odatroltide) has been shortlisted for the "Clinical Advance of the Year Award" at this year's Pharma Intelligence Scrip Awards. This Award seeks to recognize success in a clinical trial of a new drug product (biological or chemical) that is expected to lead to an advance in healthcare. Other finalists include Boehringer Ingelheim and Eli Lilly's ...
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Welcome Emmanuelle Bommier, Senior Director, Business Development, to Minaris Regenerative Medicine (United States)
Minaris Regenerative Medicine (United States) welcomes Emmanuelle Bommier in the role of Senior Director, Business Development, effective August 30, 2021. In her role as head of business development for North America, reporting to CEO, Dr. Kazuchika Furuishi, Emmanuelle will be accountable for creating new business opportunities and client management for Minaris in the United States, as well as ...
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Halo Labs Launches New Instruments For Protein, Cell, And Gene Therapy Developers – PR Newswire
Halo Labs, a life science instrumentation company developing tools for biologics researchers, today announced that it has launched its latest products – Aura+ and Aura PTx. Aura+ and Aura PTx are the next generation in Halo Labs’ popular family of instruments that combine Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM). Drug product researchers can ...
By Halo Labs
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Thermo Fisher Scientific Further Expands Global Footprint for Drug Product Development and Commercial Manufacturing
Thermo Fisher Scientific, the world leader in serving science, today announced it will further expand its footprint in North America and Europe for sterile drug product development and commercial manufacturing of critical medicines, therapies and vaccines. "We have continued to invest strategically in capacity, technology and expertise across our global network so we can accelerate innovation ...
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BioQ Pharma Announces Positive Closure of EU Regulatory Procedure for Ready-to-Use Propofol Product
BioQ Pharma Incorporated (“the Company”), a specialty pharmaceutical company focused on developing and commercializing ready-to-use infusible pharmaceuticals, today announced the positive closure of a European regulatory procedure for its propofol product. The Company’s ready-to-use infusion pharmaceutical includes the propofol drug product and delivery system in a single-use ...
By BioQ Pharma
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CD Formulation Offers Forced Degradation Studies
To ensure the safety and efficacy of the drug product, chemical stability is of paramount importance. Earlier this month, CD Formulation announced its decision to launch forced degradation studies to help researchers find ways to promote drug stability. The forced degradation study, also known as stress testing, is carried out to produce representative samples for developing stability-indicating ...
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DermBiont Announces Positive Results in Phase 2a Clinical Trial in Atopic Dermatitis with a Topical Live Biotherapeutic
BOSTON, Jan. 8, 2021 /PRNewswire-PRWeb/ -- DermBiont, a clinical-stage biotechnology company developing targeted topical therapeutics, - announced today that its Phase 2a clinical trial with its investigational drug product, DBI-001, in atopic dermatitis, has demonstrated decreases in the abundance in S. aureus, improvement in signs and symptoms of atopic dermatitis, and no safety or ...
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Minaris will be the commercial manufacturer in Europe for Skysona™, bluebird bio`s gene therapy for CALD
Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing organization (CDMO) for the cell and gene therapy industry, will be the commercial manufacturer in Europe for SkysonaTM (elivaldogene autotemcel, Lenti-D™), a product of bluebird bio, Inc. Today, the European Commission (EC) has granted marketing authorization for SkysonaTM, the ...
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In Recent Guidance, FDA aims for Patient Safety at 503B Facilities
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB) Healthcare Packaging explains: "A Dec. 10 statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram focused on the importance of ensuring compounded product quality. FDA noted that it continues to implement its 2018 Compounding Priorities Plan as part of its ...
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Natural Product Identification and Production for Drug Discovery Now Available at Creative Biostructure
Creative Biostructure Drug Discovery, a sub-brand of Creative Biostructure, established to apply its expertise in structural biology and membrane proteins to drug discovery process, now offers natural product identification and production service for drug discovery from natural products. Natural products are the source of chemical diversity and are the ideal starting point for most small ...
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