Search Results for: COMBINATION PRODUCTS Device Development for
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Perrigo & Catalent Announce FDA Approval February 26, 2020
Perrigo Company plc and its partner Catalent Pharma Solutions recently announced the US FDA has approved Perrigo’s abbreviated new drug...Zai Lab & Novocure Announce First Patient Enrolled in a Phase 2 Pilot Trial January 9, 2020
Zai Lab Limited and Novocure recently announced the first patient has been enrolled in a Phase 2 pilot clinical trial...WuXi STA Opens Oligonucleotide Large-Scale Manufacturing Facility January 6, 2020
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – recently announced the opening of its large-scale...Appili Therapeutics Acquires Clinical-Stage Program From FUJIFILM Toyama Chemical November 21, 2019
Appili Therapeutics Inc. recently announced it has signed an agreement with FUJIFILM Toyama Chemical Co., Ltd. to acquire and develop the novel……
Stevanato Group Signs License Exclusive Agreement With Haselmeier October 10, 2019
Stevanato Group, an Italy-based producer of glass primary packaging and global leader in providing integrated capabilities and solutions for combination...BIOLOGICS DELIVERY - Enabling Biologic Drug Delivery of Volumes Beyond 1 mL August 29, 2019
Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
Mino-Wrap to be Developed Through an IND Process July 31, 2019
Citius Pharmaceuticals, Inc. recently reported the company's decision to develop Mino-Wrap as a drug through the Investigational New Drug (IND)...Oculos & Optceutics Partner to Bring Expanded Services to Ophthalmic Innovators May 1, 2019
Oculos and Optceutics recently announced they are entering into a co-promotion arrangement to provide broader services for clients spanning from early research through product approval.
RISK MANAGEMENT - FDA’s Quality Risk Management Approach to New Drug Applications April 1, 2019
Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.
West Annouces Significant Agreements With Swissfillon & scPharmaceuticals February 7, 2019
West recently announced it has commenced discussions with two companies regarding the use of West’s proprietary SmartDose drug delivery platform for complex molecules.
Pharmapack Report Predicts Diversification of Innovation Leading to a Rise in Licensing & Partnering January 25, 2019
Pharmapack Europe (February 6-7, Paris Expo Porte de Versailles, Paris) has released a European Drug Delivery and Packaging report, ahead of the event’s opening, which highlights, major challenges and opportunities for the industry in the year ahead.
TrakCel & Quick Partner to Provide Industry-Leading Digital Supply Chain IT Solution for Cell & Gene Therapies January 18, 2019
TrakCel and The Quick Life Science Group recently announced a partnership to offer an integrated IT logistics orchestration platform.
SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing January 10, 2019
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
Histo-Scientific Research Laboratories & Vet Path Services Merge December 11, 2018
Histo-Scientific Research Laboratories, Inc. (HSRL), has completed its merger with Vet Path Services (VPS) to create the leading provider of...EXECUTIVE INTERVIEW - BD Integrated Systems: From Innovation to Integration November 12, 2018
Theresa Bankston, PhD, Director of the Technical Services group for BD Medical – Pharmaceutical Systems, discusses the advantages of using an integrated system for complex drug-device combination products.
Enable Injections Enters Strategic Partnerships With UCB & Apellis November 12, 2018
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
MARKET BRIEF - Alzheimer’s Disease Market Report (2016-2026) October 2, 2018
Akiko Fukui, MSc, indicates that amid several failures, the AD pipeline is large and consists of many novel mechanisms, which makes it an exciting market undergoing rapid changes despite its high risk.
Cobra Biologics, GE Healthcare & Centre for Process Innovation Collaborate to Advance Gene Therapy September 28, 2018
Cobra Biologics recently announced a collaboration with the Centre for Process Innovation (CPI), a UK-based technology innovation centre and GE...EXECUTIVE INTERVIEW - SHL Group: Expansion Driven by Our Partners August 27, 2018
Taras Seniuch, Director of Business Development at SHL’s contract manufacturing organization, SHL Pharma, talks about his company’s unique service offering for its partners.
BASi & Seventh Wave Laboratories Combine Operations to Provide Broader Solutions & Greater Scientific Expertise to Clients July 3, 2018
Bioanalytical Systems, Inc. and Seventh Wave Laboratories, LLC, recently announced they have signed an asset purchase agreement (APA) joining operations...WHITEPAPER - Addressing Regulatory Challenges for Ophthalmic Combination Products
Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..
