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PEGYLATION - PEGylation - Three Decades of Product Approvals & Technology Development October 1, 2020
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development September 30, 2020
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
Oculis to Present Significant Corporate & Clinical Development Progress September 22, 2020
Oculis S.A., a biopharmaceutical company focused on developing transformative topical ophthalmic treatments to improve the sight and lives of patients,...Vectura Partners With Monash University to Support Development of Inhaled Oxytocin to Prevent Postpartum Haemorrhage September 15, 2020
Vectura Group plc recently announced it has signed an agreement with Monash University’s Institute of Pharmaceutical Sciences (MIPS) to develop inhaled oxytocin delivered via a….
2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development August 24, 2020
This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.
Daré Bioscience Announces Initiation of Phase 1 Clinical Trial of Novel Intravaginal Ring Designed to Deliver Non-oral, Bio-identical Hormone Therapy July 27, 2020
Daré Bioscience, Inc. recently announced the initiation of a Phase 1 clinical trial of DARE-HRT1, designed to deliver bio-identical 17β-estradiol...2020 Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases June 30, 2020
This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.
Daré Bioscience Announces Receipt of $1.5 Million Under the Current Grant Supplement Award for Continued Development of User-Controlled Long-Acting Reversible Contraceptive June 17, 2020
Daré Bioscience, Inc. recently announced the receipt by its wholly owned subsidiary of $1.5 million in additional grant funding from...CURE Announces Exercise of Warrants; Obtains Valuable Proprietary Formulation & Dosage Technology June 10, 2020
CURE Pharmaceutical Holding Corp recently announced it strengthened its balance sheet with the receipt of $1.4 million in cash from...SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules June 4, 2020
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
FORMULATION FORUM - Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19 June 4, 2020
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline June 3, 2020
In part 4 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, analyzes the pipeline with an emphasis on clinical-stage products for which there is more product-related information.
Almac Discovery Enters Into Licensing Agreement for the Development & Commercialization of ALM301 May 19, 2020
Almac Discovery, a member of the Almac Group, recently announced an out-licensing partnership with an undisclosed biotechnology company in order...FORMULATION FORUM - Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway May 4, 2020
Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery & Formulation Product Approvals of 2019 March 30, 2020
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
Positive Update on the Development of New XF‐Platform Drug Formulations March 25, 2020
Destiny Pharma recently announced the completion of the initial phase of its project with MedPharm to develop new topical formulations...BIOSIMILAR DEVELOPMENT - Biosimilar Biological Products: Development & Applications March 2, 2020
Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.
leon & Nucleus Medical Announce Collaboration to Develop & Manufacture Novel Transplantation Medicine February 20, 2020
This license agreement enables Nucleus to utilize proprietary MicroJet Reactor (MJR) nanotechnology to improve stability, increase solubility and enhance bioavailability...SPECIAL FEATURE - Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results January 14, 2020
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.