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Articles
KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate April 19, 2022
KemPharm, Inc. recently announced the first subject has been dosed in a Phase 1 clinical trial designed to assess the...Daré Bioscience Initiates Phase 1/2 Clinical Study of DARE-HRT1 April 12, 2022
Daré Bioscience, Inc. recently announced the initiation of a Phase 1/2 clinical study of DARE-HRT1. DARE-HRT1 is a novel intravaginal...SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation April 4, 2022
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
Rani Therapeutics Announces Initiation of Phase 1 Study for Osteoporosis March 23, 2022
Rani Therapeutics Holdings, Inc. recently announced the initiation of a Phase 1 study of RT-102, an oral formulation of the...Soligenix COVID-19 Vaccine Boosts Neutralizing Activity Against SARS-CoV-2, Including Delta & Omicron March 17, 2022
Soligenix, Inc.recently announced the results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in non-human...SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies March 1, 2022
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
Hovione & Zerion Pharma Announce Strategic Partnership February 22, 2022
Hovione recently announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome, Zerion´s proprietary solubility enhancement….
Recipharm Announces Acquisition of Vibalogics & Arranta Bio February 18, 2022
Recipharm is continuing to build its service offerings in new biologic modalities through the acquisition of Vibalogics and Arranta Bio….
Evelo Biosciences Announces Highly Significant Reductions in Clinically Validated Inflammatory Cytokines in EDP1815 Phase 2 Psoriasis Trial February 7, 2022
Evelo Biosciences, Inc. recently announced the results of immunological biomarker analyses from its previously reported Phase 2 trial of orally-dosed...Celsion Corporation Advances Proof of Concept to Non-human Primate Challenge Study Against SARS-CoV-2 With In-Process Vaccine Candidate January 31, 2022
Celsion Corporation recently announced it has engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study with Celsion’s DNA-based approach for….
Starton Therapeutics Successfully Demonstrates Continuous Drug Delivery of Lenalidomide From a Transdermal Patch in an In Vivo Nonclinical Study With STAR-LLD January 24, 2022
Starton Therapeutics Inc. recently announced it successfully obtained promising results in a non-GLP rabbit pharmacokinetic (PK) and skin irritation study of….
Enteris BioPharma to Participate in Biotech Showcase Virtual & BIO Partnering at JPM During J.P. Morgan Week 2022 January 20, 2022
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary...Definitive Agreement to Acquire Exelead Will Strengthen the CDMO Offering for mRNA of the Life Science Business of Merck KGaA, Darmstadt, Germany January 11, 2022
Merck KGaA, Darmstadt, Germany recently announced the signing of a definitive agreement to acquire Exelead, a biopharmaceutical contract development and...Adare Pharma Solutions Announces Appointment of Tom Sellig as Chief Executive Officer January 6, 2022
Adare Pharma Solutions recently announced the appointment of Tom Sellig as Chief Executive Officer (CEO). Sellig, a 30-year veteran of the pharmaceutical and life sciences industries, will lead the….
Metrics Contract Services Appoints Commercial Manufacturing BD Lead January 4, 2022
Metrics Contract Services, a full-service contract development and manufacturing organization (CDMO) in novel oral solid dose (OSD) products, has appointed...Allarity Therapeutics Submits NDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma December 22, 2021
Allarity Therapeutics, Inc. recently announced the submission of a new drug application (NDA) with the US FDA seeking marketing approval...Intensity Therapeutics Reports Promising Early Efficacy Results Using INT230-6 as a Monotherapy or in Combination With Pembrolizumab in Metastatic Breast Cancer December 10, 2021
Intensity Therapeutics, Inc. recently reported safety, pharmacokinetic, biomarker, and efficacy data using INT230-6, with and without pembrolizumab, in heavily pretreated refractory breast cancer patients as part of the….
Fortress Biotech, Cyprium Therapeutics & Sentynl Therapeutics Announce the Initiation of Rolling Submission of an NDA for Treatment of Menkes Disease December 7, 2021
Cyprium Therapeutics, Inc., a Fortress Biotech, Inc. partner company, with support from its licensing partner Sentynl Therapeutics, Inc., a wholly owned subsidiary of Cadila Healthcare Limited, recently announced the initiation of a rolling submission of a New Drug Application….
SCYNEXIS Announces Agreement With FDA on Innovative Strategy for Approval of Oral Ibrexafungerp for Treatment of Invasive Candidiasis December 6, 2021
SCYNEXIS, Inc. recently announced initiation of a global Phase 3 study to evaluate the efficacy, safety, and tolerability of oral...Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings December 1, 2021
Adare Pharma Solutions recently announced the acquisition of Frontida BioPharm, a vertically integrated CDMO focused on oral formulations. The acquisition reinforces….
Company Profiles
Lyophilization Technology, Inc.
Lyophilization Technology, Inc. 30 Indian Drive Ivyland, PA 18974-1431 T: (215) 396-8373 F: (215) 396-8375 E: inquiry@lyo-t.com W: www.lyotechnology.com WHO...DRUG-DEVICE DEVELOPMENT - Exploring the Complexities of Drug-Device Combination Products
Jeremy Guo, Senior Vice President at WuXi Biologics, and colleagues explain that many factors need to be taken into account when producing a Drug-Device Combination Product from development testing to fill/finish and assembly.
