Formulation Development
CicloMed Expands Fosciclopirox Phase 1 Trial
CicloMed LLC recently announced the expansion of its fosciclopirox clinical development program. The fosciclopirox first-in-human Phase 1 trial has been expanded to include patients with…
Soligenix Completes Enrollment in its Pivotal Phase 3 Clinical Trial
Soligenix, Inc. recently announced it has completed patient enrollment in its Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in…
Cara Therapeutics Announces Positive Topline Data From Phase 2 Trial
Cara Therapeutics, Inc. recently announced positive topline results from its Phase 2 dose-ranging trial of Oral KORSUVAT (CR845/difelikefalin) for the treatment of pruritus in patients…
Vivera Pharmaceuticals Enters Agreement Clinical Study Agreement With Parexel Biotech
Vivera Pharmaceuticals, Inc. recently announced it has signed an agreement for Clinical Development Services with Parexel International, a leading provider of solutions to accelerate the…
IONTAS & Adaptate Biotherapeutics Enter Collaboration Agreement
IONTAS Limited recently announced it has entered into a collaboration agreement with Adaptate Biotherapeutics to generate and optimize antibodies for novel immuno-oncology targets, including access…
PPD Expands Special Patient Capabilities in Early Development Research
PPD, Inc. has expanded its early development research services by adding significant neuroscience and ethno-bridging expertise, broadening its capabilities to provide increased access to…..
Recipharm Announces Commercial Manufacturing to Support Drug Launch Following FDA Approval
Recipharm, the contract development and manufacturing organisation (CDMO), recently announced ongoing large-scale commercial manufacturing of RedHill Biopharma’s drug, Talicia (omeprazole magnesium,…..
ChemoCentryx & VFMCRP Announce Positive Topline Data From Pivotal Phase 3 Trial
ChemoCentryx, Inc. and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) recently announced positive topline data from the pivotal Phase 3 ADVOCATE trial of avacopan, an…
Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial
Avadel Pharmaceuticals plc recently announced it has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for its once-nightly…
TFF Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial
TFF Pharmaceuticals, Inc. recently announced the initiation of its Phase 1 clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of…
Akcea & Ionis Announce Initiation of NEURO-TTRansform Phase 3 Clinical Trial
Akcea Therapeutics, Inc., a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. recently announced initiation of the NEURO-TTRansform Phase 3 clinical trial for…
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
CDMO SELECTION - Ready to Launch: Developing Your Biologic With an Eye Toward Commercial Supply
Stacey Treichler, PhD, believes the development process for new biologics is complex and requires a substantial amount of time and resources, and reviews some of the areas where careful choice of CDMO is key, including cell line development and cGMP manufacturing capabilities, and how an integrated approach can be beneficial.
CONTINUOUS MANUFACTURING - Continuous Manufacturing in Pharmaceuticals: Implications for the Generics Market
Kamna Jhamb, PhD, says the highly regulated nature of the pharmaceutical sector, and the low-risk-taking nature of this market, are the two main factors that have restrained the implementation of novel methods of manufacturing by pharmaceutical industries. However, the burgeoning demand for complex and innovative therapies and rising competition have led pharmaceutical manufacturers to reconsider their methods of manufacturing.
DRUG DEVELOPMENT EXECUTIVE - ProQR: Developing RNA Therapies for Rare Genetic Disorders
Daniel de Boer, Chief Executive Officer of ProQR, discusses the use of RNA technology to directly target the underlying cause of genetic diseases.
Excision BioTherapeutics Presents Data to Support HIV Cure Using CRISPR Gene Editing Technology
On November 20 at the 6th Annual Personalized Nanomedicine Symposium, researchers working with Excision BioTherapeutics, a gene therapy company focusing on curing viral infectious diseases, delivered two oral presentations to review the multiple years of…
Appili Therapeutics Acquires Clinical-Stage Program From FUJIFILM Toyama Chemical
Appili Therapeutics Inc. recently announced it has signed an agreement with FUJIFILM Toyama Chemical Co., Ltd. to acquire and develop the novel……
Provectus Announces Presentation of Initial Results from Phase 1B Trial
Provectus recently announced that data from the company's ongoing Phase 1b/2 study of lysosomal-targeting cancer immunotherapy PV-10 (rose bengal disodium) in combination with KEYTRUDA (pembrolizumab)…
Amarantus Announces Issuance of Chinese Patent
Amarantus Bioscience Holdings, Inc. recently announced that subsidiary MANF Therapeutics has been issued a Chinese patent covering the use of mesencephalic astrocyte-derived neurotrophic factor (MANF)…
Harpoon Therapeutics & AbbVie Announce Licensing & Option Collaboration
Harpoon Therapeutics, Inc. and AbbVie Inc. recently announced an exclusive worldwide option and license transaction for HPN217, Harpoon’s B cell maturation antigen (BCMA)-targeting Tri-specific T…
