Formulation Development
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…
Zelluna & Glycostem Announce Development, License & Supply Agreement
Zelluna Immunotherapy and Glycostem Therapeutics BV recently announce they have entered into a development, license, and supply agreement. This collaboration will focus on the development…
Biogen Announces Enrollment Completion of Global Phase 3 Gene Therapy Study
Biogen Inc. recently announced the enrollment of the last patient in the global Phase 3 STAR clinical study, which is evaluating the investigational gene therapy…
Protalix BioTherapeutics & Chiesi Farmaceutici Announce Successful Pre-BLA Meeting
Protalix BioTherapeutics, Inc. and its development and commercialization partner, Chiesi Farmaceutici S.p.A. recently announced that they have completed a successful Type B Pre-Biologics License Application (BLA) meeting with the US FDA regarding….
Seelos Therapeutics Receives FDA Fast Track Designation for Intranasal Drug
Seelos Therapeutics, Inc. recently announced the US FDA has granted Fast Track designation to its new, investigational intranasal racemic ketamine program, SLS-002, for the treatment of…..
Cytel Acquires MTEK Sciences, Further Expanding Advanced Real-World Analytics Capabilities
Cytel Inc. recently announced that it has acquired MTEK Sciences to further expand its advanced real-world analytics (RWA) capabilities….
Atlas Nanotech Targets the World’s Largest Consumer Health Products Companies
Costas, Inc. DBA/Atlas Nanotech, (the Company) is currently in discussions to license their proprietary nanotechnology vitamin a (retinol) based crystalline eye drops known under the…
