Formulation Development
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…
CURE Pharmaceutical Takes First Step to Acquire Coeptis Pharmaceuticals
CURE Pharmaceutical recently announced it purchased a $200,000 convertible promissory note issued by Coeptis Pharmaceuticals, Inc., a biopharmaceutical company engaged in the acquisition, development and…
PromoCell Now Offers In Vitro Disease Models That Could Lead to New Therapies
PromoCell now offers cell disease models covering a wide range of diseases, including diabetes type 1 and 2, respiratory diseases, such as COPD and asthma,…
Centogene Signs Collaboration Agreement With Pfizer
CENTOGENE recently announced a new data access and collaboration agreement with Pfizer Inc. The agreement grants Pfizer access to CENTOGENE’s data repository, which may be…
Aravive & AstraZeneca Announce Initiation of Randomized Phase 1/2 Study
Aravive, Inc. and AstraZeneca recently announced that an investigator-sponsored Phase 1/2 clinical trial of AVB-500, a GAS6/AXL inhibitor, in combination with durvalumab, a PD-L1 inhibitor,…
NervGen Pharma Expands Platform Into Alzheimer's Disease
NervGen Pharma Corp. recently announced a research initiative to advance its proprietary therapeutic technology platform, currently in development for spinal cord injury and multiple sclerosis,…
Flexion Announces Clearance of NDA for Gene Therapy Candidate
Flexion Therapeutics, Inc. recently announced clearance of the company’s Investigational New Drug (IND) application for FX201 in knee osteoarthritis.