Formulation Development
ESCP Models - Hepatitis C Medications (Part 1)
In a series of four articles earlier this year, the principles of the ESCP Analysis process were outlined with a few simple to understand examples. To better explain the application of the process, I have summarized the evolution of Hepatitis C (HCV) treatment from naked Interferon alpha treatment through to the latest….
Novartis Announces Collaboration on HARMONIA, a Phase 3, Head-to-Head Trial Evaluating Kisqali Versus Ibrance in Patients With HR+/HER2- Advanced Breast Cancer
Novartis recently announced a collaboration with SOLTI Innovative Cancer Research (SOLTI) on HARMONIA, an international, randomized, Phase 3, multicenter, open-label study of….
Clarus Therapeutics & McGill University Announce Exclusive Worldwide Licensing Agreement to Develop & Commercialize Technology to Treat Rare Conditions Associated With Coenzyme-Q10 (Ubiquinone) Deficiencies
Clarus Therapeutics Holdings, Inc. and McGill University recently announced a licensing agreement whereby Clarus will develop and commercialize McGill’s proprietary technology designed to treat….
FDA Approves Samsung Bioepis & Biogen’s BYOOVIZ (SB11), LUCENTIS Biosimilar (ranibizumab-nuna)
Samsung Bioepis Co., Ltd. and Biogen Inc. recently announced the US FDA has approved BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab) for the treatment of neovascular….
AVEO Oncology Announces Ficlatuzumab Granted Fast Track Designation by US FDA for the Treatment of Relapsed or Recurrent Head & Neck Squamous Cell Carcinoma
AVEO Oncology recently announced the US FDA has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head…
Carrick Therapeutics Debuts Data for First-In-Class Oral CDK7 Inhibitor Samuraciclib
Carrick Therapeutics recently presented encouraging initial clinical data on samuraciclib (CT-7001), an oral and first-in-class inhibitor of CDK7, at the 2021 European Society of Medical…
Cue Biopharma Granted US Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101
Cue Biopharma, Inc. recently announced the issuance of two new United States Patents Nos. 11,117,945 and 11,104,712 from the United States Patent and Trademark Office.…
Veru Announces Positive Updated Data from Phase 1b/2 Sabizabulin Study in Men With Metastatic Castration-Resistant Prostate Cancer
Veru Inc. recently announced that updated clinical data from the positive Phase 1b/2 study of sabizabulin (VERU-111) in 80 men with metastatic castration-resistant prostate cancer…
ARCA biopharma Announces Enrollment of First International Patient in Phase 2b Clinical Trial Evaluating rNAPc2 as a Potential Treatment for COVID-19
ARCA biopharma, Inc. recently announced the first international patient has been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment…
2021 Analytical Testing eBook - Bioanalytical Testing is Fastest Growing Sector
In this annual Drug Development & Delivery analytical ebook, we present best practices in stability studies as well as the benefits of UPLC optimization…..
Micropore Technologies Announced as a Winner in Heathrow Airport’s Global Britain Business Champion Competition
Micropore Technologies is a global business that has spent many hundreds of hours travelling across the world from London’s Heathrow Airport over recent years. This…
Catalent Signs Commercial Supply Agreement With Phathom Pharmaceuticals
Catalent recently announced it has signed a commercial supply agreement with Phathom Pharmaceuticals, a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments…
Excision Receives FDA Clearance of IND for Phase 1/2 Trial of EBT-101 CRISPR-Based Therapeutic for Treatment of HIV
Excision BioTherapeutics, Inc. recently announced the US FDA has accepted the Investigational New Drug (IND) application for EBT-101, a CRISPR-based therapeutic candidate in development as…
SomaLogic Announces Strategic Collaboration With UPMC to Tailor Clinical Care Through Proteomics Technology
SomaLogic recently announced a strategic collaboration with leading health system UPMC to explore how the large-scale study of proteins and….
ProQR Announces Axiomer RNA Editing Licensing & Research Collaboration With Lilly
ProQR Therapeutics N.V. recently announced a global licensing and research collaboration with Eli Lilly and Company (Lilly) focused on the discovery, development, and….
Longeveron Partners With Kinesiometrics to Create & Implement Cutting-Edge Smart Phone App to Measure Physical Responses to Cell Therapy
Longeveron Inc. has entered into an agreement with Kinesiometrics Inc., to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality….
AzurRx BioPharma Announces Acquisition of First Wave Bio & its Proprietary Niclosamide Formulations Targeting Multi-Billion Dollar Inflammatory Bowel Disease Indications
AzurRx BioPharma, Inc. recently announced it has entered a definitive agreement to acquire First Wave Bio, Inc. in a stock and cash transaction valued at….
Denali Therapeutics Announces Initiation of Phase 1b Study of EIF2B Activator DNL343 in ALS
Denali Therapeutics Inc. recently announced that dosing recently commenced in a Phase 1b study of DNL343, its brain-penetrant small molecule activator of EIF2B, in participants diagnosed…
Kinnate Biopharma Inc. Presents Preclinical Data on its Lead FGFR Inhibitor Candidate
Kinnate Biopharma Inc. recently announced results from preclinical studies evaluating its lead Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248. These findings were presented during…
Pii Invests in Expansion of Sterile Fill-Finish Capacity & Capabilities
Pii has strategically invested in expansion of our sterile fill-finish capacity and capabilities, with production lines capable of supporting large commercial scale batch sizes. Specifically,…
