Formulation Development
Adaptimmune & Alpine Immune Sciences Announce Collaboration & License Agreement
Adaptimmune Therapeutics plc and Alpine Immune Sciences, Inc. recently announced a collaboration and license agreement to develop next-generation SPEAR T-cell products that incorporate Alpine’s secreted…
Cybrexa Therapeutics’ alphalex Platform Enables Tumor Targeting of Multiple PARP Inhibitors
Cybrexa Therapeutics recently announced preclinical data supporting the potential of its proprietary alphalex technology platform.
Caris Life Sciences Receives FDA Breakthrough Device Designation
Caris Life Sciences recently announced the US FDA has granted Breakthrough Device designation for the company’s MI Transcriptome companion diagnostic (CDx) test. Designed to detect…
Merus Announces First Patient Treated in Phase 1 Clinical Trial for Advanced Solid Tumors
Merus N.V. recently announced the first patient has been treated in its Phase 1 trial evaluating safety, tolerability, and preliminary efficacy of MCLA-145 for the…
Chinese Patent Office Issues Notice of Acceptance for Multiwavelength PhotoDynamic Therapy
Theralase Technologies Inc., a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds (PDCs) and their associated drug formulations…
Sarepta Announces Agreement With Nationwide Children’s Hospital for Rights to its Gene Therapy Program
Sarepta Therapeutics, Inc. recently announced it has recently signed an agreement with the Research Institute at Nationwide Children’s Hospital (Nationwide Children’s) giving Sarepta the exclusive…
Octapharma Study Demonstrates Cutaquig Efficacy & Safety
Octapharma presented clinical research results at the Clinical Immunology Society Annual Meeting in Atlanta demonstrating the efficacy and safety of cutaquig [Immune Globulin Subcutaneous (Human)…
Merck Announces Results from Phase 2 Trial
Merck recently announced results from a Phase 2 trial (NCT02982972) evaluating the safety, tolerability, and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine,…
HOOKIPA Achieves Research Milestone in Collaboration & License Agreement With Gilead
HOOKIPA Pharma Inc. recently announced it has achieved a further research milestone in its collaboration and license agreement with Gilead Sciences, Inc. for development of a therapeutic hepatitis B virus (HBV) vaccine.
RedHill Biopharma Submits NDA for for H. Pylori Infection Drug
RedHill Biopharma Ltd. recently announced that, following a positive pre-NDA meeting held recently with the US FDA, it has submitted a New Drug Application (NDA) to the FDA for Talicia (RHB-105) for the treatment of H. pylori infection.
Akcea & Ionis Announce European Union Drug Approval for Ultra-Rare Disease
Akcea Therapeutics, Inc. and Ionis Pharmaceuticals, Inc. recently announced that WAYLIVRA has received conditional marketing authorization from the EC as an adjunct to diet in adult patients with genetically confirmed FCS and at high risk for pancreatitis, in whom response to diet and triglyceride-lowering therapy has been inadequate.
Eloxx Pharmaceuticals Presents Positive New Data at ARVO
Eloxx Pharmaceuticals, Inc. recently presented new findings related to preclinical inherited retinal disease therapeutic development at the ARVO 2019 Annual Meeting in Vancouver, BC, on…
Calixar Signs Exclusive Licensing Agreement With Regeneron
Calixar SAS (Calixar), a biotechnology company specialized in native membrane protein stabilization, recently announced it has entered into an exclusive licensing agreement with Regeneron Pharmaceuticals,…
Emendo Biotherapeutics Enters Licensing Option Agreement With Takeda
Emendo Biotherapeutics Inc. recently announced the company signed a licensing option agreement with Takeda Pharmaceutical Company Limited. As part of the transaction, Emendo will receive…
International Stem Cell Completes Enrollment & Dosing in its Parkinson's Disease Clinical Trial
International Stem Cell Corporation recently announced the completion of subject enrollment in its Phase 1 clinical trial of ISC-hpNSC for the treatment of Parkinson’s disease.…
Catalent Invests $40 Million to Increase Patient-Centric Dose Form Manufacturing Capabilities
Catalent recently announced it is investing up to $40 million at its manufacturing facility in Winchester, KY. The investment will see the installation of new…
Emisphere Provides Development Update on Novo Nordisk Drug Using its Eligen SNAC Carrier Technology
Novo Nordisk recently announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for oral semaglutide, a glucagon-like peptide-1 (GLP-1) analogue in a tablet taken once-daily, for the treatment of adults with type 2 diabetes.
Oculos & Optceutics Partner to Bring Expanded Services to Ophthalmic Innovators
Oculos and Optceutics recently announced they are entering into a co-promotion arrangement to provide broader services for clients spanning from early research through product approval.
Caris Life Sciences Acquires Pharmatech
Caris Life Sciences recently announced it has acquired Pharmatech, Inc., a pioneer of the original Just-In-Time research system with the largest research-ready oncology network.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
