Formulation Development
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.
European Commission Approves Treatment of Moderate-to-Severe Plaque Psoriasis
AbbVie, a research-based global biopharmaceutical company, recently announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
TOPICAL DEVELOPMENT - Fast Tracking Your Way to Success
Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.
CHECKPOINT INHIBITORS - Novel Targets & Global Markets
Laurie L. Sullivan and Cheryl L. Barton, PhD, say as manufacturers expand the clinical utility and healthcare professionals become more familiar with their efficacy and safety profiles, the checkpoint inhibitor market will continue to expand, becoming the cornerstone of many cancer treatment regimens.
DRUG DEVELOPMENT - Softgel Technology for Fast-Tracked Development Programs
Jeff Browne, PhD, and Ronak Savla, PharmD, PhD, believe given the accelerated timelines associated with expedited programs, lipid-based drug formulations, encapsulated in softgel capsules, provide an attractive option for addressing the challenges facing formulators.
FORMULATION FORUM - Formulation Development From Preclinical to First-In-Human
Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2018
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, offers a short overview of drug delivery and formulation transactions and includes some of the numbers that color the trends of 2018 along with some thoughts on notable transactions and technologies.
