Formulation Development
CHARACTERIZATION CORNER - From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
Sarepta Therapeutics Announces Positive & Robust Expression & Biomarker Data
Sarepta Therapeutics, Inc. recently announced positive results from three Limb-girdle muscular dystrophy (LGMD) Type 2E clinical trial participants who received MYO-101. MYO-101 is a novel…
Foamix Announces Positive Results From Phase 3 Open-Label Safety Study Evaluating Topical Minocycline Foam
Foamix Pharmaceuticals Ltd. recently announced positive safety and efficacy data for its Phase 3 open-label safety study (FX2016-13), evaluating FMX103 in moderate-to-severe papulopustular rosacea for…
ABclonal Technology Partners With BenchSci to Boost Discoverability of its Novel Products
ABclonal Technology and BenchSci have recently entered into a partnership to provide scientists with high-class research tools for accelerating biomedical discoveries. Research scientists have always…
Cellectar Reports Positive Top-line Response Rate of 30% from R/R Multiple Myeloma Cohort in Ongoing Phase 2 Study
Cellectar Biosciences, Inc. recently announced additional positive top-line results from its ongoing Phase 2 clinical study of CLR 131, the company’s lead product candidate. In…
Nuvec: A Breakthrough Technology for mRNA/pDNA Delivery for Vaccines & Cancer Treatments
N4 Pharma Plc, a specialist pharmaceutical company, is developing Nuvec – a unique non-viral adjuvant delivery system for vaccines and cancer treatments. This silica nanoparticle…
Rockland Immunochemicals & Cellaria Sign Worldwide Distribution Agreement
Cellaria, LLC recently announced a new distribution partnership with Rockland Immunochemicals, Inc. (Rockland) that gives Rockland the rights to market and sell Cellaria’s high-quality next generation in-vitro disease models and cell culture media worldwide.
AKCEA-APO(a)-LRx Advances as Novartis Exercises Option to License
Akcea Therapeutics, Inc. recently announced that Novartis has exercised its option to license AKCEA-APO(a)-LRx, a drug to treat patients with elevated levels of lipoprotein(a), or Lp(a), and established cardiovascular disease (CVD).
U.S. FDA Grants Breakthrough Therapy Designation to Amicus Therapeutics
Amicus Therapeutics recently announced that the US FDA has granted to Amicus a Breakthrough Therapy Designation (BTD) to AT-GAA for the treatment of late onset Pompe disease, an inherited lysosomal storage disorder caused by the deficiency of an enzyme known as acid alpha-glucosidase (GAA).
BrainStorm Announces First Contracted US Clinical Site for Phase 2 Progressive MS Study
BrainStorm Cell Therapeutics Inc. recently announced Cleveland Clinic as the first US clinical site contracted for a planned Phase 2 open-label, multicenter study of repeated…
ARCA Biopharma Announces FDA Agreement for a Single Phase 3 Clinical Trial
ARCA biopharma, Inc. recently announced it has reached agreement with the US FDA regarding a Special Protocol Assessment (SPA) on the design of a pivotal…
Sapreme Technologies to Develop an Oligonucleotide Delivery Platform
Sapreme Technologies has been awarded a $7.71 million grant together with a multidisciplinary consortium including 11 other academic and industrial parties.
Moleculin Announces Out-Licensing Deal to Accelerate Preclinical & Clinical Development
Moleculin Biotech, Inc. recently announced it has entered into a sub-license agreement with WPD Pharmaceuticals (WPD), located in Poland.
Avalon GloboCare Announces Breakthrough in Identifying Human Angiogenic Exosomes/Extracellular Vesicles (EV) Derived From Endothelial Cells
Avalon GloboCare Corp. recently announced its ongoing co-development program with Weill Cornell Medicine, led by Yen-Michael Hsu, MD, PhD, Director of cGMP Cellular Therapy Facility…
Eton Pharmaceuticals Enters Into License Agreement for Two Branded Hospital Product Candidates
Eton Pharmaceuticals, Inc. recently announced that it has entered into an exclusive licensing and supply agreement with Sintetica SA, a Swiss-based pharmaceutical company, to obtain…
Aduro Announces First Patient Dosed in Phase 1 Study
Aduro Biotech, Inc. recently announced the first patient has been dosed in a Phase 1 trial of ADU-S100 (MIW815), a novel stimulator of interferon genes…
Genocea Announces Private Placement Financing of Up to $39 Million
Genocea Biosciences, Inc. recently announced it has entered into a private placement with certain existing and new investors providing for the purchase of up to…
Despite Recent Setbacks, the Ophthalmology Market Still Offers Vast Potential
Despite the ophthalmology market experiencing several research and development (R&D) setbacks during 2018, the launch of three new drugs highlights that the market still offers…
Active Biotech's Partner NeoTX Enters Clinical Collaboration With AstraZeneca
Active Biotech recently announced its partner NeoTX entered a clinical collaboration with AstraZeneca Group Plc global biologics research and development arm, MedImmune, to support Phase…
Passage Bio Launches With $115.5 Million Financing to Develop AAV-Delivered Therapeutics
Passage Bio recently debuted with a $115.-million Series A financing led by OrbiMed Advisors and joined by Frazier Healthcare Partners, Versant Ventures, New Leaf Venture Partners, Vivo Capital and Lilly Asia Ventures.
