Formulation Development
Frontera Therapeutics Doses First Patient in a Clinical Trial of Gene Therapy for the Treatment of Wet AMD
Frontera Therapeutics recently announced it has dosed the first patient in a clinical trial of its innovative gene therapy product, FT-003, at the Ophthalmology Hospital…
Seqens Group Opens Flagship Pharmaceutical R&D Center in Greater Boston
Seqens Group recently announced it has opened Seqens Boston R&D Center, a state-of-the-art, 15,000-sq-ft R&D center in Devens, MA. Serving as one of the company’s…
Gerresheimer Presents its New Clinical Trial Kit to Accelerate Drug Development
Gerresheimer presents its new Clinical Trial Kit at Pharmapack in Paris. This kit consists of sterile Gx RTF vials in nest and tub or tray…
Akoya Biosciences to Present First-of-its-Kind Spatial Multiomics Dataset
Akoya Biosciences, Inc. recently announced it will present results from a novel same-section, spatial multiomic study at the Advances in Genome Biology and Technology (AGBT)…
Aptamer Group Partners With BaseCure Therapeutics to Develop New Targeted Gene Therapies
Aptamer Group plc recently announced a new partnership with BaseCure Therapeutics for the development of Optimer-targeted gene therapies. The ability to precisely target gene therapies,…
WHITEPAPER - Case Study-Improving Bioavailability Using PBPK Modeling & Parallel Formulation Screening
A team of bioavailability experts at Catalent used the in-house bioavailability enhancement platform, OptiForm® Solution Suite, to optimize and develop….
WHITEPAPER - Infographic-Zydis® Orally Disintegrating Tablet (ODT) vs. Standard Tablets (ST)
Catalent’s proprietary Zydis® ODT platform is backed by a large number of clinical studies. This infographic provides a high level summary of studies comparing Zydis ODT against traditional oral tablets…..
First Wave BioPharma Announces Initiation of Phase 2 Trial Investigating Enhanced Adrulipase Formulation in Exocrine Pancreatic Insufficiency in Patients With Cystic Fibrosis
First Wave BioPharma, Inc. recently announced it will initiate its planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase for…
X-Chem & Kymera Expand Existing Partnership
X-Chem recently announced the expansion of its collaboration with Kymera Therapeutics, Inc. With the expanded agreement, X-Chem will serve as the primary provider of DNA-encoded….
Start-Up Innovation at Pharmapack 2023
Pharmapack Europe 2023 returns to its traditional February timing for the first time since the start of the pandemic and provides the industry with a vital early window into many of tomorrow’s technologies that improve patient experience, adherence, and delivery…..
Stemline Therapeutics Receives Approval for First & Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer
The Menarini Group recently announced the US FDA has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced…
Anti-Bb Antibody Receives US FDA Clearance to Start Clinical Trial in Naïve aHUS Patients
NovelMed recently announced the US FDA cleared the company’s investigational drug NM8074 to initiate an efficacy trial in patients with aHUS in coming months. NovelMed…
BioAegis Therapeutics Announces FDA Clearance of IND for its Inflammation Regulator Protein for the Treatment of ARDS
BioAegis Therapeutics, Inc. recently announced the US FDA has approved its Investigational New Drug (IND) application for recombinant plasma gelsolin to proceed for the….
INmune Bio, Inc. Announces Pre-Clinical Data That Support a Pioneering Approach to Treating Duchenne Muscular Dystrophy
INmune Bio, Inc. in collaboration with Professor Armando Villalta, PhD, of University California, Irvine School of Medicine, has shown targeting soluble TNF (sTNF) using a…
Ocuphire Announces Topline Results From Phase 2 Trial of Oral APX3330 in Diabetic Retinopathy & Plans for End-of-Phase 2 Meeting With FDA
Ocuphire Pharma, Inc. recently announced topline efficacy and safety results from its ZETA-1 Phase 2 trial evaluating oral APX3330 for the treatment of diabetic….
AC Immune’s Anti-Amyloid Beta Vaccine for Alzheimer’s Shows Positive Initial Interim Safety & Immunogenicity in Phase 1b/2 Trial
AC Immune SA recently announced the first interim safety, tolerability, and immunogenicity findings from the Phase 1b/2 ABATE trial of its anti-amyloid-beta (Abeta) vaccine ACI-24.060…
Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Parkinson’s Disease
Inhibikase Therapeutics, Inc. recently announced the US FDA has lifted the full Clinical Hold on IkT-148009 in Parkinson’s disease (PD). “We are grateful for the…
Eloxx Pharmaceuticals Announces First Patients Enrolled in Phase 2 Clinical Study Evaluating Treatment for Alport Syndrome
Eloxx Pharmaceuticals, Inc. recently announced the first patients have now been enrolled in its Phase 2 study of ELX-02 for the treatment of Alport syndrome…
Hyloris Announces Commercial Partnership for Maxigesic IV in 9 European Countries
Hyloris Pharmaceuticals SA recently announced its partner AFT Pharmaceuticals has signed an exclusive licensing and distribution agreement with Salus Pharmaceuticals for Maxigesic IV, a novel,…
Alvotech & Bioventure Announce Approval of AVT02 (Adalimumab) as Simlandi in Saudi Arabia
AVT02 as Simlandi is the first biosimilar approved under the strategic partnership between Alvotech and Bioventure….
