Formulation Development
Amphastar Pharmaceuticals Receives ANDA Approval for Multi Dose Vial Drug
Amphastar Pharmaceuticals, Inc. recently announced the US FDA granted approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) Multiple Dose Vial (MDV).
SunGen Pharma & Athenex Pharmaceutical Division Announce Injection Product Launch
SunGen Pharma recently announced the launch of Busulfan Injection, the second product launch through their joint venture Peterson Athenex with Athenex Pharmaceuticals. The ownership of…
CURE Pharmaceutical Expands US DEA Approval to Manufacture Pharmaceuticals Using Whole Cannabis Plant
CURE Pharmaceutical recently announced it has broadened its US Drug Enforcement Administration (DEA) license as an authorized manufacturer of Schedule 1 substances to include both…
Imugene Announces First Patient Dosed in Open-Label Phase 2 Study
Imugene Limited recently announced dosing of the first patient in an open-label, randomized multi-centre Phase 2 study with its HER-Vaxx (IMU-131) cancer vaccine for the…
Santhera Completes Patient Enrollment in Phase IV Long-term Study
Santhera Pharmaceuticals recently announced it has completed patient enrollment in the ongoing Phase IV study (LEROS) with Raxone (idebenone) for the treatment of Leber's hereditary…
Biogen Enters Agreement to Sell Its Large-Scale Biologics Manufacturing Site
Biogen recently announced it has entered into a share purchase agreement with FUJIFILM Corporation under which Fujifilm will acquire the shares of Biogen’s subsidiary, which…
Ajinomoto Bio-Pharma Services Announces Capital Expansion to Fuel Growth
Ajinomoto Bio-Pharma Services recently provided an update on several of its capital projects currently underway in both the United States and Belgium.
BioXcel Therapeutics Announces Addition of Merck KGaA & Pfizer to Clinical Collaboration With Nektar
BioXcel Therapeutics, Inc. recently announced the addition of Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada,…
Aptose Biosciences & CrystalGenomics Announce Issuance of Patent for Oral Small Molecule
Aptose Biosciences Inc. recently announced the Australian Patent Office (APO) has issued Australian Patent No. 2013371146 for CG-806, a first-in-class, highly potent oral small molecule…
ContraFect Announces $6.94 Million in Funding from CARB-X
ContraFect Corporation recently announced that the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has awarded the company up to $6.94 million in non-dilutive funding to…
Lipomedix Announces Initiation of Phase 1b Trial
Lipomedix recently announced the initiation of a Phase 1b multicenter trial (LIPORAD-2018) to identify the optimal dose, safety, and efficacy of its lead compound Promitil…
Apellis Resumes Dosing in Its Phase 3 Program for Patients With Geographic Atrophy
Apellis Pharmaceuticals Inc. recently announced that with the agreement of the independent safety monitoring committee for the company’s Phase 3 clinical program for APL-2 in…
Ritter Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Clinical Trial
Ritter Pharmaceuticals, Inc. recently announced it has completed, ahead of schedule, enrollment in its first pivotal Phase 3 clinical trial of RP-G28 for the potential…
Procarta Announces Significant Investment for New Class of Antibiotics
Procarta Biosystems recently announced $1.7 million of new funding from the Novo Holdings REPAIR Impact Fund to support development of novel therapies to combat antimicrobial resistance (AMR).
Biogen Announces Agreement to Acquire Nightstar Therapeutics
Biogen recently announced it has entered into an agreement to acquire Nightstar Therapeutics, a clinical-stage gene therapy company based in London, United Kingdom, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders.
Catalent Invests Over $27 Million to Commercialize ODT Technology
Catalent Pharma Solutions recently announced that it is to invest more than $27 million to commercialize its next-generation oral disintegrating tablet (ODT) technology, Zydis Ultra.
SPECIAL FEATURE - Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
PRODRUG TECHNOLOGY - Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs
Travis Mickle, PhD, indicates key properties that prodrugs can potentially modify generally fall within one or more of the ADME categories, with the goal being the creation of an NCE that optimizes the performance, utility, and potential life-cycle management of the parent drug.
RNA EDITING - New Editing Technology Enables Body to Repair its Own RNA
Daniel de Boer explains how the Axiomer technology, a powerful RNA-editing technique that enables the body to repair itself, is being developed as a next-generation therapeutic option for genetic disorders.
GLOBAL REPORT - 2018 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2018 product approvals.
