Formulation Development
Aravive Announces Positive Updated Data & New Biomarker Data From Phase 1b Study
Aravive, Inc. recently announced positive new data from the Phase 1b portion of the ongoing Phase 1b/2 trial of batiraxcept in clear cell renal cell…
Skye Bioscience Retains Novotech as CRO for Phase 1 Trial of Glaucoma Drug Candidate
Skye Bioscience, Inc. has recently entered into an agreement with Novotech Health Holdings for its upcoming Phase 1 study in Australia of its SBI-100 drug…
Pii Announces New President & Chief Executive Officer
Pharmaceutics International Inc (Pii) recently announced its Board of Directors has appointed Mr. John Fowler as President and Chief Executive Officer effective March 7, 2022.…
Oculis Strengthens Leading Ophthalmology Pipeline by In-Licensing Neuroprotective Drug Candidate for Glaucoma From Accure Therapeutics
Oculis S.A. and Accure Therapeutics recently announced a licensing agreement granting Oculis exclusive global rights to develop and commercialize ACT-01, a potentially disease-modifying therapy to…
Harpoon Therapeutics Receives FDA Fast Track Designation
Harpoon Therapeutics, Inc. recently announced the US FDA has granted Fast Track designation to HPN217, a BCMA-targeting TriTAC, for the treatment of patients with relapsed,…
Aeterna Zentaris Announces Notice of Allowance for US Patent Covering AEZS-150 for the Potential Treatment of Chronic Hypoparathyroidism
Aeterna Zentaris Inc. recently announced that its licensor, The University of Sheffield, has received a notice of allowance from the USPTO for its patent application No. 16/608,611…..
Enteris BioPharma to Participate in DCAT® Week 2022
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq:…
SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
DRUG DEVELOPMENT - The Promise of Cutting-Edge Microbiome-Based Therapeutics
Andrew Thomson, Brian Carpenter, and Robert Broadnax focus on how developers must strategically address and overcome specific challenges to successfully drive development and eventual adoption of microbiome-based therapies.
Sterling Pharma Solutions Expands Global API Manufacturing Capabilities With Acquisition of Novartis Facility
Sterling Pharma Solutions recently announced it had reached agreement with Novartis to acquire its Ringaskiddy campus (Novartis Ringaskiddy Limited), near Cork, Ireland. Financial details of…
NASAL DELIVERY - Improving Nasal Drug Delivery With Permeation Enhancing Technology
Stuart Madden, PhD, focuses on the use of alkylsaccharides as absorption enhancers for nasal delivery of a wide range of drug types.
FORMULATION DEVELOPMENT - Impact of Excipients & Manufacturing Process on Solubility-Enhanced Ritonavir Tablet Size & Weight Reduction
Gayatri Khanvilkar, MPharm, Ajit Bhagat, and Tejas Gunjikar, PhD, investigate bulking agents and disintegrants to develop efficacious Rotonavir tablets with improved in vitro release.
MARKET LANDSCAPE - The Future of Cancer Care Post-Pandemic: What Doctors, Patients, and the Healthcare Industry at Large Should Expect
Angelos Stergiou, PhD, explains how the COVID-19 pandemic saw failures in the healthcare delivery system not only in general medicine, but also specifically in oncology. At the same time, several opportunities came to light during such a difficult, frightening moment, bringing a number of large- and small-scale innovations forth.
GENE EDITING TECHNOLOGY - Harnessing a Cell’s Natural DNA Repair Process to Develop Medicines With Higher Levels of Precision & Durability
Mariana Nacht, PhD, reviews a new gene editing approach that harnesses a cell’s natural DNA repair process, known as homologous recombination, to insert a corrective copy of the gene (or transgene) at a precise spot in a patient’s genome.
Catalent & TFF Pharmaceuticals Announce New Inhalation Dry Powder Development & Manufacturing Agreement
Catalent and TFF Pharmaceuticals, Inc. recently announced their collaboration agreement focused on the generation, testing, and manufacture of dry powder formulations for a range of…
Editas Medicine Announces Favorable Decision From US PTO in CRISPR Patent Interference
Editas Medicine, Inc. recently announced the USPTO issued another favorable decision to the Broad Institute, Inc. (Broad) involving specific patents for CRISPR/Cas9 editing in human…
CDMOs Need to be Prepared for the Revision of the EU-GMP-Annex 1
Annex 1 of the EU-GMP-Guide Manufacture of Sterile Medicinal Products is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The current revision will have to….
After 25 Years, There is a CEO Transition at Hovione!
Hovione recently announced the Board of Directors and the shareholders have approved the appointment of Dr. Jean-Luc Herbeaux as Hovione’s Chief Executive Officer, effective….
Santhera Signs Gene Therapy Agreement With SEAL Therapeutics
Santhera recently entered into an agreement with SEAL Therapeutics, a spin-off company from the Biozentrum of the University of Basel, which will further develop a….
Durable & Deepening Clinical Responses Observed in Post-Treatment Period of Evelo Bioscience’s Phase 2 Clinical Trial
Evelo Biosciences, Inc. recently announced data from the post-treatment follow-up (Part B) of its Phase 2 trial of EDP1815 in mild and moderate psoriasis, which…
