Formulation Development
OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
Mott's Controlled Release Drug Diffusion Studies Reduce In Vitro Test Time by Over 90% & Narrow Scope of Animal Trials
Device diffusion testing is a critical step that can delay the time for an implantable drug delivery device to get through clinical trials, regulatory hurdles and ultimately, to market. Mott conducts controlled release studies for….
Veru Completes Enrollment of Phase 2 Clinical Trial of Novel Oral Drug
Veru Inc. recently announced it has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for…
Orgenesis Announces Agreement to Acquire Koligo Therapeutics
Orgenesis Inc. and Koligo Therapeutics, Inc. recently announced the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion….
Mereo BioPharma Receives FDA Rare Pediatric Disease Designation
Mereo BioPharma Group plc recently announced that the US FDA has granted Rare Pediatric Disease designation to setrusumab for the treatment of osteogenesis imperfecta (OI).…
FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients
FSD Pharma Inc. recently announced the US FDA has authorized the initiation of a Phase 2 study for the use of FSD201 (ultramicronized palmitoylethanolamide, or…
Celyad Oncology Announces Clinical Trial Collaboration With MSD
Celyad Oncology SA recently announced it has entered into a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, through…
Catalent Acquires New Biologics Facility to Create North American Clinical Manufacturing Center of Excellence
Catalent recently announced it has acquired a new manufacturing facility in Bloomington, IN, to create a North American center of excellence for early phase clinical…
Ajinomoto Bio-Pharma Services & DNDi Partner to Develop Critical Immunomodulator for Cutaneous Leishmaniasis Therapeutic
Ajinomoto Bio-Pharma Services recently announced a strategic supply partnership with the Drugs for Neglected Disease Initiative (DNDi), a collaborative, patients’ needs-driven, non-profit drug research and…
Aqualung Therapeutics Awarded NIH Fast-Track Award
Aqualung Therapeutics, an early stage biotech company developing an immune-focused, anti-inflammatory therapeutic platform for unchecked inflammation in patients with serious acute and chronic diseases, has been awarded….
Vectura Provides Status Update on Hikma's ANDA for Generic Advair Diskus VR315 (US)
Vectura Group plc, an industry-leading inhalation CDMO, recently confirmed the announcement made by its partner Hikma Pharmaceuticals PLC, which has received a minor complete response letter (CRL) from the US FDA in….
T-knife & Catalent Sign Technology Transfer & Manufacturing Agreement
T-knife GmbH and Catalent recently announced they have signed an agreement to provide technology transfer and CGMP clinical manufacturing of T-knife’s T1367 T-cell receptor (TCR) program…..
Hovione Announces Partnership to Produce Ligand's Captisol; Used in Gilead's Covid-19 Treatment
Hovione recently announced the signing of a partnership agreement with Ligand to significantly ramp up the production output of Captisol, a Ligand product, which is a chemically modified cyclodextrin proven to improve the solubility….
Thomas H. Lee Partners & Frazier Healthcare Partners Acquire Adare
Thomas H. Lee Partners, L.P. and Frazier Healthcare Partners recently announced they have acquired Adare Pharmaceuticals, which will be rebranded Adare Pharma Solutions, a leading specialty contract development….
Metrics Contract Services Begins $10-Million Plant Expansion
Metrics Contract Services recently announced it has commenced construction on the expansion of its novel oral solid dosage manufacturing facility expansion in Greenville, NC. The…
Oculis to Present Significant Corporate & Clinical Development Progress
Oculis S.A., a biopharmaceutical company focused on developing transformative topical ophthalmic treatments to improve the sight and lives of patients, recently announced that Dr. Marcia…
Knopp Biosciences Completes Enrollment in Phase 2 Trial of Oral Dexpramipexole in Eosinophilic Asthma
Knopp Biosciences LLC recently announced the completion of enrollment in a Phase 2 trial of the oral small-molecule dexpramipexole in patients with moderate-to-severe eosinophilic asthma.…
ARCA biopharma Announces Submission of IND Application
ARCA biopharma, Inc. recently announced it has submitted an Investigational New Drug (IND) application with the US FDA under the Coronavirus Treatment Acceleration Program (CTAP) to…
CombiGene & Cobra Biologics Sign Agreement to Secure GMP Production of Plasmids for Production of Gene Therapy
Cobra Biologics and CombiGene AB (publ) (CombiGene) recently announced they have signed agreements covering Good Manufacturing Practice (GMP) production of two essential….
Gain Therapeutics Announces Research Collaboration With Sumitomo Dainippon Pharma
Gain Therapeutics, Inc. recently announced it has entered into a strategic research collaboration agreement with Sumitomo Dainippon Pharma Co., Ltd. for the research and development of….
