Formulation Development
TRANSLATIONAL PHARMACEUTICS - Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
EXTRACTABLES & LEACHABLES - A Practical Approach to Extractables & Leachables
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
TOPICAL DELIVERY - Novel Approaches to Topical Antibiotics Promise Innovation in the Treatment of Acne & Rosacea
Scott Herron, MD, PhD, indicates dermatologists and their patients need a better way to deliver antibiotics effectively without contributing to the resistance problem, and an ideal solution might be a new topical antibiotic formulation.
CLINICAL TRIALS - Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
PCI Pharma Services Announces $20-Million Expansion of Biotech Technologies, Including Advanced Injectable Delivery Forms
Leading global biopharmaceutical services provider PCI Pharma Services (PCI) has announced a momentous investment in support of biologic medicines and advanced injectable delivery forms, totaling more than $20 million.
Catalent Makes Significant Investment to Expand Biologics Capacity & Capabilities
Catalent, Inc. recently announced it has commenced a $200 million capital investment in its Biologics business to expand drug substance manufacturing capacity and drug product fill/finish capacity due to projected growth among existing and future customers.
Bristol-Myers Squibb’s Acquisition of Celgene Could Position Company Amongst Top Five Most Profitable Pharma Giants
Following Bristol-Myers Squibb’s (BMS) announcement that it will acquire Celgene in a cash and stock deal with an equity value of approximately $74 billion, Edit…
Elite Pharmaceuticals & SunGen Pharma File ANDA
Elite Pharmaceuticals, Inc. recently announced it filed an Abbreviated New Drug Application (ANDA) with the US FDA for a generic version of an antibiotic product. This…
Sarepta Therapeutics Enters Strategic Relationship With Aldevron
Sarepta Therapeutics, Inc. and Aldevron recently announced they have entered into a long-term strategic relationship for the supply of plasmid DNA to fulfill Sarepta’s needs…
Acer Therapeutics Announces Exclusive License Agreement With Sanofi
Acer Therapeutics Inc. recently announced it has entered into an exclusive license agreement with Sanofi to acquire worldwide rights to osanetant, a clinical-stage, selective, non-peptide…
Merus Announces Strategic Collaboration With Betta Pharmaceuticals
Merus N.V. recently announced it has agreed to grant Betta Pharmaceuticals Co Ltd an exclusive license to develop and commercialize Merus Biclonics MCLA-129 in China. …
Allena Pharmaceuticals Achieves Alignment With FDA on Phase 3 Program
Allena Pharmaceuticals, Inc. recently announced it has reached alignment with the US FDA on both the design of URIROX-2, its second pivotal Phase 3 trial…
Outlook Therapeutics Closes Third Tranche of $20-Million Private Placement for Clinical Trials
Outlook Therapeutics, Inc. recently announced it closed on the third tranche (of four) of its $20-million private placement of common stock to BioLexis Pte. Limited,…
Cybrexa Therapeutics Selects Lead Clinical Candidate to Treat Various Solid Tumors in Combination With Chemotherapy
Cybrexa Therapeutics recently announced it has selected CBX-11 as its lead clinical development candidate for the treatment of patients with various solid tumors.
Fujifilm Commits to Further Research on Nucleic Acid-Liposome Drug Delivery System
FUJIFILM Corporation recently announced that it is working toward improving the development of nucleic acid therapeutics by using liposomal drug delivery systems.
Croda Acquires Biosector; Strengthens Pharmaceutical Offering
Croda International Plc, the speciality chemical company that creates high performance ingredients and technologies relied upon by industry and consumers globally, recently announced that it has strengthened its pharmaceutical offering by signing a definitive agreement with Brenntag Nordic A/S to acquire Brenntag Biosector (Biosector).
Kiniksa Announces Rilonacept Interim Phase 2 Clinical Data; Initiates Pivotal Phase 3 Clinical Trial
Kiniksa Pharmaceuticals, Ltd.recently announced interim data from an open-label Phase 2 clinical trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein that blocks IL-1α and…
SunGen Pharma Receives Its Second & Third ANDA Approval from US FDA
SunGen Pharma recently announced it has received its second and third ANDA approval from the US FDA. The second ANDA is Amphetamine Salts, a generic…
Intensity Therapeutics Strengthens Intellectual Property Portfolio With Issuance of Several New Patents
Intensity Therapeutics, Inc. recently announced the receipt of patents protecting the company’s technology and its lead product candidate, INT230-6, in China, Japan, Korea, Russia, and…
Aravive Biologics Initiates Phase 1b Portion of Phase 1b/2 Clinical Trial
Aravive, Inc. recently announced the company has begun treating patients in the Phase 1b portion of a Phase 1b/Phase 2 trial combining AVB-S6-500 with standard-of-care…
