Formulation Development
Chiasma Announces US Commercial Launch & Availability of the First & Only Oral Somatostatin Analog
Chiasma, Inc. recently announced the commercial launch and availability of MYCAPSSA (octreotide) capsules in the US for patients with acromegaly. MYCAPSSA, the first and only….
CorMedix Announces FDA Acceptance for Filing & Priority Review of NDA
CorMedix Inc. recently announced the US FDA has accepted for filing the company’s submitted New Drug Application (NDA) for Defencath, its product candidate to be…
LSNE-León Receives Approval From AEMPS to Manufacture Biotechnology-Based Therapeutic Products
LSNE Contract Manufacturing recently announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of clinical-stage biotechnology-based therapeutic products at…
Novavax & Canada Reach Agreement in Principle to Acquire COVID-19 Vaccine
Novavax, Inc. recently announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373,…
First Patient Dosed in AstraZeneca’s Phase 3 COVID-19 Vaccine Trial
Headlands Research is pleased to announce that on Friday, Aug. 28, its JEM Research Institute clinical trial site in Lake Worth, FL, successfully dosed the…
SPECIAL FEATURE - Injection Devices: Will COVID-19 Deliver Growth to the Market?
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
FORMULATION FORUM - Formulation Development Strategy for Early Phase Human Studies
Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.
DRUG DEVELOPMENT - Bringing New Drugs to Patients Faster by Integrating Traditionally Separate Pharma Development Functions
Nutan Gangrade, PhD, says reducing R&D project timelines saves on overhead in development while increasing the likelihood of primacy in the marketplace (which engenders significantly more sales) and describes new approaches drug developers are taking to streamline drug development.
GENE-EDITING TECHNOLOGY - The Importance of Assessing Off-Target Effects of CRISPR Gene Editing
Mark Behlke, MD, PhD, says gene editing raises legitimate questions and fears about possible risks and misuse, and given the relative technical ease and low cost of CRISPR gene editing, this is likely to find widespread use in both medicine and agriculture.
EXECUTIVE INTERVIEW - AMO Pharma: Identifying & Developing Cancer Pathway Therapeutic Candidates for Use in New Neurological Indications
Michael Snape, PhD, AMO Pharma’s Chief Scientific Officer, discusses the company’s research focus and efforts to understand and target the mechanism of action of CNS disorders associated with developmental delay with the potential to target neurogenetic disorders at their root cause.
PEPTIDE THERAPEUTICS - Oral Peptide Therapeutics – Opportunities Abound as Barriers Fall
John S. Vrettos, PhD, says numerous technologies are currently in development that are designed to enable the oral delivery of peptides. Though each has its unique set of properties and capabilities, all must overcome key obstacles to successfully deliver peptides via the oral route.
COMBINATION PRODUCTS - Development Challenges & Solutions
Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.
EXECUTIVE INTERVIEW - Nuritas Pharma: Life Changing Peptide Drug Discoveries for a Changing World
Nora Khaldi, PhD, Founder and Chief Executive Officer of Nuritas, discusses the company’s innovative approach to accelerating the discovery of novel therapeutic peptides that address unmet patient needs in multiple disease areas.
Rain Therapeutics Announces License Agreement for the Development of Proprietary RAD52 Inhibitors
Rain Therapeutics Inc. recently announced the signing of an exclusive, worldwide license agreement of a Drexel University research program to Rain for small molecule inhibitors of….
Cancer Genetics & StemoniX Sign Definitive Agreement to Merge
Cancer Genetics, Inc. and StemoniX, Inc. recently announced the entry into a definitive merger agreement. Cancer Genetics is a leader in drug discovery and….
Catalent Signs Agreement With AstraZeneca to Expand Manufacturing Support for COVID-19 Vaccine
Catalent, Inc. recently announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine….
Trishula Therapeutics Established to Advance Novel TTX-030, an Anti-CD39 Antibody
Recently, Trishula Therapeutics was launched to be solely dedicated to the development of TTX-030, a first-in-class anti-CD39 antibody, being studied in advanced cancers. The new…
Independent Studies Confirm Low Levels of Immune System Protein, Gelsolin, Associated With COVID-19 Severity
BioAegis Therapeutics Inc. recently announced that recent publications of independent studies have reported that low levels of gelsolin are associated with severe illness and organ…
Onconova Therapeutics Announces Topline Results From Pivotal Phase 3 INSPIRE Trial
Onconova Therapeutics, Inc. recently announced that INSPIRE, the company’s pivotal Phase 3 study assessing the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS)…
BioAge Discovers Key Pathway & Identifies Promising Phase 2-Ready Drug to Treat & Reverse Immune Aging, a Root Cause of COVID-19 Morbidity & Mortality in Older Patients
BioAge Labs, Inc. recently announced it has in-licensed a clinical-stage therapy with significant promise and potential in treating immune aging in older patients hospitalized with…
