Formulation Development
Spero Therapeutics Announces Positive Topline Results From its Phase 3 ADAPT-PO Clinical Trial
Spero Therapeutics, Inc. recently announced positive topline results from ADAPT-PO, the pivotal Phase 3 clinical trial evaluating Spero’s oral antibiotic candidate, tebipenem HBr, for the…
Vaxart’s Oral COVID-19 Vaccine Candidate Induces Potent Systemic & Mucosal Immune Responses
Vaxart, Inc. recently announced pre-publication of a manuscript titled Preclinical studies of a recombinant adenoviral mucosal vaccine to prevent SARS-CoV-2 infection. The manuscript describes the…
PhoreMost & XtalPi Sign AI-Based Collaboration Agreement
PhoreMost Limited and XtalPi Inc. recently announced they have entered into a drug discovery collaboration agreement…..
Exelixis & Catalent Enter Collaboration, License & Exclusive Option Agreement
Exelixis, Inc. and Catalent recently announced a partnership under which Catalent’s Redwood Bioscience subsidiary will develop multiple antibody-drug conjugates (ADCs) for….
AnGes & Brickell Biotech Announce Collaboration Agreement for the Development of a Novel DNA Vaccine Candidate for COVID-19
AnGes, Inc. recently announced a collaboration agreement with Brickell Biotech, Inc. through which Brickell has the right to develop AnGes’ proprietary….
Evonik Qualifies Advanced Aseptic Filling Line for Complex Parenteral Drug Products
Evonik recently announced the qualification of an advanced aseptic filling line for complex parenteral drug products at its FDA-inspected Birmingham….
WEBINAR ALERT! - Solid Form Selection in Drug Development by AMRI
Dr. Steef Boerrigter, Senior Research Scientist, AMRI It’s important to consider the solid form of an API in the drug development process. Using the proper…
SGS Enrolls First Patient Into Biophytis COVA Clinical Study, a COVID-19 Related Acute Respiratory Failure Treatment Clinical Trial
SGS recently announce the enrollment of the first patient into an important new clinical trial designed to examine the safety, tolerability, and efficacy of….
Gilead Sciences & Jounce Therapeutics Announce Exclusive License Agreement
Gilead Sciences, Inc. recently announced an agreement with Jounce Therapeutics, Inc., a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, to exclusively…
Avomeen & Daré Bioscience Form Strategic Partnership to Accelerate Novel Pipeline
Avomeen and Daré Bioscience, Inc. recently announced the companies have signed an agreement under which Avomeen will provide….
Alimera Sciences Announces Enrollment of First Patient in Landmark NEW DAY Clinical Trial
Alimera Sciences, Inc. recently announced it has enrolled the first patient in the company’s NEW DAY clinical trial, a randomized, controlled, multi-center study designed to…
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.
