March 12th 2025
Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.
March 9th 2025
Exosomes, polymeric nanoparticles, and DNA nanostructures offer many potential advantages.
February 17th 2025
The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.
February 8th 2025
European biopharma companies are looking beyond GLP-1s.
February 7th 2025
Increasing API and formulation complexity and new delivery strategies are driving innovations in taste-masking.
In Vivo Falls Behind In Vitro for Adventitious Agent Testing
Alternatives to animal testing and in-vivo assays are occurring as a result of recent scientific advances.
Biosimilars Gain Traction with Regulators and Manufacturers
Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.
US Leads the Way for Drug Device Innovation but Lags Behind for Sustainability, Notes Pharmapack 2021 Report
The organizers of Pharmapack Europe have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.
Celsion and Poly Pharm to Manufacture Celsion’s DNA-Based Vaccine
In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.
Real-World Evidence Shows Strong Protection from COVID-19 with J&J Vaccine and Booster
New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.
FDA Approves Biosimilar for Treatment of Eye Disease
The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.
Pfizer and BioNTech Announce Positive Results In COVID-19 Vaccine Trial for Children Ages 5 to 11
The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.
Vaccine Booster Battle Reveals Rifts Among Regulators and Sponsors
FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.
Moderna Releases New Clinical Data on COVID-19 Vaccine
Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.
Considering Titanium Dioxide Regulatory Changes
EFSA’s evaluation of risk in food products raises implications for drug product formulations.
Best Practices in Manufacturing Inhalation Drugs
When designing and manufacturing a pMDI or DPI combination drug-delivery device, the commercial stage should be kept in mind from the beginning of development.
Biden Bolsters Vaccine Production in Pandemic Preparedness Plan
The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.
Moderna and ILCM Announce Collaboration to Develop mRNA Therapeutic for CN-1
Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.
Setting a Clear Strategy for Primary Packaging
Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.
On Time Delivery: Challenges of Controlled-Release Formulations
Consistency, robustness, and understanding of the API and controlled-release excipients are essential for successful drug dosing.
Getting a Nose for Vaccines
The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.
Evaluating Okra Gum in a Floating Tablet Formulation as a Novel Drug Delivery System
The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.
Biosimilars Move to Center Stage
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
Enhanced Bioavailability of Acalabrutinib ASD Tablets In-Vivo
The pH effect encountered with oral oncology medication can be overcome with amorphous solid dispersions.
Determining Comparability of Biosimilars Through Statistical Approaches
It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.
FDA Grants Orphan Drug Designation to Aerami Therapeutics’s Imatinib
FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.
BioMed X and Janssen Start Up Research Programs in Autoimmunity and Drug Delivery
BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.
Pfizer Vaccine Approval Key to Boosting Vaccination Rates
FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.
FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech
FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.
KGI Team Adapts Vaccine Development Work to Address COVID-19
A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.
Aldevron and Ginkgo Bioworks Collaboration Yields mRNA Manufacturing Enhancement
A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.
Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada
Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.
EMA Recommends Including Adverse Reaction Warning to Janssen COVID-19 Vaccine
The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.
EMA’s PRAC Requests Additional Data on Guillain-Barré Syndrome in COVID-19 Vaccine
EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.
Syngene Announces Senior Level Appointments
Syngene International appoints two US-based executives to senior level positions.