June 24th 2025
mRNA technologies offer great promise in immunotherapy and non-immunogenic applications.
May 7th 2025
FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.
March 25th 2025
Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.
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.
Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
Vectura Signs Agreement with Incannex to Advance TBI Treatment
Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.
CureVac Releases Interim Results from COVID-19 Vaccine Candidate Trial
CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.
PHE Analysis Demonstrates Efficacy of COVID Vaccines Against Delta Variant
Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.
Sanofi Facility for Flu Vaccine Licensed by FDA
Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.
Novavax Reports on Two Vaccine Efficacy Studies
Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.
DFE Pharma Becomes Newest Partner in MMIC Collaboration
CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.
Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents
The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
AGC Biologics to Supply More Plasmid DNA for Pfizer-BioNTech COVID-19 Vaccine
AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.
FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug
FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.
Celltrion Reveals Positive Clinical Trial Data for Biosimilar Adalimumab
Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.
New Biotherapies Push Technological Innovation Forward
The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.
Considering Robotics for Drug Compounding
Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.
Further Advice on Vaxzevria Issued in Europe
EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).
Moderna and Aldevron Expand Partnership for mRNA Vaccine and Therapeutic Pipeline
Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.
Codagenix and Univercells Collaborate on Vaccine Research for Undisclosed Target
Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.
US Supreme Court Denies Sandoz Biosimilar Etanercept Petition
The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.
Filling Small Batches
Advances in automation and cleanroom technology improve efficiency for small commercial quantities of aseptically filled drug products.
Tracking Technologies Guard Vaccine Cold Chain
Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.
FDA OKs Pfizer-BioNTech Vaccine for Adolescents
Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.
Benchtop Syringe Filler for Drug Compounding
The semi-automated TipFil Syringe Filler from TurboFil Packaging Machines provides accurate and consistent fills.
Lilly Forms Pact with Diabetes Tech Companies to Integrate Connected Insulin Pen Solutions
Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.
University Researchers Identify New Additive Manufacturing Method for 3D Printed Medicines
Researchers from the United Kingdom, have identified a new additive manufacturing method that enables the 3D printing of medicine in highly porous structures.
Vectura, Inspira Pharmaceuticals Team Up to Develop Potential Inhaled COVID-19 Treatment
Vectura and Inspira Pharmaceuticals have joined forces to develop a potential inhaled therapy for COVID-19.
GSK Gets EC and FDA Approval for Endometrial Cancer Biologic, Jemperli
Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.
Overcoming Vaccine Development Challenges
Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.
Combining Multiparticulates and 3DP for Patient-Centric Dosage Forms
Aprecia and Glatt investigate manufacturing technologies to widen the formulation design space for oral delivery.
EMA’s PRAC Recommends Warning on Very Rare Side Effects of Janssen’s COVID-19 Vaccine
EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.
Bristol Myers Squibb Plans Cell Therapy Manufacturing Site in the Netherlands
Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.
Nanoform and Aprecia Explore 3D-Printed Drug Dosage Forms
The collaboration will evaluate Nanoform’s fast dissolution nanoparticles in Aprecia’s ZipDose 3DP technology platform for buccal and oral drug delivery.
Evaluating Cold-Temperature Packaging Closure Systems
Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.