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.
Balancing the Art and Science of Topical Drug Formulation
Topical drugs are attractive to patients, but these complex products pose challenges for formulators.
Advancing Spray-Dried Dispersion Formulation Development
In-vitro and in-silico tools can help predict in-vivo outcomes for low-solubility drugs formulated as spray-dried dispersions.
Raman Detects Pharma Processing Fingerprints
Raman spectroscopy delivers real time, non-destructive process insights for critical process parameters to monitor pharmaceutical manufacturing.
Handling Challenging Powders in Tableting Operations
Tests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.
Securing Each Dose: Reducing Falsification Risk with Dosage Level Authentication
Dosage-level authentication provides an added digital layer of security for pharmaceutical companies to ensure their products are not exposed to falsification.
AstraZeneca Confirms Vaccine Efficacy with Phase III Primary Analysis
AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.
Packaging Delivers Micro Dose
Smart packaging opens doors to new products for diagnosis and treatment of eye problems.
Merck to Manufacture J&J Vaccine
With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
Slovakia Approves Sputnik V Vaccine
RDIF has announced that the Sputnik V vaccine for COVID-19 has been approved in Slovakia under the emergency use authorization procedure.
J&J Vaccine Approved for Emergency Use
Distribution of the first one-dose vaccine for COVID-19 to start in early March.
Glatt and Aprecia Collaborate on 3D-Printing for Solid-Dosage Drugs
Aprecia's compression-free 3DP manufacturing platform and Glatt’s multiparticulate technologies offer solutions to pharmaceutical dosage design challenges.
EC Approves Celltrion Healthcare’s Adalimumab Biosimilar
The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).
Developments Driving Drug Delivery
Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.
Reshoring Pharmaceutical Manufacturing to the US: Can We Do It?
Advanced manufacturing technologies are available, but challenges need to be addressed.
Getting Tough on Supplies
The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.
Demystifying Complex Clinical Trial Kit Preparation
Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
Vaccine Supply Dispute Between EU and AstraZeneca Continues
The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.
Balancing Innovation Protection and Affordability
Although a necessity, companies must strike a critical balance between protecting innovations with IP and providing affordable access to medicines.
Intravacc, Cristal Therapeutics Collaborate on Novel Vaccine Platforms
Intravacc and Cristal Therapeutics have entered into a strategic collaboration for the development of novel vaccine programs against human diseases.
FDA: Stick with Approved EUAs for COVID-19 Vaccines
Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.
FDA Ends 2020 with High Drug Approval Rate
FDA approval rate speeds up despite COVID-19 complications.
Overcoming Biologic Drug Formulation Hurdles
The right partner can help companies overcome key formulation challenges for biologic drugs.
Ensuring Vaccine Supply Meets Global Needs
Shutting down the COVID-19 pandemic requires a global, selfless effort.
Oxford/AstraZeneca Vaccine Granted Emergency Use Approval in UK
Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.
Second COVID-19 Vaccine Granted EUA, Ships for Immediate Use
Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.
CHMP Gives Positive Opinion for Pfizer-BioNTech Vaccine
A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.
Helena Offers Polymer Solution to Global Cold Chain Issues for COVID-19 Vaccines, Biologics, and Therapeutics
A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.
Pfizer-BioNTech Vaccine Moves Closer to EUA
Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.
Evonik Supplies Key LNP Technology for Gene-Based Drugs
Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.