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.
Raise a Glass to Pharma Vials
Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.
Formulation and Manufacturing Trends for Parenterals
Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.
Real-Time Monitoring Drives New Logistics Solutions
As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.
Gene-Editing Techniques Target New Applications
Industry experts discuss the role of gene-editing techniques in regenerative medicine and cell-line development.
Bringing Gene Therapies to Market
Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.
Gene Therapy Production Must Pass Regulatory Hurdles
Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.
China Invests in Gene Therapy Research
Researchers in China are playing a role in advancing gene therapy development.
Fixed-Dose Combination Tablet Significantly Reduces Cholesterol, Notes Study
Daiichi Sankyo Europe has revealed the results of a Phase III study assessing the efficacy, safety, and tolerability of bempedoic acid/ezetimibe fixed-dose combination (FDC) tablet.
European Specialty Pharmaceutical Company Launches First Products in UK
Neuraxpharm Group has announced it is launching its first products in the United Kingdom.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
CURE Pharmaceutical Receives Patent for Oral Thin Film Technology
Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.
Lonza Selects Rockwell Automation for Digital Transformation of Capsule Manufacturing
Lonza plans to implement MES software to accelerate paperless, 24/7 production of drug capsules.
Suheung Opens Capsule Factory
Suheung’s new facility in Vietnam is dedicated to vegetarian capsule manufacturing.
Catalent Extends Spray Drying Capabilities in Europe
An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.
Selecting a Solid Approach
Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.
Macleods Issues Recall Due to NMBA Impurities
More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.
Catalent Biologics Acquires Vaccine Manufacturing Facilities
Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.
Lonza Expands HPAPI Capacity
Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.
Tergus Pharma Plans Commercial Manufacturing Facility
Tergus Pharma announced a partnership with Great Point Partners and construction of a new commercial manufacturing facility in North Carolina.
European Private Equity Group Acquires UK Pharma Generics Firm
European midmarket private equity group, Duke Street, has agreed to acquire Kent Pharmaceuticals and Athlone Laboratories from DCC Vital.
Hovione Technology Develops Blister-Based Inhaler
A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.
Enabling Technologies Advance Poorly Soluble Highly Potent APIs
Excipients and new processing techniques can make a real difference in the development of highly potent therapies.
Putting Drug Delivery into Patients’ Hands
Wearable and smart devices allow user-friendly subcutaneous drug delivery.
Particle Sciences Gains DEA Schedule I Registration
Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.
Catalent Closes Acquisition of Paragon Bioservices
Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.
Starch-Based Excipient for Direct Compression
StarTab from Colorcon was designed to ensure functionality and stability for direct compression tableting.
Best Practices for Developing Dry Powder Inhaler Combination Drug-Device Products
Consider both the device characteristics and the powder properties when developing a DPI combination product.
Test Methods and Quality Control for Prefilled Syringes
Empty and prefilled syringes must pass a range of quality control tests.
Recipharm Launches Development and Manufacturing Service for Inhalation Products
Recipharm Inhalation Solutions is an integrated service for inhalation products.
Working for the Greater Good
Pharma delivers a positive message with renewed efforts to eradicate malaria.