Dosage Forms

Modular process design, single-use technologies, and flexible filling lines are some of the ways manufacturers can combat challenges involved in small-batch manufacturing.

Newly approved needle-free adrenaline spray offers longer shelf life, better stability, and easier use, signaling a shift in emergency drug delivery design.

Hydrogels, drug-eluting contact lenses, and other implant technologies show real promise.

mRNA technologies offer great promise in immunotherapy and non-immunogenic applications.

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

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.

The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.

European biopharma companies are looking beyond GLP-1s.

Lonza will work with Iconovo to develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity.

With the new $94 million (€90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

The companies will use Orexo’s powder-based drug delivery technology to develop mucosal vaccines in an inhaled formulation.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Centogene NV and ROPAD consortium publish data from a landmark study identifying genetic variants that may respond to innovative cell and gene therapies.

Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

Datwyler has launched new coated plungers in its NeoFlex line that are suitable for large volume biologics.

The announcement of the pairing comes several months after Adare Pharma Solutions said it would upgrade several of its facilities, including in Milan, Italy, where the 3D printing operations will be located.

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.

The ROSS FDA-3500 dual shaft mixer is equipped with independently controlled drives and is designed to efficiently produce good turnover and impart shear to a viscous batch.

The NexGen Press 45 is the latest member of GEA Pharma & Healthcare’s NexGen Press line of tablet presses.

STADA and Alvotech have launched Uzpruvo in Europe, making it the first approved biosimilar to Stelara (ustekinumab) in the European market.

Pelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.

The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.

Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

A greater understanding of molecular and cellular biology and technological advancements are revolutionizing the field of biologics.

Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.

Advanced oral dosage forms allow for modulation of controlled- and sustained-release profiles.

Packaging and packaging line innovations are addressing the industry’s growing use of biologics.

New plans laid out by AstraZeneca will see £650 million ($828 million) be invested into the UK.