Formulation and Drug Delivery

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Inhaled vaccines must resist degradation and penetrate the mucosal lining in the airways and lungs.

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

The latest report from Clarivate has been published, highlighting 15 potential blockbusters to watch out for in 2023, the majority of which are personalized medicines.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

One can improve method precision and productivity by replacing one step in sample preparation with an automated approach.

Unique solutions are required to protect inherently unstable messenger RNA.

The decision to move forward in Phase III development stems from the threat of resistance to current malaria treatment growth.

Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.

High-concentration injectable formulations present unique challenges.

Opportunities and developments in particle engineering are providing developers with the tools to advance drug candidates successfully.

Replacing a step in sample preparation with an automated approach improves both method precision and productivity.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Gerresheimer has developed a new dropper insert for ophthalmic formulations that it is showcasing at CPHI 2022 in Frankfurt, Germany.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

Aenova Group and Microcaps are partnering to enable new customized formulations for product development and life cycle management solutions.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

Patient centricity is driving change in drug discovery and development, leading to a a new dawn in therapeutics.

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.

The author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.

One company reaches beyond traditionally-conceived male contraceptives with Vasalgel, a reversible hydrogel injectable.

Emerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.