Drug Development

Experts discuss factors that can affect the outcome of an ADME study, signs that a drug compound shows promise, red flags, and key parameters to determine safety and efficacy.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

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

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

Under the new collaboration with Tempus, GSK will have access to de-identified patient data to accelerate drug discovery, improve clinical trial design, and speed up enrollment.

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

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.

An early drug candidate screening strategy should incorporate clear targets to lessen late-stage failure.

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

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.

Sponsors should explore key considerations ahead of choosing a new outsourcing partner.

An expert from Aptamer Group reveals the potential of Optimers (a type of aptamer) in the realm of drug delivery, including its targeting capabilities, scalability, and key differences between Optimers and antibody-drug conjugates.

External expertise is beneficial in helping companies select the right tools at the right stages of development to ensure success.

There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.

Using an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.

Some of the greatest advancements in drug delivery are related to disposable delivery devices, vaccine adjuvants, and wearable pumps, according to Nicholas W. Warne of Pfizer.

FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.

A combination of eye imaging techniques and adaptive optics has revealed key details of choroideremia.

The dedicated solid-state research and development suite is designed to promote discovery of novel polymorph, salt, and cocrystal forms.

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.