Drug Development

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

Evonik has increased its global supply of plant-derived cholesterol used for mRNA vaccines and gene therapies.

TFF Pharmaceuticals and Catalent will collaborate to develop TFF's platform for manufacturing dry powder particles.

Thermo Fisher and Symphogen have extended their collaboration involving improved data workflow, which supports the discovery and development of new cancer treatments.

Technological advances are helping shape the dosage forms of the future.

Developers need to consider key challenges when approaching accelerated formulation strategies to ensure success.

Bacteriophages could be crucial weapons in the fight against antibiotic-resistant bacteria.

Adagene has announced SAFEbody multi-target collaboration with Sanofi for novel masked immuno-oncology antibody candidates.

AbbVie has acquired Syndesi Therapeutics, expanding AbbVie’s neuroscience portfolio.

Borrowing is good, but invention is best.

AstraZeneca and Neuroimmune have closed an exclusive global collaboration and license agreement to develop and commercialize NI006.

Eli Lilly and Company are investing $700 million into a Boston-based facility for the newly announced Institute for Genetic Medicine.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Noema Pharma announces first patient dosed in its Phase IIb clinical trial of mGluR5 inhibitor NOE-101 in trigeminal neuralgia.

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview Sean Tucker, PhD, chief scientific officer of Vaxart, on developing oral recombinant vaccines.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

China-based CDMO Asymchem acquires US-based chemical technology company Snapdragon.

Domainex is collaborating with Parkinson’s UK for the development of small-molecule therapies targeting the neuroinflammation that is associated with Parkinson’s disease.

Pharming Group has announced positive results from the Phase II/III study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).

In this episode of Drug Digest, Chris Spivey, editorial director, and Meg Rivers, senior editor, dive into APIs, excipients, and formulation advances, specifically pairing the right APIs and excipients for optimizing formulations.

In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

Interest in natural phytochemicals or synthetic derivatives of cannabinoids has risen.

Eli Lilly and Company has entered into a research and collaboration agreement with Entos Pharmaceuticals to develop new therapeutics for treating neurologic disorders.

The multispecific analysis of biologics is a complex task that requires appropriate strategies.

Personnel need to be trained in various analytical skill sets for biologic drug substance testing.

Toxicology studies are an important and required aspect of drug development that are performed to ensure that drugs are deemed safe prior to patient administration and use in clinical trials.

Experience is an invaluable asset for outsourcing partners, particularly as more challenging method development services are in demand.