Drug Development

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

The program will improve access to adeno-associated virus gene therapy vectors.

Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones.

Webinar Date/Time: Thu, Oct 26, 2023 11:00 AM EDT

Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Webinar Date/Time: Tuesday, October 17, 2023 at 11am EDT | 4pm BST | 5pm CEST

Webinar Date/Time: Mon, Oct 23, 2023 11:00 AM EDT

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Twin-screw granulation process insight is growing as researchers employ new analytical technologies and investigate new ways to use the equipment.

Sustainability advances are being made, but more investment is needed.

In this episode of Drug Digest, Pharmaceutical Technology’s European/Senior Editor, Felicity Thomas, discusses small-molecule APIs, excipients, and formulation advances, including a discussion about novel approaches and solutions to pediatric formulations and taste-masking, a rundown of the fundamental stages of gaining a certificate of suitability for APIs, and a deliberation on the biggest trends impacting the industry and key sessions to visit while at CPHI, with several key industry experts.

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

Webinar Date/Time: Wed, Oct 4, 2023 - 11:00 am EDT | 4:00 pm GMT | 5:00 pm CEST | 8:00 am PDT

Webinar Date/Time: Wed, Oct 11, 2023 - 11:00 am EDT | 4:00 pm GMT | 5:00 pm CEST | 8:00 am PDT

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

According to a press release, the implications go to the extent that within the next 10 years, more than 50% of approved drugs will involve AI in their development and/or manufacturing.

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide.

The agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

Advanced analytical tools generate more data in today’s labs than ever before.

Webinar Date/Time: Wed, Oct 11, 2023 11:00 AM EDT

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.