Development

FDA has spurred investment to create and develop 600 therapies.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Webinar Date/Time: Thursday, May 11th, 2023 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST

Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines.

Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.

Polyplus’ LipidBrick is designed to expand the scope of lipid nanoparticle formulation usage in mRNA therapeutics and vaccine development.

Webinar Date/Time: Thu, Apr 27, 2023 10:00 AM EDT

Predictive Oncology and Cancer Research Horizons have partnered to pursue development of cancer drugs utilizing the PEDAL platform.

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.

The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Pharmaceutical companies have shifted their approach to development of vaccines as a result of the COVID-19 pandemic.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

Decreasing vein to vein time saves lives.

There is growing pressure for robust and economically scalable viral-vector manufacturing technologies.

Webinar Date/Time: Wed, Mar 8, 2023 11:00 AM EST

CMO growth is focused on analytical testing, toxicity testing, and fill/finish operations.

A slew of late-stage clinical trials is expected to push new regenerative medicines onto the market in the next few years.

Improvement in viral vector yield has become integral to new cell and gene therapy product development.

In vivo CAR-T gene therapies could overcome the challenges faced by autologous and allogeneic treatments.

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

The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.