Formulation and Drug Delivery, Parenterals

Experts from Acuitas, Mana.bio, NanoVation, and ReCode share their input on targeted LNP engineering, which is accelerating pipeline expansion of nucleic acid therapies for chronic and rare diseases beyond the liver.

FDA’s breakthrough therapy designation for Johnson & Johnson’s co-formulated bispecific antibody therapy validates dual EGFR/MET targeting in HPV-negative head and neck cancer.

Regulatory review of Eisai’s subcutaneous lecanemab highlights how delivery innovation may expand access and scalability for disease-modifying Alzheimer’s therapies.

The European Commission’s approval of GSK’s Arexvy for adults 18 years and older expands the respiratory syncytial virus vaccine market and signals broader adoption of adult immunization strategies.

The approval of aflibercept for visual impairment from macular edema following retinal vein occlusion is based on clinical data that suggests higher-dose anti-VEGF therapy can preserve vision while extending dosing intervals.

The CDC has narrowed pediatric vaccine guidance, resetting evidence expectations and signaling potential shifts in vaccine uptake and market demand.

Non-parenteral alternatives for biologics remain a clinical imperative and a formidable challenge.

The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

Alternative delivery methods for biologics continues to be explored that offer less invasive, less painful administration.

Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

Nanoparticles offer the potential for a safer, more effective method of drug delivery to the patient.

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

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.

Companies need to consider and address formulation challenges to employ a successful reformulation strategy.

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

Manufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.

While a variety of innovations have already impacted the drug delivery landscape, improving sustainability and having the ability to make smaller volumes of drug products still require work.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.