This week we highlight the impact of emerging biopharma on the life sciences industry, a new method for delivering gene therapy, an innovative device to improve safety and sleep quality in infants, and a cutting-edge treatment for vision loss caused by age-related macular degeneration. Finally, we look at major law reforms in the European Union that could affect the pharmaceutical industry.
Each week we highlight five things happening in the life sciences industry. Here’s the latest.
A recent report indicated that 67% of all new drugs in 2022 were produced by emerging biopharma companies. Emerging biopharma is defined as companies with less than $200 million of annual research and development spend or less than $500 million of annual revenue. In 2017, such companies represented 51% of new drugs and in 2002 only 33% came from this sector. A partial driver of this uptick is a 26% increase in the number of emerging biopharma companies over the past 20 years.
Researchers have developed a bacterial nanosyringe to deliver gene therapy to human cells, a breakthrough that could revolutionize gene editing and other treatments. The nanosyringe is derived from a naturally occurring protein secretion system in bacteria called Type III secretion system (T3SS), which can inject genetic material directly into target cells. By engineering the T3SS to carry therapeutic DNA, the researchers demonstrated successful delivery of functional genes into human cells. This novel approach offers potential advantages over current gene therapy methods, including increased precision, lower cost and reduced immune response.
Happiest Baby’s SNOO Smart Sleeper, a high-tech baby cot, has been granted Food and Drug Administration approval. The sleeper has been recognized for its ability to reduce the risk of sudden infant death syndrome and improve sleep quality for babies. The device employs responsive swaddling and rocking to soothe infants, while built-in sensors monitor sleep patterns and offer data insights to parents.
Pixium Vision has received FDA breakthrough device designation for its Prima System, a bionic vision restoration system designed to treat dry age-related macular degeneration (AMD). The Prima System uses a wireless sub-retinal implant and a pair of special glasses equipped with a camera to capture images and transmit them to the implant, which then stimulates retinal cells to restore vision. This technology aims to help patients with dry AMD, a condition that currently has no approved treatments and causes progressive vision loss.
Later this month, the European Union is expected to roll out major reforms to laws impacting the pharmaceutical industry. Lawmakers have stated that the primary goals of these changes are to increase investment in research and development and to provide greater access to affordable drugs. The changes include a more streamlined regulatory approval process, requirements for increased disclosure surrounding research and development expenditures, changes to patent protection laws, and incentives for antibiotic manufacturing.