The proposed BIOSECURE Act stands poised to significantly alter the landscape of U.S.-China biopharma partnerships by addressing national security concerns through restrictive measures. Specifically, the act aims to block certain Chinese biotech equipment and service providers from the U.S. market.
The FDA's Center for Drug Evaluation and Research (CDER) has embarked on a robust modernization initiative to transform its New Drug Regulatory Program (NDRP). Launched in 2017, this comprehensive effort aims to enhance the efficiency and effectiveness of CDER processes in response to
In a significant move to improve data practices within the biopharmaceutical industry, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has partnered with the Open Applications Group (OAGi). This collaboration aims to overcome the prevalent issue of data
Huntington’s disease, a genetic disorder that leads to the gradual death of nerve cells in the brain, has long challenged the medical and scientific communities. Traditional treatments have provided only limited symptom relief, pushing the quest for innovative therapies that can alter the disease’s
Novo Nordisk, a global leader in healthcare solutions for chronic diseases, has embarked on a transformative expansion project in Clayton, North Carolina. This unprecedented $6.8 billion investment aims to significantly ramp up the company's production capacity for injectable treatments,
Omnichannel marketing has been heralded as the next frontier in customer engagement, offering a seamless and integrated experience across various channels. The biopharmaceutical industry is no stranger to this trend, with a significant number of the top 100 pharmaceutical companies adopting
Annual drug shortages are common in the US and indeed throughout the world and can be attributed to a few key issues. Experts have pointed out how policy can assist in regulating the production, manufacturing, distribution, and purchase of essential drugs to prevent shortages of critical drugs,
Optimizing cell line development (CLD) for next-generation biologics is crucial to meet the rapidly growing demand for novel therapeutic modalities. As the biologics sector evolves, it's imperative to address potential bottlenecks in the development process through strategic enhancements and
Freeline Therapeutics, known for its pioneering work in gene therapy, has unveiled a new identity and an expanded mission, rebranding itself as Spur Therapeutics. This transformation marks a significant step towards a broader and more ambitious vision that includes tackling both rare genetic
In a move that reaffirms its position as a powerhouse in the life sciences sector, Merck has made a resounding statement with a substantial €180 million investment to expand its distribution center in Schnelldorf, Germany. This ambitious project has nearly doubled the existing facility's size b
