Clostridioides difficile, commonly known as C. diff, is a significant health threat in the U.S. Recent estimates suggest that C. diff, a common bacteria, can cause infection in roughly 500,000 patients annually in the U.S., with around 30,000 of these cases resulting in death. “Actually, it’s more like 5 million when you think about it in terms of people at risk,” estimated Brian Finrow, founder and CEO of Lumen Bioscience, a biotech specializing in developing novel biologics. C. diff infection (CDI) is especially prevalent and dangerous in the immunocompromised elderly patients who are hospitalized or have been in nursing homes for long periods. “It’s a huge cost driver,” Finrow. Annual U.S. costs tied to CDI have eclipsed $6 billion per year. The infection is especially prevalent and dangerous in the elderly. Complicating matters further, recurrent CDI infections are common, affecting anywhere from 20% to 35% of patients with an initial infection.
A s…Seven biologics walking the approval tightrope in 2023
[Alpha Tauri 3D/Adobe Stock]
As we venture into the second half of 2023, the global biologics market continues to hover between robust growth and unpredictability. Valued at $461.74 billion in 2022, it’s projected to grow at a compound annual rate of 10.3% from 2023 to 2030, according to Grand View Research. In 2022, biologics edged past small molecules for the first time, as Nature reported, but sponsors face mounting scrutiny from regulators.In the spotlight is the FDA’s Accelerated Approval program, which has faced criticism following a string of high-profile cases of post-approval confirmatory trial failures. For example, the Alzheimer’s drug aducanumab won accelerated approval despite conflicting evidence from clinical trials. Oncology is another area where negative confirmatory trials of accelerated approval drugs has been a concern.
Such developments have led the FDA to increase …
Guselkumab offers sustained improvements for psoriatic arthritis patients in phase 3b trial
Data from Janssen’s phase 3b COSMOS clinical trial reveals that guselkumab (Tremfya), an inhibitor of interleukin-23 (IL-23), provides improvements in all minimal disease activity (MDA) domains for adults with active psoriatic arthritis (PsA). The benefits persist through week 48, even in patients who have seen inadequate responses to one or two tumor necrosis factor inhibitors (TNFi-IR).
The drug also had an acceptable safety profile in the study. These results are among 41 Janssen-backed abstracts being presented at the 2023 Annual European Congress of Rheumatology (EULAR) meeting scheduled for May 31 to June 3, 2023 in Milan.
In a separate post-hoc analysis of the phase 3 DISCOVER-1 and DISCOVER-2 studies, guselkumab demonstrated swift and long-lasting durability in all evaluated criteria, including dimensions related to patient-reported pain, physical components of health-related quality of life and fatigue.
Efficacy of guselkumab: A post-hoc anal…Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance
A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]
The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…
Catalent to invest $40M in biologics facility in Durham, North Carolina
Contract manufacturing giant Catalent has announced that it will set up a new biologics analytical center of excellence in North Carolina’s Research Triangle.
The new plant will offer analytical development and testing services for biologics, including cell and gene therapies.
Catalent obtained a Job Development Investment Grant (JDIG) from the North Carolina Economic Investment Committee (EIC) to provide 201 new jobs over the next five years in Durham County.
It anticipates that construction of the facility will be completed by mid-2023.
Catalent also operates a biologics and analytical center of excellence in Kansas City, Missouri. The company has committed $12 million to expand that facility.
Earlier this month, the company announced that it had opened a sizeable commercial-scale cell therapy manufacturing facility in Gosselies, Belgium.
Additionally, it expanded a clinical supply facility in Shanghai while laying off about 600 wo…
4 things to keep in mind when selecting beta bags
Image courtesy of Central Research Laboratories
Life science products like pharmaceuticals, biologics and biosimilars that feature active pharmaceutical ingredients (APIs) require the safe, efficient, contamination-free, i.e., “aseptic,” handling of raw materials and finished products. Maintaining a sterile production process demands that all components used in a cleanroom or isolator be kept contaminant-free. Beta bags play a critical role in this process, but before selecting a beta bag brand or model, the aseptic-process operator should consider four things:
1. What is the main purpose of beta bags?Alpha ports (sealed openings) used in cleanrooms and isolators give operators access to various components during an aseptic-production process, allowing the operator to retrieve items ranging from vial stoppers to syringe plungers, hand wipes to cable ties, and simple pen and paper. Contamination-free access …