Drug Delivery Technology

ARS will compete directly with EpiPen and other injectable products with inhaled neffy as the first needle-free epinephrine therapy for severe allergy attacks. EU approval is thought imminent.

Principal deputy commissioner Bumpus agrees with advisory committee findings that safety issues with ITCA 650 preclude approval, regardless of comparisons to other diabetes treatments. Final order caps a nearly eight-year regulatory saga that has grown increasingly rancorous.

ARS will compete directly with EpiPen and other injectable products with inhaled neffy as the first needle-free epinephrine therapy for severe allergy attacks. EU approval is thought imminent.

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

Altus’ breakable extended-release tablet technology will be Spektus’ holy grail in developing novel and differentiated therapies in the psychiatry space.

The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.

The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

Sanofi consumer health scientific affairs lead moves to CHPA; change in Bayer’s US consumer health marketing helm; Viatris CCO moves from same post at Moderna; Qnovia expands scientific advisory board; and Powerade powers Girls Inc. scholarships, programs.

Southeast Asia has so far not been a priority market for South Korean pharma firms, largely because of challenges such as access and affordability for patients. But a Deloitte executive suggested at a recent seminar that technology-based medicines, for example using next-generation formulation technologies, could be an initial focus for Korean firms looking to enter the rapidly growing ASEAN grouping.

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

Pinotbio CEO Dooyoung Jung shares his views on the Korean ADC industry’s situation and efforts needed for the sector to grow, the strengths of his company's camptothecin-based platform and pipeline, and R&D and business strategies.

More than 75 industry executives and experts gazed into the crystal ball and shared with Scrip their predictions around transformative technologies. Perhaps unsurprisingly, AI was the dominant theme – but gene editing, cell therapies and new targeting modalities were also among the highlights.

Keytruda becomes the first immuno-oncology agent to show an overall survival benefit in adjuvant renal cell carcinoma. Bristol gains ground on Merck and Roche in race to develop a subcutaneous checkpoint inhibitor.

Looking ahead on manufacturing and supply-related issues in 2024, respondents told Scrip to expect companies to bring their supply chains closer to home, improvements for delivery of cell and gene therapies, a focus by contract manufacturers and developers on sustainability and continued emphasis on access to critical drugs.

Following a green light in the UK in the summer, the Swiss major has bagged approval in the rest of Europe for its quicker and more convenient alternative to the IV infusion of Tecentriq.

In a tough R&D environment, delivery technology-based new drug development activities by Korean firms are poised to remain robust in 2024.

Insulet Corporation has recalled its Omnipod 5 App for Android smartphones due to a software error that could throw off the accuracy of insulin dosing by as much as one hundred times the intended amount.

Product hopping, patent manipulation, patient assistance programs and pay-for-delay are all points of inquiry in Sen. Bernie Sanders and fellow HELP Democrats latest drug pricing investigation, which targets pricey inhalers that have gone decades without generic competition.

Working for years to develop weekly or monthly oral drugs, Lyndra raises $101m and licenses commercial rights in six nations to Sun Pharma in a deal getting its lead product closer to the finish line.