Emtricitabine

HIV Drugs Show Promising Potential to Reduce Alzheimer's Risk by Up to 13% Annually

14 days ago

• UVA Health researchers discovered that HIV medications called NRTIs significantly reduce Alzheimer's risk, with annual decreases of 6-13% observed across two major health insurance databases. • The protective effect appears specific to NRTIs, which block inflammasomes linked to Alzheimer's development, and could potentially prevent approximately 1 million new cases worldwide each year. • Researchers are now calling for clinical trials of both existing NRTIs and a newly developed inflammasome-blocking drug called K9, which they describe as a safer and more effective alternative.

FTC Challenges $627M GTCR Acquisition of Surmodics Over Market Concentration Concerns

3 months ago

• The Federal Trade Commission has voted 4-0 to block private equity firm GTCR's $627 million acquisition of Surmodics, citing concerns that the merged entity would control over 50% of the outsourced hydrophilic coatings market. • GTCR already owns a majority stake in Biocoat, the second-largest provider of hydrophilic coatings, while Surmodics is the market leader, with the FTC arguing their merger would eliminate "fierce competition" that has driven innovation and price reductions. • Surmodics has expressed disagreement with the FTC's decision, stating the merger is "pro-competitive" and vowing to defend the case in court, while maintaining the deal would benefit shareholders, customers, and patients.

Merck's Doravirine/Islatravir Combo Shows Promise in Phase 3 HIV-1 Trials

5 months ago

• Merck's doravirine/islatravir (DOR/ISL) regimen demonstrated non-inferiority compared to current antiretroviral therapies in Phase 3 trials for HIV-1. • The DOR/ISL combination met primary efficacy endpoints, maintaining viral suppression in adults with virologically suppressed HIV-1 infection. • Merck plans to submit detailed findings from these trials to regulatory authorities for review and potential approval. • The ongoing Phase 3 trials are also evaluating DOR/ISL in treatment-naïve individuals, expanding its potential application.

Lenacapavir: Twice-Yearly Injection Shows High Efficacy in HIV Prevention

6 months ago

• Lenacapavir, administered as a twice-yearly injection, demonstrates a 96% reduction in HIV infection risk compared to background incidence. • Clinical trials reveal lenacapavir's superior efficacy over daily oral PrEP medications like Truvada, particularly addressing adherence challenges. • The FDA is reviewing lenacapavir for potential approval in 2025, offering a promising long-acting option for HIV prevention. • Global health experts emphasize the importance of equitable access and affordability to ensure widespread adoption of lenacapavir.

FDA Accepts Gilead's Lenacapavir for HIV Prevention with Priority Review

6 months ago

• The FDA has accepted Gilead's NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP). • Lenacapavir demonstrated 100% risk reduction in cisgender women and 96% risk reduction in a diverse population, compared to background HIV incidence. • The FDA has granted priority review with a target action date of June 19, 2025, potentially making it the first twice-yearly HIV prevention option. • Gilead is also pursuing global access, including submissions to the EMA and voluntary licensing agreements to facilitate availability in low- and middle-income countries.

FDA Approves Digital Therapeutic for GAD, Updated Novavax COVID-19 Vaccine, and New Insulin Patch Pump

9 months ago

• The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older. • Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older. • Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.

Key Trends from JP Morgan 2024: M&A Revival, AI Integration, and ADC Renaissance in Pharma

a year ago

• Major pharmaceutical companies including BMS, AstraZeneca, and J&J signal the return of significant M&A activity, with a focus on late-stage assets and deals totaling billions of dollars. • Tech giants NVIDIA, Alphabet, and Amazon make strategic moves into life sciences through partnerships, with NVIDIA launching GenAI initiatives for drug discovery alongside Recursion and Amgen. • Antibody-drug conjugates (ADCs) emerge as a leading investment area in oncology, with Daiichi Sankyo's Enhertu success driving increased clinical trials from 32 in 2013 to over 300 in 2023.