The Rx Recap: January 25-30

Welcome to this week’s roundup of the most insightful and impactful articles from the sister publications of Dermatology Times, all under One MJH Life Sciences. Our network brings together expert perspectives, clinical advancements, and industry updates to keep clinicians informed and ahead of the curve. From cutting-edge treatments to practice management strategies, here’s a look at the top stories shaping the field of medicine.

CTD402 Receives Orphan Drug Designation For T-Cell Leukemia/Lymphoma

Reported by Cancer Network, the FDA has granted orphan drug designation to CTD402, an off-the-shelf allogeneic anti-CD7 CAR-T cell therapy, for patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma. The designation is supported by early data from the ongoing phase 1b/2 TENACITY-01 trial, in which 64.1% of treated patients achieved complete remission and 91.7% achieved MRD-negative status. CTD402 is designed to resist immune rejection and be immediately available at the point of care, with developers planning an accelerated development pathway toward phase 2 evaluation.

FDA Provides Guidance on Development Pathway for Testosterone Therapy for Women

Reported by Urology Times, Aviva Bio announced progress toward clinical development of AVA-291 (d3-T), a female-specific testosterone therapy, following a type B meeting with the FDA that clarified regulatory requirements. AVA-291 is designed to preserve androgen activity while resisting aromatization, a key safety concern linked to breast cancer risk that has limited testosterone use in women. Preclinical data to be presented at AACR 2026 suggest the therapy has a markedly lower potential to stimulate breast cancer cell proliferation compared with standard testosterone. Aviva plans to initiate a phase 1 trial in early 2026, with potential applications across women’s health and select men’s health indications where aromatization constrains current testosterone therapies.

Trulicity, Botox Headline Drugs Included in the Third Cycle of Medicare Price Negotiations

Reported by AJMC, CMS announced the third round of Medicare drug price negotiations under the Inflation Reduction Act, selecting 15 high-cost medications that include major treatments for diabetes, HIV, cancer, autoimmune disease, and neurologic conditions, as well as Botox. For the first time, the list includes drugs covered under Medicare Part B in addition to Part D, with negotiated prices set to take effect in 2028. Notable selections include dulaglutide (Trulicity), marking the second GLP-1 diabetes drug negotiated, bictegravir/emtricitabine/tenofovir (Biktarvy), the first HIV therapy included, and onabotulinumtoxinA (Botox). The drugs account for about $27 billion in annual Medicare spending and are used by roughly 1.8 million beneficiaries, drawing both praise for improving affordability and criticism for excluding certain high-cost cancer therapies.

Noncompetes in Veterinary Medicine: Veterinarian Describes How Restrictions Can Strain Careers

Reported by dvm360, veterinarians highlighted the ongoing harm of noncompete agreements during a recent FTC webinar, with C.J. Caniglia, DVM, describing how restrictive clauses forced him to choose between ethical practice and supporting his family, including long commutes and limits on emergency care. Despite growing legal and political scrutiny—and a nationwide FTC ban that was proposed in 2024 but vacated in 2025—noncompetes remain common in veterinary contracts, with nearly 70% of practices still using them. Speakers and experts emphasized that these agreements suppress wages, restrict career mobility, and reduce access to veterinary services, even amid workforce shortages, prompting continued calls for reform at the state and federal levels.

FDA Grants Breakthrough Therapy Designation to Ianalumab, First Potential Sjögren’s Targeted Therapy

Reported by Rheumatology Live, the FDA has granted Breakthrough Therapy designation to Novartis’ ianalumab for the treatment of Sjögren disease, positioning it as a potential first targeted therapy for the condition, with regulatory submissions planned for early 2026. The dual ADCC/BAFF-R–targeting monoclonal antibody demonstrated significant improvements in disease activity versus placebo in the phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials, meeting primary ESSDAI endpoints and showing consistent benefits across multiple secondary and patient-reported outcomes. Monthly dosing was associated with greater efficacy, while safety was comparable to placebo, supporting ianalumab’s potential to meaningfully improve care for patients with this debilitating autoimmune disease.

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