Denise Myshko

University of Florida researchers found immune systems destroy single beta cells before attacking larger pancreatic islets, explaining Type 1 diabetes progression and why younger patients lose cells more aggressively.

To gain approvals, biosimilar manufacturers could do faster, less expensive analytical studies of their products' composition.

A 340B rebate pilot goes into effect in January for the first 10 drugs negotiated by CMS. Cash flow and administrative costs are health systems' biggest concerns.

Ophthalmologists and oncologists created a new ocular adverse event grading scale for oncology trials that addresses ambiguities and provides clear dose modification recommendations.

The biosimilar market experienced 16 new approvals by early December 2025, marking significant expansion and introducing previously unavailable biosimilar drug classes to patients.

Medicare's first negotiated drug prices, effective January 2026, provide modest discounts, with limited savings for most beneficiaries and some unintended consequences.

A new Tufts study found that Medicare price negotiations on biologics with imminent biosimilars could lead to near-term savings, but greater savings are likely from biosimilar competition.

Melanoma survival rates have doubled since 2009. New treatments, including oncolytic viruses, fecal transplants, and engineered antibodies, have shown promising results in clinical trials.

Tranexamic acid given during noncardiac surgery reduced blood transfusions by 2.4% without increasing blood clots, potentially saving millions of transfusion units annually nationwide.

A phase 3 trial showed that Jaypirca improved progression-free survival in newly diagnosed patients with chronic lymphocytic leukemia and small lymphocytic lymphoma compared with standard chemotherapy/rituximab regimen.

Early results from the LINKER-MM4 trial show high response rates for linvoseltamab, offering new hope for newly diagnosed patients.

Early results from the LINKER-MM4 trial reveal promising response rates for linvoseltamab in newly diagnosed multiple myeloma patients, with manageable side effects.

Jaypirca demonstrated non-inferior response rates compared with Imbruvica in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, with fewer cardiovascular events and dose reductions.

Venclexta-azacitidine combination offered better responses with less hospitalization and lower symptom burden compared with standard chemotherapy in patients with acute myeloid leukemia who are fit for transplant.

Adults with sickle cell disease face longer emergency department wait times for pain treatment than children, with women experiencing more delays than men.

A budget model analysis finds that biosimilars for Prolia and Xgeva could provide cost savings for health plans.

Drug approvals this year have reflected the trend in clinical development of biologics shifting from intravenous to subcutaneous administration, offering shorter injection times, home use, and cost savings for cancer, Alzheimer’s, and inflammatory diseases.

Kamuvudines are a new class of drugs that are derived from the anti-HIV nucleoside reverse transcriptase inhibitors. They are designed to inhibit the inflammasome, part of the innate immune system that is triggered in geographic atrophy.

CMS has released the negotiated prices for the second set of drugs for Medicare Part D through the Inflation Reduction Act. Discounts range from 38% for Austedo and Austedo XR to 85% for Janumet and Janumet XR.

Itvisma is a one-time gene therapy approved for both children and adults with spinal muscular atrophy. It will be available in December.

A provision in the One Big Beautiful Bill delays or exempts high-spending medications with orphan indications from Medicare drug price negotiations.

Beginning in January 2026, Optum Rx is removing reauthorizations for two new drug classes: hormone therapies and knee osteoarthritis injectables.

A pilot program limiting the patient co-pay to $50 could burden Part D plans, depending on whether manufacturers discount their prices — and by how much.

Eylea HD offers two dosing options for patients with retinal vein occlusion: 8-week and 4-week dosing intervals.

Promising new medications for resistant gonorrhea, such as zoliflodacin and gepotidacin, are waiting for FDA approval, and they offer hope for effective treatment options.

Redemplo has been approved to treat adults with familial chylomicronemia syndrome. The therapy will be available by the end of the year and will have an annual wholesale acquisition cost of $60,000.

The findings in a new study published in Health Affairs suggest that Semglee’s interchangeability status may have partially increased adoption by supporting improved formulary coverage.

In addition, Elevidys’s indication for non-patients has been removed, and the gene is now indicated only to treat ambulatory patients four years of age and older with Duchenne muscular dystrophy.

Increased adoption of biosimilars requires regulatory changes, educational efforts, and PBM reimbursement policies that enable fair competition, argues Dr. Benjamin Rome in a new paper.