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Clinical Decision Support Software Can Warn of Potential Stroke 

New clinical decision support software designed to analyze computed tomography (CT) results may speed treatment by notifying providers of a potential stroke in their patients. The FDA has permitted marketing of Viz.AI Contact (Viz.AI), a computer-aided triage software application that uses an artificial…
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New Psoriasis Biologic Ilumya Receives FDA Approval

Sun Pharma’s $80 million psoriasis licensing deal with Merck & Co. just paid off with an FDA approval, according to a FiercePharma report. But now, another challenge begins: The new med will go up against established psoriasis player Johnson & Johnson. The FDA has officially green-lighted the Indian…
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FDA Turns Down a Third Generic Version of Advair

The FDA has declined to approve Novartis’ generic formulation of fluticasone propionate/salmeterol (Advair, GlaxoSmithKline), according to a report from FiercePharma. Approval of the Novartis’ generic had been anticipated for the first half of 2018. Novartis said it has received a complete response…
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Good News for Risankizumab, Tremfya, Otezla, and Taltz at AAD Meeting

Promising new findings in the treatment of plaque psoriasis, oral ulcers, and genital psoriasis have been reported at the 2018 American Academy of Dermatology Annual Meeting in San Diego. Risankizumab Outperforms Stelara More patients with plaque psoriasis treated with risankizumab (AbbVie/ Boehringer…
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Novartis Goes 2–0 Against J&J in Psoriasis Treatment

Novartis has touted more clinical data showing its blockbuster drug secukinumab (Cosentyx) is better at treating plaque psoriasis than Johnson & Johnson’s rival product ustekinumab (Stelara), according to a BioPharma Dive report. Twelve weeks into the phase 3 CLARITY study, two-thirds of patients…
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FDA, FTC Target Unproven Opioid Addiction Treatments

Federal authorities are cracking down on 15 companies that are making unproven claims about unapproved products’ ability to help treat opioid addiction and withdrawal. The FDA and the Federal Trade Commission (FTC) jointly posted warning letters to the marketers and distributors of 12 opioid cessation…
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New Treatments, Screening Methods Dramatically Reduce Breast Cancer Deaths

In the last few decades, dozens of new breast cancer drugs—from chemotherapies to targeted compounds—have become available for clinical use, and mammogram technology has gone from film to digital. But are the changes making a difference in how many women die of breast cancer? The answer to that…
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FDA Approves Third Breast Cancer Indication for Verzenio

The FDA has approved abemaciclib (Verzenio, Eli Lilly and Co.) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced or metastatic…
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Lynparza Approved for Germline BRCA-Mutated Metastatic Breast Cancer

The FDA has approved olaparib (Lynparza, AstraZeneca/Merck) for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant,…
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Iodine Deficiency May Reduce Pregnancy Chances, NIH Study Suggests

Women with moderate to severe iodine deficiency may take longer to achieve a pregnancy compared to women with normal iodine levels, according to a study by researchers at the National Institutes of Health. The study is the first to investigate the potential effects of mild to moderate iodine deficiency—common…
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Merck’s Keytruda Extends Lung Cancer Survival in Combination Trial

Early results from a key study have shown that a cocktail of Merck’s blockbuster drug pembrolizumab (Keytruda) and two chemotherapy agents helped lung cancer patients live longer and stopped the disease from advancing, according to a recent Reuters report. The results cement Merck’s position as…
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Gastric Bypass Benefits for Diabetic Heart Complications Can Fade

For obese people with diabetes, doctors have increasingly been offering gastric bypass surgery as a way to lose weight and control blood glucose levels. Short-term results are often impressive, but questions have remained about the long-term benefits of such operations. Now, a large, international study…
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Lenvima/Keytruda Combo Wins Breakthrough Therapy Status for Kidney Cancer

The FDA has granted a breakthrough therapy designation for Eisai’s multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (Lenvima) in combination with Merck’s anti-programmed death-1 therapy pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic…
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Hospitals to Form Their Own Generic Drug-Maker

Sick and tired of dealing with generic drug shortages and unpredictable price increases, five large U.S. health systems are taking an unusual step, Fierce Pharma reports: they're forming their own nonprofit generic drug-maker. Representing more than 450 hospitals, nonprofit groups Intermountain Healthcare,…
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Study Estimates Nonoptimized Medications Cost the U.S. $528.4 Billion Annually

Rising drug prices have gotten a lot of attention lately, but the actual cost of prescription medications is more than just the dollars and cents on the bill, according to a recent study. Researchers at the University of California San Diego (UCSD) estimate that illness and death resulting from nonoptimized…
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