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…
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…
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…
The FDA has updated the product label for the cancer drug nilotinib (Tasigna, Novartis) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive…
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…
The CMO of Molina Healthcare of Utah grew up, let’s say, not rich. He says that and a varied background—including a stint in the Air Force—helps him deal with changing policies involving a challenging population.
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…
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…
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,…
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…
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…
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…
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…
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,…
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…
