News Wire

Cabozantinib (Cabometyx, Exelixis, Inc./Ipsen) improved overall and progression-free survival among previously treated liver cancer patients in the pivotal phase 3 CELESTIAL trial, according to results being presented at the 2018 ASCO-GI Symposium in San Francisco. At the planned second interim analysis…
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’s Center for Biologics Evaluation and Research has expanded the indication for Fluarix Quadrivalent (influenza vaccine, GlaxoSmithKline) to include use in people 6 months of age and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses…
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…
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…
As part of its efforts to enhance transparency around drug approval decisions, the FDA is exploring ways it can continue to build on its obligation to share information, says FDA Commissioner Scott Gottlieb, MD. The agency is especially focused on information that can improve patient care and better…
The FDA has approved a supplemental new drug application (sNDA) for afatinib (Gilotrif, Boehringer Ingelheim) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations as detected by…
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 shortage of small-volume parenteral solutions often supplied in intravenous fluid bags is affecting virtually all U.S. hospitals, according to results of a survey by the American Society of Health-System Pharmacists (ASHP). Nearly all of the respondents (99.1%) to the informal, nonscientific survey…
The Trump administration will allow states to test requiring some Medicaid recipients to work or participate in community activities such as volunteering or jobs training as a condition of eligibility for the government health insurance program for the poor. The Centers for Medicare and Medicaid Services…
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…
New expert guidance released by the Society for Healthcare Epidemiology of America offers advice to hospitals on determining when they can safely discontinue contact precautions for patients with multi-drug resistant bacteria. The framework, published in Infection Control and Hospital Epidemiology,…
An FDA advisory committee has declined to recommend approval of a proposed new oral testosterone replacement therapy (Tlando, Lipocine Inc.). Lipocine said the Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) voted six in favor and 13 against the benefit–risk profile of Tlando, which…
A U.S. charity offering assistance to patients for their out-of-pocket drug costs has sued the federal government over restrictions on its ability to communicate with drug-makers who donate to it, according to a Reuters report. The charity, Patient Services, Inc. (PSI), filed the lawsuit in federal…
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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