News Wire

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…
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…
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…
Researchers at Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital have developed a capsule that can deliver a week’s worth of human immunodeficiency virus (HIV) drugs in a single dose. This advance could make it much easier for patients to adhere to the strict schedule…
The FDA has granted a breakthrough therapy designation to voxelotor (previously called GBT440, Global Blood Therapeutics) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD. The breakthrough therapy designation for voxelotor was based…
The FDA has expanded the approved indications for denosumab (Xgeva, Amgen) to include the prevention of skeletal-related events in patients with bone metastases with multiple myeloma. The medication was already approved to prevent skeletal events in patients with bone metastases from solid tumors. The…
Pembrolizumab (Keytruda, Merck) significantly improved recurrence-free survival compared with placebo in a phase 3 trial investigating the anti-PD-1 medication as monotherapy for surgically resected high-risk melanoma. Based on an interim analysis and following review by an Independent Data Monitoring…

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