News Wire

The FDA has approved a new indication for durvalumab (Imfinzi, AstraZeneca)–– treating patients with unresectable stage III non–small–cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. Durvalumab becomes the first treatment approved to reduce the risk…
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…
A federal judge in Delaware has overturned a jury’s verdict requiring Gilead Sciences to pay a record $2.54 billion because its hepatitis C drugs sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni) infringed a patent held by rival Merck & Company, according to a Reuters report. The verdict had…
The flu-related deaths of 22 more children were reported during the week ending February 10, federal officials say, bringing the pediatric toll to 84 for this grim flu season. Nearly 20,000 people have been hospitalized so far, with weeks to go. Several of the childhood deaths occurred weeks earlier…
This year’s vaccine has been 36% effective against viruses that have made for a particularly trying flu season––but some age groups are receiving “no statistically significant protection,” according to interim estimates released by the Centers for Disease Control and Prevention (CDC). Vaccine…
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…
Avelumab (Bavencio, Merck KGaA/Pfizer Inc.) did not improve overall survival compared with docetaxel in a phase 3 trial among patients with unresectable, recurrent, or metastatic non–small-cell lung cancer (NSCLC) whose tumors were positive for programmed death ligand-1 (PD-L1+) and whose disease…
The FDA has approved apalutamide (Erleada, Janssen Pharmaceutical Companies), the first treatment indicated for nonmetastatic, castration-resistant prostate cancer. “This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread…
The FDA has permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized the Banyan Brain Trauma Indicator (Banyan Biomarkers, Inc.) in less than six months as part of its Breakthrough Devices…
Prescription drug costs are expected to see the fastest annual growth among health care expenditures over the next decade, the Centers for Medicare and Medicaid Services (CMS) predicts, rising an average of 6.3% a year due to higher drug prices and more use of specialty drugs such as those for genetic…
A new report from Senator Claire McCaskill (D-Missouri) found that five opioid manufacturers paid nearly $9 million to 14 outside groups between 2012 and 2017, alleging that the advocacy groups often “amplified messages favorable to increased opioid use.” The groups—many of which work on chronic…
The FDA has approved tezacaftor/ivacaftor and ivacaftor (Symdeko, Vertex Pharmaceuticals, Inc.) to treat the underlying cause of cystic fibrosis (CF) in patients 12 years of age and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene…
Novartis’s Sandoz division has won FDA approval for a larger dosage of glatiramer acetate injection (Glatopa) for multiple sclerosis (MS) patients, ending a costly delay that allowed rival generics makers to beat it to market, according to a Reuters report. The FDA approved a 40-mg/mL injection of…
A new study makes a strong case for the importance of government support for basic research: Federally funded studies contributed to the science that underlies every one of the 210 new drugs approved between 2010 and 2016. Researchers at Bentley University scoured millions of research papers for mentions…
The Trump administration has outlined policy changes it says will lower drug prices, but some experts are skeptical that the actions will accomplish that goal, according to a FierceHealthcare article. The White House’s Council of Economic Advisers (CEA) issued a 30-page report that offers a slew of…

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