News Wire

The FDA has issued a complete response letter (CRL) in reply to a supplemental new drug application requesting permission to include new data in the clinical trials section of the U.S. label of vortioxetine (Brintellix, Takeda/Lundbeck) for treating certain aspects of cognitive dysfunction in adults…
A new analysis of the prehistoric origin of malaria suggests that it evolved in insects at least 100 million years ago, and that the first vertebrate hosts of the disease were probably reptiles, which at that time would have included dinosaurs, according to a report from Oregon State University (OSU).…
The Manhattan U.S. Attorney has asked Novartis AG to provide records of approximately 80,000 “sham” events in which the government says doctors were wined and dined so they would prescribe the company’s cardiovascular drugs. The Swiss drug maker and the U.S. Attorney’s office are engaged in…
When California’s aid-in-dying law takes effect this June, terminally ill patients who decide to end their lives could be faced with a hefty bill for the lethal drug secobarbital (Seconal). It retails for more than $3,000. Last year, the drug’s manufacturer, Valeant Pharmaceuticals, doubled the…
The Centers for Disease Control and Prevention (CDC) has issued new guidance and information to prevent Zika virus transmission and its health effects. The new information includes updated interim guidance for healthcare professionals for counseling patients about pregnancy planning and the timing of…
The FDA has denied Eagle Pharmaceuticals’ request for seven years of orphan drug exclusivity in the U.S. for Bendeka, a liquid, low-volume (50 mL), 10-minute infusion formulation of bendamustine hydrochloride. Bendeka was approved in December 2015 for the treatment of patients with chronic lymphocytic…
Positive results have been reported from a phase 2b study of ALD403 (Alder BioPharmaceuticals), a monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide (CGRP). Patients with chronic migraine demonstrated that ALD403 prevented migraine during the entire…
During the past 20 years, advances in routine care have allowed many people with sickle cell anemia to live into middle age and beyond. But early adulthood, a time when patients make a switch from pediatric to adult care, can be perilous for these individuals, according to a report from Kaiser Health…
The FDA has issued draft guidance intended to support the pharma industry in its development of generic versions of approved opioids with abuse-deterrent formulations (ADFs) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. The new guidance is among a number…
Mixed findings have been reported from the phase 3 APEX (Acute Medically Ill VTE Prevention With Extended-Duration BetriXaban) study, which evaluated the superiority of extended-duration anticoagulation with oral betrixaban (Portola Pharmaceuticals) compared with standard-of-care anticoagulation with…
Analysts at Thomson Reuters have issued a report detailing seven drugs that will likely hit blockbuster status this year—defined as earning more than $1 billion annually. These treatments are listed below. Obeticholic Acid for Liver Disease The farnesoid X receptor agonist obeticholic acid (Intercept…
Rural hospitals have been on the brink of financial disaster for years, but it now seems that state and federal lawmakers may finally be willing to help. Since 2010, 71 rural hospitals have closed, driven by congressional spending measures that cut Medicare payments and by the Patient Protection and…
Hackers have demanded a ransom from two more Southern California hospitals and federal authorities are investigating the case, according to a report from Kaiser Health News. Prime Healthcare Services Inc., a national hospital chain, said the attackers infiltrated computer servers at two of its California…
March 24 marks the day in 1882 when German microbiologist Robert Koch announced he had discovered Mycobacterium tuberculosis (Mtb), the bacterium that causes TB. Today, more than a century later, TB remains one of the world’s deadliest diseases, according to a new report from the National Institute…
The FDA has given the green light to reslizumab (Cinqair, Teva Pharmaceuticals) for use with other asthma medications for the maintenance treatment of severe asthma in patients 18 years of age and older. Reslizumab is approved for patients who have a history of severe asthma attacks (exacerbations)…

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