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The FDA this week approved Coagadex, Coagulation Factor X (Human) for hereditary Factor X (10) deficiency. Until the new orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.

Laboratory diagnostics are essential tools of physician practice, informing many medical decisions. Physicians will increasingly rely on companion and other types of lab diagnostics that consider genetic, proteomic, or other markers in connection with drug treatment strategies.

Pain management is a problem for patients, practitioners, pharmacists, and others. Many patients are not getting the care and relief they deserve, even when they suffer from acute or chronic pain. In this blog post, Srinivas Nalamachu, MD asks if its possible to balance patient access to pain medication with safety and economic value.

The CEO of Valeant Pharmaceuticals, which is being investigated by the government for raising drug prices, predicted more modest price increases ahead for the pharmaceutical industry.

Prescription opioid use disorders and deaths increased for the most recent 10 years tracked, even though the percentage of non-medical use of prescription opioids decreased, according to a new study.

There is new hope for patients with multiple sclerosis (MS) after positive data on Gilenya and the investigational drug ocrelizumab was presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

Soon after the FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC), it approved Opdivo (nivolumab) for an expanded use – to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

The first biosimilar product was approved this spring. Pharmacists will want to familiarize themselves with this new class of therapies. Below are the five top things that a pharmacist should know about biosimilars.

Pulmonary fibrosis (PF) organizations and healthcare providers are lauding the update of the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis, which was last updated in 2011.

FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1.

A novel influenza drug will advance in development, thanks to funding from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

Pharmaceutical companies are charging up to 600 times what certain cancer drugs cost to make, and Americans are paying more than double the price charged in Europe for the tyrosine kinase inhibitors (TKIs).

The FDA’s accelerated drug reviews skip some important research methods – they typically do not use trials with active comparators or clinical outcome measures, according to two new studies.

FDA approved Tresiba (insulin degludec injection, Novo Nordisk) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection, Novo Nordisk) for the treatment of diabetes mellitus.

Proteus Digital Health along with the pharmaceutical company, Otsuka, has submitted the first Digital Medicine New Drug Application (NDA) for the combination tablet of Abilify (aripiprazole) embedded with a Proteus ingestible sensor.

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Regeneron Pharmaceuticals in Tarrytown, New York, are partnering to develop a novel Ebola virus treatment.