Up until recently, the deadline for pharmaceutical companies and contract manufacturers to meet serialization regulations regarding assignment of product identifiers to packages was November 26 of this year. Now the FDA has made the decision to push this date back to November of 2018, a one year delay. Many industry representatives feel this delay indicates that manufacturers in both the …
Pharma Marking – FDA Approves Vosevi For Hepatitis C
The FDA has recently given approval to Gilead Sciences for the use of the company’s Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets to re-treat adults who suffer from chronic hepatitis C virus infection, or HCV. According to reports, the single-tablet regimen is effective in most patients; two studies supported the claim that about 96% of patients involved in …
Pharma Coding – Opana ER Pulled From Market Following FDA Request
Everyone knows opioid painkillers have been in the news for quite some time, as these drugs have been found to be highly addictive and abused. Recently it was announced that Endo would pull Opana ER from the market after the FDA asked the pharmaceutical manufacturer to pull the drug about 30 days ago. Opana ER, or oxymorphone hydrochloride, is reported …
Pharma Coders – Experimental Drug To Treat Psoriasis
Psoriasis is a common skin condition with no known cure at the moment, however India’s largest drug manufacturer, Sun Pharmaceutical, and South Korea-based Samsung BioLogics have recently signed an agreement regarding the manufacture of Tildrakizumab in experimental treatment of this frustrating condition. According to news reports, the FDA (U.S. Food & Drug Administration) and EMA (European Medicines Agency) are reviewing …
Pharma News – Takeda’s Instanyl DoseGuard Controls Opioid Dosing
Everywhere we turn today, we hear news about the “opioid” crisis; lives have been impacted throughout the U.S. and North America as some who’ve taken opioids for pain management have become addicted, while others get their “fix” on the streets. Recently in pharma news, it was announced that Takeda Pharmaceuticals International AG will use an e-Lockout device that essentially limits …