Ocaliva (obeticholic acid) is a drug manufactured by Intercept Pharmaceuticals for treatment of PBC or primary biliary cholangitis, a rare and chronic disease of the liver that damages the organ as a result of the bile build-up that occurs when the bile ducts become damaged, inflamed, or are destroyed. Now, the FDA has issued a warning regarding excessive dosing of …
Trump Signs FDARA Into Law – Impact To Medical Products And Patients
On Friday August 18, President Trump signed FDARA (FDA Reauthorization Act 2017) into law. H.R. 2430 was passed by the House of Representatives on July 12, and the Senate passed the bill on August 3. This bipartisan legislation essentially reauthorizes the MDUFA (Medical Device User Fee Amendments), PDUFA (Prescription Drug User Fee Act), and other user fees that make it …
Pharma Coding – Bristol-Myers Squibb Acquires IFM Therapeutics
Recent news reports reveal that BMS and IFM Therapeutics have signed an agreement in which Bristol-Myers Squibb will acquire full rights to IFM’s NLRP3 and STING agonist programs in an effort to target innate immunity pathways that could potentially assist the body’s natural defenses in recognizing tumors and attacking them, expanding and complementing Bristol-Myers Squibb’s immuno-oncology portfolio. Reports claim BMS …
Pharma Coders – Naloxone Prescription Reform In Maine
Narcan, the brand name of naloxone, a drug used to reverse overdose in those who have taken opioids, will become available in Maine without a prescription from a doctor, as one keyword added to the bill last month would make it possible for pharmacists to prescribe the medicine. News reports state Assistant Attorney General, Andrew Black, said in written testimony …
FDA’s Decision To Delay Serialization Regulations Indicates Stragglers
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 …