Industry News

Eagle Pharmaceuticals, Inc. announced that it has entered into an agreement with the National Institutes of Health (“NIH”)/National Institute on Drug Abuse (“NIDA”) to explore the use of Ryanodex® in the treatment of hyperthermia related to MDMA (“Ecstasy”) and Methamphetamine intoxication, which is a life-threatening condition mostly affecting adolescents and young adults.

TSO3 Inc. has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a universal design of its STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Sterilizer was originally cleared for commercialization in the U.S. in December 2014. The new clearance enables the company to streamline assembly and shipping around a single sterilizer platform that meets global regulations for electromechanical design.

The U.S. Food and Drug Administration  issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.

KemPharm, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a fee waiver and has refunded the full user fee amount of $2,374,200 for its New Drug Application (NDA) filing for KP201/APAP, the Company’s investigational immediate release combination of its hydrocodone prodrug, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is currently under priority review by the FDA.  The FDA has set a target action date under the Prescription Drug User Fee Act of June 9, 2016.

MediciNova, Inc., and the JASDAQ Market of the Tokyo Stock Exchange announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia.

Asia's premier biopharmaceutical company, today announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved its biosimilar Insulin Glargine.  This is a significant achievement for Biocon and its commercial partner, FUJIFILM Pharma Co. Ltd (FFP) as it endorses our endeavor to bring high quality, yet affordable, world class products to diabetes patients in Japan.

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

Pfizer Inc. announced  that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for XELJANZ® (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). The EMA will now initiate its review of the XELJANZ MAA.

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved CINQAIR® (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.