Pharma News

The government will focus on devolution, decentralisation and timely responsiveness to expand the reach and effectiveness of health programmes under the National Health Mission (NHM), union Health Minister Jagat Prakash Nadda said on Tuesday.

The World Health Organization (WHO) on Tuesday urged the Southeast Asian countries to promote educational campaigns regarding self-management of diabetes and make its treatment cost effective.

Chugai Pharmaceutical Co., Ltd. and Maruho Co., Ltd. announced that Chugai has acquired the marketing approval of "Marduox® Ointment" (Marduox) for the indication of psoriasis vulgaris, which has been jointly developed by Chugai and Maruho.

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The U.S. Food and Drug Administration  issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic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.

Researchers have identified an enzyme that is likely to lower the risk of heart related diseases caused by antiviral medicines used for human immunodeficiency virus (HIV).

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Patients with skin infections are less likely to take all their prescribed antibiotic doses after leaving the hospital, resulting in new infection or needing additional treatment for the existing skin infection, says a study.