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The U.S. Food and Drug Administration  issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic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

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.

Focusing majorly on health, the Delhi government on Monday hiked its budgetary allocation for public health by Rs.472 crore over last year, and proposed a three-tier health system with opening of 1,000 mohalla (community) clinics and 150 polyclinics in various parts of the city.

Just one session of a non-invasive brain stimulation technique can reduce core symptoms of anorexia nervosa, including the urge to restrict food intake and feeling fat, says a study.

The Chilean health ministry has confirmed the first case of sexually transmitted Zika virus in the country, the media reported on Sunday.The 46-year-old woman was infected with the virus as she had unprotected sex with her partner, who was infected with Zika in Haiti, said the ministry on Saturday.