Pharma News

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced the company has submitted a new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The submission is based on the pivotal pharmacokinetic studies that demonstrated bioequivalence of ARYMO ER 15 mg, 30 mg and 60 mg to equivalent doses of MS Contin (morphine sulfate controlled-release). In addition, the submission includes a comprehensive battery of abuse-deterrent studies (Category 1, 2 and 3) which were conducted to support abuse-deterrent label claims for intravenous injection, snorting and oral abuse.

Merck, known as MSD outside the United States and Canada, announced  that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is already approved for use in boys 9 through 15 years of age for the prevention of these diseases. GARDASIL 9 is also approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today announced it has agreed to purchase Bristol-Myers Squibb’s late stage HIV R&D assets. In a separate deal, ViiV Healthcare has agreed to acquire Bristol-Myers Squibb’s HIV portfolio of pre-clinical and discovery stage research assets. Each deal is subject to clearance by the regulatory authorities and is expected to complete in early 2016.

A researcher from George Washington University is exploring the possibility of using a new technique for human reproduction and its ethical and practical implications.

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Chronic alcohol use, when combined with repeated binge drinking, causes more damage to the liver than previously thought, says an Indian-origin researcher from University of Missouri-Columbia.

Gene variants linked to cell senescence or biological ageing, autoimmunity, and Alzheimer's disease play an important role in determining whether we would live over 100 years or not, new research has found.

A diet high on fat but very low on carbohydrates which is generally favoured by body-builders may be effective in treating schizophrenia, new research has found.

A drug currently used to treat patients with osteoporosis can protect stem cells from ageing, a breakthrough study has found.