Issue link: https://www.e-digitaleditions.com/i/626800
8 January 2016 Tablets & Capsules LOOKING FORWARD Ť VWSUHVHUYDWLYHIUHHIRUPXOD Ť VWSKDUPDFHXWLFDOJUDGHQRQJHODWLQ FDSVXOHRIYHJHWDORULJLQ Ť VWFDSVXOHIRULQKDODWLRQWKURXJK '3,GHYLFHV QUALICAPS ® HAS A STRONG RECORD OF PIONEERING IN NEW FORMS OF DRUG ADMINISTRATION, DEVELOPING CAPSULES WITH FEATURES SO WIDELY ACCEPTED AND TRUSTED AS TO BECOME INDUSTRY STANDARDS. :HFRQWLQXHWRSXVKRQZDUGVLQ WKHFUHDWLRQRIWKHQH[WJHQHUDWLRQ FDSVXOHLQDUHDVVXFKDVELRDYDLODELOLW\ DQGQHZPDWHULDOVFKHPLVWU\ DQGWHFKQRORJLHV :HDUHLPDJLQJQRWRQO\WKHFDSVXOH RIWKHIXWXUHEXWDOVRWKHIXWXUHRI KHDOWKFDUHLWVHOIDQGDUHZRUNLQJ WRZDUGVLWHYHU\GD\ FDA issues draft Guidance on IND safety, reporting WASHINGTON, DC—The FDA issued a draft Guidance, "Safety Assessment for IND Safety Reporting," to help sponsors of investigational new drug (IND) applications. It discusses how sponsors should detect and report—as early as possible—serious and unexpected suspected adverse reactions and clinically important increased rates of previously recog- nized serious adverse reactions. Pfizer, GSK collaborate on continuous manufacturing modules NEW YORK, NY—Pfizer and GlaxoSmithKline (GSK) agreed to col- laborate to improve the design of Pfizer's modules that assemble into a system for the continuous manufacture of oral solid dosage forms. GSK has technical and regulatory experience in continuous manufacturing. For more information about Pfizer's PCCM and continuous manufacturing, see the May 2015 article, "Arden House con- ference: Continuous manufacturing gains momentum." FDA approves Genvoya to treat HIV SILVER SPRING, MD—The FDA approved Gilead Sciences' Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) to treat adult and pediatric patients infected with HIV-1. The once-daily tablets include a new form of tenofovir that hadn't been approved. Allergan to merge with Pfizer DUBLIN, IRELAND—Allergan and Pfizer plan to merge. The transac- tion, valued at approximately $160 bil- lion, would be the biggest acquisition in pharmaceutical history. The com- bined company will keep the Pfizer name, maintain its global operational headquarters in New York, and estab- lish its principal executive offices in Ireland. GPhA: Generics save USA $254 billion in 2014 WASHINGTON, DC—The US health care system saved $254 billion in 2014 thanks to generic drugs, according to the Generic Pharma- ceutical Association's (GPhA) seventh annual "Generic Drug Savings in United States" report. Generics taken by seniors and older adults (ages 40 to 64) in 2014 accounted for about 80 percent of the $254 billion in savings. The report also noted that the 3.8 bil- lion generic prescriptions of 2014 account for 88 percent of all the drug products dispensed in the USA but only 28 percent of drug costs. Most savings were for products used to treat mental health ($38 billion), hyperten- sion ($27.9 billion), and cholesterol ($26.8 billion). Teva, Takeda partner to supply generics in Japan JERUSALEM, ISRAEL—Teva Pharmaceutical and Japan's Takeda Pharmaceutical agreed to a joint ven- ture to supply generic drug products in Japan. The Japanese generics market is large and it's expected to continue growing strongly. Under the agree- ment, Teva would hold a 51 percent stake and Takeda the remaining 49 percent.