Articles by Anna Rose Welch

61. “Hyper-Innovation” In Pharma: FDA Approvals Are Just The Start 1/14/2015

    It’s clear, after 2014's surge in FDA approvals, that the industry has increased its productivity. Pharma is slowly clawing its way out of what Forbes has labeled the “painful trough” of 2005-2010. But what do these recent approvals tell us about where we are headed — or where we need to be headed — as an industry?

62. How Bill Gates Is “Drawing” Pharma Into The Future 1/14/2015

    Over the past year, there has been an explosion of debate about the necessity of being vaccinated for illnesses that had been eradicated or have seen lower death rates. I’m not going to enter this argument; rather, I’m more intrigued by a project that has been put forth to celebrate the progress made in global health care with vaccines

63. FDA Launches Pharma Quality Office To Improve Drug Manufacturing, Agency Teamwork 1/14/2015

    We should expect to see even more attention lavished on pharmaceutical quality in 2015. This week, the FDA announced the launch of its long planned-for Office of Pharmaceutical Quality (OPQ).

64. Has AbbVie Started A Hep C Drug Pricing Revolution? 1/7/2015

    Right before the holidays, the FDA gave a nod to Viekira Pak, a new AbbVie drug cocktail credited with curing over 90 percent of those with genotype 1 hep C. Overall, it was a considerable year for HCV treatments. . 2014 was also the year of the “Great Pricing Wars.” 

65. FDA News Roundup: Amgen, Janssen, Actavis, And More 11/19/2014

    Amgen’s BLA for its cholesterol drug evolocumab was accepted by the FDA for review. Evolocumab is responsible for stopping a key protein, proprotein convertase subtilisin/kexin type 9 (PCSK9), which often halts the removal of “bad cholesterol” from the blood.

66. FDA News Roundup: Sanofi Pasteur, Ranbaxy, Eli Lilly, And More 11/11/2014

    Isavuconazole has garnered yet another orphan drug designation from the FDA for isavuconazole, this time for the treatment of invasive candidiasis/candidemia.

67. FDA News Roundup: Baxter, Lundbeck, Daiichi Sankyo, And More 11/4/2014
68. Weekly Pharma Manufacturing News Roundup — October 31, 2014 10/31/2014
69. FDA News Roundup: Merck, Eisai, Novartis, And More 10/29/2014

    In a unanimous vote, The Dermatologic and Ophthalmic Drugs Advisory Committee voted to support the approval of AIN457 (secukinumab) for adults suffering from moderate-to-severe plaque psoriasis that are also appropriate candidates for systemic therapy and phototherapy.

70. FDA News Roundup: Eisai, Pfizer, Roche, Boehringer Ingelheim, And More 10/20/2014