Articles by Anna Rose Welch

51. Weekly Pharma Manufacturing News Roundup — October 31, 2014 10/31/2014
52. 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.

53. FDA News Roundup: Eisai, Pfizer, Roche, Boehringer Ingelheim, And More 10/20/2014
54. Weekly Pharmaceutical Manufacturing News Roundup— October 17, 2014 10/16/2014

    In the news this week, CPhl released part 2 and 3 of its 2014 annual report discussing the need for new technologies and Quality by Design, while also addressing the challenges facing API manufacturers. The biosimilar market is set to see increases a steep increase in value by 2018, and a new survey highlights the Life Sciences industry’s concerns about and goals for the pharma supply chain.

55. FDA News Roundup: Chimerix, Horizon, Regeneron, And More 10/15/2014
56. Weekly Pharma Manufacturing News Roundup — October 8, 2014 10/8/2014

    Packaging World published a Q&A with Kevin O’Donnell, Senior Partner of Exelsius, discussing distribution practices for time and temperature-sensitive pharmaceutical/biological products.

57. FDA News Roundup: Bristol-Myers Squibb, Pfizer, Ariad, Salix, And More 10/6/2014

    Bristol-Myers Squibb’s Biologics License Application (BLA) for its melanoma drug, Opdivo, was accepted for priority review by the FDA. The drug, an investigational PD-1 immune checkpoint inhibitor, was also granted accelerated review by the EMA.

58. EMA, CHMP, NICE News Roundup: AstraZeneca, Gilead, Novartis, And More 10/3/2014

    AstraZeneca received several articles of good news from European regulators recently. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Moventig (naloxegol) for patients with opioid-induced constipation (OIC) who have not been successfully treated with laxatives.

59. FDA News Roundup: Gilead, AbbVie, Boehringer Ingelheim, And More 10/2/2014

    Gilead had great success with the FDA last week when the agency gave the green light to its two HIV drugs, Tybost (cobicistat) and Vitekta (elvitegravir). Tybost is a once daily therapy that has been approved for use with other anti-retroviral agents and works by increasing blood levels of protease inhibitors.

60. Weekly Pharma Manufacturing News Roundup — September 30, 2014 9/30/2014

    A Pharmaceutical Processing article discusses the factors that are driving the future of high toxic pharmaceutical manufacturing. In particular, the article highlights a risk-based approach for manufacturing pharmaceutical products for pharma and CMOs planning to expand or add high-potency API manufacturing capacity to their offerings. The article breaks down the risk-based approach into three categories: Hazard characterization, OEL Setting, ADE setting, and Hazard Bands.