Articles by Anna Rose Welch

  1. 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.

  2. 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.

  3. FDA News Roundup: Baxter, Lundbeck, Daiichi Sankyo, And More 11/4/2014
  4. Weekly Pharma Manufacturing News Roundup — October 31, 2014 10/31/2014
  5. 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.

  6. FDA News Roundup: Eisai, Pfizer, Roche, Boehringer Ingelheim, And More 10/20/2014
  7. 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.

  8. FDA News Roundup: Chimerix, Horizon, Regeneron, And More 10/15/2014
  9. 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.

  10. 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.