Articles by Anna Rose Welch

  1. 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.

  2. 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.

  3. 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.

  4. FDA News Roundup: MedImmune, Celgene, Lundbeck, And More 9/29/2014

    AstraZeneca’s R&D arm, MedImmune, received fast track designation from the FDA for its investigational monoclonal antibody (mAb) MEDI3902 indicated to prevent Pseudomonas aeruginosa (P. aeruginosa)-caused pneumonia.

  5. FDA News Roundup: Eli Lilly, Tekmira, Regeneron, AstraZeneca, And More 9/25/2014

    In the face of the Ebola threat, the FDA has granted Tekmira Pharmaceuticals permission via an “Expanded Access” or a “Compassionate Use” program to distribute its investigational Ebola treatment, TKM-Ebola, to people with confirmed or suspected infection.

  6. Weekly Pharma Manufacturing News Roundup — September 23, 2014 9/23/2014

    Three experts in part one of CPhl’s second annual report have voiced their expectations for the industry and have come out in favor of several “radical changes” that will help spur innovation and reduce pharma manufacturing costs

  7. FDA News Roundup: Baxter, Mylan, Shire, And More 9/22/2014

    NPS Pharmaceuticals received a nod of approval from an FDA Advisory Committee for its Hypoparathyroidism disorder drug, Natpara.

  8. EMA, EC, NICE Weekly News Roundup: Roche, GSK, Janssen, And More 9/19/2014

    Roche’s and Chugai Pharma’s RoACTEMRA was approved in the EU for those with severe rheumatoid arthritis (RA) that were not previously treated with methotrexate (MTX).

  9. Weekly News Roundup For Pharma Manufacturers — September 17, 2014 9/17/2014

    In the news this week, generics are saving the U.S. health system trillion; “shadow” pharma contract manufacturing is on the rise; and a market survey shows that conventional tablet formulations could be losing patients’ favor. Several countries are also experiencing drug shortages, leaving many desperate for viable treatment.

  10. FDA News Roundup: Astellas, Sanofi Pasteur, Orexigen, and More 9/15/2014

    Biopharmaceutical company Molecular Templates got a nod of approval from the FDA on its Investigational New Drug (IND) application for MT-3724 last week. MT-3724 is a next-generation immunotoxin compound that induces direct cell death by inactivating ribosomes in CD20-expressing cells. Now that approval has been granted, the company plans to launch a phase 1 clinical trial program for the drug candidate, investigating its potential as a monotherapy in refractory non-Hodgkin’s lymphoma. The study will be held at Memorial Sloan-Kettering Cancer Center and New York University’s Langone Medical Center, joined eventually by a site in an oncology center in Texas.