Articles by Anna Rose Welch

81. FDA News Roundup: Merck, UCB, Pfizer, Ipsen, And More 9/8/2014

    In the news this week, the FDA recently approved the first immunotherapy for melanoma, as well as drugs for epilepsy and myelodysplastic syndrome. The FDA also cleared several drugs for new indications, QIDP status, and orphan drug status.

82. Weekly News Roundup For Pharma CROs, CMOs — September 3, 2014 9/3/2014

    The Wall Street Journal profiles a recent survey of members of the Royal College of Physicians in the U.K. who overwhelmingly came out in favor of clinical trial data transparency. Nearly 90 percent of those surveyed believe that publishing the results of clinical trials, even those that reveal negative results, will result in better medicines and healthcare. Eighty-one percent argue that it’s a “moral duty” for drug makers to open up completed data to trial participants, the public, and the scientific community. There are still lingering concerns among those surveyed that increased transparency could hamper a company’s commercial interests and that data should not be made public, however these percentages are small — 10 percent and 5 percent respectively. 

83. Weekly News Roundup For Pharma CROs, CMOs—August 26, 2014 8/26/2014

    In the news this week, both the pharma packaging market and thin-film drug manufacturing market are predicted to see increases; biotech investors could hold the key to outsourcing contracts; and the emergence of new technologies and strategies in the lab could be leading to more accurate drug development.

84. Weekly News Roundup For Pharma CROs, CMOs — August 19, 2014 8/19/2014

    An article on Packaging Digest entitled “What You Need To Know About Prescription Traceability” discusses serialization following the release of the Drug Quality and Security Act of 2013.  The article goes into detail about the change of ownership and transaction details (“transaction statement” and “transaction document”), as well as packaging requirements and evolving EPCIS standards. Packaging Today also featured a recent article about the impact of Europe’s Falsified Medicines Directive and the way some pharma companies are keeping up with traceability requirements.

85. Weekly News Roundup For Pharma CROs, CMOs—August 12, 2014 8/12/2014

    A new CPhI Pharma Insights and InformEx U.S. market report was recently released, which reveals that the U.S. should expect to see generics production return, especially as safety concerns about overseas generic production continue to grow.

86. Weekly News Roundup For Pharma CROs, CMOs — July 22, 2014 7/22/2014
    The FDA has issued a new guidance explaining how the agency handles Prior Approval Supplements (PAS) under the generic user fee amendments (GDUFA) program, Regulatory Affairs Professionals Society (RAPS) says. FDA approval of the PAS is a key step in ensuring a change in a drug’s manufacturing process can be implemented. The FDA has specified that a decision for PASs will be announced within 6 months following submission or 10 months if a facility inspection is required. In 2015, the FDA hopes to meet these standards in 60 percent of cases, followed by 75 percent in 2016, and 90 percent in 2017.