Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications. | |
| Featured Story | Tuesday, August 7, 2018 It’s that time of year again—the time when lead pharmacy benefits manager Express Scripts ignites pharma’s ire with a brand-new list of formulary exclusions. This time, Express Scripts barred 48 drugs, some of them key launches for their makers. |
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| Top Stories Of The Week Monday, August 6, 2018 Regeneron and Bluebird bio have teamed up to develop anti-cancer cell therapies. The collaboration combines Regeneron’s antibody expertise with Bluebird’s cell therapy toolkit in a bid to expand the list of tumors modified T cells can treat. Monday, August 6, 2018 Hoping to fend off generics to its big-selling Lyrica, Pfizer racked up 68 patents. Then, to soften the blow from eventual copycats, it rolled out a patented, long-lasting formula, Lyrica CR, and steered patients to it. As a report sees it, that's a perfect example of how drugmakers are gaming the patent system. Tuesday, August 7, 2018 Spark Therapeutics’ hemophilia A gene therapy reduced bleeding by 97% in a phase 1/2 trial but sent one patient to the hospital, leading the biotech's stock to dip about 30% before the market opened. Tuesday, August 7, 2018 China’s Zhejiang Huahai Pharmaceutical set off a global recall after it informed global regulators last month that it had discovered the suspected cancer-causing impurity N-nitrosodimethylamine in its valsartan API after changing its manufacturing process. But the FDA is now reporting that the tainted ingredient may have been on the market for years, not weeks or months. Friday, August 3, 2018 Regulatory T cells, or Tregs, can limit the power of the immune system to fight cancer. Scientists have now found a way to suppress the activity of Tregs to enhance immuno-oncology treatments. Monday, August 6, 2018 Pfizer has tapped Antares Pharma for the development of a self-administered combination drug-device rescue pen for an undisclosed medicine, shortly after investing $465 million in a new sterile injectables plant. Monday, August 6, 2018 Judging from the load of press releases in our inboxes, FDA Commissioner Scott Gottlieb is a chatty guy—and so is the agency, now that he's at the helm. The FDA issued more than twice as many releases in the first half of this year—126 of them—as it did during the same period of 2017. And Gottlieb himself puts out statements on "everything," according to one PR pro. Monday, August 6, 2018 Merck & Co.’s Ebola vaccine rVSV-ZEBOV will once again be deployed in an outbreak in the Democratic Republic of Congo. But this time around, distribution could face security as an extra challenge. Monday, August 6, 2018 Premier Research, a global CRO, acquired Regulatory Professionals and will merge the firm into a new division focused on the regulatory process for biotech, pharma and medical device companies. This week's sponsor is Rho. | | [Webinar] Understanding New Drug Applications (NDAs) Tuesday, August 14 | 1pm ET / 10am PT Understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and get tips that can help you avoid common pitfalls in the submissions process. Register Now! | Resources Sponsored by: WCG Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals. Sponsored by: Veeva Industry Research: See new results from one of the industry's largest, global clinical operations surveys. Sponsored by: Medidata Accelerate Clinical Research as Study Complexity Grows Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. |