| 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! |
| Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications. | |
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Featured Story | | | Friday, July 27, 2018 Merck & Co.’s blockbuster cancer drug Keytruda has delivered growth again in the second quarter, but this time, it has seized the PD-1/L1 crown from Bristol-Myers Squibb’s archrival, Opdivo. |
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Top Stories Of The Week Wednesday, August 1, 2018 Even in an industry dominated by a few huge companies, disruption happens sometimes—and 2017 was one of those times. GlaxoSmithKline surpassed Merck to top the vaccine industry by sales, generating $7 billion compared to Merck's $6.5 billion; and it stands to be a long-term switch, too. Tuesday, July 31, 2018 Pfizer has culled Type 1 diabetes and cancer drugs from its early-phase pipeline. The actions affect anti-IL7R antibody PF-06342674 and third-generation, mutant-selective EGFR tyrosine kinase inhibitor PF-06747775. Tuesday, July 31, 2018 Shire has quietly cut the trial of an FDA fast-tracked fatty liver disease drug, although it’s not giving much away about what happened. Tuesday, July 31, 2018 A California drugmaker has been eviscerated in an FDA warning letter after inspectors found it using “kitchen cooking pots and household power tools” to manufacture a drug for vaginal use to stop bleeding after cervical biopsies. Monday, July 30, 2018 Biogen's troubled MS drug Zinbryta is at the center of a discrimination and retaliation lawsuit filed by a former sales manager. Friday, July 27, 2018 The accumulation of amyloid-beta in the brain is believed to be a culprit behind neurodegeneration, but the underlying mechanism of the buildup is not yet clear. Now, scientists have found that the brain's lymphatic system might play a key role in both Alzheimer’s and age-related dementia. Monday, July 30, 2018 Last year, Pfizer and Bristol-Myers Squibb’s Eliquis replaced Johnson & Johnson’s Xarelto as the leader of the novel oral anticoagulant class. And now, thanks to a $1.65 billion performance in the second quarter, it’s about to unseat an even bigger foe: warfarin, the drug that's been a standard therapy for decades. Monday, July 30, 2018 The FDA recently finalized an eagerly awaited guidance on the incorporation of electronic health records and real-world data into clinical trials and product submissions, including the use of patient medical histories, pharmacy records, radiology scans and lab test results from routine care, including from foreign clinical sites. Tuesday, July 31, 2018 Merck's big-selling HPV shot, Gardasil, continued to gain steam in the second quarter, and executives see "significant" growth prospects ahead for the shot. Wednesday, August 1, 2018 Novartis will partner with Albumedix, a U.K.-based specialist in recombinant human albumin, to explore using the company’s technology as a possible drug delivery platform for several therapies. 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: Veeva See results from the Tufts eClinical Landscape Study – CRO Report on current data management practices, goals, and challenges for contract research organizations (CROs). |
