Today's Rundown Johnson & Johnson, Bayer still looking for answers in aborted Xarelto study Analysis counters concerns about Amgen heart failure drug Amgen's Repatha tied to greater risk reduction in high-risk heart attack patients Caladrius single injection helps heart disease that hits women the hardest Novartis hoping for 2nd go at broader use with 'profound' Entresto subdata MedCo's PCSK9 rival inclisiran hits LDL AstraZeneca's Farxiga outcomes data look even better in patients without diabetes Amarin's Vascepa halts progression of arterial plaque in key study AstraZeneca's Brilinta linked to less bleeding solo than as an aspirin add-on Janssen drops clinical sites for smartphones, wearables in 100% virtual Invokana study Lilly, Boehringer's Jardiance cuts CV hospitalizations over rival diabetes meds Featured Story | Saturday, November 16, 2019 More than a year after Johnson & Johnson and Bayer pulled the plug on an open-label study for anticoagulant Xarelto in patients after a rare valve replacement procedure, the drugmaker is still grasping at straws for what exactly happened. |
|
---|
| Top Stories Monday, November 18, 2019 Amgen has found no evidence that heart failure drug omecamtiv mecarbil hampers diastolic function in a post hoc analysis of phase 2 data. The finding may quell concerns that the effect of the cardiac myosin activator on the cardiac cycle will have negative side effects on diastolic filling times. Sunday, November 17, 2019 PHILADELPHIA—Amgen's Repatha may already be far ahead in the PCSK9 field, but new competition is on its way. A new analysis in high-risk heart attack patients could give it some more ammo for that fight. Monday, November 18, 2019 We tend to think of heart disease and heart disorders to be, in the main, things that affect men more than women, but this is of course not true. Sunday, November 17, 2019 PHILADELPHIA—It's been just a few weeks since Novartis' Entresto flopped a crucial heart failure study in what the drugmaker called a "narrow miss." Now, subanalyses from multiple studies show Entresto had a "profound effect" on some patients, giving Novartis hope for a second go. Monday, November 18, 2019 The Medicines Company has posted more late-phase data linking its siRNA inclisiran to steep declines in LDL cholesterol. Inclisiran achieved a placebo-adjusted drop in LDL cholesterol of 58%, although it failed to drive the positive changes in cardiovascular outcomes seen in an earlier study. Saturday, November 16, 2019 Turns out AstraZeneca's "paradigm shifting" outcomes data for SLGT2 med Farxiga show an even greater cardiovascular benefit for patients who don't have diabetes than for those who do—and this for a drug designed specifically to treat the disease. Sunday, November 17, 2019 WIth an FDA decision to expand Amarin's Vascepa label to include cardiovascular risk reduction looming, a new imaging study shows the drug could have an effect on stopping the progression of plaque in the arteries. That could help explain Vascepa's game-changing CV outcomes. Sunday, November 17, 2019 AstraZeneca's longtime clot-buster Brilinta has seen some of its shine wear off as other drugs—not the least of which SGLT2 star Farxiga—have charted a new course. But the British drugmaker still has hopes for its old stalwart, and aspirin-beating bleeding data in acute coronary syndrome could help. Saturday, November 16, 2019 Johnson & Johnson’s pharmaceutical arm Janssen is launching its first completely virtual clinical trial, using personal smartphones and wearable devices to track participants with no in-person site visits required. Sunday, November 17, 2019 PHILADELPHIA—In its quest to become the dominant SGLT2 diabetes med for heart failure, Eli Lilly and Boehringer Ingelheim's Jardiance has used real-world data to beat up on its GLP-1 rivals. But Jardiance isn't resting there. Now, it's touting DPP-4 inhibitor-topping data to support its case, too. Enrollment Showcase Resources Sponsored by: Veeva Systems Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade. Sponsored by: SHYFT Analytics This whitepaper provides a snapshot of where the biopharma industry is now, where it's heading, and how companies are allocating their resources to adapt & grow. Sponsored by: IBM Watson Health IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology. Sponsored by: IBM Watson Health Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting. Sponsored by: IBM Watson Health Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more. Sponsored by: Roche and IQVIA A global landscape study of funding trends and innovations. Sponsored by: ON24 Discover solutions to the most common challenges faced by medical device companies. Sponsored by: Eli Lilly and Company in partnership with Xcenda Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system. Sponsored by: Clarivate Analytics 18 high-value new licensing deals worth in excess of $500 million took place during the second quarter of 2019 -Get the Q2 2019 Biopharma licensing report for full details and insights. Sponsored by: Patheon, by Thermo Fisher Scientific Is your API development on track? Sponsored by: Evidera The use of pragmatic randomized trials (PRTs) can answer if a treatment is safe and effective. Learn how PRTs can collect RWE to meet regulator and payer needs. Read now. Sponsored by: BBK Worldwide Get the latest data on how people are using apps to manage their health, and learn how you can leverage it in the development of your next clinical trial app. Sponsored by: Blue Latitude Health Report: How to design digital services that deliver value and improve outcomes for patients, healthcare professionals and the healthcare systems they serve Sponsored by: Article Galaxy powered by Reprints Desk This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. Sponsored by: Evidera Learn how multi-stakeholder advice can refine and evaluate evidence generation plans to align with regulatory and HTA needs, and the role and value of RWE. Read now. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. ThinkLive2019 Explore these articles and videos from this year’s ThinkLive Summit and cover some of the industry’s most pressing topics, from supporting biosimilars to drug pricing policy. Countdown to Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register Now at www.drugstomarket.com/drugbootcamp and start Pre-Boot Camp Preparation |