Janssen Gets Euro Priority Tag for CAR-T Therapy JNJ-68284528

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) designation for the companys investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-68284528 (JNJ-4528). PRIME offers enhanced interaction and early dialogue to optimise development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.1

The PRIME designation of this novel BCMA CAR-T therapy highlights the value of regulatory innovation in the European Union, said Sjaak Bot, Vice President, Head EMEA Regulatory Affairs at Janssen Biologics B.V. We hope to bring this important advance to patients as quickly as possible and this PRIME designation, the first for Janssen, marks an important milestone towards potential market approval.

The PRIME designation is based on results from the Phase 1/2 LEGEND-2 study (NCT03090659) evaluating LCAR-B38M CAR-T cells, sponsored by Nanjing Legend Biotech Co.,2 and the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating JNJ-4528, sponsored by Janssen and being conducted in collaboration with Legend Biotech USA Inc.3 Results from the LEGEND-2 study were presented at the American Society of Hematology (ASH) 2018 annual meeting.4 Results from the CARTITUDE-1 study will be presented in the future.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Janssen-Announces-Investigational-CAR-T-Therapy-JNJ-68284528-Granted-PRIME-Desig-28359965/

Abiomed: Cardiogenic Shock Survival Up Significantly since Impella FDA PMA OK

Three years ago this week, Abiomed’s (NASDAQ: ABMD) Impella heart pump received its FDA PMA approval for AMI cardiogenic shock.

At the time of Impella’s FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance (IQ) Database was 51% in the United States1. Today, Impella heart pumps, combined with the adoption of best practices, which include the use of Impella pre-PCI, have contributed to a significant increase in cardiogenic shock survival and native heart recovery. New data from the IQ Database on nearly 5,000 patients treated between April 2018 and March 2019 show an increase in survival from 51% to 67%2, a relative increase of 34% in survival.

Since FDA PMA approval, Abiomed has collected data on nearly 100% of U.S. Impella patients in the observational IQ Database. This clinical data, combined with the FDA post-approval studies embedded in Abiomed’s prospective cVAD Study, helped identify and validate best practices for Impella use associated with improved survival and native heart recovery. These best practices, including use of Impella pre-PCI, reduction of inotropes, early identification of shock, and hemodynamic monitoring with pulmonary artery catheters, have now been validated in multiple publications: Journal of Interventional Cardiology, 2014: Placement of Impella pre-PCI is associated with more complete revascularization and improved survival to discharge in the setting of AMI cardiogenic shock (65% with Impella placed pre-PCI vs. 41% post-PCI, p=0.023).

American Journal of Cardiology, 2017: Initiation of Impella before PCI and prior to initiation of inotropes or vasopressors is independently associated with improved survival. Survival to discharge was 68%, 46%, 35%, 35%, and 26% for patients requiring 0, 1, 2, 3, and 4 inotropes before mechanical circulatory support, respectively

https://www.marketscreener.com/ABIOMED-8215/news/Abiomed-Cardiogenic-Shock-Survival-Rates-Improve-Significantly-in-Three-Years-since-Impella-FDA-PM-28359591/

Intercept to Present on 1st Successful Phase 3 for Liver Fibrosis Due to NASH

Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that multiple OCA abstracts will be presented at the International Liver Congress 2019, the 54th Annual Meeting of the European Association for the Study of the Liver (EASL), in Vienna, Austria from April 10, 2019 through April 14, 2019.

‘We are thrilled to be presenting our groundbreaking Phase 3 REGENERATE results during the Opening Ceremony and General Session of the 2019 International Liver Congress, which promises to be a watershed event for the hepatology community,’ said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. ‘In addition to REGENERATE, we will be presenting a late-breaking poster on a placebo-controlled study of OCA showing physiologic improvement of liver function in NASH patients with fibrosis, as assessed by the HepQuant quantitative liver function test. In PBC, we are looking forward to a late-breaking oral presentation of an investigator-initiated study which showed that the addition of bezafibrate to OCA improved both cholestasis and pruritus, underscoring the rationale for our plan to develop a fixed dose combination of these two agents.’

https://www.marketscreener.com/INTERCEPT-PHARMACEUTICALS-11718561/news/Intercept-Pharmaceuticals-to-Present-Results-from-the-First-Successful-Phase-3-Trial-in-Patients-w-28359590/

LivaNova reports preliminary Q1 revenue $251M, consensus $264.58M

https://thefly.com/landingPageNews.php?id=2889210

Medtronic says HVAD system shows stroke reduction in retrospective analysis

Medtronic announced the results of an analysis on the impact of stroke severity in patients receiving its HeartWare HVAD System as destination therapy, showing that targeted blood pressure management helped reduce serious strokes. The HVAD System is a left ventricular assist device that helps increase the amount of blood that circulates through the body in patients with advanced heart failure; the destination therapy indication refers to patients who are not candidates for heart transplants. The retrospective analysis, presented at the 2019 International Society for Heart and Lung Transplantation Scientific Sessions, used data from both the ENDURANCE and ENDURANCE Supplemental randomized trials, the company said.
https://thefly.com/landingPageNews.php?id=2889211

LivaNova ‘currently reviewing’ 2019 guidance

LivaNova is currently reviewing its 2019 guidance and will provide updates and report its full financial results for first quarter 2019 in connection with its earnings call on Wednesday, May 1

https://thefly.com/landingPageNews.php?id=2889103

Oklahoma AG dismisses all but one claim against Teva, J&J in opiod case

Oklahoma Attorney General Mike Hunter dismissed without prejudice several claims filed against opioid manufacturers, including Purdue Pharma, Teva (TEVA) and Johnson & Johnson (JNJ), saying he is “refocusing the case on its central claim, abating the public nuisance caused by the companies’ decades-long fraudulent marketing campaigns.” The public nuisance claim provides the state with a comprehensive plan to address and remediate the effects the opioid crisis continues to have across the state, the AG said. Dismissing the claims without prejudice does not limit the state’s ability to reassert these claims in the future if necessary. Nor does it reduce the amount of damages the state is seeking from the defendants in the lawsuit. The trial remains set to begin May 28. Attorney General Hunter said: “Moving forward with the state’s public nuisance claim moots most of the issues raised by the defendants in discovery, allowing the parties and the judge to focus on preparing for this trial, set to begin in less than eight weeks.”

https://thefly.com/landingPageNews.php?id=2889106