FDA accepts Eli Lilly’s NDA for type 2 diabetes triple combination tablet

The FDA has accepted Boehringer Ingelheim and Eli Lilly’s (NYSE:LLY) New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes.

Empagliflozin is marketed as Jardiance in U.S.

Linagliptin is marketed as Tradjenta tablets in U.S.

https://seekingalpha.com/news/3468865-fda-accepts-eli-lillys-nda-triple-combination-tablet-adults-type-2-diabetes

Pacira Publishes Pivotal Study on Exparel as Single-Dose Nerve Block

Pacira BioSciences, Inc. (NASDAQ: PCRX) today announced the publication of its multinational Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-injection interscalene brachial plexus nerve block (ISNB) in patients undergoing total shoulder arthroplasty or rotator cuff repair. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 48 hours compared with placebo and a standardized pain management protocol alone. The data, which provided the basis for FDA approval for this indication, were published in Pain Medicine.

The study’s primary endpoint was pain intensity scores through 48 hours; secondary endpoints included total postsurgical opioid consumption, percentage of opioid-free patients; and time to first opioid rescue.

A total of 140 patients enrolled across 16 surgical centers in the United States, Belgium, and Denmark were randomized to receive an ultrasound-guided single-dose ISNB with either EXPAREL 133 mg (n=69) or saline placebo (n=71). Compared to patients receiving placebo, patients in the EXPAREL group demonstrated a statistically significant:

https://www.globenewswire.com/news-release/2019/06/04/1863829/0/en/Pacira-Announces-Publication-of-Pivotal-Study-of-EXPAREL-as-a-Single-Dose-Interscalene-Brachial-Plexus-Nerve-Block-in-Patients-Undergoing-Shoulder-Surgery.html

CVS Health Outlines Strategy to Accelerate Growth

Significant Expansion of HealthHUBs^® will Help Drive Differentiated, Consumer-Centric Health Experience; 1,500 Expected to Open by End of 2021

Strong Execution on Aetna Integration Projected to Drive Approximately $300 – $350 Million of Synergies in 2019; Synergies of Approximately $800 Million Projected in 2020

Reaffirming 2019 Full Year Guidance; Consolidated Revenues $251.2 to $254.4 Billion, GAAP Operating Income $11.8 to $12.0 Billion, Adjusted Operating Income $15.0 to $15.2 Billion, GAAP diluted EPS $4.90 to $5.05, Adjusted EPS $6.75 to $6.90

Expect to Deliver $7.00+ Adjusted EPS in 2020, Mid-Single Digit Percent Adjusted EPS Growth in 2021, and Low-Double Digit Percent Adjusted EPS Growth in 2022 and Beyond

https://finance.yahoo.com/news/cvs-health-outlines-strategy-accelerate-104500829.html

Allogene: FDA Clears Application for BCMA Allogeneic CAR T Therapy

• ALLO-715 Utilizes Gene-Editing of TRAC and CD52 Loci to Enable Allogeneic CAR T Therapy
• ALLO-715 will be Evaluated in Combination with ALLO-647, Allogene’s Proprietary anti-CD52 Antibody as Part of the Lymphodepletion Regimen 
• Allogene Plans to Initiate the UNIVERSAL Study for ALLO-715 in Relapsed/Refractory Multiple Myeloma in the Second Half of 2019

Allogene Therapeutics, Inc. (ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that the U.S. Food & Drug Administration (FDA) has cleared Allogene’s Investigational New Drug (IND) application for ALLO-715 in patients with relapsed/refractory multiple myeloma. The Phase 1 portion of the UNIVERSAL study, which will include ALLO-647 as part of the lymphodepletion regimen, is expected to be initiated in the second half of 2019.

https://finance.yahoo.com/news/allogene-therapeutics-announces-fda-clearance-114500176.html

Celgene, Acceleron: FDA Accepts Luspatercept License Application

U.S. Food and Drug Administration grants priority review for beta-thalassemia indication and sets target action date of December 4, 2019

U.S. Food and Drug Administration sets target action date of April 4, 2020 for myelodysplastic syndromes indication

Luspatercept EU Marketing Authorization Application also validated

Celgene Corporation (CELG) and Acceleron Pharma Inc. (XLRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s Biologics License Application (BLA) for luspatercept, an investigational erythroid maturation agent, for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. The FDA has granted Priority Review to this BLA for the evaluation of the beta-thalassemia indication and set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 4, 2019. The FDA has also set a PDUFA date of April 4, 2020 for the evaluation of the MDS indication.

https://finance.yahoo.com/news/celgene-corporation-acceleron-pharma-announce-113000756.html

VBI Vaccines Expands on Data from Phase 1/2a Glioblastoma Study

• Well tolerated at all doses with no safety signals
• Three patients in high dose (10 µg) cohort showed evidence of stable disease by MRI
• 10 µg dose selected for Part B of the study, which is expected to initiate enrollment mid-year 2019

VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, presented a poster on Sunday, June 2, 2019, at the American Society of Clinical Oncology (ASCO) Annual Meeting that exhibited expanded clinical data from Part A of the Phase 1/2a study of VBI-1901 in recurrent Glioblastoma (GBM) patients.

The poster presented data on a total of 18 patients enrolled in Part A of the study, which was a multi-center, open-label, dose-escalation study across three dose cohorts of VBI’s vaccine immunotherapeutic, VBI-1901 – 0.4 µg, 2.0 µg, and 10.0 µg.  Part A was designed to evaluate the safety and tolerability of VBI-1901, and to define the optimal immunogenic dose level to test in the Part B extension phase of the study, which is expected to initiate enrollment mid-year 2019.  Part B of the trial will further assess immunologic responses and potential correlations with tumor and clinical responses.

Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Infrastructure at Herbert Irving Comprehensive Cancer Center, and principal investigator of the study commented, “Though early, the data we’ve seen to-date in this Phase 1/2a study of VBI-1901 are intriguing, yet of course require confirmation in later phase and additional trials.  The patients in this study, and more generally in the recurrent GBM setting, are immunocompromised and have very few effective treatment options available to them. Any treatment that could demonstrate even some benefit would be incredibly meaningful for these patients and their families.  I look forward to seeing additional data from Part B of the study.”

https://www.globenewswire.com/news-release/2019/06/04/1863878/0/en/VBI-Vaccines-Reports-Data-from-Part-A-of-the-Ongoing-Phase-1-2a-Study-of-VBI-1901-in-Recurrent-Glioblastoma-GBM-Patients-at-ASCO-2019.html

Veru Adds Androgen Deprivation Therapy to Prostate Cancer Pipeline

— VERU-100 Is a Proprietary Peptide Formulation Designed with Multiple Beneficial Clinical Attributes Addressing the Shortfalls of the Current Multi-Billion-Dollar Androgen Deprivation Therapy Market —

— Reached Agreement with FDA on an Expedited Regulatory Pathway and Clinical Development Strategy —

Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and prostate cancer supportive care, today announced that it has added to its robust prostate cancer drug development pipeline, a proprietary biologic drug candidate, VERU-100, for the treatment of hormone sensitive advanced prostate cancer, an established multi-billion-dollar global market.  VERU-100 was internally developed in collaboration with Drug Delivery Experts, LLC of San Diego, California (DDE Labs).

“The target product profile for VERU-100 is most compelling having a number of advantages over currently available androgen deprivation therapies. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist designed to be administered as a small volume subcutaneous 3-month depot injection without a loading dose. As a GnRH antagonist, it will immediately suppress testosterone with no testosterone surge upon initial or repeated administration and no testosterone micro-increases which may adversely affect patient outcomes — a problem which potentially occurs with approved LHRH agonist drugs like LUPRON®, ZOLADEX® and ELIGARD®,” said Peter N. Schlegel, M.D., James J. Colt Professor and Chairman of the Department of Urology at Weill Cornell Medicine and Urologist-in-Chief at New York-Presbyterian / Weill Cornell Medical Center.  “Currently, there are no GnRH antagonists commercially approved beyond 1 month, making VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot — an attractive choice for androgen deprivation therapy.”

The Company recently met with the FDA and received agreement that VERU-100 qualifies for an expedited regulatory pathway. Based on FDA input, the Company plans to commence a single open label, multicenter dose-finding Phase 2 clinical trial in approximately 50 men, followed by a single open label, multicenter Phase 3 clinical trial in approximately 100 men. Veru is in the process of scaling up GMP manufacturing of drug product to prepare for the clinical trials of VERU-100. The Company plans to submit an Investigational New Drug application by no later than calendar Q1 2020.

Based on current cash on hand and expected cash from current sales forecasts, along with existing sources of capital, the Company does not anticipate the need for a new equity financing until at least fiscal 2021, even with additional costs related to the VERU-100 clinical development.

https://www.globenewswire.com/news-release/2019/06/04/1863861/0/en/Veru-Adds-Breakthrough-Novel-Androgen-Deprivation-Therapy-Formulation-to-its-Advancing-Prostate-Cancer-Drug-Pipeline-Following-Successful-Meeting-with-FDA.html