Medical Tidbits, Novartis highlights new CTL019 Phase II data demonstrating 93% complete remission in pediatric patients with r/r ALL

 The latest findings from an ongoing Phase II study of CTL019, an investigational chimeric antigen receptor T cell (CART) therapy, further support its potential in the treatment of children and young adults with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The study found that 55 of 59 patients (93%) experienced complete remissions (CR) with CTL019. These results will be presented in an oral session at the 57th American Society of Hematology (ASH) Annual Meeting on Monday, December 7 (Abstract #681, 3:15 p.m.)[1].

In the study, median follow up was 12 months, overall survival was 79% at 12 months (95% CI, 69-91%) and relapse-free survival was 76% at six months (95% CI, 65-89%) and 55% at 12 months (95% CI, 42-73%). Results found that 18 patients had ongoing CR after 12 months of therapy[1].

“This clinical trial of CTL019 is the largest study of a CART therapy in pediatric patients with relapsed or refractory acute lymphoblastic leukemia, and it is helping us better understand the therapy’s potential to achieve durable responses in this patient population,” said lead investigator Stephan Grupp, MD, PhD, the Yetta Deitch Novotny Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania (Penn), and director of Translational Research in the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia (CHOP). The ongoing study of CTL019 in pediatric patients with r/r ALL is being led by Dr. Grupp at CHOP and is sponsored by Penn. for more information visit http://www.novartis.com

MiMedx Updates The Status Of Its More Than 5,400 U.S. Hospitals Under ContractCONTRACTS CURRENTLY COVER MORE THAN 5,400 OF THE 5,700 HOSPITALS IN THE UNITED STATES

MARIETTA, Ga., Dec. 7, 2015 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today an update of its total portfolio of National Account contracts. read more

ERYTECH Announces Presentation of Additional Data at the American Society of Hematology 57th Annual Meeting

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) , the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other malignancies with unmet medical needs, announces that investigators presented additional results from the pivotal Phase 2/3 clinical trial with GRASPA that add to the body of data supporting the potential benefit of GRASPA in combination with chemotherapy in the treatment of Acute Lymphoblastic Leukemia (ALL). read more

Takeda and Cour Partner to Develop Novel Therapies for Celiac Disease and Other Gastrointestinal Diseases

OSAKA, Japan & CHICAGO–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TOKYO:4502) and Cour Pharmaceutical Development Company, Inc. today announced a partnership to research and develop novel immune modulating therapies for the potential treatment of celiac disease. The partnership will focus on using nanotechnologies based on Cour’s Tolerizing Immune Modifying nanoParticle (TIMP) platform, which can be extended to certain autoimmune and allergic conditions by inhibiting the abnormal immune responses that cause disease, without affecting the beneficial parts of the immune system.read more

Celgene and Acceleron Announce New Results from an Investigational Study with Luspatercept in Beta-Thalassemia Presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) and Acceleron Pharma Inc. (NASDAQ:XLRN) today announced preliminary results from two Phase 2 clinical trials of luspatercept in patients with beta-thalassemia were presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition. Results highlighted in an oral presentation showed that luspatercept increased hemoglobin levels, reduced transfusion burden, improved health-related quality of life measures and had beneficial effects on liver iron concentration in patients with beta-thalassemia. Celgene and Acceleron are jointly developing luspatercept. read more

Counsyl Wins World Technology Network Award

Counsyl awarded the 2015 winner of the Health and Medicine category

SAN FRANCISCO–(BUSINESS WIRE)–Counsyl, a health technology company that offers DNA screening for diseases that can impact women, men and their children, has been announced as the winner of the World Technology Award in the Health and Medicine category. Award recipients were selected by the World Technology Network (WTN) – a global community comprised of the most innovative people and organizations at the forefront of science and technology and related fields. read more

Acerta Pharma Announces Study Published in New England Journal of Medicine Demonstrates Acalabrutinib (ACP-196) Shows Marked Activity in Relapsed Chronic Lymphocytic Leukemia

EDWOOD CITY, Calif. & OSS, The Netherlands–(BUSINESS WIRE)–Acerta Pharma B.V. (Acerta), a clinical-stage biopharmaceutical company, announced today the New England Journal of Medicine (NEJM) has published Phase 1-2 clinical data on the investigational drug acalabrutinib, a novel, second-generation, selective and potent inhibitor of Bruton’s tyrosine kinase (Btk). The study showed a 95 percent response rate in patients with relapsed chronic lymphocytic leukemia (CLL), the most prevalent form of adult leukemia. The NEJM manuscript for acalabrutinib can be found at www.NEJM.org. read more

Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept

Holzkirchen, 8 December, 2015 – Sandoz, a Novartis company and the global leader in, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer’s EU-licensed Enbrel® (etanercept) * – a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis – more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs)[1] and approximately 3.7 million Europeans with psoriasis.[2]

“Today, only 5% of severe psoriasis patients in North America and Europe have access to life-changing biologic treatment options** such as etanercept” said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics” McCamish continued. 

Marken Announces Completion Of New Moscow Depot  

RESEARCH TRIANGLE PARK, N.C., Dec. 8, 2015 /PRNewswire/ — Marken announced today the completion of their newest fully owned depot in Moscow for both clinical and commercial pharmaceutical drug storage, clinical trial services and distribution.

Wes Wheeler, Marken’s CEO, commented on the trends in the industry, “Russia continues to be an important global clinical trial center, with the number of Phase III clinical trials in the 3rd quarter 2015 growing at 14% and with 203 new clinical trials approved to start in Russia in the same quarter. * With this in mind, we decided to expand our presence in this important country and build a new facility near the Sheremetyevo airport to serve our clients more efficiently.” read more

Post Traumatic Stress Disorder Identified as Major New Market Opportunity for BNC210  

Australian drug development company Bionomics Limited (ASX:BNO, OTCQX:BNOEF) will launch a key Phase 2 trial of its novel anxiety drug BNC210 as a treatment for post-traumatic stress disorder (PTSD), following a US$12 million private placement to US institutional investors.

The new trial is expected to begin in the first half of 2016, with patients to be recruited at several trial sites in Australia and New Zealand. All patients enrolled will have experienced severe trauma, including war, natural disasters or have been involved in serious accidents.

The program will be funded with a US$12 million Private Placement to four US institutional investors. read more

BioAtla Enters Into Strategic License And Option Agreement With Pfizer For A New Class Of Antibody Therapeutics  

BioAtla LLC, a biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that it has entered into a license and option agreement with Pfizer Inc. (NYSE: PFE) to advance the development and commercialization of a new class of antibody therapeutics based on BioAtla’s CAB platform and utilizing Pfizer’s proprietary antibody drug conjugate (ADC) payloads. read more

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