Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.
,“A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies” read more
MOLOGEN AG: First patient recruited in combination study with lefitolimod and Yervoy®
BERLIN–(BUSINESS WIRE)–The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its collaborator, the University of Texas MD Anderson Cancer Center (MD Anderson), has enrolled the first patient in the combination study (FPI: first patient in) with a checkpoint inhibitor. In the phase I study MOLOGEN’s TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703) is tested in combination with the immunotherapy ipilimumab (Yervoy®) in patients with advanced solid malignancies. The collaboration has been initiated in January 2016 based on the idea that the combination of these two immunotherapies could have synergistic effects leading to a broader activation of the immune system. MD Anderson is conducting the trial and will recruit around 50-60 patients at its center in Houston Texas, US. MOLOGEN is providing the ISR lefitolimod (MGN1703). Patient recruitment is expected to be completed at the beginning of 2018. read more
ASTRAZENECA ENTERS INTO AGREEMENT TO RESOLVE FASLODEX PATENT LITIGATION IN THE US
AstraZeneca today announced that it has entered into an agreement with Sandoz, Inc. and affiliates (“Sandoz”) to resolve Faslodex (fulvestrant) patent litigation in the US relating to Sandoz’s generic fulvestrant product, for which it is seeking FDA approval.
The US Faslodex patents in question are due to expire in January 2021, with paediatric exclusivity continuing until July 2021. On 12 July 2016, the United States District Court for the District of New Jersey entered a consent judgment filed by AstraZeneca and Sandoz, which includes an injunction preventing Sandoz from launching a generic fulvestrant product until 25 March 2019, or earlier in some circumstances.
INRatio and INRatio2 PT/INR Monitor System by Alere: Recall – Potentially Inaccurate INR Results
AUDIENCE: Cardiology, Laboratory, Gastroenterology, Infectious Disease, Nursing, Pharmacy
ISSUE: Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System.
BACKGROUND: In December 2014, Alere initiated a voluntary correction to inform users of the INRatio and INRatio2 PT/INR Monitoring System that patients with certain medical conditions should not be tested with the system. As part of its commitment to ensuring the safety of patients, Alere proactively reported these device concerns to the FDA and began conducting a thorough investigation into these events.
Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.
Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.
THOUSAND OAKS, Calif. , July 12, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration’s ( FDA ) Arthritis Advisory Committee . ABP 501 is a biosimilar candidate to Humira® (adalimumab), an anti-tumor necrosis factor-alpha (TNF-a) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.
During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.
“As a developer of innovative medicines and biosimilars, Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars,” said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . “Today, we’re looking forward to discussing the efficacy, safety and immunogenicity profile of ABP 501, Amgen’s first prospective biosimilar, with the FDA advisory committee. If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases, as well as play a key role in long-term disease management.”
The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.
Lilly and Howard University partner on summer Medical Scientific Fellowship
Unique program addresses industry’s lack of underrepresented minorities
INDIANAPOLIS, July 12, 2016 /PRNewswire/ — Lilly USA, LLC will partner with Howard University this summer on an inaugural Minority Fellowship program for post-graduate minority professionals embarking on careers in science or medicine. The fellowship aims to increase collaboration and address the lack of minorities in the pharmaceutical industry by providing training to future healthcare professionals.
The program—a component of the larger Medical Scientific Fellowship—is open to physicians, doctorate, and scientific-degreed post-graduates interested in the drug development process. Participants will spend a year of training at Lilly (NYSE: LLY) to gain knowledge on the complexities of drug development, the regulatory environment, and the roles that scientists and healthcare providers play in this multifaceted process. They will also have the chance to work on special projects on topics of interest, such as health disparities.