Medical Tidbits, Juno Therapeutics to Resume JCAR015 Phase II ROCKET Trial

biosimilars, breaking medical news, biotech news

SEATTLE–(BUSINESS WIRE)–Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that the U.S. Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).

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®

  • Collaboration with MD Anderson Cancer Center, US
  • Phase I study to evaluate combination of ISR lefitolimod (MGN1703) and checkpoint inhibitor Yervoy®
  • Combination of immunotherapies could lead to a broader activation of the immune system

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 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.

First Amgen Biosimilar Candidate and Adalimumab Biosimilar Candidate to be Reviewed by U.S. FDA Advisory Committee

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.

SinuSys™ Corp. Receives FDA Clearance for the Vent-Os® Sinus Dilation Family of Devices

ration, an innovative sinus health company, today announced receipt of FDA clearance for a full family of sinus dilation devices, adding two new devices that will expand the company’s portfolio of low-pressure, self-expanding dilation devices to enable dilation of the frontal and sphenoid sinuses to address sinusitis symptoms. The addition of the new devices complement the previously FDA cleared Vent-Os device for maxillary sinus dilation. The FDA clearance will enable the company to bring the simplicity, patient tolerability and long-term patency shown by the maxillary system to the treatment of frontal and sphenoid sinuses. The new devices will be immediately available in the USA.

Provectus Biopharmaceuticals Announces PV-10 Data Discussed at 6thEuropean Post-Chicago Melanoma/Skin Cancer Meeting

Dr. Sanjiv Agarwala Presented PV-10 Phase 3 Study Design in Symposium on Current Clinical Trials

KNOXVILLE, Tenn.–(BUSINESS WIRE)–Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,, a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or the “Company”), today announced that data on PV-10 as a treatment for melanoma was presented June 30, 2016 at the 6th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany.

Pfizer Receives FDA Approval for Prevnar 13® in Adults Age 18 Through 49

Prevnar 13 is the only pneumococcal vaccine approved in the U.S. for patients 6 weeks through adulthood

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S. Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is the only pneumococcal vaccine approved across the lifespan. read more


Inotek Pharmaceuticals Initiates Phase 2 Dose-ranging Trial of a Fixed-Dose Combination of Trabodenoson, a Novel Treatment for Glaucoma, andLatanoprost

-Data Expected in 2017-

LEXINGTON, Mass–(BUSINESS WIRE)–Inotek Pharmaceuticals Corporation (NASDAQ: ITEK), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases, today announced the initiation of a Phase 2 dose-ranging trial of a fixed-dose combination (FDC) of trabodenoson and latanoprost. Glaucoma is one of the leading causes of blindness, and occurs when there is damage to the optic nerve as a result of elevated eye pressure. While the goal of glaucoma treatment is to preserve vision; lowering intraocular pressure (IOP) —a risk-factor for glaucoma—has been shown to prevent progressive vision loss. read more

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