H.C. Wainwright analyst Ed Arce believes the risk/reward for Paratek Pharmaceuticals is “positively-skewed” into Wednesday’s FDA panel meeting for omadacycline. The analyst expects a “relatively smooth” panel and would be buyers of the stock heading into the early October FDA action date. Arce keeps a Buy rating on Paratek with a $55 price target.
Monday, August 6, 2018
Mallinckrodt forms research partnership with Washington University
Mallinckrodt announced it has formed a collaborative research partnership with Washington University School of Medicine in St. Louis, a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. The company will fund up to $10M in research grants over a five-year period, and expects the collaborative initiative to result in multiple research programs, with a particular focus on rare diseases.
Teva says FDA approves Granix injection for indication in pediatric patients
Teva Pharmaceutical Industries announced that the U.S. FDA has approved GRANIX Injection for a new vial presentation and indication in pediatric patients 1 month and older. GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The new vial presentation of the product will be available for use in 300mcg/1mL and 480mcg/1.6mL single-dose vials. The prefilled syringe presentations will continue to be available as well. “The new pediatric indication and vial presentation of GRANIX expand the range of treatment options that can be of benefit to both patients and healthcare providers,” said Brendan O’Grady, EVP and Head of North America Commercial at Teva. GRANIX was approved by the FDA in August 2012. GRANIX vials are expected to be available in the U.S. shortly.
OncoSec signs research agreement with UCLA
OncoSec Medical announced that it has entered into a research collaboration agreement with the University of California, Los Angeles, or UCLA, on behalf of Roger Lo and his research team. Under the research collaboration, Lo and his research team will perform genetic, transcriptomic and methylomic analyses of patients in OncoSec’s PISCES/KEYNOTE-695 Phase 2b clinical trial, which is evaluating TAVO in combination with KEYTRUDA, or pembrolizumab, for the treatment of metastatic melanoma in patients that have progress after receiving all available treatments including anti PD-L1 checkpoint immunotherapy.
Biocept enters into agreement with healthcare network
Biocept announces that it has entered into an agreement with a large integrated healthcare delivery network to evaluate the clinical utility and cost effectiveness of using Biocept’s Target Selector testing in patients diagnosed with non-small cell lung cancer, or NSCLC. As part of the agreement, the Company’s liquid biopsy testing will be used to profile patients who have been diagnosed with NSCLC and/or have progressed on EGFR targeted therapy. Key objectives of the collaboration are to evaluate improvements in the molecular profiling rate of advanced NSCLC patients and the reduction of the overall cost of patient care
Ironwood announces plans to reduce workforce by approx. 125 employees
Ironwood expects to save approximately $75M-$100M in full year 2019 operating expenses, primarily within SG&A. Ironwood plans to reduce its workforce by approximately 125 employees, primarily consisting of field-based sales employees. Ironwood estimates that it will incur aggregate charges in connection with the reduction in its workforce of approximately $10M-$13M for one-time employee severance and benefit costs, termination fees, and other contract-related costs, primarily in 2018, nearly all of which are expected to result in cash expenditures. In connection with the implementation of the lesinurad test markets, Ironwood previously reduced its workforce in January 2018 by approximately 60 field-based sales representatives.
Sunday, August 5, 2018
Immunovia adds institution partners for pancreatic cancer diagnostic study
Immunovia AB today announced that the Karolinska Institutet is to participate in PanFAM-1, the largest ever prospective study looking at early diagnosis in high-risk individuals with Familial Pancreatic Cancer (FPC). Designed to validate Immunovia s innovative blood test, IMMray PanCan-d, the study will analyze more than thousand individuals over three years across sites in Sweden, the US and Europe already offering FPC screening programs. The aim is to improve the outcome for the cancer patients and to prove the overall healthcare benefits of testing persons with heredity for pancreatic cancer. In Sweden, the early participation of nearly all key centers raises the possibility of creating a national screening program. Parallel to this Immunovia is also running a study for another newly identified high risk group, new onset diabetics over 50 years of age.
“When it has been possible to intervene early with surgery we have had been able to significantly raise survival rates in our clinic, as has been the case with our colleagues in the other sites involved in PanFAM-1,” says PI Dr Urban Arnelo of the Pancreatic Surgery Unit, Division of Surgery, Department of Clinical Science, Intervention and Technology (CLINTEC) Karolinska Institutet. “However, we still lack accurate, non-invasive early diagnostic tools and are now interested to participate in the study to see if IMMray PanCan-d could provide the answer.”
“We are delighted that Karolinska Institutet participates in the PanFAM-1 study for two reasons. Firstly this marks a major step forward as we aim to establish a national program for early detection of pancreatic cancer among major risk groups here in Sweden and secondly because of their worldwide reputation as a center of excellence in oncology,” commented Mats Grahn, CEO, Immunovia.
The other PanFAM-1 partners to date are: Mount Sinai, New York; Knight Cancer Institute at Oregon Health and Sciences University, Portland, OR; The University of Pittsburgh Medical Center Pittsburgh, PA; The Massachusetts General Hospital, Boston, MA; NYU School of Medicine, New York; The University of Liverpool, UK; Ramon y Cajal Institute for Health Research Madrid, Spain; University Hospital of Santiago de Compostela, Spain, Clnica Universidad de Navarra, Spain; and Linkping University Hospital and Sahlgrenska University Hospital, Gothenburg – both in Sweden. Advanced discussions over potential participation continue with several other European and US centers running high risk surveillance programs.
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