The ideal candidate will have audit experience in both public and private companies, experience in various industries such as (real estate, financial (banking),…From Squar Milner – Mon, 06 Feb 2017 23:13:54 GMT – View all San Diego jobs
The Lab Assistant/Technician I is an entry-level support position, responsible for facilitating the efficient operation of biotech and pharma research laboratories through general support activities such as labware cleaning and steri […
5+ years in marketing and/or product management in a biotechnology or CLIA laboratory environment. GenomeDx Biosciences is a dynamic entrepreneurial molecular…From GenomeDx Biosciences – Mon, 06 Feb 2017 21:14:08 GMT – View all San Diego jobs
Kelly Scientific is seeking Quality Assurance/Quality Control personnel. We have a number of open positions with our clients in San Diego. Seeking candidates with experience in Quality Assurance, or Quality Control with Document control. Experience w […
Biotechnology Company in Sorrento Valley Now hiring Entry Level Lab Technicians and Research Associates!
Performs basic laboratory tasks and functions within the reagent standards chemistry and biology department. Performs set up of fi […
Excellent accuracy and attention to detail. Good organizational, interpersonal, leadership and communication skills….From Postings.com – Mon, 06 Feb 2017 17:31:23 GMT – View all San Diego jobs
17-year-old Digital Marketing company that provides Social Media, Web Marketing, SEO and other online marketing solutions to businesses throughout the USA. We love to hire recent college grads with a passion and a burning desire to jump-start their c […
Renova Therapeutics enters into agreement to receive stresscopin investigational new drug file from Janssen
Plans development as treatment for Acute Decompensated Heart Failure
SAN DIEGO, Calif., Feb. 6, 2017 /PRNewswire-USNewswire/ — Renova™ Therapeutics, Inc., a biotechnology company developing gene therapy treatments for congestive heart failure and type 2 diabetes, announced today that it has entered into an agreement with Janssen Pharmaceuticals, Inc., whereby the investigational new drug (IND) file for stresscopin – a hormone involved in responses to physiological stress – will be transferred from Janssen, where it was previously under development. Renova Therapeutics plans to advance development of the stresscopin program as RT-400, a peptide infusion treatment for episodes of Acute Decompensated Heart Failure (ADHF).
In the United States, ADHF accounts for approximately half of all heart failure-related causes of hospitalization.1 From 2005 to 2010, the average estimated number of ADHF hospitalizations in the U.S. was 1.76 million.2 Annual mortality following an ADHF hospitalization is about 30%.3
“Obtaining this stresscopin program IND helps propel forward the development of our peptide infusion product candidate, RT-400,” said Jack W. Reich, Ph.D., CEO and Co-founder of Renova Therapeutics. “With this data, we hope to see promising results as we initiate pivotal trials.”
In addition, Renova Therapeutics holds an exclusive license to the stresscopin peptide from the nonprofit Research Development Foundation.
About Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF) is a severe episode of acute respiratory distress in which a heart failure patient experiences a sudden or gradual onset of the signs of heart failure that requires either initiation or escalation of treatment to relieve symptoms and prevent death. ADHF is caused by severe fluid congestion of the body’s organs, especially the lungs, due to the failing heart providing inadequate circulation.
Symptoms of ADHF can include difficulty breathing, waking up from sleep gasping for air, fatigue, swelling of the legs or feet, as well as chest pain and pressure. Most episodes require immediate emergency room visits or hospitalizations for treatment.
Current treatment options for ADHF primarily involve reducing the organ fluid levels with diuretics, delivered intravenously, and stabilizing heart function with vasodilators such as nitroglycerin. Additional treatments can include providing breathing support using a face mask or breathing tube, as well as an ultrafiltration process to remove fluids in people with ADHF associated with kidney failure.
About Renova Therapeutics
Renova Therapeutics is developing definitive, one-time gene therapies and peptide infusion treatments to restore the health of people suffering from chronic diseases. The first indications the company is pursuing are gene therapy treatments for congestive heart failure (CHF) and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company’s lead product, RT-100, is a treatment that delivers a therapeutic gene directly to the heart during a routine outpatient procedure and has the potential to increase heart function in millions of patients with CHF. The company’s product pipeline also includes a groundbreaking gene therapy in preclinical stage for sufferers of type 2 diabetes, as well as a peptide infusion therapy for the treatment of acute decompensated heart failure. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.
1 Chang PP, Chambless LE, Shahar E, et al. Incidence and Survival of Hospitalized Acute Decompensated Heart Failure in Four US Communities (from the Atherosclerosis Risk in Communities Study). The American journal of cardiology. 2014;113(3):504-510. doi:10.1016/j.amjcard.2013.10.032.
2 Agarwal SK, Wruck L, Quibrera M, et al. Temporal Trends in Hospitalization for Acute Decompensated Heart Failure in the United States, 1998–201. Am. J. Epidemiol. 2016; 183(5):462-470.
3 Dhingra A, Garg A, Kaur S, et al. Epidemiology of heart failure with preserved ejection fraction. Curr Heart Fail Rep. 2014; 11(4):354–365.
SOURCE Renova Therapeutics
- Chief Executive Officer Ken Horne to present at the BIO CEO & Investor Conference 2017 and the Cowen Health Care Conference -
SAN FRANCISCO, Feb. 6, 2017 /PRNewswire/ — Symic Bio, a clinical-stage biotech company that is developing a new category of therapeutics focused on matrix biology, today announced that Ken Horne, Chief Executive Officer, will present at the following upcoming events:
BIO CEO & Investor Conference
Date: Monday, Feb. 13, 2017
Time: 9:30 a.m. EST
Location: Waldorf Astoria, New York
Cowen and Company Health Care Conference
Date: Monday, March 6, 2017
Time: 3:30 p.m. EST
Location: Boston Marriott Copley Place
About Symic Bio
Symic Bio is a clinical-stage biotech company that is developing a new category of therapeutics that are matrix regulators. Matrix regulators target the non-cellular component of tissue and enable new ways to affect disease and healing processes. Matrix regulators have potential applications in a wide variety of indications. Symic Bio currently has two clinical candidates, SB-030 for the treatment of critical limb ischemia and SB-061 directed at disease modification in the treatment of osteoarthritis. In addition, Symic Bio is investigating applications in the areas of fibrosis, oncology and diseases of the central nervous system.
Gitanjali Jain Ogawa
The Trout Group
SOURCE Symic Bio
Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataz(TM) New Animal Drug Application
SAN FRANCISCO, Feb. 6, 2017 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has received a technical section complete letter for effectiveness from the U.S. Food and Drug Administration’s Center for Veterinary Medicine for Mirataz™ (mirtazapine transdermal ointment) approving the technical section.
The basis for this complete letter was a multicenter, randomized, double-blind, placebo-controlled pivotal field study that enrolled 230 cats to assess the effectiveness of Mirataz in managing weight loss in cats. The primary endpoint was mean percentage change in body weight from Day 1 to Week 2. At Week 2, the mean percent increase in body weight from Day 1 was 3.94% in the Mirataz group (n=83), versus 0.41% in the placebo group (n=94) (p<0.0001). Based on a preliminary review of the safety data, the drug appears to be well tolerated.
Richard Chin, CEO of KindredBio, stated, “This is a major milestone for KindredBio, and it is a testament to the quality of the submission and the significant unmet medical need that it was reviewed by the FDA in a single cycle and ahead of the standard (ADUFA) timelines. We look forward to the launch of the first FDA-approved drug for the management of weight loss in cats, the most common reason for feline veterinary visits in United States. We expect the approval of Mirataz in the second half of 2017 assuming no unforeseen delays in the review process.”
About Kindred Biosciences, Inc.
Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats and horses. The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.
These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.
For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
SOURCE Kindred Biosciences, Inc.