New Brunswick, NJ - According to Katie Eder, "Rutgers team behind new heart treatment. A new Rutgers study may lead to better treatment of systolic heart failure, one of the most common cardiac disorders in which the ability to pump blood becomes restricted and whose risks increase with age. Using a pharmaceutical treatment for systolic heart failure developed by Cytokinetics Inc. that is being tested in clinical trials, new research at Rutgers Robert Wood Johnson Medical School determined the precise interaction between the drug and what researchers call the cardiac "motor."
Immunomedics Announces Orphan Drug Designation for Veltuzumab for the Treatment of Immune Thrombocytopenia
Morris Plains, NJ - Immunomedics, Inc. today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan status for the use of veltuzumab, the Company’s humanized anti-CD20 antibody, for the treatment of immune thrombocytopenia (ITP). In a Phase 1 study,1 low-dose veltuzumab, as a single agent, produced an objective response rate of 55 percemt in 38 response-assessable patients with relapsed ITP, including 11 patients (29 percent) who reported a complete response.
Jersey City, NJ - According to Eric Strauss of NJBiz, "A North Carolina drug development company is selling off one of its businesses and moving to Jersey City. Scynexis Inc. will relocate from Research Triangle Park effective Aug. 1, it said in a news release, and focus on developing its SCY-078 antifungal drug."
Kenilworth, NJ - According to Eric Strauss of NJBiz, "Merck is acquiring an Israeli biopharmaceutical company for $95 million in cash, the drugmaker announced Tuesday. The Kenilworth-based company’s deal for cCAM Biotherapeutics, which is focused on cancer immunotherapies, could potentially include up to $510 million in milestone payments, it said."
Kenilworth, NJ - Merck, known as MSD outside the United States and Canada, announced today that the company's commitment to HIV and AIDS, which started with a research and development program initiated in the mid-1980s during the early years of the epidemic, is now entering its fourth decade. To commemorate Merck's 30 years of commitment in this area, the company is launching a new effort, “Positively Committed.” The campaign highlights the company’s contributions, including the development of innovative therapies to address the unmet medical needs of people infected with HIV-1.
Princeton, NJ - Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
Basking Ridge, NJ – According to New Jersey Business Magazine, Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for the treatment of upper limb spasticity (ULS) in adult patients to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors. Clinical improvement may be expected one week after administration of Dysport®.”
Trenton, NJ - According to Tom Bergeron of NJBiz, "Novartis officials were hoping the FDA would give approval for what they hope will be a blockbuster drug for heart failure by the end of the summer. On Tuesday, they got even better news. The U.S. Food & Drug Administration approved Entresto (formerly called LCZ696) six weeks ahead of the priority review action date."
Washington D.C. - The Food and Drug Administration (FDA) has announced a research partnership with PatientsLikeMe, an online patient community, to explore the potential for patient-generated health data to identify dangerous drugs. The FDA already collects data about instances of dangerous drug side effects, called adverse events, though its access to this information is limited to patients who voluntarily report adverse events directly to the FDA and aggregated data from insurers and electronic medical records. FDA hopes this new partnership, which grants it access to 110,000 adverse event reports related to 1,000 different medications from PatientsLikeMe users who voluntarily share their data, will allow for more a detailed understanding of how patients take medicine.
New Brunswick, NJ - Janssen Pharmaceutical has furthered its strategic partnership with the Rutgers University School of Engineering by providing $6 million to expand research that will help pharmaceutical companies develop new ways to manufacture prescription medicines.
Kenilworth, NJ - Merck announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection. Within 60 days of submission, the FDA will determine whether it will accept for review Merck's application as filed. The company plans to submit additional license applications in the European Union and other markets by the end of 2015.
Trenton, NJ – In a press conference this week, the New Jersey Senate Republican leadership released a 36 bill package to improve the state of innovation, the strengthen the workforce and grow the economy. The bills seek to usher in growth through policies pertaining to science and technology, STEM education, improving the state’s existing economic development practices, regulation reductions as well as agriculture enhancements without adding additional costs to the budget.
Trenton, NJ - Debbie Hart, president and CEO of BioNJ, and Dean Paranicas, president and CEO of the HealthCare Institute of New Jersey, write a great opinion article in the Courier Post, discussing the success of the New Jersey biopharma industry.
Trenton, NJ – According to Linda Johnson of The Associated Press, “The global pharmaceutical industry is pouring billions of dollars into developing treatments for rare diseases, which once drew little interest from major drug makers but now point the way toward a new era of innovative therapies and big profits. The investments come as researchers harness recent scientific advances, including the mapping of the human genome, sophisticated and affordable genetic tests, and laboratory robots that can screen thousands of compounds per hour in search of the most potent ones.”
Santa Monica, CA – Faster Cures, a research center at the Milken Institute, summarized their recent webinar on April 7th and offers an in-depth explanation on the U.S. Food and Drug Administration's (FDA) Patient-Focused Drug Development (PFDD) initiative. The webinar speakers highlight that “under the fifth authorization of the Prescription Drug User Fee Act (PDUFA) to hold at least 20 disease-specific meetings to better understand patients' experiences with symptoms, impacts on daily living, and available therapies.”
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