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.
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New Brunswick, NJ - The researchers at Rutgers found in a new study that overindulging especially in high-fat food could be caused not by a lack of fortitude, but by the unmanageable hormonal response triggered by an imbalance in the brain. If a person lacks the willpower to stop over eating, the best way a person can deal with such ordeal is to have a series of strategic fight-back foods ready. These are foods that will keep the cravings of a person at bay and at the same time have their brain satisfied by signaling to the stomach that it is full. Foods that can stop overeating are actually available.
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."
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.
Trenton, NJ - Dr. Stephen Ostroff, Acting Commissioner of the Food and Drug Administration (FDA), will serve as the featured luncheon speaker at the 3rd Annual BioNJ CEO Summit, Take It to the Top, scheduled for October 9 at the Bridgewater Marriott. Dr. Ostroff will participate in a fireside chat with Dr. William Hait, Global Head of Research and Development for Janssen, the pharmaceutical companies of Johnson & Johnson, entitled: Expediting Therapies and Cures to the Patients Who Need Them: The Evolving Role of the FDA.
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."
Montclair, NJ - NJ Spotlight today published an op-ed authored by Dean J. Paranicas, President and Chief Executive Officer of the HealthCare Institute of New Jersey (HINJ) on the subject of patent reform legislation currently pending before the U.S. House of Representatives.
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.
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.
Madison, NJ - The Medical Innovation Impact Index (MI3), a new method for evaluating the impact of regulation on medical innovation, has been developed at the Initiative for Patient Centered Innovation (iPCI) of Fairleigh Dickinson University’s (FDU) Rothman Institute of Innovation and Entrepreneurship. The inaugural MI3 Alert pertains to new FDA (Food & Drug Administration) draft guidance documents and a Senate proposal for accelerating the approval of certain medical devices.
Bridgewater, NJ - Celgene's expansive approach to partnering continues to bear fruit, as two of the Big Biotech's in-licensed treatments have been added to the FDA's fast-track program, promising a speedy regulatory review as each approaches Phase III.
New Brunswick, NJ - According to Craig McCarthy, "Johnson & Johnson will be the first company to seek formal advice on providing experimental drugs to the desperately ill -- or "compassionate use"-- before they are approved, reports say. The New Jersey-based drug company appointed a bioethicist Thursday to create a panel, according to The New York Times, charged with making decisions for patient's request for the trial drugs."
Teaneck, NJ – According to Hugh Morley of the Record, “Former medical company executive, Dr. Joseph V. Gulfo doesn't want to fight anymore. And that's good news for Fairleigh Dickinson University.” After two years battling to get a melanoma detection device approved by the U.S. Food and Drug Administration, the former CEO of Mela Sciences is now the FDU's Rothman Institute of Innovation and Entrepreneurship.
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.”
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