Endo International plc announced that its operating company Endo Pharmaceuticals Inc. received FDA approval of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism, commonly known as Low-T. Read more...
Novartis announced that the European Commission has approved the use of Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. Read more...
Janssen announced that the European Commission has granted conditional approval to Sirturo (bedaquiline) in the European Union, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB). Read more...
Boehringer Ingelheim announced results from the Phase 3 STARTVerso4 trial in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Read more...
Alexza Pharmaceuticals, Inc. announced the U.S. commercial launch of ADASUVE (loxapine) inhalation powder 10mg by its commercial partner, Teva Pharmaceutical Industries Ltd. ADASUVE is an orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
Advanced Accelerator Applications (AAA) announced that it has received orphan drug designation status for their radiopharmaceutical, Gallium-68 DOTATATE. The orphan drug designation has been granted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use of Gallium-68 DOTATATE as a diagnostic agent for the management of Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs).
Potential side effects of many of today’s therapeutic drugs can be downright frightening — just listen carefully to a drug commercial on TV. These effects often occur when a drug is active throughout the body, not just where and when it is needed. But scientists are reporting progress on a new tailored approach to deliver medicine in a much more targeted way.
University of Florida researchers say memory trouble doesn’t have to be inevitable, and they’ve found a drug therapy that could potentially reverse this type of memory decline. The drug can’t yet be used in humans, but the researchers are pursuing compounds that could someday help the population of aging adults who don’t have Alzheimer’s or other dementias but still have trouble remembering day-to-day items.
Drugmakers Eli Lilly and Boehringer-Ingelheim said Tuesday that the Food and Drug Administration didn't approve their diabetes treatment empagliflozin because of concerns about a facility where the drug will be made. The companies said the FDA isn't asking for new studies of empagliflozin. They said they intend to reply to the agency as soon as possible.
GE Healthcare announced that Clarient Diagnostic Service, Inc., a GE Healthcare company, has made significant upgrades to its fluorescence in situ hybridization (FISH) technologies to improve virtual analysis of testing results for a variety of blood diseases, including leukemia, lymphoma, myelodysplastic syndrome, and myeloma.
Clinical Study in the Czech Republic Confirms Blood-based Septin9 Test as Alternative for CRC ScreeningMarch 5, 2014 9:45 am | News | Comments
Epigenomics, the German-American cancer molecular diagnostics company, announced findings from a study executed in different centers in Prague, Pilsen, and Brno. According to the study, in late 2013 blood-based Septin9 testing could be an attractive screening alternative to established methods for a population that would otherwise be non-compliant to colorectal cancer screening.
Roche presented new data from the LUTE / VERSE Phase 2b studies investigating lebrikizumab in patients with severe uncontrolled asthma. The data showed that asthma attacks were reduced by 60 percent in lebrikizumab-treated patients with a high level of the biomarker periostin, compared to only 5 percent in patients with a low level of periostin.
Limited resources and other barriers have long stymied advances in medical research infrastructure in Africa. But the situation is starting to change. Many countries are making greater investments in science as part of broader efforts to tackle local health problems. Novartis is working with local partners across Africa to build research capacity.
Merck Announces Results from Phase 2b Study of MK-8237, an Investigational House Dust Mite Sublingual Allergen Immunotherapy TabletMarch 5, 2014 12:23 am | by Merck | News | Comments
( BUSINESS WIRE ) Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). The data were presented for the first time...
With the biopharmaceutical market valued at $70 billion and counting, scientists need every improvement they can get to design and develop these drugs faster and more accurately. A novel technology that will bring synthetic biology to industrial scale promises to dramatically enhance the development pipeline.