Neurologists say minimally invasive delivery of the drug tPA directly into potentially lethal blood clots in the brain helped more patients function independently a year after suffering an intracerebral hemorrhage, a deadly and debilitating form of stroke. Rates of functional recovery with the active tPA treatment far surpassed those achieved with standard supportive therapy.
Researchers have discovered the first U.S. cases of whooping cough caused by a germ that may be resistant to the vaccine. Health officials are looking into whether cases like the dozen found in Philadelphia might be one reason the nation just had its worst year for whooping cough in six decades.
Three clinical trials that seek to find more effective treatments for influenza are enrolling volunteers with influenza at the National Institutes of Health’s Clinical Center in Bethesda, Md., and at several dozen other domestic and international sites.
Idenix Pharmaceuticals Inc. is ending development of two hepatitis C drugs after regulators told the biopharmaceutical company the drugs would remain on clinical hold. The drugs, IDX184 and IDX19368, are both nucleotide inhibitors that prevent the virus from making copies of itself.
Federal regulators say approval of the first generic version of cancer drug Doxil will help resolve a lingering shortage triggered by manufacturing deficiencies. The shortage of the Johnson & Johnson injectable medication, made under contract by Ben Venue Laboratories, has continued on and off for a few years.
A Phase 3 clinical trial of breast cancer drug Abraxane in combination with current standard of care gemcitabine in patients with advanced pancreatic cancer has demonstrated substantially improved survival times, with double the number of patients surviving two years.
Spectrum Pharmaceuticals Inc. has regained the marketing rights to its bladder cancer drug apaziquone and made progress in discussions of the drug with regulators. Spectrum also revised a deal with its partner Allergan Inc., and will have the right to market the drug in the U.S., Europe, and other regions.
Dilaforette announces that the company has approval from the regulatory authority in India to start a Phase 2 study with sevuparin in patients with moderate to severe malaria. The primary objective of the study is to evaluate safety along with several efficacy parameters.
Genentech announced positive results from Stage 1 of CLL11, a Phase 3 trial investigating the efficacy and safety of obinutuzumab (GA101) plus chlorambucil chemotherapy, compared with chlorambucil alone in people with previously untreated chronic lymphocytic leukemia (CLL).
Sanofi said that the Food and Drug Administration will review its experimental multiple sclerosis treatment Lemtrada. The FDA will conduct a standard 10-month review and will make a decision on whether to approve the drug for relapsing multiple sclerosis in late 2013.
Keryx Biopharmaceuticals' potential kidney disease drug, Zerenex, performed much better than placebo in a late-stage clinical trial. Keryx is submitting an application for approval of the drug to both the U.S. Food and Drug Administration and European regulators in the second quarter of 2013.
Dengue fever, a potentially life-threatening disease prevalent in many tropical and subtropical regions of the world, can be spread to humans by infected mosquitos. Dengue has recently made inroads to the United States, with a number of cases reported in Florida.
Biotech drugmaker Ampio Pharmaceuticals Inc. said the Food and Drug Administration accepted its application to start testing the eye drug Optina. Optina is designed to treat diabetic macular edema, which can cause blurred vision and blindness.
A clinical trial will evaluate a drug candidate called cyclodextrin as a possible treatment for Niemann-Pick disease type C1 (NPC), a rare and fatal genetic disease. There are currently no therapies approved by the U.S Food and Drug Administration available to treat NPC.
Cancer Research UK is launching a trial of an experimental drug shown to simultaneously block many enzymes that control cancer cell growth and death. The "master-switch" experimental drug, owned by Astex Pharmaceuticals, could potentially treat a range of cancer types.
Argos Therapeutics Inc. announced that the first patients have been enrolled in the ADAPT Phase 3 clinical trial for AGS-003. ADAPT is studying AGS-003's ability to extend overall survival versus standard therapy alone in newly diagnosed patients with unfavorable risk metastatic renal cell carcinoma.
Nexavar is the only therapy currently approved to treat hepatocellular carcinoma in Europe and the United States, and represents a new class of drugs that specifically targets cancer cells or their surrounding environment, while leaving normal cells unaffected, causing less damage to the patient.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended marketing authorization for Jetrea, a medicinal product indicated for the treatment of adults with vitreomacular traction, an eye condition which can cause severe visual disturbance.
The Food and Drug Administration said it has approved Allergan's Botox injection for a new use in treating patients with overactive bladder that does not respond to conventional medications. About 33 million people in the U.S. have the problem, according to the FDA.
Immunovaccine Inc. reported positive results from a Phase 1 clinical study of the company’s cancer vaccine, DPX-Survivac, for the treatment of ovarian cancer. The analysis, which now includes all patients enrolled in the study, confirmed previously reported results and uncovered new findings.
Radius Health Inc. is providing an update regarding the progress of its Phase 3 study of BA058. BA058 is a novel synthetic peptide analog of hPTHrP, an anabolic, bone-building drug being studied for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Cancer Research UK and AstraZeneca have opened a study of an investigational drug called AZD0424 that is being tested for the treatment of a range of cancers. The Phase 1 clinical trial will recruit up to 30 patients, initially across all solid tumor types.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has confirmed the recommendation to suspend the marketing authorizations of Tredaptive, Pelzont, and Trevaclyn used to treat adults with dyslipidemia.
For the nearly 30 million Americans who suffer from a rare disease, there's heartening news: Drugmakers have been shifting much of their research away from pills for the millions to uncommon disorders that often kill prematurely because there are few or no treatment options.
Aspireo Pharmaceuticals Ltd. announced results of an interim analysis of a Phase 1b study. This study is investigating the safety, side effect profile, as well as pharmacokinetic and pharmacodynamic profile of multiple ascending doses of Somatoprim in healthy male volunteers.