The medication, called Sklice, whose active ingredient is ivermectin, an anti-parasite drug long taken orally, will be sold in the United States by Sanofi’s vaccines division, Sanofi Pasteur U.S., the company said.

Other recent drug-related recalls include:

• Prescription birth control pills with incorrect dosage and/or incorrect packaging sequence, which could lead to unintended pregnancies.

• Over-the-counter “dietary supplements” that contained undeclared prescription drugs, such as sibutramine and tadalafil. (Sibutramine can cause increased heart rate and blood pressure. It has been withdrawn from the market.)

Certain serogroup B Neisseria meningitidis (MenB) vaccines proved effective in clinical trials and controlled a clonal MenB outbreak in New Zealand; however, the high strain specificity of these vaccines limited their usefulness, especially in infants and young children, according to background information in the article.

Nicoletta Gossger, M.D., of the University of Oxford, United Kingdom, and colleagues assessed the immunogenicity (the ability to produce an immune response) and reactogenicity (producing adverse reactions) of a vaccine developed to provide broader protection, a multicomponent serogroup B meningococcal vaccine (4CMenB), in a large group of infants, given in 2 different schedules, with or separately from routine vaccines. The multicenter, randomized controlled study included 1,885 infants enrolled at age 2 months from August 2008 to July 2010 in Europe. Participants were randomized to receive (1) 4CMenB at 2, 4, and 6 months with routine vaccines (7-valent pneumococcal and combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b vaccines); (2) 4CMenB at 2, 4, and 6 months and routine vaccines at 3, 5, and 7 months; (3) 4CMenB with routine vaccines at 2, 3, and 4 months; or (4) routine vaccines alone at 2, 3, and 4 months. The primary outcome the researchers measured was the percentage of participants with human complement serum bactericidal activity (hSBA) titer (concentration) of 1:5 or greater against 3 MenB strains specific for vaccine antigens (NZ98/254, 44/76-SL, and 5/99).

The Food and Drug Administration said on Tuesday Kalydeco was effective in treating people with the life-shortening disease, which impairs the lungs and digestive system.

Vertex shares shot up as much as 11 percent after the announcement of the approval, which came well ahead of the FDA’s expected April 18 decision date.

The biopharmaceutical company plans to enroll about 10,000 patients in the placebo-controlled trial for demonstrating that the drug Contrave does not unacceptably increase the risk of major adverse cardiovascular events.

Orexigen will conduct the trial under a “special protocol assessment” from the U.S. Food and Drug Administration.

The injectable drug is already approved to prevent fractures caused by cancer that has spread to the bone, and it is seen as one of the most important growth drivers for the world’s largest biotechnology company.

Xgeva delayed the spread of cancer to the bone by a little longer than four months in a clinical trial of 1,432 men with prostate cancer who had stopped responding to hormone therapy.

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), PBC - an autoimmune liver disease characterized by inflammation of the bile ducts that ultimately causes bile to build up and damage the liver - typically occurs between the ages of 40 and 60, primarily affecting women. Medical studies have identified the presence of anti-mitochondrial autoantibodies (AMA) to enzymes involved in the production of the body’s energy (pyruvate dehydrogenase complex-PDC-E2) in up to 95% of PBC cases.

Currently, the standard therapy for PBC is UDCA or liver transplantation in patients who have progressed to end-stage liver disease. However, previous studies have shown that UDCA may be ineffective in up to 40% of PBC patients and 10% could require transplantation or die from the disease. “Small trials using immunosuppressants have failed to demonstrate significant clinical benefit or carry unacceptable safety profiles,” said Dr. Christopher Bowlus with UC Davis Health System in California and lead author of the current study. 

In patients with a subarachnoid hemorrhage, even after the burst weak spot in the vessel is closed, irritation from the initial bleeding can cause blood vessels to constrict, cutting off normal blood supply and resulting in even more brain damage. This is often called a “second stroke.” The vessel constriction is called angiographic vasospasm (VSP), which can occur about three to 14 days after aneurysm rupture.

“We don’t have very effective treatments for this complication,” said R. Loch Macdonald, M.D., study lead author and head of neurosurgery at St. Michael’s Hospital, University of Toronto in Ontario, Canada. “The treatment in use now is very expensive and risky and doesn’t work very well, and about half of the patients suffer permanent problems from it.”

The Effect of Clazosentan on Clinical Outcome after Aneurysmal Subarachnoid Hemorrhage and Endovascular Coiling (CONSCIOUS-3) Study included 571 patients with a ruptured aneurysm treated with an endovascular coil, a device used to repair the ruptured blood vessel.

Researchers led by Professor David Brown, School of Pharmacy and Biomedical Sciences, University of Portsmouth, simulated a customer search and evaluation of 184 retrieved sites using evaluation tools focusing on quality and safe medicine use.

Results showed that a potential purchaser of statins is likely to encounter websites from a wide geographical base of generally poor quality. 

The drug, called Kalydeco and developed by Vertex Pharmaceuticals, counters the effect of one specific mutation in the gene that accounts for 4 percent — or about 1,200 — cystic fibrosis cases in the United States.

“This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease,” Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research at the F.D.A., said in a statement issued by the agency.

The Food and Drug Administration has approved Erivedge under the agency’s priority review program. The program provides an expedited six-month review process for drugs that may result in major treatment advances.

Erivedge is for patients with advanced basal cell carcinoma who are not candidates for radiation or surgery, or for those whose cancer has spread. BCC is the most common form of skin cancer in the country. It grows slowly and is generally curable.

By stopping pain at the source, continuous wound infusion with local anesthetic produces lower pain scores, reduced morphine use, and less nausea and vomiting, according to the new research. “Moreover, a positive effect on superficial and deep wound pain was still present three months later,” write Dr Jose Aguirre and colleagues of Balgrist University Hospital Zurich, Switzerland.

Continuous Wound Infusion Reduces Pain after Hip Surgery
The study included 76 patients undergoing minimally invasive hip arthroplasty surgery. In all patients, a specially designed wound catheter was placed into the hip joint during the operation. In one group, the catheter was used to infuse ropivacaine, a local anesthetic drug, into the joint at the end of the procedure and for 48 hours afterward. The other group received continuous wound infusion with an inactive placebo solution.

Influenza, an acute viral infection, affects hundreds of thousands of people a year and puts an enormous strain on healthcare providers globally. The last pandemic flu outbreak in the UK – swine flu – was in 2009 when it claimed 457 lives. While previous pandemics have been more serious, there is a heightened risk of more severe pandemics in the future.

The scientific collaboration used a research method known as “Human Viral Challenge Studies”, where healthy volunteers are infected with influenza virus, and their immune responses closely monitored in an isolation unit. 

The drug, Erivedge, which was co-developed by Curis Inc, was given a green light by the Food and Drug Administration more than a month ahead of the expected March 8 decision date. It was approved for use by adults whose cancer cannot be treated with surgery or radiation or whose disease has spread to other parts of the body or returned following surgery.

Erivedge, known chemically as vismodegib, is the first drug to gain FDA approval for advanced basal cell carcinoma. Curis, which earned a $10 million milestone payment as a result of the approval, is entitled to royalty payments on sales of the drug.

The first cancer vaccine Sipuleucel-T (Provenge™) was licensed last year for use in prostate cancer patients unresponsive to hormone treatment. Unfortunately, this cell based vaccine only improves patient survival by an average of 4.1 months. Vaccines for infectious diseases are highly effective at generating immune responses that prevent infection with bacteria or viruses. The immune system can also protect us against tumours and in theory a vaccine approach should be effective against cancer. In practice this has proven very difficult because unlike infectious diseases, tumours are derived from normal human cells, and not made up of foreign substances or antigens capable of triggering an immune response. The tumours instead produce molecules that suppress the efficacy of the immune system. They generate regulatory cells that inhibit the immune response that could potentially clear the tumours.

Professor Mills’ group has developed a novel vaccine and immunotherapeutic approach that can overcome these obstacles and has the potential to significantly improve on existing technologies.