The U.S. Food and Drug Administration has expanded the indication for Tibotec Pharmaceuticals’ PREZISTA (darunavir) tablets once-daily dosing as a part of the HIV combination therapy in adult patients who have not taken medication for HIV before. Also, PREZISTA has been approved as a twice-daily for use in adults with a prior experience of treatment. With this approval, the protease inhibitor when administered with 100 mg PREZISTA/r (ritonavir) and other ARVs (antiretroviral agents) can be used for the treatment of HIV-1 infection.

After two years of its approval, the Advisory Committee on Immunization Practices has detected no major problems with the safety of the HPV vaccine, Gardasil. The vaccine is used to protect against infection caused by the sexually transmitted virus, the HPV, that leads to genital warts and cervical cancer. The Center for Disease Control and Prevention has recommended the vaccination of girls at the age of 11 (much before they turn sexually active). No serious side effects have been found.

Scientists from the University of Cambridge have found that alemtuzumab, a drug originally developed for leukemia can curb the progression of multiple sclerosis (MS) even reverse some damage caused by the neurological disorder. The drug, a monoclonal antibody, has also been tested for treatment of other immune system disorders. Alemtuzumab targets the cells of the immune system that attack the myelin sheath and the nerve fibers.

A study conducted by researchers at the University of Wisconsin Hospital, Madison has concluded that wheezing illness in childhood caused by rhinovirus is associated with the development of asthma. The doctors reported that almost 90% of kids who suffered from wheezing related to rhinovirus at 3 years of age developed asthma by the age of 6 years. Also, episodes of rhinovirus wheezing may help in revealing children who are predisposed to the disease.

MedImmune has licensed the use of its proprietary reverse genetics technology by a Hungary-based manufacturing and research firm, Omnivest, to develop new vaccine strains for the production of non-live vaccines for influenza in humans. The technology enables generation of viruses such as influenza from segments of DNA. It requires the manufacturers to work only with segments of genome of the virus and not directly with highly infectious strains. Before this, MedImmune has licensed the technology to CSL Limited (Australia), sanofi pasteur, Novartis, GlaxoSmithKline and BIKEN (Japan).

The U.S. Food and Drug Administration has given the approval to Lev Pharmaceuticals, Inc’s Cinryze™ (C1 inhibitor [human]) for preventing angioedema attacks in patients suffering from hereditary angio-edema (HAE). Cinryze is expected to be commercially available for prophylaxis against HAE later this year. It should be noted that Cinryze is the first and the only therapy approved by FDA for routine prophylaxis against attacks caused by the deficiency of C1 inhibitor. The approval will benefit the people suffering from the painful swelling.

Bristol-Myers Squibb Co.’s Reyataz (atazanavir) capsule (300 mg) has been approved by the U.S. Food and Drug Administration for use in combination with ritonavir (100 mg) to treat HIV-1 infection. On the basis of results of the year-long trial which show that atazanavir was as effective as lopinavir along with ritonavir in achieving virologic response  in adult patients who received tenofovir and emtricitabine (300 mg/200 mg once daily) therapy simultaneously.

The US Food and Drug Administration has given approval to Wockhardt for manufacturing and marketing its Promethazine hydrochloride injection. The drug which is used for the treatment of allergy to blood or plasma; nausea, motion sickness and vomiting related to certain types of surgery and anesthesia will be available in the doses of  25 mg/ml and 50 mg/ml. The antihistamine gives relief from nasal stuffiness and inflamed eyes as a result of hay fever. Symptoms like itching, rashes and swelling are also taken care of.

ImmunoVaccine Technologies‘ DepoVax, depot vaccine formulation, has shown positive results in pre-clinical phase. The patented product has achieved single-dose efficacy in the treatment of cancer and other infectious disease vaccine models. Based on a new approach that uses liposomes which encapsulate a target antigen and adjuvant, DepoVax relies on a hydrophobic oil carrier that enhances vaccine induced cell-mediated immunity significantly.