Genentech, Inc. has submitted an application to the U.S. Food and Drug Administration  for its product Avastin® as a therapy for patients of glioblastoma who have received a treatment previously. If the supplemental Biologics License Application (sBLA) is accepted by the FDA, the drug can be considered for a provisional approval for treatment of cancer and other such deadly diseases. Glioblastoma is the most aggressive form of brain cancer. It has no cure. The study found that Avastin, when as evaluated as a single agent, showed that 43 percent of patients experienced no progression of disease.

Novartis Pharmaceuticals Corporation has launched two new dosage strengths of its product Stalevo®, which is approved for use in treatment of Parkinson’s disease. With the approval of 75 and 125 tablets of Stalevo, physicians have another option to prescribe to patients who go through end-of-dose “wearing off”. The product simplifies treatment because it provides more sustained levodopa levels in the blood by combining it with the enzyme inhibitors carbidopa and entacapone.

A recent study has concluded that the use of statin drugs leads to reduction in the risk of Alzheimer’s disease (AD) by 67%. The multi-center trial assessed cognitive changes in the patients for four years. Widely used as drugs to lower cholesterol levels, statins are also safer drugs. Nymox Pharmaceutical Corporation holds global patent rights for the use of statins for the treatment of AD.

he U.S. Food and Drug Administration has provided the patients of schizophrenia with an administration option for RISPERDAL(R) CONSTA(R) ([risperidone] Long-Acting Injection) by approving a new injection site, the deltoid muscle in the arm. RISPERDAL CONSTA was previously approved as a gluteal injection only. The indication was given on the basis of a study which showed that the gluteal and deltoid injections of RISPERDAL CONSTA were bioequivalent routes of administration. The new site is also safe and tolerable. The new packs of RISPERDAL CONSTA will now have two separate with the needle for deltoid injection being smaller gauge and shorter than the gluteal needle in length. RISPERDAL CONSTA is marketed in the U.S. by Janssen(R).

The U.S. Food and Drug Administration has approved AstraZeneca’s once-daily Extended-Release Tablets, SEROQUEL XR (quetiapine fumarate) for the acute treatment of episodes of depression and mania related to bipolar disorder. In the long term, patients suffering from this disease may experience depressive symptoms as long as three times to that of manic symptoms. It must be noted that this is the first such medication approved buy the regulatory authority for treating the serious psychiatric illness.

A retrospective analysis of 25 patients at The Walton Centre in Liverpool has come up with a finding that rituximab lowers the frequency of attacks in patients suffering from neuromyelitis optica and also improves disability in them. Rituximab could be beneficial for patients who have not responded to various immuno-therapies. Authors of the study report that the median post-treatment rate was 0 relapses per year (follow-up of 19 months) as compared to 1.7 relapses before the treatment. The Median Expanded Disability Status Scale scores also improved. A controlled trial is difficult to conduct owing to the rarity of the disease and need to treat it early.

Eli Lilly and Company has announced that the Committee for Medicinal Products for Human Use (CHMP) has expressed a positive opinion in recommending the approval of Zypadhera (olanzapine long-acting injection) for maintenance treatment of schizophrenia in adult patients. The stand taken by the CHMP will have to be confirmed by the European Commission for the new indication to be considered as approved. The CHMP formed its opinion on the basis of data derived from eight studies, involving 2,054 patients.

Recent tests of Tysabri (developed by the Irish company Elan) have come up with positive results which were put before the World Congress on Treatment and Research in Multiple Sclerosis in Montreal. The doctors have concluded that the drug has the potential to come up as an effective treatment for patients suffering with multiple sclerosis. The medication is also useful in slowing down the progression of disability.

Pfizer Inc. and Medivation Inc. have entered into an agreement for development and commercialization of Dimebon. Dimebon is Medivation’s investigational drug to be used in the treatment of Alzheimer’s disease and Huntington’s disease, currently in Phase III of its trial involving patients with mild-to-moderate Alzheimer’s disease. The companies will share all U.S. development and commercialization expenses along with U.S. profits/losses with Pfizer assuming the larger share (60%). In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S.

The FDA has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome. Requip tablets have been approved in the 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram dosages. Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc. have received approval to market the ropinirole hydrochloride tablets.