GlaxoSmithKline’s blockbuster diabetes drug Avandia is facing new scrutiny by regulators in the United States and Europe. The U.S. Food and Drug Administration has released a review by the agency ahead of an expert panel meeting to determine whether the drug is safe enough to remain on the market. At the same time, the European Medicines Agency said it would also review whether the drug should remain on the market following the recent publication of two studies that raised questions about a higher risk of heart attacks in patients using the drug. FDA reviewer Thomas Marciniak, in a posting on the F.D.A.’s web site, said GSK’s misreading of the Avandia study, known as the Record trial, were so profound, that they “suggest serious flaws with trial conduct,” The New York Times reported. “One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks.

Merck said it will phase out eight research sites and eight manufacturing sites as part of a restructuring started in December following its acquisition of Schering-Plough. The company said it expects its total workforce to be reduced by approximately 15 percent across all areas of the combined company worldwide as part of the initial phases of its merger restructuring program. Merck said it remains committed to achieving its previously announced synergy target of $3.5 billion in ongoing annual savings in 2012. Merck expects the initial phases of the merger restructuring program to result in savings of approximately $2.7 to $3.1 billion in 2012 toward the $3.5 billion target. The company estimates that cumulative pretax costs for the initial phases of the merger restructuring program will now range from $3.5 billion to $4.3 billion.

The U.K.’s National Institute for Health and Clinical Excellence said in a draft guidance that it is not recommending Roche’s Avastin (bevacizumab) for use in combination with taxane for breast cancer patients whose disease has spread to other parts of the body. The advisory body to the U.K.’s National Health Service said evidence submitted to it by the drug manufacturer did not show bevacizumab to significantly improve or extend the lives of patients with metastatic breast cancer. NICE said the uncertain clinical benefit, combined with the amount of money the NHS is being asked to pay for the drug, meant it was unable to recommend bevacizumab (in combination with a taxane) as a first-line treatment for metastatic breast cancer.
 

The National Institute for Health and Clinical Excellence said Takeda’s Mepact (mifamurtide) has not been shown to significantly increase the overall survival of patients with a form of bone cancer more than currently available treatments. The draft guidance from the advisory body to the U.K.’s National Health Service said because of uncertainties over the drug's effectiveness, combined with the high cost that the NHS is being asked to pay for the treatment, means it is unable to recommend mifamurtide, in combination with post-operative chemotherapy drugs, for the treatment of non-metastatic, surgically treatable osteosarcoma.

GlaxoSmithKline and XenoPort said that their experimental drug to prevent migraine headaches failed in a mid-stage clinical trial. GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo. The primary endpoint of the 30-week study was the change from baseline in the number of migraine headache days during the last four weeks of treatment prior to taper. The failure of the study, the companies said, may be a consequence of the unexpectedly high placebo response rate observed. The most common adverse event was dizziness, which was generally mild or moderate and did not lead to discontinuation in the majority of patients. Eight patients who received GSK1838262 and two who received placebo experienced serious adverse events during the trial. Of these events, two were deaths in patients receiving GSK1838262. One was due to bronchopneumonia and was assessed by the investigator as not related to the study drug. The second death resulted from an accidental overdose involving medications other than GSK1838262, but the relationship of this event to the study drug could not be established.

Hi-Tech Pharmacal said it is suspending the sale of several products until it resolves issues raised in a warning letter sent to it from the U.S. Food and Drug Administration. The warning letter primarily dealt with the marketing of several products that FDA states require FDA approval and manufacturing practices related to those products. Sales of these products totaled approximately $5 million in fiscal year 2010. Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and over-the-counter products for the general healthcare industry. The company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products.