The consumer defense group Public Citizen formally requested that the Food and Drug Administration stop review of Eli Lilly and Daiichi Sankyo Co blood thinner drug Effient (Prasugrel) stating a presumed risk of the tested dose for the presentation study.

The EU Commission of Trade will take more than a month to analyze the proposed Pfizer takeover of Wyeth, the most important drug maker´s merger of the decade. The deal is valued around 68 billion dollars and will make the biggest pharmaceutical company of the trade.

GlaxoSmithKline Plc. obtained by the Federal Trade Commission, formal permission to acquire privately owned skincare company Stiefel Labs. Inc. The deal was proposed April 20th. last year in more than 3.500 million dollars.

Roche Holding AG cut the price of its Tarceva lung-cancer drug for the U.K.’s National Health Service, gaining the recommendation of the National Institute for Health and Clinical Excellence (NICE), a government agency that advises on the cost-effectiveness of medicines.

The number of serious drug reactions and deaths reported to the U.S. government shot up in the first three months of this year to set a new record, the health industry watchdog Institute for Safe Medication Practices reported – nearly 21,000 serious drug reactions, more than 4,800 deaths according to the Food and Drug Administration data. Heparin and Chantix/Champix lead the list. Further details.

The U.S. Department of Health and Human Services updated its HIV treatment guidelines, placing Gilead´s Truvada (a combination of Emtriva and Viread) as preferred regimen. GlaxoSmithKline´s Epzicom is listed as alternative. Further details.

The U.S. Food and Drug Administration has sent letters to several large U.S. and European drugmakers pointing out that they are on record for misleading consumers about their attention deficit and hyperactivity disorder (ADHD) medications in different sales pitches and promotions. The companies include Johnson & Johnson, Shire, Eli Lilly & Co, Novartis and Covidien unit Mallinckrodt, who were all told to stop using these promotions.

German pharmaceutical Boehringer Ingelheim´s Pradaxa, a new blood clot drug, has been recommended for use on Britain´s state health service as a treatment to reduce the risk of venous thromboembolism following hip or knee surgery, the National Institute for Health and Clinical Excellence (NICE) announced.

Forest Laboratories Inc announced the U.S. Patent Office rejected all pending claims involving a patent covering the company´s hypertension drug Bystolict, recently approved. Exclusive rights could move down to 2015. Further details.

Teva Pharmaceutical Industries Ltd and Barr Pharmaceuticals Inc reported each company had received a request for additional information from the U.S. Federal Trade Commission regarding their planned merger.

NICE (National Institute for Health and Clinical Excellence) has published guidance recommending Bristol-Myers Squibb´s Baraclude (entecavir) as an option for treatment of eligible patients with chronic hepatitis B (CHBV).

Britain´s healthcare watchdog NICE has recommended Novartis AG´s high-priced injectable eye drug Lucentis for the National Health Service (NHS), under a special plan that will cap the cost of treatment to the state. The scheme allows 14 shots covered by NHS; Novartis covers the cost of any further shots.

The Food and Drug Administration (FDA) posted on its website a rule confirming a former policy limiting drugmakers´ changes to package inserts before FDA approval. Reactions from market say rule protects companies even though they may have knowledge of potentially hazardous side effects. Further details.

The UK’s cost-effectiveness agency (NICE) has published a draft guidance initially recommending Johnson & Johnson/Schering-Plough drug Remicade (infliximab) for use in England to treat severe acute ulcerative colitis, but only in patients who cannot use ciclosporin. Remicade is approved for psoriasis and rheumatoid arthritis in the U.S. as well as in Europe.

The European Medicines Agency (EMEA) stated it was assessing two cases of progressive multifocal leukoencephalopathy (PML) reported last month in multiple sclerosis (MS) patients being treated with the drug Tysabri.

The Food and Drug Administration (FDA) approved 18 generic drugs made by India´s largest generics maker, Ranbaxy Laboratories Ltd., even as the U.S. Justice Department continued to investigate whether the company delivered adulterated or false data to get its products cleared. Former FDA officials and lawmakers are questioning why the FDA would accept any new data by the company considering the reasons for the judicial probe. Further details.

Biotech Amgen Inc. reports on another filing with the U.S. Securities and Exchange Commission (SEC), regarding a second subpoena – from the U.S. District Attorney´s Office in Seattle, Washington state - connected to its blockbuster EPO anemia drugs Aranesp and Epogen, questioning the safety and efficacy of the products. Further details.

Britain´s National Institute for Health and Clinical Excellence (NICE), the government cost-effectiveness panel, has rejected Pfizer Inc., Roche Holding AG, Bayer AG and Wyeth´s cancer treatments for use in advanced kidney cancer patients on the National Health Service due to these drugs not qualifying in the agency´s measurement that determines if a medicine helps patients live longer or improves quality of life. Several companies are questioning NICE´s decisions.