The FDA is scheduled to decide later this week whether to give preliminary approval to Mircera, which like other anemia drugs uses a genetically engineered protein to boost red-blood-cell production. Anemia, a blood disorder that causes weakness and shortness of breath, often develops in patients who are receiving chemotherapy for cancer or who have chronic kidney disease. Analysts are divided on the chances for Mircera’s approval, given the safety issues raised last week. Citigroup analyst Paul Heldman put Mircera’s chances for approval at 35 percent, down from his prediction of 65 percent before last week’s meeting. Thomas Weisel Partners analyst M. Ian Somaiya, however, says the FDA’s decision on the Roche drug might not be impacted by last week’s FDA meeting since the experts only looked at anemia drug use in cancer patients. Roche is seeking approval to use Mircera in patients with chronic kidney disease. Roche says clinical trials show Mircera has a similar safety profile as existing anemia drugs. Still, preliminary approval for Mircera could further pressure Amgen shares, Somaiya said. Johnson & Johnson might also feel a pinch since it sold nearly $3.5 billion of Procit, its anemia drug, last year. But the impact would be lessened because the drug maker is far more diversified than Amgen. If approved, Mircera would have one major advantage over competitors: it is given in longer-lasting monthly doses compared with weekly doses for Amgen’s Aranesp and Epogen. Dialysis center operators, such as DaVita Inc., which operates nearly 1,300 clinics in the U.S., could reduce costs if kidney disease patients only needed monthly rather weekly anemia drug infusions. Shares of Amgen rose 32 cents Wednesday, to $54.33, in trading.160Want local news?Sign up for the Localist and stay informed Something went wrong. Please try again.subscribeCongratulations! You’re all set! WASHINGTON – Besieged investors in biotech giant Amgen Inc. could be dealt another blow this week if federal regulators approve a rival anemia drug. Amgen shares have dropped 15 percent, to just over $54, since Thursday, when a panel of government advisers recommended that additional warning labels be added to the company’s blockbuster anemia drugs. The Food and Drug Administration typically follows such recommendations and had already asked Amgen and Johnson & Johnson in March to add label warnings about the increased risk of blood clots, heart attack and death when their anemia drugs are used at higher-than-recommended doses. Since nearly half of Amgen’s annual revenue of $13.9 billion last year came from anemia drug sales, federal approval of Mircera, a rival drug made by Swiss drug company Roche, could make things tougher for Amgen investors. The stock is already 30 percent below its 52-week high of $77 hit in late October. Wall Street analysts slashed stock ratings for Thousand Oaks-based Amgen last week after the expert panel told the FDA that the company’s anemia drugs need a comprehensive study to verify their safety. More analyst downgrades came after the government said it might stop paying for Medicare patients to receive the drugs if they have certain types of cancer.
Spain international Martinez nodded in from a corner on 59 minutes as the German champions overcame a lacklustre display from Mourinho’s side who face Leicester City at home on Friday.“In the week, we have to organise the week in a way so we can be fresh for Friday because, on Friday, the Premier League starts. We play for points and it’s with the players we have,” Mourinho told MUTV.“There is no time to cry. Players are not going to be here on Friday and we have to go with best possible team and with a great mentality.”Mourinho still remains hopeful of strengthening his side in the transfer window before the August 9 deadline, with Brazil international midfielder Fred the club’s top signing this summer.“My CEO knows what I want for quite a long time,” Mourinho told German TV ahead of Sunday’s game. “I know he tries to do the best for me, and I still have a few days to wait and see what is going to happen.”Marcus Rashford and Victor Lindelof returned for United on Sunday after their post-World Cup break, although the visitors lost Eric Bailly to injury after the interval following a collision with Serge Gnabry.“Finally, it’s over. Finally, such a difficult pre-season is over. The players were, once more, brilliant, they could not have done better than what they did,” added Mourinho to MUTV.Rashford wore the number 10 short, previously the Old Trafford property of the likes of Wayne Rooney and Zlatan Ibrahimovic.“He wanted it. He always wanted it,” said Mourinho.“Of course, he respected Rooney and then Zlatan wanted to have it. Of course, he was in the shadow, waiting for the opportunity and now the shirt is empty.“It’s something fantastic for the kid, let’s give the shirt to him.”Bayern, under new coach Niko Kovac, will head back to their training camp in Tegernsee ahead of next weekend’s German Super Cup against Eintracht Frankfurt.0Shares0000(Visited 1 times, 1 visits today) 0Shares0000Manchester United coach Jose Mourinho will pit his team against Leicester in the Premier League opener on August 10MUNICH, Germany, Aug 6 – Jose Mourinho admitted that he may not have his ideal side at his disposal when Manchester United open their Premier League campaign on Friday.United’s roller-coaster pre-season ended in defeat on Sunday when Javi Martinez’s second-half header earned Bayern Munich a 1-0 victory at the Allianz Arena.