Sept 3- AstraZeneca Plc on Thursday said the U.S. Food and Drug Administration approved a new dose of its blood thinner Brilinta intended for longer-term use in patients with a history of heart attack or a condition known as acute coronary syndrome. The FDA approved Brilinta tablets at a new 60 milligram dose that would be taken along with aspirin beyond a year...» Read More
Given investor reaction to the Vytorin/Zetia news yesterday, you might draw the conclusion the huge cholesterol drug franchise might be doomed. Sure, analysts say, prescriptions and sales are gonna go down some more, but they're not going to zero.
Yoda made an appearance at the American College of Cardiology (ACC) conference here in Chicago on Sunday. At the end of his speech in the opening session, the outgoing president of the organization played a "Star Wars" clip with the sage saying, "Try not. Do or do not. There is no try." He was trying to make a point about the ACC's role in forging healthcare reform.
I don't know how I missed this one, but the Wall Street Journal's Health Blog didn't forget that this week that Pfizer and, perhaps, some men and women are celebrating the tenth birthday of Viagra. So, happy birthday little blue pill.
Ahead of the world's biggest gathering of cardiologists in Chicago this weekend, there's a flurry of news about stents--the expensive little wire mesh tubes that prop open clogged arteries. First, the Food and Drug Administration has posted new proposed guidelines for pre-and post-market testing of the controversial devices.
This morning, Bear Stearns biotech analyst Mark Schoenebaum and a couple of members of his research team hosted a conference call with a 50-page PowerPoint about Amgen. The purpose was to drill down into the looming court decision over whether Roche will be able to launch a competing anemia drug in the U.S. for kidney dialysis patients.
Shares of Canada's biggest biotech initially hit a new intra-day low this morning of 10 bucks a share this morning, but rallied into the close as investors seem to like the fact that the company may have extricated itself from allegations of financial fraud.
Investors now think that a biotech company with less than one-third the revenue of Amgen is worth more than the former sector king. Elizabeth Trotta at TheStreet.com took note of this late last week but I thought it was worth pointing out.
These days there's been a lot of media attention paid to the Merck and Schering-Plough partnership on the cholesterol-fighting drugs Zetia and Vytorin. But there's another less-known and little-talked-about respiratory MRK/SGP joint venture.
Merck this morning announced that it has filed for Food and Drug Administration approval of its blockbuster cervical cancer vaccine, Gardasil, for women 27-45 years old. Right now it's approved for females 9-26.
Shares of Amgen closed just above 43 bucks yesterday. That's more than a five-year low. And they're falling even lower in early trading this morning. Today the company is making its first investor presentation since last week's FDA advisory committee vote to restrict usage of Amgen's anemia drugs on cancer patients.
This St. Patrick's Day morning several analysts are out with their official takes on Genentech's investor meeting last Friday and of the half dozen or so I've seen so far, I'd say the reaction is definitely mixed. I also wanted to throw in a few more notable quotables from CEO Art Levinson at the Friday presentation.
So guess which analyst happened to be selected first to query Genentech management at the start of the Q and A portion of the biotech company's analyst meeting? Yep. Mark Schoenebaum from Bear Stearns.
Amgen, the world's biggest biotech company in terms of sales (Genentech dwarfs Amgen in market cap: $86 billion vs. $51 billion) and Dow component Johnson & Johnson avoided a worst-case scenario this afternoon.
Last year Genentech shares traded as high as nearly 88 dollars, but ended 2007 around 67 bucks. But according to the company's new proxy statement all of Genentech's top-tier executives saw their total compensation go up.
Ahead of the big FDA Advisory Committee meeting tomorrow, Amgen held a quick conference call with some reporters this afternoon. The outside panel of experts will be deciding whether to recommend putting more restrictions on the use of the blockbuster drugs used to fight anemia in cancer patients getting chemo. For Johnson and Johnson and especially Amgen, the stakes are high.
Everyone's favorite small-cap biotech put out a press release this morning, announcing that the Food and Drug Administration has agreed to change the Special Protocol Assessment (SPA) for Dendreon's Provenge.
Shares of biotech giant Amgen fell as low as $43.14 (a new bottom) this morning after the briefing documents for Thursday's Food and Drug Administration Advisory Committee meeting were posted on the agency's website.
Billionaire Alfred Mann must not have liked watching stock in the company bearing his name fall to another new low today in the wake of Eli Lilly giving up on inhaled insulin.
This is a big week for the world's top-two biotechnology companies and their investors. Amgen goes before an FDA Advisory Committee Thursday about the side effects of its bread-and-butter franchise Aranesp.
First, Pfizer gave up on its inhaled insulin Exubera, then NovoNordisk threw in the towel and now it looks like Lilly is going to bow out. Alkermes, which is working on a palm-sized product called, "AIR Insulin," put out a press release today saying it expects its partner on the device, Lilly, to decide next week that it will exit the deal. ALKS shares hit a new low on the news.