Amgen wins FDA approval for cholesterol-lowering drug Repatha.» Read More
If you haven't seen it yet, check out the new homepage of the Food and Drug Administration web site www.fda.gov. The agency unveiled it the other day. The interior of the web site still looks pretty much the same.
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.
A federal grand jury and the Securities and Exchange Commission have been investigating the anti-money laundering practices of Fidelity Investments, according to a report in the Boston Business Journal.
Scientists advising the Food and Drug Administration said anemia drugs sold by Amgen and Johnson & Johnson should be allowed to stay on the market for chemotherapy patients.
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.
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.
When I got back from the Pfizer analyst meeting in New York City this afternoon, I found a treasure trove of PDF documents in one of my inboxes from a couple of Dendreon/Provenge proponents from their Freedom of Information Act request to the Food and Drug Administration...
U.S. regulators have rejected a long-acting injectable form of Eli Lilly and Co's blockbuster schizophrenia drug Zyprexa, the company said Thursday, sending its shares down almost 2 percent.
Analysts raised forecasts for Roche Holding on Monday after U.S. regulators approved its Avastin drug for treating advanced breast cancer, adding a potentially significant new revenue source.
I always prefer it when pharmaceutical/biotech execs and analysts can break out of their scientific/financial jargon and give good soundbites or quotes. So, among the flurry of research notes I've received over the weekend and this morning on the Genentech Avastin news the award goes to Rodman & Renshaw's Mike King who writes, "The biotech leader has its groove back."
Shortly before the closing bell trading in shares of Genentech was halted for news pending. Then, right after the bell the company issued this press release announcing the Food and Drug Administration has granted "accelerated approval" to Genentech's Avastin for use on breast cancer.
The Supreme Court on Wednesday made it harder for consumers to sue manufacturers of federally approved medical devices.
The world's biggest drug company is spending chump change to take out a little biotech at a 118 percent premium. Pfizer, which has a cash hoard of more than $20 billion, is plunking down a paltry (for Pfizer, that is) $195 million in cash money to buy Encysive Pharmaceuticals.
Taking an extra day off to extend the long weekend before we go into a very busy period. Possibly a week from today (Friday) Genentech could get word from the Food and Drug Administration on its cancer drug Avastin for breast cancer. The agency could approve it, reject it or delay making a decision.
After the closing bell yesterday Genentech popped out a stock-moving press release. The world's most highly-valued biotech announced that its drug Avastin when used in combo with Sanofi-Aventis' chemo drug, Taxotere, helped women with a certain type of aggressive, advanced breast cancer live longer without the disease getting worse.
The current issue (February 18, 2008) of New York Magazine has a story that it teases on the cover above the masthead, "No Smoking Wonder Drug." Below it in drug-label fine print the sub-head is: "Makes quitter talk to potted plants."
Anyone who has followed the Dendreon/Provenge saga knows there are a lot of passionate people attached to it. And apparently one of them may go by the name Mike Huckman. Last night it was brought to my attention that my name appears (or appeared) on line 277 of this online petition.
Regulators said they're reviewing the safety of Allergan's Botox and a competing product after reports of deaths and serious reactions in some patients.
The Food and Drug Administration continues to get a lot of attention and scrutiny. In an editorial over the weekend "The New York Times" wrote, "The F.D.A. desperately needs an infusion of money and talent." Then, "USA Today" today is running a front-page article on something I recently blogged about and other reporters tackled a few weeks ago regarding the agency approving so few drugs last year.