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POPSD-Mab Does It Amgen's osteoporosis drug met its goals, and serious infections may be less of a problem than expected. But the devil will be in the details -- it's hard to gauge the potential for the drug without more information on safety and efficacy. This is a medicine that will compete with long-marketed drugs and cheap generics. Still, this is good news for Amgen, which is why the stock is up 15% in after-hours trading. Quotes from the press release are below; click the link to read the whole thing.
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POPSBristol/Lilly: The Battle Begins Fighting words. Effient is supposed to be a new-and-improved Plavix; Plavix is the second-best seller in the drug industry, used to prevent heart attacks by keeping blood from clotting.
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POPSNissen & Califf On Avandia, Last Year Googling around for information on meta-analysis, I came across this great conversation between two of the world's top cardiologists, Steven Nissen and Robert Califf, about Avandia, from a year ago. It's a great read.
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POPSWhere Doctors Get Information According to doctors, according to a survey conducted by the drug industry's trade group that Ed Silverman at Pharmalot.com wrote about this morning. One interpretation is that sales reps aren't that influential. The drug industry trade group, PhRMA, is going with that approach. The other interpretation is that doctors don't realize the influence visits with drug industry sales representatives have on them. There's no way this survey could tell the difference.
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POPSAcross The Atlantic Europe approves Merck's niacin/flush-blocker combo pill, called Tredaptive. The U.S. brand name was meant to be Cordaptive, but Merck has told Wall Street the U.S. Food and Drug Administration wants a lot more data, delaying re-submission as much as five years. It would be interesting to know why European and U.S. regulators don't see eye-to-eye, but unfortunately the regulatory process is pretty opaque. And everybody is left guessing.
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POPSFDA Nixes "Approvable" Letters This could make the world less confusing -- "approvable letters" and "nonapprovable letters" both mean "we're not approving this drug." But it could also mean less info for investors -- the two types of letters were at least a way of communicating how forcefully the FDA was saying "No." It will be interesting to watch how this develops.
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POPSThe NYT On Avastin The New York Times has a long takeout in the Sunday paper on the conundrum raised by Genentech's Avastin: How much can society afford to pay for a treatment that, while beneficial, only extends median survival by a little bit? An interesting bit of new information comes out in between the analysis and stirring narrative. Genentech and Roche have spent more than $2.25 billion to develop Avastin. That's an interesting figure -- about as much as the drug made in sales last year. It does serve as a reminder that it is drug companies, not the government, that really pay for developing new medicines. What makes the Avastin conundrum difficult is that it is one of the biggest sellers introduced in recent memory. If Avastin's not worth the money, there are some hard questions that need to be asked about the incentives currently at work in drug development.
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POPSMyriad Genetics Rebounds This speaks volumes about the way many investors felt about Myriad's Alzheimer's drug development program. The drug, Flurizan, failed yesterday. Shares dutifully fell. But today they ramped up to a level before the failure. This makes sense, because the drug development program was high risk, and was a drag on the company's genetic testing business. Now, investors can bet on a genomics and diagnostics company without worrying that a risky Alzheimer's drug is about to fail.
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POPSMyriad's Flurizan Fails There were plenty of reasons to be skeptical, so this doesn't neccesarily dent the amyloid hypothesis. Still a disappointment. Myriad's diagnostic test business is cushioning the blow. Click on the article to read a nice take from Adam Feuerstein over at TheStreet.com.
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POPSYou Thought Wrong. Here's Why. From The New York Times, by neuroscientist Sam Wang and Sandra Aamodt, a former editor in chief of Nature Neuroscience. A quick explanation of why rumors get remembered as facts.
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POPSSinguClar: Not Meant To Be The Don Quixote of respiratory therapeutics finally hangs up his sword. There will be no combo pill of Merck's Singulair and Schering's Claritin; apparently the combo is no better than either drug alone.
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POPSVanda Drug Posts Good Results But the medicine is very similar to Rozerem, which has turned out not to be a big seller. Whether it has much potential as a treatment is debatable.
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POPSAnother Disappointment For Merck The FDA has opted not to approve the cervical cancer vaccine Gardasil for women aged 27 through 45. Gardasil remains approved for girls and women aged 9 through 26. Lately, Merck's record with the FDA seems blemished. Exactly what issues does the agency have with Merck's Gardasil application? Merck doesn't really say.
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POPSPrasugrel Delayed The Food and Drug Administration will take another three months to make a decision on Lilly's blood thinner. Given the lack of an advisory panel and the controversy surrounding the drug, this is not a huge surprise. Exactly what info the FDA needs going forward is not clear.
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POPSVytorin Stabilizing? It's hard to tell, but it seems as if market share for Vytorin could be leveling out. However, the overall size of the cholesterol market is also something to watch. An important question for Merck and Schering is whether market share really stablizes, goes into a very slow decline, or eventually turns around.
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POPSElan and Wyeth Release Alzheimer's Results Elan and Wyeth have released results of a phase 2 study of bapineuzumab, an attempt at treating Alzheimer's that is the most watched drug in the pharmaceutical business right now. Plenty to puzzle over. There seems to be a consistent effect in patients who don't carry a genetic variant called APOE4, which raises the risk of Alzheimer's. Why would high-risk patients be the ones to who didn't get a benefit? That will need some explaining. It also hurts confidence in the study that the subgroups that show benefit were done after the study finished, not specified beforehand. But this is still pretty good data. Full results will be presented at a medical meeting later this summer. Late-stage trial results won't be available for a couple years.
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POPSIsn't It Ironic? Don't ya think? Cypress Biosciences got a bump from the approval of Eli Lilly's Cymbalta for fibromyalgia. Lilly shares dipped slightly.
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POPSAcadia Schizophrenia Drug Fails Acadia does a nice job not spinning the results. (See the press release below.) The company has another drug, pimavanserin, in trials for psychosis related to Parkinson's. That drug is also being tested for schizophrenia as an add-on to other therapies. What's interesting is that the failed drug, ACP-104, was a metabolite of Clozapine, a very effective antipsychotic with harsh side effects. In theory, using the metabolite should result in a better drug, but it doesn't always work out this way. Sometimes, as in this case, you get something that's not effective at all. That's a painful reminder of how little we know about biology and chemistry and how much sheer luck is still involved in inventing new medicines.
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POPSA Big Deal An Invitrogen-Applera combo could have a big impact, particularly in the genomics market.
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POPSIpsen Buying Tercica The weak dollar strikes again, as another U.S.-based biotech gets bought by an overseas drugmaker. Ipsen already owned 25% of Tercica, which makes a hormone for treating children who are not growing adequately. Still, that 104% premium is pretty eye-catching.
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POPSFDA Looking Into Safety of RA Drugs TNF blockers like Remicade, Enbrel, Humira, and Cimzia are big sellers for drug companies. The FDA's investigation is preliminary -- part of the agency's effort to let consumers know about potential problems earlier. This was partly a response to the Avandia controversy. Click the link for the FDA's Early Communication.
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POPSCan't Always Believe The Briefing Docs Ligand got hammered because FDA scientists were doubtful about its Promacta. But a panel says the data support its use. Of course, the FDA doesn't have to follow the advice of its panels. Still, things are looking a lot better for Ligand -- proof that even scathing briefing documents don't have to sink a drug. It ain't over 'til it's over.
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POPSThe Platypus Has No Stomach A strange fact learned via Carl Zimmer, who got it from the journal Genome Biology. The platypus genome was the subject of much fanfare recenty. (It's amazing how many organisms are getting sequenced lately -- P&G actually funded the sequencing of the organism that causes dandruff.) It turns out some key genes involved in the digestion are missing, and that this shouldn't be surprising because the platypus apparently lost its stomach somewhere along the evolutionary path that led it away from other mammals. It seems to be alone among vertebrates in this strange feat.
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POPSMerck Wins Vioxx Appeals The current tally of wins and losses, according to a Merck spokesman: "Of the 18 plaintiffs whose cases went to trial, only three have outstanding product liability judgments against Merck. "
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POPSLundbeck Likes Myriad. Should You? It's a good sign that Lundbeck was willing to pay $100 million up front, but Flurizan is still seen as a bit of a long bet. If it shows a real benefit, even a small one, this could be a pretty big drug, but the risk here is big, too.
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POPSXience Beats Taxus And Abbott shares rise. One question: How does Xience compare to bare metal stents when it comes to blod clots, particularly those known as late-stent thromboses, which causes such a furor with regard to previous drug-coated stents?
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POPSMerck's Cordaptive Rejected This is a pretty decisive blow against the Merck product -- the FDA issued a "not approvable" letter. The FDA also rejected the brand name Cordaptive.
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POPSVertex Beats Schering-Plough In Hep C Race That's the takeaway from both Bernstein analyst Geoffrey Porges and Adam Feuerstein, who has been following this battle closely over at TheStreet.com. Click the link to read the whole story.
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POPSGINA Finally Passes! Forbidding companies and insurers from using the results of genetic tests to deny people jobs and medical coverage is a big deal. Some of the top minds in genetics have been pushing for this law for a long time.
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