Posts Tagged ‘Amgen’


Impactiviti Daily will not be published next week, as I will be attending the annual Society of Pharmaceutical and Biotech Trainers conference (SPBT) in Orlando.


As the pre-ASCO news heats up, the big headline will be leukemia treatments – specifically, BMS‘ Sprycel and Novartis‘ Gleevec and Tasigna (just inTasigna shown superior to Gleevec in slowing CML: 18-month results). Treatments in this class, by the way, are something near miracle drugs. They’ve totally revolutionized blood cancer treatments. In related news, Novartis’ Afinitor (approved for kidney cancer) meets goals in a trial for pancreatic cancer.

Why should you be interested in a “nanosponge”? Well, there’s this – Scientists have found that a delivery system based on a technique called nanosponge is three to five times more effective at reducing tumor growth than direct injectionmore

Will Amgen‘s new osteoporosis drug Prolia find its true home in oncology treatment? – The company has also applied for FDA approval to market the drug to breast cancer and prostate cancer patients who are undergoing a hormone treatment that weakens their bones. What’s more, the company is conducting tests designed to show that Prolia prevents cancer from spreading to the bones — an indication that could push sales of the drug to as much as $6 billion annually, some analysts predictmore Also – huge sales force push for Prolia.

20% of high school students abuse prescription drugs. Wow – sobering.


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How to reduce e-mail ping-pong. You know all that back-and-forth? Here’s a way to undercut it at the start!


See-through animals. Ten of them. Amazing.


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Abbott making a big India buy – The speculation that has been fuelling the shares of Piramal Healthcare over the past few days has been put to rest after Abbott Laboratories announced Friday that it will buy a unit of the Indian pharmaceutical companymore

Lots of Oncology. Rituxan: cutting lymphoma recurrence – The final phase of a drug study finds that two years of treatment with rituximab (Rituxan) cuts in half the risk that follicular lymphoma patients who respond to chemotherapy will suffer a recurrence of the diseasemore And, some good news on sarcoma: An experimental drug from Ziopharm Oncology Inc. helped keep fast-growing sarcomas, lethal tumors that can grow to the size of basketballs, in check 77% longer than a standard treatment, a company-sponsored study foundmore Plus, Amgen experimental drugs slow down some tumors.

Some side effects of popular cholesterol-lowering drugs? – Drugs to lower cholesterol and prevent heart disease, taken by millions of people worldwide, increase the risk of cataracts, kidney failure, muscle pain and liver dysfunction, a study of more than 2 million Britons foundmore


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The Doctor Won’t See You Now training.


It’s spring, and the weather’s fine. So, go on one of America’s Scenic Drives.

AND, a pharma spoof – So, What’s your Problem with Gram-Negative Bacteria?


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Teva aggressively seeking to “genericize” Merck‘s Singulair, Amgen‘s Neupogen.

Warren Buffet pulling back from pharma investments that contain 2 letters (P&G, J&J).

GSK‘s nausea drug Zofran may help with drug withdrawal symptomsGlaxoSmithKline Plc’s Zofran, approved to treat nausea and vomiting, appears to reduce symptoms of withdrawal from morphine, codeine, heroin, OxyContin and similar pain medicines, a study shows. The drug, which is now available as a generic called ondansetron, was used to treat eight men for morphine withdrawal, according to a study in the Journal of Pharmacogenetics and Genomics. Compared with placebo, the patients receiving ondansetron were less likely to experience anxiety, hot flashes, aches, restlessness, nausea and vomiting.


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Sanofi-Aventis suspends sale of Acomplia in Europe. Acomplia, an obesity drug that once looked like it would be a blockbuster for Sanofi-Aventis, is being pulled off the market in Europe. The EMEA, the European version of the FDA, said today that a key committee “concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union.”…more

Jim Edwards summarizes what he calls Pfizer‘s Race to the Bottom. With some similar commentary on Novartis‘ growth/shrinkage.

Merck announces more big cuts – As part of its earnings announcement, the drugmaker says it expects to eliminate approximately 7,200 positions – 6,800 active employees and 400 vacancies – across all areas of the company worldwide by the end of 2011, with about 40 percent of the total reductions coming in the US (see statement). This amounts to 12 percent of the workforce…more

Pfizer’s Chantix: going down…or up, depending on which continent you’re on…US researchers say even more warnings needed.

FDA: Another day, another stall – U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc to study the pill in more depth, a company spokeswoman said on Tuesday…more And, while we’re at it, a thumbs down (for now) for Abbott‘s new version of Vicodin. Oh, and hey, let’s delay Abbott’s new cholesterol drug while we’re in foot-dragging mode!

Novartis buys up Nektar’s pulmonary business – Nektar Therapeutics  today announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash…more

Will BMS lead the charge in buying up undervalued biotechs?

Earnings roundup for Schering, Pfizer, Roche here’s the scoop.

What about Amgen’s growth? An interesting analysis here. Plus – how 6 pharma companies have dodged (or not) the current financial crisis (extracts from earnings announcements from Pfizer, Bayer, Abbott Labs, Gilead, Wyeth and Genentech, all on the topic of how each company has fared in the crisis.)

Celgene seems to be doing quite OK.

J&J’s HIV drug gets expanded approval – U.S. health regulators have expanded approval for Johnson & Johnson’s Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday…more

Avastin: what doesn’t this drug do? – After tagging the antibody drug with a radioactive tracer and injecting it into mice, researchers found it successfully targeted cancer cells and this enabled them to produce well-defined images of tumours during scanning…more

Speaking of which, does leukemia drug Campath help stop early stage MS? Fascinating possibility – A drug developed to fight leukemia appears to stop multiple sclerosis in its early stages and restore lost function to patients, British researchers said on Wednesday…more

Forest Labs growing green – Forest Laboratories Inc posted higher-than-expected quarterly profit on Tuesday, fueled by stronger sales of its drugs for Alzheimer’s disease and depression and lower research spending…more

Biologics and safety concerns: really not a big surprise here – Approximately one in four biologics approved since 1995 in the US and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a Black Box warning, according to a study in the Journal of the American Medical Association…more

Take a Chill, Pill: are oral cancer drugs all they’re cracked up to be?

B-I has some encouraging potential early results for novel cancer drugs.

The WSJ talks about healthcare, IT, and the future. Interesting stuff.

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King begins hostile takeover proceedings with Alpharma – Brain Markison, King’s ceo, is disappointed that Dean Mitchell, Alpharma’s ceo, hasn’t responded to his initial offer $1.4 billion offer, which amounted to $33 a share. So Markison raised the bid to $37, or $1.6 billion, and is going directly to shareholders…more

J&J’s Christine Poon to retire.

ImClone to BMS: maybe we’re already dating – The drugmaker calls the $60-a-share bid by Bristol-Myers Squibb ‘inadequate,’ and goes on to say in a statement this morning that famed corporate raider Carl Icahn, who chairs ImClone’s board, has had ’several conversations with the ceo of a large pharmaceutical company,’ which was not named…more And more BMS-to-ImClone here, and on the response here.

Meanwhile, BMS grounding its fleet – Bristol-Myers Squibb is preparing to shut down its aviation operation at Trenton-Mercer Airport, sell four aircraft and dismiss about 32 employees as the drugmaker and leading Mercer County employer seeks to cut costs, according to sources familiar with the company’s plans…more

Amgen violating patents?

Can Botox relieve migraines?

FDA reports rare brain infection/death with Rituxan – The agency says a woman died of the rare viral infection more than a year and a half after discontinuing the drug, which is used to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, and is marketed in the US by Genentech and Biogen Idec…more

Sanofi fills top job with Viehbacher from Glaxo – Chris Viehbacher, GlaxoSmithKline Plc’s head of North American operations, is to take a top job with French drugmaker Sanofi-Aventis, a person familiar with the situation said on Tuesday…more

Januvia, 2 years in: thumbs up – Merck & Co’s diabetes drug Januvia substantially improves blood sugar levels over two years of treatment when combined with the older drug metformin and is generally well tolerated, new data on Tuesday showed…more

Experimental diabetes drug (BMS/AZ) promising – Bristol-Myers Squibb and AstraZeneca’s experimental diabetes drug Onglyza significantly improves blood sugar control when added to older medicines, researchers said on Monday…more

Fast track for cancer drug Afinitor – An experimental drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer. Novartis said on Tuesday that RAD001 or everolimus, which it plans to sell under the brand name Afinitor, had been accepted for fast review given the medicine’s potential to help patients who fail to respond to standard therapy…more

Tysabri for cancer? – Biogen Idec and Elan Corp have launched the first clinical trial of their multiple sclerosis drug Tysabri for patients with relapsed or refractory multiple myeloma, the companies said on Friday…more

Celgene gets a fast track for lung cancer drugCelgene Corporation (NASDAQ: CELG) today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy…more

Is Pfizer interested in Bayer?

Sample trouble: drives up costs? – Free drug samples provided by drugmakers to doctors could actually be costing uninsured patients more in the long run, according to a new retrospective study in the Southern Medical Journalmore

The Allergan-Medicis “death match” – Allergan and Medicis have been locked in a highly profitable death-match for several years, with both companies bringing out me-too versions of the others’ products, just like Coke and Pepsi…more

But will it be posted in the Post Office? The FDA 20The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed…more

Zimmer growing some spine.

GSK and Valeant on epilepsy drug tie-up.

Pfizer and Medivation to work together on Alzheimer’s/Huntington’s treatment.

Genentech and Roche acting merged: facilities closing – The fallout from Roche’s looming acquisition of Genentech has started. Roche will close a research facility in Palo Alto, Calif., where a 1,000 people work, the San Jose Mercury News reports. Back in July Roche said it would pull the plug on the lab in Stanford Research Park, but the company hedged, saying the closure would happen if the bid for Genentech were successful. Genentech has demurred so far, but most people think it’s just a matter of time before the deal happens. And now, Roche told the Mercury News it’s closing the plant, no matter what…more

No vigil for Provigil at TakedaCephalon Inc. will end its co- promotion agreement with Takeda Pharmaceutical Co. in North America for the sleep-disorder drug Provigil, because net sales dropped to less than $850 million this year…more

UCB: Yep, we’re specialty now. Translation: downsizing – If you can’t buy a biopharmaceutical company, you might as well become one. UCB Pharma last week announced that it will trim 17 percent of its work force—about 2,000 employees—in order to reestablish the company as specialty drug firm….more

Every once in a while you want to visit here – Forbes’ New Drugs to Watch page.

This is way cool – A little-used cancer drug called bryostatin can repair brain tissue if it’s administered within 24 hours after a stroke, according to U.S. researchers. Current stroke treatments must be administered within three hours and aren’t able to repair damaged brain tissue, the scientists said…more

Shire and Vyvanse for ADHD – One of the recent unheralded successes of the drug world was Shire Pharmaceuticals‘ launch of Vyvanse, a new, long-acting treatment for attention deficit and hyperactivity disorder. The fact that so little attention has been paid to Vyvanse is a shame because the take-up of this drug has been impressive — it appears to be well on its way to supplanting Adderall XR as the king of the ADHD drugs…more

I kinda think this one’s a no-win for Genentech – Negative public opinion just keeps piling on to Genentech regarding its pricing policy on Lucentis and Avastin. This weekend saw a big Associated Press story describe how the company is refusing to ask the FDA to approve Avastin for use in treating “wet age-related macular degeneration,” an eye condition that leads to blindness. Genentech is doing this, most people believe, because Avastin would be a much cheaper treatment for wet AMD than Lucentis, another Genentech drug. It costs about $60 per dose to use Avastin on the disease, and $2,000 to use Lucentis…more

Speaking of no-win – releasing Vytorin data…more

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So, who is getting all those free drug samples, anyway? The poor, or the wealthy insured? A recent study puts this to the test.

Some refreshing candor – Novartis CEO Dan Vasella admits that he uses Lipitor (Pfizer‘s cholesterol drug) instead of Novartis’ Lescol. Medical responsibility triumphs over marketing spin!

Prasugrel, a promising Lilly/Daiichi Sankyo drug, is about to be submitted to the FDA. This will be an interesting one – the drug has blockbuster potential, but will it be fast-tracked – or side-tracked?

Very promising new Hepatitis B treatment may be on the horizon.

Breaking news from Chicago – two new filings. Takeda‘s DPP-4 inhibitor (Alogliptin, for diabetes) has now been filed for approval, as well as TAP‘s new GERD treatment.

Sciele gets approval for new formulations of its Sular HBP drug.

Mylan gets the OK to market a generic version of Zyrtec.

Who needs sleep? Just snort the latest sleep-replacement chemical!

BD gets the go-ahead for a rapid staph test, quickly identifying the presence of antibiotic-resistant strains.

The latest lawsuits for off-label promotion – Pfizer and LipitorAmgen and Enbrel.

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Barren pipelines abound – the drug drought of pharma.

Schering‘s promising clot drug continues to do well in trials.

Amgen and Roche go another round in court over anemia drugs – this round to Amgen.

Sleep drugs – wildly popular, but how effective? Related news: Sepracor‘s earnings (and a 16% cut in the sales force).

The 2007 drug company layoff tally – sobering.

Takeda‘s experimental cholesterol drug (lapaquistat) takes a hit.

Gila monster saliva diabetes drug looking good in longer-lasting version (Amylin‘s Byetta)

OK, it’s not pharma, but it’s a very cool idea for treating skin cancer – portable, inexpensive light therapy. Fascinating.

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