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Posts Tagged ‘Effient’

FDA to Zeltia: NO – An FDA advisory committee has handed Spain’s Zeltia a crushing blow, deciding against a combination therapy that includes its lead cancer drug Yondelis (trabectedin) by a vote of 14 to 1. The news cost Zeltia 35 percent of its share price…more

FDA to Shire: Fast-track – Shire plc, the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease…more

Pfizer: We want to be #3! – Pfizer Inc. plans for its worldwide sales of medicines for treating cancer to increase 10-fold by 2018, said Andreas Penk, regional president of the company’s cancer business in Europe. Pfizer, the world’s biggest drugmaker, had about $2.5 billion in cancer-medicine sales in 2008, according to the company. Pfizer plans to become the third-largest maker of cancer treatments, up from about seventh now…more

Daiichi chief talks about Effient.

Med Device firms and Kickbacks – Several large medical device companies have been accused of marketing their products for unapproved uses while charging the federal government, according to documents unsealed in Houston federal court…more

PLUS – What if I was to go back into Pharma Sales?

AND – some recent stats on physicians on-line (globally). Pretty big. And while we’re at pretty big, here is the horrendous tangle that could be the future of healthcare here in the U.S.

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Finally – FDA approves DSI/Lilly blood thinner Effient. Narrow indication with warnings, however – The approval makes Lilly‘s Effient the first real competition to the blood thinner Plavix, the world’s second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibbmore

Debate ignited over newer vs. older schizophrenia drugs – Schizophrenia patients given a cheap older drug are less likely to die prematurely than people on newer treatments, despite the older product’s well-known adverse side effects, Finnish researchers said on Mondaymore

Sermo and AMA get into a public spat. Who represents doctors, really?

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Finally! New anti-clotting drug prasugrel (Effient) is given a thumbs up by advisory committee! Great news for Daiichi Sankyo and Eli Lilly.

King Pharmaceuticals the latest to announce major layoffs (22% of workforce). Ouch.

Intermune gets hopeful results in late-stage trials of experiment lung disease drug.

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Roche‘s MabThera can help extend CLL patients’ lives. Meanwhile, surprisingly good results for AZ‘s lung cancer drug Iressa. But, disappointment for an experimental lung cancer drug being developed by Amgen and Takeda. And, Novartis‘ promising kidney cancer drug Afinitor gets the FDA delay treatment (fuller Novartis pipeline update here).

Glaxo gets U.S. approval for platelet drug Promacta.

Biotech bankruptcies looming?

AstraZenecacutting, selling, stopping.

More positive info for Takeda‘s experimental gout drug.

Can Pharma learn from the Detroit automaker situation? Some good thoughts here.

Generic coming? Let’s hike the price! – Cephalon has already taken heat for off-label promotion of its narcolepsy drug Provigil. Now, facing the prospect of generic competition to Provigil in 2012, the company is dramatically hiking Provigil’s price…more

Javelin tosses 15% – Javelin Pharmaceuticals, Inc., a leading developer of novel products for pain management, today announced that it will reduce its workforce by approximately 15 percent. The reduction is intended to reduce Javelins cost structure…more

Cancer drugs for diabetes? The mice say maybe… – Two popular leukemia drugs, Gleevec and Sutent, kept lab mice from developing type 1 diabetes and put 80 percent of diabetic mice in remission, an international team said on Monday…more

J&J patch leads to costly settlement.

Merck’s Gardasil promising in boys – Scientists are reporting at a scientific meeting in Nice, France, today that 90% fewer men ages 16 to 26 years developed genital warts and other lesions after receiving Gardasil…more

Pfizer: big bucks toward stem cells – Over the next five years, the drugmaker will create dual facilities in the UK and Massachusetts to use stem cells to treat heart disease, diabetes, cancer and vision loss common among the elderly. In doing so, Pfizer is touting that it becomes the first big pharma to have such a dedicated effort, which will include hiring 70 scientists to staff the labs…more

Beauty fillers, ugly side effects? – An ugly side of the beauty business emerged today, as an FDA briefing listed 930 reports of side effects for injectable wrinkle fillers such as Restylane and Juvederm…more

King’s new pain pill might make the grade – An FDA advisory committee determined that Remoxy is less susceptible to abuse than the notorious OxyContin, suggesting the pill will win FDA approval, Bloomberg News reports, although the committee did not take a formal vote…more

FDA to require meta-analyses of diabetes drugs.

More questions about Effient? – Researchers have overestimated the ability to the experimental drug without causing dangerous bleeding, according to a prominent cardiologist, Reuters writes. Prasugrel, you may recall, has twice been delayed by the FDA, which is reportedly set to hold an advisory meeting early next year…more

Major Amylin layoffs – The 25 percent staff reduction, which follows sluggish sales of its flagship Byetta diabetes med, is designed to save more than $100 million next year. After the dust clears, Amylin will have 1,800 employees…more

All right, what’s the big deal with the Crestor/Jupiter/cholesterol study? Some questions answered.

Did you know that the FDA gives drug review vouchers? Neither did I – Two months ago, a new program got under way in the US to promote the development of drugs for so-called neglected diseases that continue to plague the poorest nations. Here is the outline: a drugmaker that seeks approval of a drug to treat one of these infectious diseases gets a voucher, which awards an expedited FDA review of a new drug application for any other med…more

Amgen doing an “Obama” to market new drug? – Taking a leaf out of the marketing playbook of President-elect Barack Obama, biotechnology company Amgen Inc plans to make use of the Internet and social networking sites to market its drugs to consumers…more, plus another take here.

Merck: we still have heart – Merck wants the world to know that when it comes to developing new drugs for cardiovascular disease, the company is in the fight for the long haul…more

The cost of rep sales calls. Have a calculator handy. From John Mack’s Pharma Marketing blog.

I have some real problems with this. Brand-name drug manufacturers liable for generic injuries – A ruling on Friday by a California appeals court is likely to spark a good many lawsuits against big pharma. The upshot – brand-name drugmakers were put on notice that they can be held liable not only for harm caused by their own meds, but also for injuries caused by a generic drugmaker selling a copycat version…more

More doctors quitting.

This is really funny. From the Colbert Report, via PharmaGossip.

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Novartis to cut a bunch more (sales) jobs; does another management shuffle – As reorganizations go, this one reaches most parts of the company. First, the drugmaker is cutting 550 sales reps, although half of the jobs are said to vacant, as part of a new business model with five new regional units for reaching doctors and insurers called “Customer Centric Initiative” (back story). The move should save $80 million annually as of 2010…more

But, at least Novartis is making some profitIn good times and in bad times, people will get sick. That reality has helped Swiss drug maker Novartis post strong earnings for the third quarter on Monday, in spite of the banking crisis and global economic slowdown. Yet even as the pharmaceutical sector sticks to the pattern of being insulated from greater financial troubles, growth at Novartis will not be as robust as last year…more

Is specialty pharma the place to be? – Here are some interesting numbers to chew on…

B-I has some interesting stuff in the pipeline – Boehringer Ingelheim announced that patients and physicians may have several innovative Type 2 Diabetes treatment alternatives available in the coming years. At its Second International Research & Development Press Conference, Boehringer Ingelheim unveiled a pipeline of unique oral anti-diabetic compounds in phase II and III, establishing the company in the Type 2 Diabetes arena…more

Genentech sales soaring – It seems Genentech made the right choice in turning down a takeover bid from its majority holder, the Swiss pharmaceuticals company Roche Holding: its sales are soaring and investors apparently don’t mind that its latest earnings missed Wall Street’s estimates, possibly because of costs associated with defending itself against the bid…more

New study: Vioxx does cause heart risks – An analysis of an infamous Vioxx study found the notorious painkiller does, indeed, double the risk of heart attacks and strokes, although the likelihood of a serious cardiovascular event lessened one year after people no longer took the pill…more

Pfizer’s desperate times/desparate measures – As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees – a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us…more

Effient: wait ’til Feb – Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee have been contacted about their availability for a February panel meeting specifically on prasugrel, sources tell The Pink Sheet. And the agency’s Drug Safety and Risk Management Advisory Committee may also be convened…more

Fred Baron to receive Tysabri after all (this human/medical interest story is a bit involved, but brings up important issues about experimental/compassionate use).

High-dose Zevalin with stem-cell infusion leads to strong survival results for NHL.

Abbott’s experimental bioabsorable stent looking very interesting – Abbott today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries…more

FDA becomes FDelAy – Takeda drug, others stalled at agency. Who needs those stinkin’ deadlines?? But, next-generation Astelin (from Meda) does get an approval.

Wisconsin Medical Society bans pharma gifts – The doctors’ group, which boasts 12,000 members, has joined a growing number of academic medical centers, professional societies and legislators that have decided gifts from the pharmaceutical industry are questionable, if not unacceptable forms of influence…more

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