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Archive for the ‘Daiichi Sankyo’ Category

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Had a great time last week at the SPBT conference. Planning to get out a summary post later this week…

TODAY’S NEWS:

Big news for Novartis: FDA panel unanimously recommends approval for oral MS drug – A Food and Drug Administration panel has unanimously backed the safety and effectiveness of Novartis’  multiple sclerosis treatment fingolimod. The panel voted 25-0 in support of fingolimod’s “substantial evidence of effectiveness” in treating patients with relapsing remitting multiple sclerosis. That makes it likely the drug will be the first oral MS treatment to gain FDA approval, beating Merck, Sanofi  and Teva – all of which are developing their own oral MS drugs – to the punchmore

Glaxo cuts 700 more sales/marketing positions – A Glaxo spokeswoman said 700 sales and marketing staffers (and related support staff) have taken buyout offers in recent months, while others’ jobs are being cut. She declined to give a total figure, but said the cuts are affecting “a variety of different positions in the U.S. pharma commercial staff.”more

Uncomfortable links being investigated – ARB high blood pressure drugs/cancer; Daiichi‘s Benicar and heart disease; troubling new data on GSK‘s Avandia and heart disease.

A “pill mill” in Kansas and multiple fatalities from the “lollipop of death.”

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Fresh from the tube this weekend: the first ever DTC commercial for medical devices?

JUST FOR FUN

This may just be the most hideous website “designed” by man. Do not click with any consumables in your mouth…

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Review of this week’s snow-impacted ePharma Summit conference is now up on the blog!

TODAY’S NEWS

Benicar for kiddies – Olmesartan medoxomil (Benicar), approved in 2002 to treat high blood pressure in adults, has been sanctioned by the U.S. Food and Drug Administration to treat the same condition in children aged 6 to 16, drug maker Daiichi Sankyo said Thursdaymore

Ouch. More cuts at The Medicines Co. – Medicines Co said it would cut 43 jobs, or 26 percent of its field-based workforce, by the end of February, and take a related charge of $3.5 million in the first quartermore

Billy Tauzin leaving as head of PhRMA – The head of the influential trade association for drug manufacturers announced Thursday night that he is leaving his job. The development comes amid uncertainty over the fate of President Barack Obama’s health care overhaul, which the drug association had backed after striking a deal with the White House and Senate Democrats to limit costs to the industry in the legislationmore

J&J launches new social media initiatives.

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Visual treat – Out-of-this-world coral photos. Yum.

JUST FOR FUN

31 Awesome benches. Oddly amusing!

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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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OK, so it’s a “baker’s three” (8) today. Makes up for yesterday’s zero…!

Patent-holder urges FDA to NOT approve prasugrel (from Lilly/Daiichi Sankyo).

Novartis getting cold feet at the Alcon altar? – Novartis betrothed itself to Alcon, but it may not follow through with the engagement. CEO Daniel Vasella told Bloomberg that his company might just pass on its option to buy a majority stake in the eye-care companymore

Abbott and AstraZeneca apply for combo drug approval – CERTRIAD is an investigational compound containing the active ingredients of CRESTOR and TRILIPIX under development by Abbott and AstraZeneca for the treatment of mixed dyslipidemiamore

Hope for treating resistant TB? – An experimental drug that starves the bacteria responsible for tuberculosis makes conventional therapy five times more effective against drug-resistant TB, doctors reported on Wednesday. The company-run study found that the Johnson & Johnson drug TMC207, if added to a standard cocktail of five other TB medicines, cleared traces of the tuberculosis bacteria in the sputum of 48 percent of the volunteers after eight weeks. Only 9 percent of patients given the five older drugs alone showed that type of improvement…more

Genzyme buys up rights to Campath from Bayer (for potential MS treatment)

Takeda‘s nex-gen diabetes drug (alogliptin) delayed in Europe also. Major blow.

Questions swirling around Roche/Genentech‘s Avastin – Cancer researchers are beginning to ask why Roche‘s very expensive and very lucrative drug Avastin is not providing bigger survival gains for cancer patients… “Is it a home run drug? No,” says Jennifer Litton, a breast cancer specialist at M.D. Anderson Cancer Center. “When I’ve seen it work, it works phenomenally, but we need to get smarter as to who those people are that get those dramatic responses.”more

PLUS – what is J&J up to? Here’s the preview

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Ortho-McNeil launches Facebook page for adult ADHD sufferers.

Lilly and Amylin teaming up to produce once-a-week diabetes pen.

Good stuff on Merck KGaA‘s oral MS drug. That company and Novartis both bringing groundbreaking new ones to market.

LATE BREAKING – big cuts at Seattle’s ZymoGenetics.

And, hey, why not a bit of speculation to spice up the day? Should Sanofi buy Biogen?

Finally, a bit of Training Fresh Air. I really like this approach by Daiichi-Sankyo.

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I like this approach, taken by Daiichi-Sankyo. A lot. – Designed to improve a reps’ knowledge and understanding of hypertension and related cardiovascular disease, ASH’s Hypertension Accreditation Program will train more than 700 Daiichi sales team members in the first year of the program…To achieve accreditation, sales reps will undergo rigorous training (approximately 10 hours of home study prior to the live course, 13 hours of intense classroom training over two days, and six hours of homework) that concludes with a one-hour written exam administered by ASH…In 2008, a “Hot Spot” survey conducted by the online physician community Sermo revealed that physicians prefer to interact with more highly-trained reps who are better educated and prepared to engage in higher-level discussion about relevant diseases and available treatments.

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Prasugrel – the saga continues. Gets approval to launch in the EU; positive study results versus Plavix for a certain group of patients; but controversy swirls around FDA approval process.

Synta‘s Phase III trial for melanoma drug fails badly. In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a study a trial for metastatic prostate cancer and a monotherapy dose escalation study.

Wearisome to report – more scandals. AstraZeneca buried some Seroquel data? Ranbaxy falsified records and gets major smackdown. Forest accused of off-label marketing practices (anti-depressants for children). And, from Peter Rost’s blog, here’s an interesting chart showing who paid the most/least in government fines and settlements since 2000 (the winner on the “least” scale: Novartis!)

Sanofi gets US clearance to market Apidra pen. Sanofi-Aventis  has won U.S. approval to market its Apidra Solostar injection pen which contains insulin to treat diabetes, the world’s third-biggest drugmaker said on Thursday. The disposable pen is prefilled with Apidra, which is indicated to improve glycemic control in adults and children of at least four years with type 1 diabetes or adults with type 2 diabetes, the most common form of the disease.

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Ahhh, the politics of drug approval processes. Some sniping going on about who was and wasn’t included in the FDA review panel for prasugrel. No matter what choices you make, somebody’s going to paint a bulls-eye on your back. Just sayin’…

Promising new treatment for MDS (Celgene‘s Vidaza) – A new drug sharply improves the survival rate of patients with a bone-marrow disorder that often develops into acute myeloid leukaemia (AML), according to a study released Wednesday. Up until now, there has been no known treatment for the disorder — called myelodysplastic syndrome (MDS) — besides bone-marrow transplant, which is suitable for only a small percentage of patients.

Merck and Novartis vie worldwide for top sales force honorsNew TNS Healthcare research shows that physicians in four out of the five major European countries — the UK, Germany, Spain and Italy — give Novartis top marks for effectively delivering key sales and service activities. Merck takes the top spot in the US and ties with Novartis in the UK and Germany. In 2008, Merck and Novartis tied for the top spot in the US, with the highest ratings across all service activities. This year, Merck pulls ahead in the US, with stronger ratings for both its Web-based physician services and its patient information programs.

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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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