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Archive for the ‘Avandia’ Category

As is becoming a more common event, this week’s news posting is being composed from an airport hotel room. My NJ ASTD colleagues are networking at the Annual Technology Training Showcase in Bridgewater; I’m in Chicago watching UConn stomp Gardner-Webb in basketball – oh, well.

It’s been another noisy week in pharma, mainly with the blacker black box for Avandia (see links below).

With GSK‘s Avandia woes deepening, Takeda is about to launch an advertising blitz for Actos. Meanwhile, GSK experiments with new selling models (including fewer sales reps, of course…)

Why restrict rough product news to one Top 5 company? Sanofi‘s Acomplia gets another cloud perched over it.

Reorganization is in the air, at least in New Brunswick. Changes at J&J.

Good news Bad news for Roche. Good news – anemia drug approved by FDA! Bad news – can’t sell it…

I’m sorry. Really. Here’s a $135 million apology.

Samples for sale! Go directly to…

Forteo goes one up on Fosamax.

Door locked in Pittsburgh. Another Med. Ctr. restricts drug reps.

Not necessarily news, but a nice resource I just came across. Selling Power’s Pharmaceutical Newsletter (free registration).

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The Good Stuff:

BMS gets approval for new oncology drug (for breast cancer) Ixempra.

Merck gets new HIV drug (Isentress) approved in the U.S. And, their Januvia diabetes drug gets new uses approved.

Abraxis gets cancer drugs approved.

J&J gets Doribax (for intra-abdominal and urinary tract infections) approved.

Bayer reports upbeat MS drug results.

Glaxo: new use of HIV drug Lexiva OK’d.

The Bummers:

Say what? Viagra and other impotence drugs may be causing hearing loss??

Pfizer pulls the plug on Exubera, lets partner Nektar know after the press release.

Novartis details job cuts, and some executive shuffling at the top. They will end a contract sales force agreement with InVentiv Health as part of the pullback.

Major job cuts at struggling Boston Scientific.

J&J‘s drug biz not growing as rapidly as has been typical. Here’s why.

Genentech posts “only” 22% year over year earnings growth. This is apparently considered a disappointment…

VA scraps most use of Avandia.

Byetta and acute pancreatitis: beware!

Pfizer and Wyeth report large charges in their earnings reports (buy Lilly has good numbers)

Speculation, gossip, other stuff:

Biogen hangs out a “For Sale” sign.

Pfizer jumps into Sermo, the physician networking site. Not everyone is thrilled.

Who is Pfizer going to buy up next? Genzyme? Everyone is hot on biotech acquisitions these days…

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Prasugrel, the upcoming rival to $6 billion drug Plavix, gets a write-up. This is a crucial new drug for co-promote partners Daiichi-Sankyo and Eli Lilly.

Good Samaritan drug rep loses leg, gains lots of supporters.

The ferment continues in the diabetes marketplace. JAMA article further muddies the waters for GSK‘s Avandia, while putting a positive spin on Takeda‘s rapidly ascending rival treatment Actos. Meanwhile, Merck reports encouragement for the Januvia/Janumet family.

King’s Altace reign may soon end with generic competition, while patents on Skelaxin are also under pressure.

Cephalon experiences more pain with Fentora, a painkiller tied to (off-label) deaths.

Propecia, the hair growth drug, and its encouraging uses for prostate cancer.

JUST IN: Lilly’s Evista approved for breast cancer.

And, I’m with the WSJ Health blog on this one. Which drug-coated stent is better? Are they better than bare-metal stents? Does anybody really know what time it is? Sheeeesh.

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Novartis gets approval for Reclast, a once-per-year osteoporosis treatment. That’s a game-changer – very cool advance that should lead to far better patient compliance.

A long-ish article on Wyeth‘s efforts to find Alzheimer’s treatments. It’s a risky R&D commitment, but nobody questions that desirability of finding new advances here. Also, MedAd News has a brief interview piece on Wyeth’s biopharma organization.

Novo Nordisk reports encouraging Phase 3 results for yet another diabetes treatment. Liraglutide is a human analogue of a naturally occurring hormone. Novo is developing it for the treatment of type 2 diabetes and hopes to submit it for regulatory approval in mid-2008. (Editorial note: I really respect Novo’s business model re: diabetes. Focus, focus, focus!)

Forest and Daiichi Sankyo to co-promote pending hypertensive (combo) treatment. Azor incorporates amlodipine besylate and olmesartan medoxomil, which are respectively the main ingredients in Pfizer’s Norvasc and Daiichi Sankyo’s Benicar.

EyeonFDA blog reports that the FDA drug approval rate ain’t what it used to be. I think we all knew that, but the article has a link with numbers, if you’re into that.

Eye-opening letter from Jim Cornelius, CEO of BMS, to employees, addressing an upcoming need to reorganize (read: downsize). It’s an interesting one, actually. There is a bit of corporate-speak, as in these phrases: “…as part of resetting our cost base, there would need to be headcount reductions in some parts of the company…The changes we are considering center around the transformation of our model to execute our strategy…Your compliance and integrity will be vital as, moving forward with our productivity transformation, we will empower decision-making at the appropriate levels throughout the company.” But, to be fair, other parts of the letter are pretty plain and straightforward…for a CEO.

Business Week reports that Medicis is making good progress in the derm market.

Are Glaxo and Novartis making stupid investments in vaccines? A 40-person company thinks so…

Antisoma may be on to something good for lung cancer.

And now, a handful of longer analysis pieces, from MedAd News and Pharmaceutical Executive:

Does the blockbuster model have a future?

Avandia Sales Away

Tibotec (a J&J company) gets AIDS.

A look at the drugs of tomorrow.

Marketing to professionals

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In a backside-covering move, the FDA has gone public with the “news” that it has nothing to report – yet – about possible heart risks for users of Nexium/Prilosec.

Yes, the FDA caught grief for not going public earlier with some data about Avandia. But what good is accomplished by raising issues like this when the data analysis is not complete? This is a P.R. move, not a sound clinical/regulatory decision. All it does is scare people.

If/when there is real and substantial evidence of a problem, then certainly get the word out. But let’s put science before lame attempts to deflect blame.

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A minor comeback for Novartis’ Zelnorm.

Avandia gets a reprieve, of sorts…to remain on the market, but undoubtedly with a raft of warnings and cautions. Meanwhile, more encouraging data on Actos, which appears to avoid the Avandia effect. And was that data “covered up” earlier??

J&J to cut 4% of its workforce. Sanofi announces that its U.S. sales force has steadily declined, by 11%, over the past 2 years.

Bristol and ImClone to push oncology treatment Erbitux into expanded trials.

Combo pills – some fly high (Vytorin), others have a hard time getting off the ground.

The current figurehead for pharma whistleblowing, Dr. Peter Rost, gets a new assignment as a blogging journalist at Brandweek NRx.

Class action lawsuit against Novartis for bias against female employees will proceed.

Very cool – electrical stimulation device in brain “re-awakens” man in a minimally conscious state.

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Two weeks worth of news articles linked here:

Medical News

Actos: safer than Avandia?

Cialis going toward a once-daily version (but shouldn’t it be once every day-and-a-half??)

Novartis gets some approvals in Europe, including new diabetes treatment Galvus

Wyeth’s Pristiq gets stalled by FDA (Pristiq is a cousin of Effexor)

GPC setback on cancer treatment

Promising HIV treatments: competitive upcoming products from Pfizer and Schering

Corporate News

Medpointe being bought by a Swedish firm

AZ slashing jobs (mostly overseas)

Some earnings reports: BMS, Celgene, Mylan, Shire

Pfizer entering the patent black hole: Losing Lipitor

Schering’s reliance on cholesterol pills

Motley Fool asks – Amylin: Two hit wonder?

Next up on the Whistleblower Express: Novartis

Purdue hammered again with fines for Oxycontin marketing

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And, a long-ish article in Pharmaceutical Executive magazine entitled Fixing the Sales Model.

Plus: Medical Marketing and Media’s annual lollapalooza of Agencies and Brands. Some good info and downloads here.

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