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Crohn’s Disease / Ulcerative Colitis Clinical Developments November 2015

Ulcerative Colitis / Crohn’s Thought Leader Panel #20 2015-11 Therapeutic Area: Inflammatory Bowel Disease Disease Area(s): Crohn’s disease, Ulcerative Colitis Specialty/Location: Gastroenterology / N. America, Europe Publication Date: November 2015 Principal Authors: Tricia L. Hanlon; Jeff Berk   Product Code: …
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Posted in Crohn's disease, gastroenterology, inflammatory bowel disease, ulcerative colitis | Tagged , , , , , , , , , , , , , , , , | 2 Comments

Multiple Myeloma

Interview OHIID02782     Interview Topics   multiple myeloma     Physician Demographics TL # 10605 Specialty:  Hematology Geography: Boston, MA Interview Date =  01/22/2013     Interview Transcript   Let’s talk about myeloma.   We might need the whole …
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Posted in CANCER, Multiple Myeloma | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

IMF Myeloma Workshop Mayo Nov 17

The IMF sponsored a superb multiple myeloma workshop at Mayo Scottsdale.  Street cred to Joe Mikhael (Mayo), Jonathan Kaufman (Emory), Keith Stewart (Mayo), Angela Mayo (Mayo), and Kelly Cox from the International Myeloma Foundation.  Having just gotten back from EORTC …
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Posted in CANCER, melanoma | Leave a comment

Rheumatology TLP #36 2012-08 Lupus / Rheumatoid Arthritis

Before we talk about lupus and rheumatoid arthritis, this is what Bartlett Lake, AZ looks like from the back of a Streetglide.  In July.  When the thermometer on the bike is maxed out somewhere beyond the 130 F line.  Those …
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Posted in ankylosing spondylitis, IMMUNOLOGY, lupus, psoriatic arthritis, Rheumatoid Arthritis, rheumatology | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Melanoma Thought Leader Panel #31 2012-07

    We’ve finally gotten around to publishing Melanoma Thought Leader Panel #31  2012-07.  As always, if you’re a patient, email me (jeff@boltinternational.com) and we’ll figure out which sections will be helpful for me to give you, Pro Bono.  I’ll …
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Posted in CANCER, melanoma | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 1 Comment

BOLT / MedPredict Rheumatology Thought Leader Panels

Posted by Jeff Berk; BOLT International   Greetings from sunny Scottsdale, AZ.  But I repeat myself.  Here in the Desert we’re in the middle of AZ Bike Week.  There must be 100,000 motorcycles rumbling around town.  Organ-donor heaven, right?!  I …
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Posted in ankylosing spondylitis, IMMUNOLOGY, psoriatic arthritis, Rheumatoid Arthritis | Tagged , , , , , , , , , , , , , , , , | Leave a comment

Multiple Sclerosis Pharmacoeconomics

Posted by Jeff Berk; BOLT International / MedPredict   A recent University of Rochester School of Medicine study (Noyes et.al; 2011; see http://www.neurology.org/content/early/2011/07/20/WNL.0b013e3182270402.abstract) compared disease modifying therapy to supportive care and found that “the cost-effectiveness of all DMTs far exceeded …
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Posted in IMMUNOLOGY, Multiple Sclerosis, multiple sclerosis, Neurology | Tagged , , , , , , , , , , , | Leave a comment

Multiple Myeloma February 2012

Hematology / Oncology Thought Leader Panel #29     Okay, so ASH 2011 is behind us.  It was a terrific meeting for multiple myeloma.  I had a chance to speak with a great group of Thought leaders just after the …
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Posted in CANCER | Tagged , , , , , , , , , , , , , , , , , , , | 1 Comment

Gastroenterology Thought Leader Panel #13 2011-12

I haven’t been blogging very much lately.  I don’t personally have inflammatory bowel disease (I know, TMI), but with the way I’ve been eating this Christmas, I’m able to mimic at least temporarily many of the symptoms (I know, REALLY …
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Antithrombotics for Acute Coronary Syndrome

Posted by Jeff Berk; BOLT International   Been a while, kids.  Lots of meeting, including AACR/EORTC in the Peeps Democratic Republic of Kalifornia, San Francisco, and then ASH in ditto ditto ditto, San Diego.  The Dark Side owns all that …
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Posted in acute coronary syndrome, antiplatelets, Antithrombotics, Cardiovascular, DVT/PE, SPAF | Tagged , , , , , , , , , , , , , , , | Leave a comment

Melanoma Patient Support (Topic #1) & Psoriasis (Topic #2)

Posted by Jeff Berk, BOLT International;   Desert Man Haiku: Obama dearest, What’s best way to wipe my ass? Can you show me how?   Desert Man Toilet Paper     Melanoma Patient Support:   I get a ton of …
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Posted in dermatology, IMMUNOLOGY, melanoma, psoriasis, psoriasis, psoriatic arthritis | Tagged , , , , , , , , , , , , | 3 Comments

Melanoma Thought Leader Panel #28 2011-11

Posted by Jeff Berk, BOLT International; As I pen this blog, it is 85 degrees (Fahrenheit, for you poor 3rd-worlders condemned to the metric system) and dry as a bone in Scottsdale, AZ.  As an aside, I once had a …
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Posted in CANCER, melanoma | Tagged , , , , , , , , , , , , , , , , | 1 Comment

Rheumatology Fantasy Formulary 2011

Posted by Jeff Berk; BOLT International     So I don’t post as often as I’d like.  Read between the lines…     Interloper Haiku: The Lord’s great “GRACE” test. I’m a guest in my own home. Will they EVER …
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Posted in ankylosing spondylitis, IMMUNOLOGY, lupus, psoriatic arthritis, Rheumatoid Arthritis, rheumatology | Tagged , , , , , , , , , , | Leave a comment

Eating for Your Life: Nutrition During Cancer

Posted by Melanie Bowen via Jeff Berk, BOLT International;     Stylized representation of some sort of nutritious food.  p.s.  Sorry Melanie.  If you thought you were going to get posted WITHOUT a sarcastic intro…  Not Today!   So I …
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Pharma Karma: ASBMR Shoots Itself in the Foot

Posted by Jeff Berk; BOLT International         If only it was this easy to trade in the ASBMR.   Every ASBMR I switch off buying dinner with one of BOLT’s Osteoporosis Thought Leaders.  It’s a tradition that’s …
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Melanoma: BRAF, MEK, NRAS, PD-1, cMET

Posted by Jeff Berk; BOLT International   Here’s some irony for you.  If you live in Arizona and want to buy a nice machine gun, you have to wait about 4 months for ATF (Alcohol, Tobacco & Firearms; the Arizona …
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Posted in CANCER, melanoma | Tagged , , , , , , , , , , , , , , , , , , | 2 Comments

Mesenchymal Neural Stem Cells for Multiple Sclerosis

Posted by Jeff Berk; BOLT International       Las Vegas Haiku:   Vegas, How it works – Either you’re in on the joke, or you are the joke.           I’m going to apologize ahead of …
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Posted in IMMUNOLOGY, Multiple Sclerosis, multiple sclerosis, Neurology | Leave a comment

The Effect of Neutrinos on EDSS Scores in patients with Multiple Sclerosis

Posted by Jeff Berk; BOLT International   In the interest of investigative reporting, I snuck into the Women’s restroom in one of the trendy Snottsdale bars last night, just to get a handle on any differences in what a woman …
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Posted in IMMUNOLOGY, Multiple Sclerosis, multiple sclerosis, Neurology | Tagged , , , , , , , , , , , , | Leave a comment

BOLT’s Rheumatology Fantasy Formulary – Unmet Needs

Posted by Jeff Berk; BOLT International A few clients took advantage of my offer to pre-buy BOLT’s upcoming Lung Cancer Landscape.  Early sales are always nice, and with the proceeds…  well let’s just say that I’m GIDDY over the new …
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Posted in ankylosing spondylitis, IMMUNOLOGY, lupus, psoriatic arthritis, Rheumatoid Arthritis | Tagged , , , , , , , , , , , , , , | Leave a comment

Lung Cancer, But First… Props to Zelboraf (vemurafenib)

Posted by Jeff Berk; BOLT International Boy oh boy!  One of the fundamental tenets of quantum physics was demonstrated this week.  I am just stunned, but IT’S TRUE:  FDA approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable …
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Posted in CANCER, melanoma, Non-Small Cell Lung Cancer | Tagged , , , , , , , , , , , , , , , , | Leave a comment

Antiplatelets and Antithrombotics

Posted by Jeff Berk, BOLT International Oops Haiku: Stoned in parent’s car… Drops joint, OH SHIT IT’S ON FIRE… Pretty orange sky.             Arizona’s State Weed           So we finally straightened …
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Posted in acute coronary syndrome, antiplatelets, Antithrombotics, Cardiovascular, DVT/PE, SPAF | Tagged , , , , , , , , , , , , , , | Leave a comment

AMG-785 / CDP7851 (Amgen / UCB )

Posted by Jeff Berk; BOLT International   Now that I write a blog I get a lot more emails than ever before.  My favorites are from patients who we either connected to some of BOLT’s thought leaders for treatment, or …
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Brilinta Approval Day

Posted by Jeff Berk; BOLT International   First a piece of serious business.  Well, mostly serious.  Matt Anderson introduced me to David Cook’s book and website, Golf’s Sacred Journey a.k.a. Links of Utopia.  I suck at golf.  I like it.  …
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Psoriasis / Psoriatic Arthritis: It’s a Pawn-Eat-Pawn World

Posted by Jeff Berk; BOLT International     First, a note on yesterday’s blog.  Yes, I really did spot smoke coming from the engine of that boat.  We SCREAMED at this father to throw his life-vested baby girl, plus older …
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Posted in dermatology, IMMUNOLOGY, psoriasis, psoriasis, psoriatic arthritis | Tagged , , , , , , , , , , | Leave a comment

stealing beers and saving lives

Posted by Jeff Berk; BOLT International Dateline:  Sandpoint Idaho, July 23 2011.  I guess I’ll take the 5th on the beer-stealing boondoggle.  But we really did fish four souls out while this sob was going up in flames.  Now I …
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Bleeding Definitions in Clinical Trials

Thanks to Monica Lewinsky’s boy-toy, we can now say with confidence that the meaning of the word(s) “bleeding definitions” depends on what the meaning of the word(s) ‘bleeding definitions’ is.  Sound complicated?  I feel your pain.   If you ask Michelle’s …
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Posted in antiplatelets, Antithrombotics, Cardiovascular, DVT/PE, SPAF | Tagged , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Lyrica (pregabalin) for Pain and Sleep

Posted by Jeff Berk; BOLT International       Typical mooring at the Scottsdale Yacht Club.       Pregabalin Haiku:   I take Lyrica* It’s a party in a pill Friends inside my head * (This is a Haiku.  …
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Posted in Neurology, Pain, sleep | Tagged , , , , , , , , , , , | Leave a comment

What Will Obama Do About Ticagrelor (Brilinta / Brilique; AstraZeneca)

Posted by Jeff Berk; BOLT International Item #1:  Re: Joey Chestnut (and this is not my quote and I don’t know the source), “He’s ingested more bad meat than Boy George”.  The man is simply untouchable.  Five consecutive championships.  But …
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Ustekinumab and Tofacitinib in Crohn’s and Ulcerative Colitis

Posted by Jeff Berk; BOLT International     Today’s Photo:  Scottsdale Municipal Landfill.   Today’s Temperature: “Dry Heat”   Today’s  Haiku:   Woman’s face tightens. Releases horrific gas. Checkout line faux pas.     Okay, before you send me an …
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Posted in Crohn's disease, gastroenterology, IMMUNOLOGY, inflammatory bowel disease, ulcerative colitis | Tagged , , , , , , , , , | Leave a comment

Multiple Myeloma – 1st Line

Posted by Jeff Berk, BOLT International;   The cave dwellers of the land that we now know as England had rather unsophisticated lingual skills.  Short guttural sounds were used to convey long, complex meanings.  One of these sounds, “nan” meant …
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Commercial Train Wrecks for Postmenopausal Osteoporosis Train Wrecks

Posted by Jeff Berk; BOLT International   I’m in a foul mood tonight.  Just pissy.  This lil’ feller with eight hairy legs sums up what I look like right now. I’d tell you why, but the BOLT Pharma Blog isn’t …
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Posted in osteoporosis, parathyroid hormone | Tagged , , , , , , , , , , , , , , , , | Leave a comment

2010 Gastroenterology Fantasy Formulary Survey

Posted by Jeff Berk; BOLT International     Good evening, peepers and peepses.  Hope everybody had a great weekend.  So tonight I want to talk tangentially about forecasting, and i (eventually, once I’m done rambling) want to do it by …
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Posted in Crohn's disease, gastroenterology, inflammatory bowel disease, ulcerative colitis | Tagged , , , , , , , , , , , , , , , , , | Leave a comment

How to Develop a c-MET Inhibitor for NSCLC

So before I share some thoughts on how to develop a c-MET inhibitor for non-small cell lung cancer, I can’t resist commenting on the executive order, issued today by Darryl (I was in Run-D.M.C. before I was a community organizer) …
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Posted in CANCER, Non-Small Cell Lung Cancer | Tagged , , , , , , , , , , , , | Leave a comment

ASCO Survival Data

Posted by Jeff Berk, BOLT International;   I’m purposely NOT loading lots of Google search terms into this blog, so ONLY my dedicated readers are going to find it and get some free advice.  Not necessarily GOOD advice, but since …
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Posted in CANCER, colorectal cancer, melanoma | Tagged , , , , , , , , , | Leave a comment

Tofacitinib (tasocitinib) for Psoriasis; Pfizer

Posted by Jeff Berk, BOLT International;     I’m sitting on a Southwest flight to Chicago.  I was going to rant about TSA before getting on to the psoriasis portion of this blog.  But since good sarcasm only attacks those …
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Metabolics for Pancreatic Ductal Adenocarcinoma

Posted by Jeff Berk, BOLT International;   So I survived my blog last night with no sarcasm, and I’m happy to report that I’m none the worse for wear.  We’re all headed to Chicago for the next week.  For ASCO, …
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Posted in CANCER, pancreatic ductal adenocarcinoma | Tagged , , , , , , , , , , , , , , , , , , | 4 Comments

Melanoma: MDX-1106 (anti-PD-1 antibody; Medarex / Bristol-Myers Squibb)

Posted by Jeff Berk, BOLT International;   When I published my last blog I sort of hinted at getting through a single one without sarcasm.  This, folks, is the one!  So before we talk about melanoma, I have a public …
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Posted in CANCER, melanoma | Tagged , , , , , , , , , | 11 Comments

The Rapture, Tofacitinib Joint Space Narrowing and Pricing

Posted by Jeff Berk, BOLT International;   Of the three great mysteries in the news this week, I sort of expect to have data on two of these in my lifetime.  And as for Mr. California Preacher (no, silly, not …
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Posted in IMMUNOLOGY, Rheumatoid Arthritis | Tagged , , , , , , , , , , , | Leave a comment

XL-281 (Bristol-Myers Squibb; Exelixis); BRAF for Melanoma

Posted by Jeff Berk, BOLT International:   Two more weeks and we’ll be in the midst of another ASCO fiasco.  This year I’m going to be prepared.  I’ll bring my own pens and a notebook (okay, not really.  Thanks Steve …
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Teddy Bear Cholla and Unmet Needs in the Treatment of Female Sexual Dysfunction

Posted by Jeff Berk, BOLT International;   For one blog, I’m going to be completely serious and free of sarcasm.  This isn’t that blog.  Just so you know. So let’s get started… This is Opuntia bigelovii, better known as “Teddy …
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Posted in Female Sexual Dysfunction, Women's Health | Tagged , , , , , , , , , , , , | Leave a comment

I Can’t Remember If I Blogged About Alzheimer’s Recently

Posted by Jeff Berk, BOLT International;   This is the time of year where we really can’t understand why they pay the local Phoenix TV weathermen.  I mean, “meteorologists”.  Seriously, though, how hard is it to predict “100 and sunny” …
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Posted in Alzheimer's / MCI, Neurology | Tagged , , , , , , , , , , , , , , , , | Leave a comment

BMS-708163 (Bristol-Myers Squibb) for Alzheimer’s Disease and Mild Cognitive Impairment

Posted by Jeff Berk, BOLT International;   My next meeting is going to be ASCO.  Can I tell you, I’m so beyond thrilled to be getting to go to another meeting in Chicago.  Maybe this time my hotel room will …
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Evil Bisphosphonates Can Make Even SERMS Look Good

Posted by Jeff Berk, BOLT International;   Have you been missing your cactus photo?  Here ya go.   Blogging today from Charles de Gaulle.  Here’s a shout out to Guilhem Bousquet.  Nicest Frenchman I know.  Pretty good oncologist to boot. …
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Treating Deep Vein Thrombosis in Multiple Myeloma

Posted by Jeff Berk, BOLT International;   Another beautiful day in Paris.  Unfortunately, all I got to see of it was the basement under the Louvre.  Fortunately, Big Daddy is paying for me to be here at the International Myeloma …
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Posted in Antithrombotics, CANCER, Cardiovascular, DVT/PE, Multiple Myeloma | Tagged , , , , , , , , , , , , , , , , , , | 2 Comments

Actemra / RoActemra (tocilizumab; anti-IL6) East and West

Posted by Jeff Berk, BOLT International; I spent the day yesterday writing blogs.  Just kidding.  It was too nice of a day in Paris to do anything other than skate the city.   So I zipped to-and-fro for 6 hours.  Until …
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Lung Cancer Trial Designs

Posted by Jeff Berk, BOLT International;   I’m sitting in the British Airways lounge at Sky Harbor airport.  My flight’s delayed by 30 minutes because some inbred British guy wanted to make an honest woman out of some chick I …
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Posted in CANCER, Non-Small Cell Lung Cancer | Tagged , , , , , , , , , , , , | 1 Comment

Hepatitis C Virus; TMC-435 (Tibotec / Medivir / J&J)

Posted by Jeff Berk, BOLT International;   First some business:  We had our 10,000th hit on the blog.  YAY!  Somebody in Princeton, NJ, at Biovid.  So there.  You be our 10,000th, and u get a free plug.  New Jersey.  What …
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Posted in Hepatitis C, Infectious Disease | Tagged , , , , , , , , , , , | 1 Comment

lorvotuzumab mertansine; IMGN901 (ImmunoGen)

Posted by Jeff Berk, BOLT International;   I’m leaving for Paris in a couple of days, 13th International Myeloma Workshop.  And for that, I’m psyched.  I’m really looking forward to seeing a number of BOLT’s Myeloma Thought Leaders; some for …
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Posted in CANCER, Hodgkin's lymphoma, Multiple Myeloma | Tagged , , , , , , , , , , , , , , , , , , , , | 1 Comment

Hepatitis C Virus: Warehousing in the Age of Protease Inhibitors

Posted by Jeff Berk, BOLT International In follow up to the questioner regarding what BOLT’s Infectious Disease Thought Leader panel thinks about warehousing hepatitis C patients vs. treating them today, we asked that very question a couple months back.  So …
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Ocrelizumab and Ofatumumab for Relapsing Remitting Multiple Sclerosis

Posted by Jeff Berk, BOLT International;     Here’s your cactus flower of the day; cereus aethiops.  One of the “queen of the night” cacti, named because the flowers bloom at night and wither by mid morning.  Thus, the best …
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Posted in IMMUNOLOGY, Multiple Sclerosis, multiple sclerosis, Neurology | Tagged , , , , , , , , , , , , , , , , , , | 1 Comment

Eliquis (apixaban) and ARISTOTLE

Posted by Jeff Berk, BOLT International;   They say that once you put it on the web, it’s there FOREVER.  So tonight I’m going to post this photo of an echinopsis LA (who came up with that name?) and… some …
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Posted in Antithrombotics, Cardiovascular, DVT/PE, SPAF | Tagged , , , , , , , , , , , , , , , | Leave a comment

Tofacitinib Deaths in Context

Posted by Jeff Berk, BOLT International;   So I’m flying back from some meeting and I’m too brain dead to even fire up my IPad.  As is my custom, i peer between the seats and watch whatever the stranger sitting …
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Simponi (golimumab) Clinical Development for Ulcerative Colitis and Crohn’s

Posted by Jeff Berk, BOLT International   I got ten emails overnight, basically all saying “post more stuff related to the upcoming DDW meeting”.  The second highest request was eight emails.  For 2nd place, you get these pretty purple flowers. …
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Posted in Crohn's disease, gastroenterology, inflammatory bowel disease, ulcerative colitis | Tagged , , , , , , , , , , , , , , , , , , , | Leave a comment

betrixaban (Portola / Merck)

  Posted by Jeff Berk, BOLT International   This is an echinopsis hybrid.  They’re easy to crossbreed and sometimes they even have pretty color to them.  I hear that the Ohio valley had poopy weather today.  Nya Nya na na …
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Actimid; pomalidomide (Celgene) for Multiple Myeloma

Posted by Jeff Berk, BOLT International;   So my GF thinks that the only reason I write this blog is to make you, dear reader, look at my cactus photos.  For today, and only for today, I’ll stipulate that this …
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Posted in CANCER, Multiple Myeloma | Tagged , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

MEK in Melanoma

Posted by Jeff Berk, BOLT International; Why no blogs for the past few days?  Well, I’ll tell ya.  I got this new pair of inline skates, and they’ve needed some feet in them to break ‘em in.  OMG These things …
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Habits & Practices in the Treatment of Alcoholism

Posted by Jeff Berk, BOLT International;   I like martinis.  A lot.  Vodka.  Straight up.  Blue cheese stuffed olives.  A little spritz of vermouth.  When I was younger we’d throw some sodium metal into a still of reagent grade ethanol …
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Posted in Psychiatry, substance abuse / alcoholism | Tagged , , , , , , , , , , | Leave a comment

ALLEGRO – Laquinimod in RRMS

Posted by Jeff Berk, BOLT International;   Short and sweet today…  ALLEGRO results were presented at AAN.  Laquinimod produced a 23% lower relapse rate vs placebo in relapsing remitting multiple sclerosis.  While “statistically significant”, this result is a yawner (in …
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Posted in IMMUNOLOGY, Multiple Sclerosis, multiple sclerosis, Neurology | Tagged , , , , , , , , , , , , , | Leave a comment

Afinitor and Sutent for Pancreatic Neuroendocrine Tumors

Today saw two positive votes for new therapies for the treatment of pancreatic neuroendocrine tumors from FDA’s ODAC.  Novartis’s Afinitor (everolimus) got the thumbs up by a 10-0 score.  Pfizer’s Sutent (sunitinib) “eeked out” an 8-2 win. The ODAC approval …
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Hungry for Breakfast? Dimebon is TOAST

Posted by Jeff Berk, BOLT International   Okay, maybe not quite yet breakfast food for Alzheimer’s disease when added to Aricept (donepezil).  But here’s my prediction:  CONCERT will publish 1Q2012 and then we should officially be ready to butter dimebon …
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Posted in Alzheimer's / MCI, Neurology | Tagged , , , , , , , , , , , , , , | Leave a comment

Prolia/Xgeva (denosumab), Steve Jobs & Bill Gates

Posted by Jeff Berk, BOLT International;  Tonight, I’m going to blog about Prolia/Xgeva (denosumab).  So here goes…  I’m a Mac guy.  Why? THEY JUST WORK.  I wrote my thesis up on a funky little box in the ‘80’s.  I still …
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DVT / PE in Cancer

Posted by Jeff Berk, BOLT International;  I have one more day in the dog kennel (a.k.a. AACR 2011; Orlando) before heading back to my beloved desert.  It’s been a great meeting and I SHOULD be blogging about cancer.  But… the …
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Posted in Antithrombotics, Cardiovascular, DVT/PE | Tagged , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Smoothened PaTCHes of Hedgehogs

Posted by Jeff Berk, BOLT International;  I’m spending the week at AACR 2011, in Orlando.  If you’re here, give me a shout!  I really like this meeting.  Not quite as crazy as ASCO, and less pompous than ASH.  There have …
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Posted in basal cell carcinoma, CANCER, colorectal cancer, Gorlin's syndrome, medulloblastoma, pancreatic ductal adenocarcinoma | Tagged , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Pharmacoeconomics of IBD Drugs (Crohn’s, Ulcerative Colitis)

Posted by Jeff Berk, BOLT International:   In many categories, (rheumatoid arthritis, psoriasis, osteoporosis just to make the point) payers have passed the tipping point, and now they can drive prescribing based on whether parenteral dosing requires an infusion.  Gastroenterology …
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Posted in Crohn's disease, gastroenterology, inflammatory bowel disease, ulcerative colitis | Tagged , , , , , , , , , , , , , | Leave a comment

Ondero (linagliptin; Boehringer-Ingelheim)

Posted by Jeff Berk, BOLT International;  I got a question by email from a blog reader wanting to know what BOLT’s Diabetes Thought Leader panel thinks of Ondero (linagliptin).   So, short and sweet — the following is some insight from …
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Melanoma: Can GSK2118436 overtake PLX-4032 (a.k.a. RG-7204 a.k.a. RO5185426)?

Posted by Jeff Berk, BOLT International;   I have melanoma on the brain this week.  Yervoy (ipilimumab; Bristol-Myers Squibb) was approved, and I shared earlier in the week some of the thoughts on that drug which I took from BOLT’s Melanoma …
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Posted in CANCER, melanoma | Tagged , , , , , , , , , , , , , , , , , | Leave a comment

Prices for Multiple Sclerosis Therapies Are Too High! Aren’t They?

Posted by Jeff Berk, BOLT International;  I got an email today asking when i was going to shut up about the Arizona weather.  I will when the sky stops looking like this:          This notocactus bloomed …
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Posted in IMMUNOLOGY, Multiple Sclerosis, Neurology | Tagged , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Opioids and Royal Pains

Posted by Jeff Berk, BOLT International;  A couple of weeks back Pfizer recalled one of the key products that came their way via the acquisition of King Pharmaceuticals. Some lots of Embeda, an extended release “abuse resistant painkiller” did not …
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Posted in Neurology, Pain | Tagged , , , , , , , , , , , , , , , , , , , , | 1 Comment

IL23s, Integrins and MAdCAMs at DDW 2011

Posted by Jeff Berk, BOLT International;  Just to rub it in…  The air temp in AZ is 90, and the pool temp is 93.  There is one cloud.  It’s East of us.  Could be over New Mexico.  Anyway…  Presumably, you’re …
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Posted in Crohn's disease, gastroenterology, inflammatory bowel disease, ulcerative colitis | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Merck bails on betrixaban; Returns rights to Portola

Posted by Jeff Berk, BOLT International;  Merck announced today that they have returned to Portola all rights to betrixaban.  BOLT spoke with our SPAF (prevention of stroke in patients with atrial fibrillation) Thought Leaders last month and asked them to …
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Posted in Antithrombotics, Cardiovascular | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Arcapta™ Neohaler™ (indacaterol; QAB149) for COPD

Posted by Jeff Berk, BOLT International;  On March 9, 2011 indacaterol 75 mcg received a positive review (13-4) from FDA’s Pulmonary-Allergy Advisory Committee for use as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive …
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Posted in COPD, Respiratory | Tagged , , , , , , , , , , , , | Leave a comment

Yervoy (ipilimumab; CTLA4 inhibitor) is in Bloom

Posted by Jeff Berk, BOLT International; We survived our raindrops.  But golly, how do the rest of you cope with the clouds and mud and stuff?  On the bright side, we did get our first flowers of the spring to …
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Cancer Diagnostics – The Lay of the Land

Posted by Jeff Berk, BOLT International; It’s so cold and rainy here in the desert today we might as well be living in New Jersey.  Anyway…  One of our Pharma friends asked about diagnostics.  Big topic, and we ask every …
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Posted in CANCER, Multiple Myeloma, Non-Small Cell Lung Cancer | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Hedgehog/Smoothened at ASCO 2011

Posted by Jeff Berk; BOLT International Here in Arizona the scorpions are out. While that can mean a lot of things to a lot of people, to us it means that it’s not too soon to be thinking about ASCO …
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Posted in CANCER, pancreatic ductal adenocarcinoma | Tagged , , , , , , , , , , , , , , , , , , , , | Leave a comment

Lilly and Avid Receive Complete Response Letter from FDA for Amyvid™ (florbetapir F 18 injection)

  Posted by Jeff Berk; BOLT International Today FDA refused to approve Amyvid™ for the detection of beta-amyloid plaque in the brains of living patients. The complete response was primarily focused on the need to establish a reader training program …
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Posted in Alzheimer's / MCI, Neurology | Leave a comment

Merck (boceprevir), Vertex (telaprevir) Hepatitis Drug Reviews In Late April 2011

FDA will review two NS3/4A protease inhibitors, Merck’s boceprevir on April 27 and Vertex’s telaprevir on April 28.  Both drugs have shown success in increasing hepatitis C cure rates when added to pegylated interferon and ribavirin.  A couple of months …
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Posted in Hepatitis C, Infectious Disease | Tagged , , , , , , , , , , , , , | Leave a comment

Pradaxa pharmacoeconomics

Today Boehringer-Ingelheim’s Pradaxa (dabigatran) achieved preferred Tier 2 formulary status with pharmacy benefit managers Medco Health Solutions and CVS Caremark.  CVS Caremark and Medco added Pradaxa to their commercial preferred drug lists, and Medco added the drug to its Part …
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Posted in Antithrombotics, Cardiovascular | Tagged , , , , , , , , , , , , , , , , , | Leave a comment

CCR1 Antagonists for Rheumatoid Arthritis?

Some of our Thought leaders participated in a workshop recently, where the value of developing chemokine receptor antagonists for rheumatoid arthritis was one of the topics of conversation.  The overwhelming consensus of that working group was that the evidence doesn’t …
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Posted in IMMUNOLOGY, Rheumatoid Arthritis | Tagged , , , , , , , , , , , | Leave a comment

Melanoma, brain mets and BRAF inhibitors

We asked our Thought Leaders to compare BRAF inhibitors from GlaxoSmithKline (GSK-2118436) and Roche ( RO5185426 aka PLX-4032 aka RG-7204) in relation to efficacy on melanoma with brain metastases.  The key claim for an efficacy advantage for GSK2118436 will be …
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Movectro (cladribine) for RRMS complete response letter

This week FDA gave their complete response to Merck-Serono’s Movectro (oral cladribine) registration application for relapsing remitting multiple sclerosis. The Agency is requiring more safety data, calling for additional analyses or new studies. Cladribine was recently approved in Russia and …
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Posted in IMMUNOLOGY, Multiple Sclerosis | Tagged , , , , | Leave a comment