B cell depletion benefits ME/CFS patients
Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) showed clinical improvement after extended treatment with the anti-B-cell monoclonal antibody rituximab. This result suggests that in a subset of patients, ME/CFS might be an autoimmune disease.
Rituximab is a monoclonal antibody against a protein on the surface of B cells known as CD20. When the antibody is given to patients, it leads to destruction of B cells, which are the producers of antibodies, proteins that are made by the immune system to counter infections. The drug has been approved by the US Food and Drug administration to treat diseas...
Source: virology blog - July 10, 2015 Category: Virology Authors: Vincent Racaniello Tags: Basic virology Information autoimmune disease B cell chronic fatigue syndrome mecfs monoclonal antibody myalgic encephalomyelitis rituximab viral virus Source Type: blogs
Inside the Open Payments Data: Two-Thirds of Transactions Worth $20 or Less; Research and Royalties Account for Majority of Total Value
Yesterday, the Centers for Medicare and Medicaid Services published the second year of Open Payments data, detailing the transfers of value made from pharmaceutical and device manufacturers to physicians and teaching hospitals in 2014. The top line total has received most of the headlines—“docs get $6.5 billion from drug and device companies.” Here, with data courtesy of Open Payments Analytics, we break down some of those payments in detail, with more to follow in subsequent articles.
Small Payments Fill the General Database:
Overall, there were 11.41 million records published, covering 607,000 physicians and ...
Source: Policy and Medicine - July 2, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
The Need For Publicly Funded Trials To Get Unbiased Comparative Effectiveness Data
Comparative effectiveness research was one of the hotly debated components of the Affordable Care Act. The pharmaceutical industry is marketing driven, with pharmaceutical companies spending more on marketing than they do on research and development. The need for a marketing edge can also drive drug development.
As illustrated by the discussion below of Gazyva and Nexium, drugs can be developed at higher doses than the drugs they are intended to replace. When the newer, higher-dose drugs are tested against the older, lower-dose drugs, the trials are intended to show that the newer, higher dose drugs are superior to the old...
Source: Health Affairs Blog - February 20, 2015 Category: Health Management Authors: Robert Bohrer Tags: All Categories Business of Health Care Comparative Effectiveness Innovation Pharma Policy Research Source Type: blogs
Orphan Radiopharmaceuticals And Other Libations
It has been a few years since I've made it to the Society of Nuclear Medicine annual meeting, so long actually that the Society has since changed its name, and is now called the Society of Nuclear Medicine and Molecular Imaging, I personally think this was prompted by the unfortunate amusement among the puerile (like yours truly) related to the original title's initials. SNMMI just doesn't have the same ring to it, but they don't ask me about these things. The exhibit hall is about 1/50th the size of the massive trade show at the RSNA, but most of the big players have a presence.Herr Großkopf, the huge animated head,...
Source: Dalai's PACS Blog - June 14, 2014 Category: Radiologists Source Type: blogs
Precision Oncology: Interview with Presage Biosciences Founder Dr. James Olson
As the costs of sequencing and drug testing continue to be driven down, we’ll increasingly see technologies that take into account differences between people and even within people. The hope is that this will lead to ultra-personalized medicine. One of the most anticipated use cases is in oncology because there is even a level of heterogeneity within the same solid tumor, leading to drug ineffectiveness or even resistance. Presage Biosciences is one company that hopes to pioneer this personalized and data-driven approach, which they call ” precision oncology.” We had the opportunity to interview its fou...
Source: Medgadget - December 3, 2013 Category: Technology Consultants Authors: Shiv Gaglani Tags: Medgadget Exclusive Oncology Source Type: blogs
Orphan Drugs - The Seattle Times explains
The mining of rare diseasesThirty years ago, Congress acted to spur research on rare diseases. Today, we have hundreds of new drugs — along with runaway pricing and market manipulation, as drugmakers turn a law with good intentions into a profit engine.By Michael J. Berens and Ken ArmstrongHer vision failed first.Then she fell asleep at school from inexplicable fatigue. Even walking proved difficult, often impossible, as she knocked into furniture and walls. It was like an electrical switch in her body toggled without warning. Some days she was in control, most she was not.Specialists were s...
Source: PharmaGossip - November 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week will soon draw to a close. This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is somewhat uncertain at the moment, although there is a soccer match involving one of the short people. We also hope to tidy up around the mansion and, perhaps, catch up with some old friends. And you? Anything interesting planned? If the weather is accommodating, this may be an opportunity to enjoy the great outdoors. Or maybe plan a trip to Portland, Maine, to enjoy the new recreational law. You could also contemplate the future of your health insurance. Whatever you do, have a g...
Source: Pharmalot - November 8, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? We are quite busy this morning as we scramble to play catch up after dining with interesting sources last night. The routine never stops. And so, to cope, we are reaching for that treasured cup of stimulation and invite you to do the same. After all, there is much to be done. On that note, here is a new batch of tidibits. We hope your day goes well and do stay in touch...
How Cancer Drugs Can Skip Randomized Trials (Reuters)
Merck Halts Sale Of Combo Pill For Diabetes And Cholesterol (Philadelphia Inquirer)
Sanofi Cholesterol Drug Is Touted As A Potential Blockbuster (Reuters)
Pfizer...
Source: Pharmalot - September 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and nice to see you again, especially after protracted technical problems that disrupted service yesterday. We apologize for the snafu and look forward to resuming the usual menu of interesting items today. Toward that end, we are brewing our mandatory cup of stimulation and have assembled a few tidbits below. So please dig in. Meanwhile, we hope your day is productive and rewarding. And as always, do stay in touch. We like to hear about fascinating developments...
Chinese Hospital Staff Punished For Kickbacks (Bloomberg News)
Aurobindo Employees Protest At Government Office (The Hindu)
New Roche Leukemia ...
Source: Pharmalot - July 24, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Drug Costs In Hospitals & Clinics To Rise 4 Percent
The cost of medications administered by clinics and hospitals are expected to rise by as much as 4 percent this year, which is less than in previous years, thanks to the increasing availabitily of lower-cost generics, according to a study in the American Journal of Health-System Pharmacy.
Specifically, medication expenditures are projected to rise between 1 percent and 3 percent across all clinics and hospitals not run by the federal government. But medication costs are forecast to increase between 2 percent and 4 percent in clinics, while there will be a 1.5 percent gain ih hosptials.
“In the aggregate, drug expenditur...
Source: Pharmalot - February 19, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Affordable Care Act Contraceptives Epogen Lovenox Procrit Prolia Remiicade Rituxan Xgeva Source Type: blogs
ABT-199 Clinical Trial Suspended (Updated)
Abbott - whoops, pardon me, I mean AbbVie, damn that name - has been developing ABT-199, a selective Bcl-2-targeted oncology compound for CLL. Unlike some earlier shots in this area (ABT-263, navitoclax), it appeared to spare platelet function, and was considered a promising drug candidate in the mid-stage clinical pipeline.
Not any more, perhaps. Clinical work has been suspended after a patient death due to tumor lysis syndrome. This is a group of effects caused by sudden breakdown of the excess cells associated with leukemia. You get too much potassium, too much calcium, too much uric acid, all sorts of things at once, ...
Source: In the Pipeline - February 15, 2013 Category: Chemists Tags: Cancer Source Type: blogs
One Down, 13 To Go: A Biosimilar Bill Falls Flat
As more than a dozen state legislatures mull over bills that would make it more difficult to allow substitution of biosimilars, at least one effort appears to have gone nowhere. Despite identical bills that were introduced in the state Senate and House in Mississippi, the twin pieces of legislation failed to proceed to committee votes and, as a result, cannot be reintroduced in the current legislative session.
This apparently marks the first such defeat for a closely watched effort by such big biotechs as Genentech and Amgen to thwart rivals from having easy entre to their lucrative markets. Over the past few weeks, you ma...
Source: Pharmalot - February 8, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen Avastin Biologics Biosimilars Eli Lilly FDA Genentech Herceptin Roche Source Type: blogs
In a Pre-emptive Strike, Amgen & Genentech (Roche) Lobby States to Block Biosimilars
No doubt you've heard of how Amgen essentially paid off U.S. Senators to sneak a provision in the "fiscal cliff" bill that delays price restraints on a class of drugs used by kidney dialysis patients, including Sensipar, a drug made by Amgen (see "Big Pharma buys off the Senate"). That "richly embroidered loophole" will cost taxpayers a half a billion dollars.Although a bill was proposed to close the Amgen loophole in federal law, Amgen and Genentech, which is owned by Roche, are lobbying (i.e., paying) state lawmakers to block generic versions of their products according to the New York Times (see here). Specifically, the...
Source: Pharma Marketing Blog - January 29, 2013 Category: Pharma Commentators Tags: Amgen Genentech Roche Lobbying generics biosimilar Source Type: blogs
Lipitor & Plavix: The Last of the Small Molecule Best Sellers?
Forbes just published a list of "Best Selling Drugs of All Time" (see here). I created the following chart from the data cited (click on it for a larger view):"Tellingly," notes the Forbes author, Simon King, "each of the products in the list above best positioned to record an increase in peak annual sales over the next five years is a biologic; Humira, Enbrel, Rituxan, Herceptin and Lantus being the chief candidates. This is driven by a number of factors – the later launch of certain brands, for example – but also illustrates the robustness of leading biologic franchises that do not face direct substitutable generic c...
Source: Pharma Marketing Blog - January 28, 2013 Category: Pharma Commentators Tags: Drug prices Plavix Humira Lipitor Pfizer drug pipeline orphan drugs Blockbuster Source Type: blogs
