Biosimilars Update: FDA Staff Recommends Approval of First Biosimilar in U.S.; Agency Accepts Third Biosimilar Application For Review
FDA’s “Purple Book,” which lists all licensed biological products, currently has an empty column under the “biosimilar” heading, which would state imitation products deemed “highly similar” next to the listed reference. That may change soon. Tomorrow, the FDA will consider whether the Agency should approve Novartis AG's copy of Neupogen, Amgen Inc.'s successful injectable biologic used to prevent infection in patients on chemo therapy. FDA staff reviewers recommended approval for the copy on all five of its proposed indications yesterday.
View the FDA Briefing Document in advance of the Oncologic Drugs...
Source: Policy and Medicine - January 6, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
You Say You Want Some Revolutions? - Famed Academic Physician Dr Milton Packer's Endless Alternating Turns as Drug Company Spokesperson and FDA Advisor
Last week, we noted we again discussed the web of conflicts of interest that is draped over medicine and health care, and seems responsible for much of our current health care dysfunction. We have discussed examples of conflicts of interest affecting clinical research, clinical teaching, clinical care, and health care policy. Each time I think we must have cataloged all the useful examples, a striking new one appears.Only a few days later, yet another new variant has in fact appeared. A New Kind of Revolving Door A new version of the "revolving door" apparently was first noted by Public Citizen, and t...
Source: Health Care Renewal - September 16, 2014 Category: Health Management Tags: Avandia Bristol-Myers-Squibb conflicts of interest FDA GlaxoSmithKline Milton Packer Novartis Pfizer revolving doors sacubitril Source Type: blogs
Biosimilars Update: FDA Releases “Purple Book”; Two Companies File Biosimilar Applications, Industry Responds to Draft Guidance
Vaccines, allergy shots, blood components, and gene therapies are examples of biological products. Most biologics are produced in living organisms, such as plant or animal cells, whereas small molecule drugs (most pharmaceuticals) are typically manufactured through chemical synthesis. The inherently complex nature of biologics makes them expensive to develop and impossible to copy in the manner traditionally associated with the approval of generic drugs.
BioSIMILAR, not BioEQUIVALENT
Enter “biosimilars,” which the Food and Drug Administration (FDA) defines as biological products that are highly similar to an already ap...
Source: Policy and Medicine - September 15, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Martha Rosenberg writes
This article was posted on Monday, March 17th, 2014 at 2:44pm and is filed underHealth/Medical, Pharmaceuticals. 0 0 51http://dissidentvoice.org/2014/03/big-pharma-helps-milk-lobby-with-dangerous-drug/? (Source: PharmaGossip)
Source: PharmaGossip - March 18, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Keyboard Lethargy
In looking at my dear blog, I see that I haven't posted in an entire month. (I even missed a scoop: Dr. Robert Taylor, formerly CEO of TeraRecon, is now vice president of global business development and technology innovation for Siemens' syngo imaging informatics business unit, according to AuntMinnie. Maybe he will be able to get Siemens PACS going properly.) I'm certain, well, I hope in a perverse way, that my readers are horribly disappointed in me. But did you call? Did you write? Did you check to see if I was still alive? Ugh...sorry, I was channeling my Jewish grandmother for a moment. There, I'm bette...
Source: Dalai's PACS Blog - January 6, 2014 Category: Radiologists Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, folks, and how are you today? Yet another busy day is unfolding here on the Pharmalot corporate campus, where the leaves are blanketing the grounds and the short people are, as always, hustling off to the local schoolhouses for what we hope is an education. As for us, we are busy downing another cup of stimulation, since we are scrambling to keep up with our to-do list. We suspect that you can relate. A treadmill is a treadmill. Meanwhile, here are some tidbits to get you started. Have a smashing time conquering the world and do stay in touch...
UK's MHRA Recalls Five Wockhardt Drugs Over Plant Problems (Reut...
Source: Pharmalot - October 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? We are just fine, thank you, although as busy as ever, thanks to a calendar brimming with meetings and phone calls this week. In fact, we will be leaving a wee bit early today in order to chat with a high-level type at a large company. More on that later. Meanwhile, here are some tidbits, as usual, which we trust you will find useful. So, have a smashing day and do stay in touch...
Bayer Is Latest Target In China Bribery Probe (South China Morning Post)
Bristol's Yervoy Drug Falls Short In Prostate Cancer Study (Reuters)
Genentech Aims For Precedent With FDA OK For Breast Canc...
Source: Pharmalot - September 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Predicting Response to Therapies with Genomics: Our recent paper is out!
Conclusions
Our data show that peripheral blood gene expression profiles are suitable for determining gene panels with high discriminatory power to differentiate responders from non-responders in infliximab therapy at baseline in CD and RA, which could be cross-validated successfully. Biostatistical analysis of peripheral blood gene expression data leads to the identification of gene panels that can help predict responsiveness of therapy and support the clinical decision-making process.
As usual, I’m more than happy to receive feedback! (Source: ScienceRoll)
Source: ScienceRoll - July 3, 2013 Category: Geneticists and Genetics Commentators Authors: Dr. Bertalan Meskó Tags: Genome science Source Type: blogs
A Watershed For Biosimliars: EU Recommends Copies Of Remicade
In a defining moment for the advent of biosimilars, European regulators have recommended two versions of the Remicade blockbuster injectable treatment, marking the first time that such an endorsement has been issued for monoclonal antibodies.
The recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use was given to biosimilars from South Korea’s Celltrion and Hospira for the same indications granted Remicade – a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis (here is the...
Source: Pharmalot - June 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Ulcerative colitis tamed
Traci posted this wonderful story of her dramatic relief from years of ulcerative colitis:
Dr. Davis,
For 24+ years I have suffered from Ulcerative Colitis (UC). This past Christmas, my stepmother recommend that I read your Wheat Belly book. I did because I had decided to remove carbs from my diet at the beginning of the year. She said your book would be a great supplement to my carb reduction. I had no idea that by reading your book my symptoms of UC would disappear!!!
Normally, I am treated with a medicine called Remicade which is administered via IV. Usually I receive this medicine every 2 months. Guess what??? It’s ...
Source: Wheat Belly Blog - March 6, 2013 Category: Cardiology Authors: Dr. Davis Tags: Ulcerative colitis 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
Up And Down The Ladder… Job Changes
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?
And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Coronado Biosciences hired Harlan Weisman, who was already a director at t...
Source: Pharmalot - January 4, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Alexza Pharmaceuticals AMAG Pharmaceuticals armagen technologies Blend Therapeutics Coronado Biosciences Eli Lilly National Quality forum NewLink Genetics OvaScience Sanofi SciFluor Life Sciences Trimel Pharmaceutical Source Type: blogs
How Much? Payers And The New Pfizer RA Pill
Two months ago, the FDA approved a pill from Pfizer called Xeljanz that is being used to treat adults with moderately to severely rheumatoid arthritis who did not respond to, or cannot tolerate, methotrexate, a standard of care. Some Wall Streeters expect the drug, which competes with such biologics as Humira, to become a blockbuster.
The drug is the first in a class of medications known as JAK inhibitors for RA and data has indicated the pill would offer similar efficacy to such widely used injectables that, collectively, generate some $13 billion in annual sales for treating rheumatoid arthritis. As noted previously, Xel...
Source: Pharmalot - January 3, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbvie Amgen Enbrel Humira Pfizer Rheumatoid Arthritis Xeljanz Source Type: blogs
Wardround 25xi11
Reading for TuesdayHow to Handle Being Out of Your Depth: 6 Tips from a Con ManCan be found on websitewww.artofmanliness.comTwo minute talks for FridayIf each of the patients on today ’s wardround had asked “can I drive when I go home?” what would be the answer?Have a look at the DVLA guidance on driving and tell us what you have learnedClinical QuestionHow common are serious infusion reactions with Infliximab and how should they be managed?Review and Expert Opinion on Prevention and Treatment of Infliximab-related Infusion Reactions. Medscape. LLA Lecluse, et alAudit questionIf patients have a condition that would r...
Source: MJM Wardrounds - November 25, 2011 Category: Universities & Medical Training Source Type: blogs
May 2011: How is Your Crohn’s Today?
Hello Everyone! I hope that you are doing well today! It is time for us to have another edition of How Is Your Crohn’s Today?. For those of you who are new to the blog, every now and then I like to check in with everyone for updates and your Crohn’s is holding up. I’ll tell you how I am doing, and you reply in the comments section about your current status.
I finally went to see my rheumatologist and did my yearly bone scan. I was reluctant to go because I was so afraid that my bone density would be worse and I have been anxious about taking the Reclast medication again. As I wrote in a previous blog, I have b...
Source: Life with Crohn's - May 6, 2011 Category: Other Conditions Authors: Kelly R Tags: Crohn's disease Crohn's blog Crohn's disease medicine Crohn's disease1 Crohn's doctor dealing with crohn's disease side effects Source Type: blogs
