MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'biogenerics'. Sat, 03 Sep 2011 02:49:57 +0100 http://www.medworm.com/index.php?rid=3570064&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsrC_yVcpSfQ%2F Welcome back. We hope your weekend was pleasant and refreshing. Now, of course, the routine returns. Deadlines and meetings loom, yes? To cope, we are brewing the required cup of stimulation. Feel free to join us, or grab a bottle of water if you prefer. Meanwhile, here are a few interesting items to help you along. Have a great day, everyone, and do stay in touch… Astellas Sweetens Bid And Buys OSI Pharma For $4B (Reuters) Merck Service Union Ratifies Contract (The Reporter) Pfizer Cuts Pregnant Mare Urine Suppliers (Portage) Merck Reveals Pitfalls Of Biogenerics (Seeking Alpha) Lingering Questions About Sirtris Pharma Research (Boston Globe) Abbott Adds 75 Jobs In Ireland (Donegal Democrat) Pfizer’s New London Complex Generates Mixed Interest (Hartford Courant) (Source: Pharm... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3570064 Mon, 17 May 2010 11:55:00 +0100 3570064 http://www.medworm.com/index.php?rid=3322629&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbOW8qNg2sho%2F A report from the General Accountability Office found that among all Medicare Part D beneficiaries who used at least one specialty tier–eligible drug in 2007, 55 percent reached the catastrophic coverage threshold, after which Medicare pays at least 80 percent of all drug costs. In contrast, only 8 percent of all Medicare Part D beneficiaries who did not use a specialty tier–eligible drug reached this threshold in 2007. Specialty tier–eligible drugs accounted for 10 percent, or $5.6 billion, of the $54.4 billion in total prescription drug spending under Medicare Part D plans in 2007. And Medicare beneficiaries who received a low-income subsidy accounted for most of the spending on specialty tier–eligible drugs—$4.0 billion, or 70 percent of the total, according to the GAO. High-c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3322629 Tue, 02 Mar 2010 17:21:36 +0100 3322629 http://www.medworm.com/index.php?rid=3176120&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Flr8SPbkRoWk%2F Some late-in-the-game, behind-the-scenes dealmaking appears to be under way involving generic drugmakers, the White House and Henry Waxman, who chairs the House Energy & Commerce Committee over granting biotechs 12 years of exclusivity against biogenerics, the Associated Press writes. The skirmishing comes as Congress edges closer to a final version of health care reform legislation. The drive to shrink the protection period to a rumored 10 years has prompted opposition from the pharmaceutical industry, which argues the longer period is needed to encourage investments needed to produce biotechs. “Fair data protection of at least 12 years is critically important to the future of medical progress in America,” Ken Johnson, PhRMA’s senior vp, tells the AP. Three dozen pa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3176120 Fri, 15 Jan 2010 01:44:44 +0100 3176120 http://www.medworm.com/index.php?rid=2453039&cid=t_131160_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2009%2F06%2Fmedco-cfo-sees-generic-insulin-by-2013.html This isn't meant to be a primer on the role of the Pharmacy Benefits Managers (or PBMs), but few people realize just how massive the role of the PBM really is in today's healthcare reform debate. These companies know the score when it comes to the drug costs, prescription and usage patterns and the outlook on where things are likely to be going.The Role of the PBM in the U.S. Healthcare "System"PBMs are probably one of the biggest players in the U.S. healthcare field that most people have at best, only a hazy idea of their role in managing the cost of healthcare. For people with chronic medical conditions, they may know these companies as the mail-order companies they're forced to order 90-day supplies from. Increasingly, however, many healthcare plans are placing caps on prescriptions fil... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=2453039 Wed, 03 Jun 2009 18:00:00 +0100 2453039 http://www.medworm.com/index.php?rid=2325153&cid=t_131160_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2009%2F04%2Fwelcome-back.html No, I'm not referring to the cheesy 1970's TV show starring John Travolta. But with the New Year already well underway (by more than 3 months, no less), I know its been quite a while since my last blog posting. Since April 1st was my birthday, I decided to post to let everyone know I haven't disappeared (and as Mark Twain once wrote "Reports of my demise have been greatly exaggerated"). I've been very quiet on the blogging front for the past few months, and I had a good reason (I really don't need a reason but I have one anyway): I was in the process of moving into a new place. I did the move mostly by myself (meaning no movers), and mostly when I had free time (meaning on the weekends and evenings, basically all of my "free" time). Of course, I still have a job to occupy my time during no... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=2325153 Fri, 03 Apr 2009 12:00:00 +0100 2325153 http://www.medworm.com/index.php?rid=2027779&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F479597413%2F The drugmaker is hosting its annual R&D briefing for Wall Street analysts and fund managers, where surprises are usually not on display. This time, however, Merck execs are saying they want to establish a new unit to make generic biotechs, which some calls biogenerics, biosimilars or follow-on biologics, although there are subtle differences between these terms. In any event, the basis for the effort is Merck’s acquistion of GlycoFi, a biotech bought two years ago for its proprietary glyco-engineering technology. The move represents what Merck execs are caling a “significant” opportunity since so patents on so many big-selling biologies are scheduled to expire through 2017. Merck’s first follow-on biologic is for anemia, with plans to in 2012, and another five ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2027779 Tue, 09 Dec 2008 15:11:13 +0100 2027779 http://www.medworm.com/index.php?rid=1981289&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F458346037%2F This topic may have fallen off the radar screen amid the presidential election and the recession, but the rising cost of biologics continues to be a problem. And the Federal Trade Commission wants to shape the discussion before Congress and the FDA proceed with a framework that will permit drugmakers to create and market lower-cost versions. So, at 8:30 am EST today, the FTC will conduct a workshop organized into five panels to discuss the following issues: the price and market share effect of entry by both biosimilar and biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process. The FTC, you may recall, wrote a lette... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1981289 Fri, 21 Nov 2008 12:22:29 +0100 1981289 http://www.medworm.com/index.php?rid=1833423&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F402967745%2F The prices of specialty meds most commonly used by Medicare Part D beneficiaries to treat such maladies as cancer, rheumatoid arthritis and multiple sclerosis have risen faster than inflation every year since 2004 and rose three times the inflation rate last year, according to a survey from AARP. “The skyrocketing cost of specialty drugs is especially tragic for those suffering from diseases like cancer and multiple sclerosis,” John Rother, AARP’s executive vp of policy and strategy, says in a statement. “These drugs can provide comfort and hope to these individuals and their families. But even the most miraculous drug is useless if a person can’t afford to take it.” The survey, which covered 144 brand-name and generic meds, will be used by AARP in its battle to speed appro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1833423 Thu, 25 Sep 2008 17:07:22 +0100 1833423 http://www.medworm.com/index.php?rid=1809934&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F396407683%2F You’re not surprised, are you? In any event, expanding the use of low-cost generics, including versions of biologics, would be near the top of their health care agendas, according to their advisers, who were speaking at a conference for the generic industry. “We know that expanding the use of generics and eliminating barriers to that goal must be a centerpoint of any health reform effort,” Dora Hughes, a health care adviser for Obama, according to the Associated Press. And McCain adviser Douglas Holtz-Eakin echoed the sentiment: “Controlling health care costs has to be the imperative of any effective health care reform.” And both campaigns pledged their support to help create a market for generic biologics, a long-sought goal of generic makers such as Mylan L... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1809934 Thu, 18 Sep 2008 17:36:42 +0100 1809934 http://www.medworm.com/index.php?rid=1739487&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F377447735%2F Lost amid the presidential campaign, the sour economy and other sobering distractions over the past few months, the advent of follow-on biologics continues to lurk in the background as a significant issue that can be expected to regain attention sooner than later. Biologics, of course, are expensive - costing tens of thousands of dollars and up annually. But there is no approved regulatory framework allowing biotechs to develop and market follow-ons, although three bills are lingering in Washington. A Congressional Budget Office report found the cost of a Senate bill, if enacted, would reduce total expenditures on biologics by $25 billion between 2009 and 2018. Now, the Federal Trade Commission is examining the issue with an eye toward sorting out competitive issues, incentives and patents... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1739487 Fri, 29 Aug 2008 11:21:17 +0100 1739487 http://www.medworm.com/index.php?rid=1709299&cid=t_131160_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F08%2Fgeneric-insulin-in-2008-dont-bet-on-it.html Remember Insmed? Well, back in February, I posted a story I called "Meet Mike Coleman", which was coined from the Pharmalot news story featuring a YouTube video entitled "Meet Mike, Your Generic Biologics Lobbyist". Well, this morning's Washington Post has another story on the company's marketing efforts to advocate legislation passes to permit biogenerics, which quite frankly, seems unlikely to pass in 2008, but I'd never say never when politics are concerned.One has to wonder, since the law currently considers insulin a "drug" not a biotech medicine, and under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, a "generic" doesn't have to be an exact duplicate of the brand-name original in order to be approved by the FDA. So why isn't Insmed applying to make generic insulin an... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1709299 Thu, 14 Aug 2008 14:00:00 +0100 1709299 http://www.medworm.com/index.php?rid=1606130&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F331710557%2F In doing so, Insmed apparently becomes the first US company to demonstrate bioequivalence for a follow-on biologic. The next step is for the drugmaker to meet with the FDA in hopes of receiving a green light to proceed with a Phase III study for its INS-19 which, like Neupogen, would combat neutropenia, a common side effect of chemotherapy. Neupogen, by the way, is a $1 billion seller. A Phase I trial involving 32 patients receiving either a dose of Insmed’s INS-19 or Amgen’s Neupogen found that the way the two biologics interacted with the body was statistically indistinguishable, while the concentration of G-CSF (G-CSF stimulates the production of white blood cells) for the two products were identical, according to Insmed. Here’s the statement. Two years ago, the FDA approved O... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1606130 Thu, 10 Jul 2008 13:02:22 +0100 1606130 http://www.medworm.com/index.php?rid=1546986&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F320500932%2F The Congressional Budget Office has released its long-awaited assessment of the cost of a Senate biogenerics bill and found that the legislation, if enacted, would reduce total expenditures on biologics in the US by $25 billion between 2009 and 2018. Over that 10-year period, savings would equal roughly 0.5 percent of national spending on prescription drugs, valued at wholesale prices. Moreover, the bill would reduce budget deficits - or increase surpluses, depending on your point of view - by $6.6 billion over the same period. A few other CBO calculations: Direct spending by the federal government would decrease by $46 million over the 2009-2013 period, and by $5.9 billion over the 2009-2018 period; most of those savings would accrue to the Medicare program. Federal revenues would increa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1546986 Thu, 26 Jun 2008 12:48:53 +0100 1546986 http://www.medworm.com/index.php?rid=1396426&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F276992439%2F One of these days, biosimilars will become available in the US. Of course, that depends on when Congress gets around to deciding on how these meds should be approved and regulated. Right now, there are three proposals floating around Congress, which are being fought over, primarily, by generic drugmakers, biotechs, insurers, large employers and consumer groups because the meds usually cost thousands of dollars a month per patient. Given the dickering over the complexities of the issue and the fact that this is an election year, which is likely to slow congressional movement, the US market is likely to take off slower than other markets, according to Kalorama Information. Nonetheless, the research firm posits that biosimilars will still hit $5.8 billion by 2012 if one bill or another actual... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1396426 Thu, 24 Apr 2008 16:00:39 +0100 1396426 http://www.medworm.com/index.php?rid=1391300&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275359444%2F In a decision that shows how difficult it is to copy biologics, the FDA has rejected Genzyme’s request to sell a version of its Pompe disease drug, called Myozyme, which the drugmaker planned to manufacture at an additional site. But the agency ruled that any Myozyme made at the second plant should be considered a different product because of small differences in its chemical structure, The Boston Globe reports. In order to sell the latest version of the drug in the US, Genzyme will have to file another application with new data showing the drug is safe and effective in large numbers of patients. Pompe disease is a rare, debilitating genetic illness that prevents people from breaking down a common sugar called glycogen, which can then build up in the body’s cells and weaken the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1391300 Tue, 22 Apr 2008 12:10:41 +0100 1391300 http://www.medworm.com/index.php?rid=1376871&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F271659592%2F The behind-the-scenes machinations that will determine the blueprint for allowing generic biologics - or biosimilars, as many call them - is threatening to emerge as a consumer healthcare issue. Or that’s what is hoped by a group of generic drugmakers, insurers, pharmacy chains and major employers. With lobbying heating up in Washington, the Coalition for a Competitive Pharmaceutical Market has aligned itself with several consumers groups to begin a newspaper campaign that portrays brand-name drugmakers and biotechs as flying into Washington DC to unfairly line their pockets at the expense of patients. A letter was also sent today to the House Energy and Commerce Committee. The biosimilar issue is, of course, complicated, but a key sticking point is the extent to which brand-name com... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1376871 Wed, 16 Apr 2008 20:38:01 +0100 1376871 http://www.medworm.com/index.php?rid=1322423&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F257007687%2F As the US grapples with a pathway for biogenerics, Health Canada has beat the FDA to the punch and issued a draft guidance. The agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway, FDA News reports. If finalized, a so-called subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes, FDA News continues. A subsequent-entry biolo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1322423 Mon, 24 Mar 2008 12:27:16 +0100 1322423 http://www.medworm.com/index.php?rid=1307753&cid=t_131160_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F03%2Frep-eshoo-decries-congressional.html What would you say to a Congresswoman who behaves like a hypocrite? Well, California's 14th District (an area I'm very familiar with, having lived in the district for nearly a decade during the 1990's) House Representative Anna Eshoo deserves just such a rebuke today. Ms. Eshoo, who was on the San Mateo County Board of Supervisors when I resided in Foster City, represents the district where many biotechnology firms and venture capitalists are based, encompassing much of Silicon Valley and stretches up the San Francisco Peninsula.Just what has she done? Well, she has sponsored legislation aimed at "cleaning up the House" which she claims is to restore the confidence of the American people in their government. Sounds convincing so far. One of the key elements in her proposed legislation aims... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1307753 Mon, 17 Mar 2008 15:45:00 +0100 1307753 http://www.medworm.com/index.php?rid=1305019&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F251713783%2F As promised last month, Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has now introduced legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, plus an extra two years for a medically significant innovation. That adds up to, yes, 14 years. (This is the bill and this is the summary). Not surprisingly, the BIO trade group was ecstatic in its praise for Eshoo and Joe Barton, a Texas Republican who joined her in sponsoring the bill, which calls for studies to demonstrate safety and efficacy; requires the FDA to create a mechanism to determine whether products are interchangeable and also requires the agency to issue guidances for biosimilar approv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1305019 Sat, 15 Mar 2008 00:50:37 +0100 1305019 http://www.medworm.com/index.php?rid=1250426&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F239479388%2F David Snow may be a Republican, but he knows when legislation is in his best interest. And efforts by Democrats to make biogenerics a reality and to create a safety net for millions of uninsured Americans will mean more business for Medco Health Solutions, the pharmacy benefits manager that he runs. Dave doesn’t say who’ll win his vote in the upcoming election, but he does sound happy in an interview with The Star-Ledger of New Jersey (which owns Pharmalot). Here is an excerpt… SL: Wal-Mart could be moving into the pharmacy-benefits business. Are you worried? Snow: A lot of people shake in their boots when they hear the name Wal-Mart in any industry. This is a very, very complicated business with serious barriers to entry. I just don’t think they’re going to p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1250426 Fri, 22 Feb 2008 16:16:16 +0100 1250426 http://www.medworm.com/index.php?rid=1242296&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F237584533%2F Some wags say the debate over biologics may not go anywhere this year, but one congresswoman is supposedly on the verge of introducing a bill to resolve the controversy. Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has drafted legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, according to the FDA Law blog. The draft would amend the Public Health Service Act by adding a section that would allow biologic licenses to be submitted and include info demonstrating the med is biosimilar based on analytical studies, animal studies, and a clinical study or studies (such as an immunogenicity assessment and pharmacokinetics or pharmacodynamics). Und... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1242296 Tue, 19 Feb 2008 14:16:45 +0100 1242296 http://www.medworm.com/index.php?rid=1233330&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235193140%2F After nearly a decade of resisting, biotech companies want a law passed this year that lets generic drug companies sell cheaper copies of their medicines. Biotechs, of course, have never had the competition from generics that brand-name drugmakers face when patents expire. While the FDA lacks authority to approve generic biotechs, several bills introduced in Congress during the past year would change that, the Associated Press writes. Biotech companies say they are ready for that change - so much so that their main trade group is making the legislation a top priority in 2008. And the Bush administration recently said it supports that aim. The shift comes as election-year politics are expected to turn Washington away from biotech’s interests. Many political observers expect Democrats ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1233330 Thu, 14 Feb 2008 22:01:15 +0100 1233330 http://www.medworm.com/index.php?rid=1200755&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F229036633%2F The White House requested a $2.4 billion budget for the agency for the 2009 fiscal year starting in October, up 5.7 percent from 2008. And the Bush administration includes new funds to speed review of generics and new authority to approve biosimilars, which are also sometimes referred to as generic biologics. Generic drugmakers have been pushing the FDA for specific guidance on developing biosimilars, an issue that has gained traction as part of the larger health care debate because existing biologics are expensive, often costing tens of thousands of dollars a year per patient. “A pathway filled with roadblocks to access, including excessive market exclusivity provisions, is an empty promise for countless patients who need these affordable life-saving medicines,” Kathleen Jaege... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1200755 Mon, 04 Feb 2008 18:13:14 +0100 1200755 http://www.medworm.com/index.php?rid=1119360&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F207045342%2F Lying on the beach? Sprawled across the couch? Maybe you’re in the office trying to catch up while things are quiet? Wherever you are, there are always interesting tales to read. Here are some we found during our own time off this week (Did we say we were on vacation?) Enjoy…. A little company in Canada is high on marijuana. Cannasat Therapeutics is testing its first product, CAT-310, which it says takes away the so-called “buzz” of marijuana that makes some terminally and chronically ill patients, particularly the elderly, uncomfortable and anxious, The Toronto Star reports. The med is aimed directly at the $4 billion neuropathic pain market that is mainly serviced by various opiates, anti-convulsants and anti-depressants. The idea is to mimic smoked cannabis throu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1119360 Thu, 27 Dec 2007 14:45:04 +0100 1119360 http://www.medworm.com/index.php?rid=977432&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F174822466%2F A rainy morning here in the nation’s medicine chest. Even so, there are always rays of sunshine emanating from the news. So grab a cup of coffee or tea and enjoy the warmth… Europe Opens Its Doors To Cheaper Biogenerics (The Chicago Tribune) ImClone Profits Fall On Charge (Yahoo/AP) Celgene Earnings Rise On Higher Sales (Yahoo/Reuters) And here are a couple of interesting tales you may have missed…. The indefatigable Amgen ceo, Kevin Sharer, who doesn’t know a crisis when he sees one, hopes that a new drug, denosumab, could become a “double blockbuster,” both as a twice-a-year treatment for osteoporosis and as a remedy for cancers of the bone. And so Forbes writes that for denosumab to succeed, Amgen will have to battle with Novartis and its once-a-year ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=977432 Thu, 25 Oct 2007 11:40:35 +0100 977432 http://www.medworm.com/index.php?rid=729954&cid=t_131160_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F133022675%2F The House may have passed the FDA Amendments Act last night but some issues are far from settled. A big outstanding issue is what happens with biogenerics? The House bill doesn’t include a so-called pathway, which is included in the Senate version. And as The Wall Street Journal writes, it’s not clear whether House leaders, including Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, will compromise. Different House members have introduced divergent bills, but the Energy and Commerce Committee hasn’t moved forward with any of them, the paper notes. In an interview yesterday with the paper, Mr. Dingell signaled that he will oppose inclusion of the copycat biotech-drug language in a final bill. Although he supports a pathway, he has safety concerns as... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=729954 Thu, 12 Jul 2007 15:21:34 +0100 729954 http://www.medworm.com/index.php?rid=728716&cid=t_131160_150_f&fid=35781&url=http%3A%2F%2Fwww.qdinformation.com%2Fqdisblog%2F2007%2F05%2F21%2Fspending-on-biotech-drugs-to-reach-25-by-2012%2F Express scripts is now reporting that in five eyars, by 2012, biotech drugs will account for 25% of all expenditures on drugs. The market was $54 billion in 2006 and is expected to reach $99 billion by 2010. SignOnSanDiego.com > News > Business > Biotechnology — Spending on biotech drug prescriptions rising: I think this shows you why so many big pharma companies are either buying or investing in biotech. Also, since there is currently no biogenerics industry and regulation is only now starting to be worked on it is no wonder. Technorati Tags: biotech, biogenerics Copyright © 2007 QDIS Blog. This Feed is for personal non-commercial use only. If you are not reading this material in your news aggregator, the site you are looking at is guilty of copyright infringement. Pl... QDIS Blog blogs http://www.medworm.com/rss/comments.php?id=728716 Tue, 22 May 2007 02:24:30 +0100 728716 http://www.medworm.com/index.php?rid=728737&cid=t_131160_150_f&fid=35781&url=http%3A%2F%2Fwww.qdinformation.com%2Fqdisblog%2F2007%2F03%2F13%2Fgeneric-biotech-drugs-could-save-71-billion%2F Back in Feb an AP story stated that if there were such a thing as generic version of major biologics that it could save over $71 billion over ten years. Generic Biotech Drugs Could Save $71B The study evidently assumes a 25% decrease in price off brand name biologics. This figured is based on the price of the human growth hormone now available as a generic in Europe. I’m not sure how well this particular instance is representative of all the other classes of biologicals that would be eligible . The study was sponsored by Express SCripts and they claim it is conservative because it only includes insulin, erythropoietins, growth hormones, and treatments for multiple sclerosis. While it is interesting to speculate, I personally don’t think this would be representative of how the... QDIS Blog blogs http://www.medworm.com/rss/comments.php?id=728737 Tue, 13 Mar 2007 15:00:05 +0100 728737 http://www.medworm.com/index.php?rid=728743&cid=t_131160_150_f&fid=35781&url=http%3A%2F%2Fwww.qdinformation.com%2Fqdisblog%2F2007%2F03%2F09%2Feuropean-regulators-to-congressional-panel-use-caution-biogenerics%2F Here is a recent article in the Boston Globe. They report that European regulators testified to a congressional panel that some biological products can fairly easily be produced such as insulin and human growth hormone. Others are too complicated to be safely duplicated. Caution urged on biologic drugs - The Boston Globe Europe has had biogenerics for the last four years but European regulators have required human clinical trials for these products. I think there is need for talking about what process may be in the best interest of patients and is safe. I’d like to see criteria developed for biologics that would allow it to be determined which can be safely approved in a fashion similar to the current generics model based on bioequivalence, and which would have to undergo human trial... QDIS Blog blogs http://www.medworm.com/rss/comments.php?id=728743 Fri, 09 Mar 2007 18:28:38 +0100 728743