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 'hatch'. Sat, 03 Sep 2011 02:36:23 +0100 http://www.medworm.com/index.php?rid=4976207&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-30La5fXibE%2F The US Supreme Court has agreed to review a complicated and controversial case that may alter the way brand-name drugmakers use patent law to delay generic competition (see this). At issue is the ability of generic drugmakers to seek FDA approval under a provision of the Hatch-Waxman Act to market a drug for uses not covered by patents held by brand-name drugmakers. The case has generated considerable interest and, in fact, the US Solicitor General urged the court to conduct a review. Wall Street, meanwhile, has signaled that, if the status quo continues, brand-name drugmakers will have a new means of fending off unwanted generic rivals. The Generic Pharmaceutical Association says the review is needed because a Federal Circuit ruling “threatens to eliminate a critical check on brand-name... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976207 Mon, 27 Jun 2011 20:53:16 +0100 4976207 http://www.medworm.com/index.php?rid=4872472&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FadgmeRx2WXw%2F The Obama administration is urging the US Supreme Court to review a complicated and controversial case that may alter the way brand-name drugmakers use patent law to delay generic competition. At issue is the ability of generic drugmakers to seek FDA approval under a provision of the Hatch-Waxman Act to market a drug for uses not covered by patents held by brand-name drugmakers. Not surprisingly, the case has generated considerable interest in the generic industry, as a quick peek at the Supreme Court docket makes clear (see here to see who has filed a brief). Wall Street, for instance, has signaled that, if the status quo continues, brand-name drugmakers will have found a new means of fending off unwanted generic rivals. In a statement, the Generic Pharmaceutical Association says the Supr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872472 Fri, 27 May 2011 13:08:59 +0100 4872472 http://www.medworm.com/index.php?rid=4862924&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPY8LOK5kv_0%2F Once again, the US Federal Trade Commission is trying to thwart pay-to-delays deals and its latest effort is a brief in which the agency has asked an appeals court to reverse a lower court ruling that sanctioned a settlement between Schering-Plough and two generic drugmakers - Upsher Smith and ESI, which was a division of Pfizer’s Wyeth - over the K-Dur blood pressure med. The background: In 1995, the two generic drugmakers sought FDA approval to sell versions of K-Dur, but Schering-Plough, now owned by Merck, filed suit for patent infringement. Just before the trial, Schering-Plough agreed to pay Upsher $60 million not to sell a generic until 2001, and the FTC filed suit (read here). Separately, Schering-Plough agreed to pay ESI up to $15 million to agree not to sell a generic until... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862924 Wed, 25 May 2011 12:02:39 +0100 4862924 http://www.medworm.com/index.php?rid=4841429&cid=t_102835_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FdPEE57zMGPY%2F By Ilya ShapiroThis morning I outlined the stakes of today’s seminal cloture vote on Goodwin’s Liu’s nomination to the Ninth Circuit.  Well, now we have a result: cloture failed 52-43, with Senator Ben Nelson (D-NE) joining all voting Republicans except Lisa Murkowski (R-AK) against cloture. Three Republicans plus Max Baucus (D-MT) were absent, while Orrin Hatch (R-UT) voted present because of his previous strong position against filibusters. This is the first judicial nominee filibustered since the Gang of 14 brokered an agreement on President Bush’s nominees in 2005, forestalling then-Senate Majority Leader Bill Frist’s use of the so-called nuclear option (changing Senate rules to eliminate the judicial filibuster).  That agreement, to the extent it&#821... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4841429 Thu, 19 May 2011 19:21:57 +0100 4841429 http://www.medworm.com/index.php?rid=4715023&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3EmIsWhgxuY%2F Late last month, the US Supreme Court asked the Obama administration for its views on a complicated and controversial spat that has the potential to alter the way brand-name drugmakers use patent law to delay generic competition (look here). Whether the Supremes choose to review the case is unclear, but by asking the US Solicitor General to comment, the court has signaled a hearing is, indeed, a possibility. The case, meanwhile, is being closely watched, as one might imagine. A growing number of generic drugmakers have begun filing briefs with the Supreme Court, explaining why a review is warranted. And Wall Street has signaled that, if the status quo continues, brand-name drugmakers will have hit on a new means of fending off unwanted generic rivals. Here is the background: In 2005, Novo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715023 Thu, 14 Apr 2011 12:00:05 +0100 4715023 http://www.medworm.com/index.php?rid=4642995&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuZGC-ukK-wc%2F Should generic drugmakers be required to strengthen product labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded med? This question goes to the heart of a pair of state lawsuits filed by two women, who claim generic drugmakers should be held liable for failing to warn of serious side effects. However, the drugmakers, which include Actavis and Pliva, claim federal law preempts the lawsuits, because they would be required to offer labeling that is different from what appears on the label of the brand-name drug. The generic drugmakers further maintain that permitting such lawsuits to proceed in state courts would raise their costs, which would, ultimately, be passed on to consumers. This complicated issue will be heard this coming We... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642995 Mon, 28 Mar 2011 13:12:39 +0100 4642995 http://www.medworm.com/index.php?rid=4399826&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTU6O6Hd_s60%2F Another day, another letter to the FDA commish from a group of bipartisan US senators over the biologics debate. The latest missive comes from health committee chair Tom Harkin, John McCain, Chuck Schumer and Sherrod Brown, who are “extremely concerned about possible misinterpretations” of the biosimilars statute “that could further delay the availability of generic biologic drugs.” They are referring to a provision in the healthcare reform law that says generics can enter the market after a brand-name biologic has had exclusivity for 12 years. But earlier this month, a different group of senators - Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry - wrote FDA commish Margaret Hamburg to urge a different interpretation that would favor brand-name drugmakers and biotechs. At issue... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399826 Tue, 25 Jan 2011 16:57:23 +0100 4399826 http://www.medworm.com/index.php?rid=4382949&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbWRWTVXZO5M%2F Another nasty lobbying battle has broken out over biosimilars. And the latest involves a group of generic drugmakers, insurers and pharmacy benefit managers, which are pushing back against a recent effort by brand-name drugmakers to weaken a part of healthcare reform that is supposed to create competition for expensive biologics. The provision says generics can enter the market after a brand-name biologic has had exclusivity for 12 years. But earlier this month, a bipartisan group of four US Senators - including Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry - wrote FDA commish Margaret Hamburg to urge a different interpretation that would favor brand-name drugmakers and biotechs. Their letter was circulated on and beyond Capitol Hill by, among others, the BIO trade group. At issue is... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4382949 Fri, 21 Jan 2011 14:25:26 +0100 4382949 http://www.medworm.com/index.php?rid=4331236&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FED0DYDEIm1U%2F The controversy over so-called pay-to-delay settlements between brand-name and generic drugmakers has prompted attorneys general from 32 states to file an amicus, or friend-of-the-court brief urging the US Supreme Court to review the deals, which the states say thwart competition and block needed access to lower-cost medications. The move comes less than a month after three pharmacy chains and a wholesaler petitioned the court to rule on the issue, which has divided other federal courts (see this) and spurred the Federal Trade Commission into a Quixotic quest to urge Congress to pass a law to restrict these deals (back story). The case that precipitated these filings involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331236 Tue, 11 Jan 2011 13:26:37 +0100 4331236 http://www.medworm.com/index.php?rid=4331240&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ffs_tQgfFVm0%2F Nothing like a trade off between generations. A new study suggests that extending data exclusivity for small molecule brand-name drugs will lead to higher drug costs in the short term, but down the road, more than 200 additional drugs would be approved as a result of the increased revenue generated, offering increased industry incentives. And this would also boost life expetancy for future generations. In other words, today’s patients pay more, but tomorrow’s patients can get a better deal. Data exclusivity, you may recall, refers to the exclusive access to clinical trial data and, right now, brand-name drugmakers are granted five years for data submitted during the FDA approval process. There’s also an extra three years for supplemental applications and six months more f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331240 Mon, 10 Jan 2011 14:55:34 +0100 4331240 http://www.medworm.com/index.php?rid=4272601&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpAmBhLecykw%2F The controversy over the so-called pay-to-delay settlements is bubbling up to the US Supreme Court. Three pharmacy chains and a wholesaler have asked the court to review the issue because they maintain the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. The issue has become a cause celebre for the US Federal Trade Commission (look here), which has been lobbying Congress to enact legislation to restrict the settlements, and has also divided courts across the country, which is why the Supreme Court was asked to review the topic and settle the matter. The case cited by the retailers and wholesaler involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiot... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4272601 Mon, 20 Dec 2010 15:41:59 +0100 4272601 http://www.medworm.com/index.php?rid=3721960&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F28WlTkAyHMw%2F A proposal to end those controversial ‘pay-to-delay’ deals between brand-name and generic drugmakers was passed by the House of Representatives last night as part of a measure to fund wars. Ironic, yes? Or maybe appropriate. In any event, the bill now goes to the Senate, Bloomberg News reports. Under the proposal, drugmakers could be fined if the Federal Trade Commission or the courts determine they struck deals to preserve a brand-name drug patent by delaying introduction of a lower-priced generic equivalent (see page 74). This is “just another signal of the growing support in Congress for ending this unconscionable behavior by some pharmaceutical companies,” FTC chairman Jon Leibowitz tells the news service. The FTC, you may recall, has made a mission of ending these dea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3721960 Fri, 02 Jul 2010 12:55:23 +0100 3721960 http://www.medworm.com/index.php?rid=3633422&cid=t_102835_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F06%2Flouisiana-officials-alan-levine-peggy-hatch-urge-osha-involvement-bp-oil-spill%2F Louisiana Health and Hospital Secretary Alan Levine and Environmental Quality Secretary Peggy Hatch are urging the US Occupational and Safety Health Administration to become more involved in monitoring the health of the thousands of workers cleaning up the BP oil spill. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3633422 Sat, 05 Jun 2010 18:33:21 +0100 3633422 http://www.medworm.com/index.php?rid=2725213&cid=t_102835_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F08%2F21%2Fua-research-team-designing-holographic-imaging-system-for-ovarian-cancer%2F University of Arizona researchers Jennifer Barton and Ray Kostuk have received a five-year, $2.4 million grant from the National Institutes of Health to build the instrument that they hope will one day be used to monitor women at high risk for ovarian cancer. Two University of Arizona [UA] researchers have formed a research team to [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2725213 Sat, 22 Aug 2009 02:26:23 +0100 2725213 http://www.medworm.com/index.php?rid=1739487&cid=t_102835_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=1255191&cid=t_102835_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F240867149%2F Earlier this month, the US Federal Trade Commission filed a lawsuit accusing Cephalon of paying more than $200 million to four rivals for keeping generic versions of its Provigial sleep-disorder pill off the market. The move was the latest effort in a long-running battle by the agency to thwart settlements it labels costly to consumers. Brand-name drugmakers, however, say the deals make sense if patent litigation can be minimized. In an editorial in The Washington Post, Jon Leibowitz, one of five FTC commissioners, says the Cephalon case may land before the Supreme Court. Here is an excerpt… “Getting health-care costs under control is a daunting and multifaceted challenge. But one simple approach could save consumers billions of dollars annually: stopping pharmaceutical compani... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1255191 Mon, 25 Feb 2008 13:02:23 +0100 1255191 http://www.medworm.com/index.php?rid=478803&cid=t_102835_87_f&fid=34882&url=http%3A%2F%2Fbreathspakids.blogspot.com%2F2007%2F01%2Fdiet-supplements-safety-and-children.html We're used to media pieces that warn us of the nutritional inadequacies of our diet or suggestions that intensive farming strips our food of nutritional value to the point where we would all be well-advised to take supplements. Lots of lifestyle media advise us to be wary of pharmaceutical preparations and to consider 'safer, natural' alternatives. The New York Times has published an interesting essay: Diet Supplements and Safety: Some Disquieting Data (use Bug Me Not if it asks for a log-in and read the correction) that is taken from Dan Hurley's Natural Causes: Death, Lies and Politics in America’s Vitamin and Herbal Supplement Industry. I haven't seen the book but it has attracted some adverse comments from interested parties on amazon.com (which is why I've given the US rather than U... Breath Spa for Kids blogs http://www.medworm.com/rss/comments.php?id=478803 Wed, 17 Jan 2007 17:27:00 +0100 478803