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Analysts predict gloomy future for major drugmakers
Patent expiration and generic competition continue to threaten the revenue of big pharmaceutical companies and will probably cause the industry to experience negative growth in 2011, an analyst said. A Lehman Brothers health care expert says that while acquisitions may help drugmakers replenish their pipeline and regenerate profit, major changes in research and development are also necessary. Financial Times (5/8)
Novartis teams up with U.K. firm for generic asthma treatments
Novartis AG, the parent company of Sandoz, has reached an agreement with U.K.-based Vectura Group to develop generic versions of next-generation asthma treatments, Sandoz CEO Andreas Rummelt announced. The companies are setting up manufacturing in eastern Germany and will use Vectura's GyroHaler dry power device to produce copies of inhaled asthma drugs. The Guardian (London)/Reuters (5/8)
Celgene prepares to conquer global market
Celgene Corp. is planning to expand beyond the European market for blood cancer and inflammatory disease treatments in the next five years, capitalizing on its acquisition of Pharmion to sell its products in more than 100 countries worldwide. "We look toward the future with utmost confidence," Chief Executive Sol Barer told analysts Thursday. The Star-Ledger (Newark, N.J.) (5/9)
Dialysis centers report run-up in heparin prices
Global recalls of tainted supplies of the blood thinner heparin have caused the drug's price to double since mid-April, according to major dialysis centers in the U.S. APP Pharmaceuticals, which became the sole U.S. distributor of heparin after Baxter International recalled its products, said it has tripled production and that the higher prices do not cover all the expenses of manufacturing the drug. USA TODAY (5/8)
FDA official calls for clinical trial regulations
The FDA is working with the HHS Office for Human Research Protections to develop a final rule for registering institutional review boards as part of the agency's efforts to provide clinical study regulations instead of guidances. Current regulations do not take into account issues such as data standardization, electronic health records and all groups -- including vendors and contract research organizations -- involved in clinical trials, a senior FDA official said. FDAnews (5/9)
Bill would promote therapies for brain disorders, injuries
Lawmakers have introduced a bill that would allocate $200 million in federal funds to spur the development of new treatments for brain and nervous system diseases and injuries. Funds from the National Neurotechnology Initiative Act are also aimed at adding and training FDA staff, as well as improving coordination among 16 branches within NIH that focus on brain-related injuries. Scientific American (5/8)
Bush administration proposes limits to Medicare-plan marketing
The Bush administration on Thursday recommended that health insurance agents be prohibited from using door-to-door marketing and other aggressive strategies to enroll older people in Medicare's private plans and prescription drug program. America's Health Insurance Plans head Karen Ignagni said the move is "an important step to ensure beneficiaries can rely on the information being provided to make the Medicare coverage decisions that are right for them." The Wall Street Journal (free content) (5/9)
Pilot program for safe drug disposal launched in Milwaukee
Milwaukee-based Capital Returns has teamed up with the University of Wisconsin Extension and the Wisconsin Department of Natural Resources to launch a program that will allow some residents to ship their unused drugs to Capital Returns for proper disposal. The pilot program, which is set to be rolled out next week in Waukesha and Winnebago counties, is aimed at preventing expired or unused medicines from entering the water supply. Chicago Tribune/Associated Press (free registration) (5/8)
FDA expands approval of Bristol-Myers' Abilify
Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd. have obtained FDA clearance to market Abilify as an adjunctive therapy to lithium and valproate for the treatment of bipolar episodes in adults. The agency also approved a new dosing plan for adults who take the drug. CNNMoney.com/Associated Press (5/8)
FDA sees surge in counterfeit drug cases
The FDA recorded an eightfold hike in the number of new counterfeit drug cases between 2000 and 2006, according an editorial in The Lancet. Substances such as chalk and antibiotics are used to produce fake medicines, which are expected to generate $75 billion in 2010, the article said. Google/The Press Association (5/8)
New drug type shows promise in treating various ailments
Scientists have developed vasopressin-receptor antagonists, a new class of drugs that could be used to treat conditions including kidney disease and brain hemorrhage, researchers report. Also known as vaptans, the drugs target the vasopressin system, which plays a role in regulating blood flow and water retention in the body. Google/The Press Association (5/8)
BioDelivery mouth patch for cancer pain holds potential
BioDelivery Sciences International announced that BEMA Fentanyl, a mouth patch for use in patients with breakthrough cancer pain, offered more relief than a placebo and was found safe for patients in a Phase III trial. The FDA is expected to decide Aug. 31 whether to approve the product for marketing. American City Business Journals/Raleigh/Durham (5/8)
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