Medical
FDA Plans Faster Review Of Onyx-Bayer Cancer Drug
June 28, 2012 3:21 pm | News | CommentsThe FDA will review Onyx and Bayer's application for the colorectal cancer drug candidate regorafenib in six months instead of the usual 10.
How The New FDA Bill Will Shape Pharmaceuticals
June 27, 2012 9:26 am | News | CommentsMost importantly, the bill extends the FDA's budget for reviewing new drugs and medical implants, but lawmakers have added dozens more provisions.
Swiss Drug Maker Roche To Cut 1,000 Jobs In U.S.
June 26, 2012 1:29 pm | News | CommentsThe Basel, Switzerland-based company says its closure of the site in Nutley, N.J., will consolidate R&D with operations in Switzerland and Germany.
US Court Backs Teva Patents On MS Drug Copaxone
June 25, 2012 3:15 pm | by The Associated Press | News | CommentsTeva had accused rival companies of infringing on patents covering the drug's chemical composition, and will now be free from generic competition until 2014.
FDA Probes Safety Issues With Metal Hip Implants
June 25, 2012 2:24 pm | by Matthew Perrone, AP Health Writer | News | CommentsImplants made with metal stems and sockets have been recently favored over ceramic versions, but U.K. surgeons say they're falling faster than expected.
Roche Diagnostics Plans $300M In Upgrades
June 20, 2012 11:30 am | News | CommentsRoche Diagnostics Corp. says it plans to spend $300 million over the next decade on projects at its North American headquarters in Indianapolis.
Alexion Pharmaceuticals Wins Conn. Aid For 300 Jobs
June 19, 2012 1:41 pm | News | CommentsThe biopharmaceutical firm says it will establish its global headquarters in New Haven with $20 million in loan forgiveness based on successful job creation.
Hologic A Step Closer To Gen-Probe Acquisition
June 19, 2012 9:10 am | News | CommentsMedical device maker Hologic came a step closer to completing its $3.76 billion acquisition of diagnostic test maker Gen-Probe after it passed a regulatory bar.
UK: No Health Risk From Faulty Breast Implant
June 18, 2012 7:57 am | by Meera Selva, Associated Press | News | CommentsA top British medical expert says faulty French-made breast implants do not pose any long-term health problems to women.
CryoLife To Settle 2 Lawsuits
June 15, 2012 8:45 am | News | CommentsMedical device maker CryoLife Inc. said Thursday it agreed to settle lawsuits with Medafor Inc. and CardioFocus Inc.
J&J Gets FTC Clearance To Buy Synthes
June 12, 2012 8:43 am | News | CommentsJohnson & Johnson will have to sell its system for surgically treating serious wrist fractures to win clearance of its $21.3 billion acquisition of Synthes.
Silicone Extrusion Technology Delivers High-Precision Products
June 8, 2012 12:42 pm | News | CommentsSaint-Gobain Performance Plastics (SGPPL) HealthCare Markets, a leading supplier of high-performance medical device components, introduces Compass Technology, a new co-development for silicone extrusion.
J&J To Stop Selling Pelvic Mesh Tied To Lawsuits
June 5, 2012 2:28 pm | by Matthew Perrone, AP Health Writer | News | CommentsWhile J&J insists its products are safe and that it is not recalling them, the FDA argues the company's methods are less effective than traditional procedures.
GOP Plays Offense In Medical Device Tax Fight
June 5, 2012 9:26 am | by Alan Fram, Associated Press | News | CommentsRep. Erik Paulsen, R-Minn. said the 2.3 percent tax would eat up dollars that otherwise might go toward research and development — and jobs.
Fla. Jury Awards $75M To Family Of Dead Smoker
June 1, 2012 9:31 am | News | CommentsA man's widow and daughter sued Philip Morris, R.J. Reynolds, Lorillard and Liggett, blaming his death on an unbreakable cigarette habit.
J&J Gets FDA Warning About Handling Of Complaints
May 31, 2012 9:18 am | News | CommentsThe FDA says a J&J unit received 227 complaints about various products and most often closed them without a thorough investigation.
Senate Bill Aims To Increase Drug Import Safety
May 25, 2012 9:24 am | by Matthew Perrone, AP Health Writer | News | CommentsU.S. regulators would inspect more drug manufacturing facilities in China, India and other foreign countries in order to ensure quality.
Boston Scientific Gets Approval For New Leg Stent
May 18, 2012 9:09 am | News | CommentsMedical device maker Boston Scientific Corp. said it received U.S. approval for a new type of stent to treat blocked arteries in the legs.
Agilent Buying Dako For $2.2B
May 17, 2012 9:03 am | News | CommentsAgilent Technologies Inc. said it is buying the cancer diagnostic company to help it develop a wider range of cancer-fighting products.
Medtronic: Bone Graft Investigation Is Over
May 16, 2012 9:39 pm | News | CommentsMedical device maker Medtronic Inc. said Wednesday that federal prosecutors have closed their investigation of the company's InFuse bone graft.
CryoLife Buying Vascular Graft Maker For $17M
May 15, 2012 9:50 pm | News | CommentsMedical device maker has agreed to buy Hemosphere Inc., which makes a vascular graft that is used in kidney dialysis patients, for $17 million in cash.
Alere Skids On Expected Recall, Federal Subpoena
May 11, 2012 2:23 pm | News | CommentsShares of the medical diagnostics company slipped after it announced that the government was concerned over its marketing and quality-control testing.
Seven Success Criteria For Hiring A GMP Consultant
May 11, 2012 1:33 pm | by The QA Pharm | Blogs | CommentsThere is nothing worse than throwing a bunch of consultants at a problem without knowing the boundaries of the project or defining the expected results. Unfortunately, it happens all the time. It ends in frustration for all parties involved. A formal scope of work (SOW) helps both the client and the consultant to set expectations of each other, and agree on basic assumptions that are critical to success.
Omnicare Pays $50 Million To Settle DOJ Case
May 11, 2012 12:52 pm | News | CommentsThe company said there were no allegations that drugs were illegally diverted to someone without prescriptions and no patients were harmed.
Two Molecular Biologists Get $500K Medical Prize
May 11, 2012 9:29 am | News | CommentsThe two men performed pioneering research on how cells express their genetic information at The Rockefeller University in New York City.
