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- Autonomous Receives PMA Approvable Letter with Expansion of Range of Correction and Announces Addition to Sales Team
- ORLANDO, Fla.--BW HealthWire--July 29, 1998--Autonomous Technologies Corporation (NASDAQ NM: ATCI) announced today that the FDA has completed its review of its LADARVision Excimer Laser System premarket approval application PMA. In the letter received yesterday, the Center for Devices and Radiological Health CDRH stated it has concurred with the February 13,...
- Research articles 1998-07-29
- Autonomous Receives PMA Approvable Letter with Expansion of Range of Correction and Announces Addition to Sales Team
- ORLANDO, Fla.--BW HealthWire--July 29, 1998--Autonomous Technologies Corporation (NASDAQ NM: ATCI) announced today that the FDA has completed its review of its LADARVision Excimer Laser System premarket approval application PMA. In the letter received yesterday, the Center for Devices and Radiological Health CDRH stated it has concurred with the February 13,...
- Research articles 1998-07-29
- Hologic, Inc. F4Q09 (Qtr. End 09/26/09) Earnings Call Transcript
- Question-and-Answer Session Operator Operator Instructions. Our first question comes from JPMorgan's Tycho Peterson. Tycho Peterson - JPMorgan Yeah, good afternoon. Wondering, and congrats, Rob, on the promotion. I was wondering if you can comment a little bit on just some of the early marketing message around Cervista and...
- Earnings calls 2009-11-09
Additional Resources
- Allos Therapeutics: Smallcap Biotech with FDA Catalyst
- Mike Havrilla submits: Allos Therapeutics ALTH is small-cap cancer biotech which filed a NDA on 3/25/09 for pralatrexate (PDX) in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH requested priority (six-month) review for the application, with an expected 60-day period for the FDA to accept the filing...
- External links 2009-04-27
- Document Shows Rogue Bextra Operation Inside Pfizer
- The "information" document filed by federal prosecutors against Mary Holloway describes what appears to be a rogue sales unit inside Pfizer dedicated to selling the painkiller Bextra off-label and at unapproved doses. Holloway is believed to be a former Pfizer employee (see Peter Rost's join-the-dots conclusion) although documents in the...
- Blog posts 2009-04-06
- Advanced Medical Optics, Inc. Q3 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator : [Operator Instructions]. And your first audio question comes from the line of Chris Cooley with FTN Midwest Securities. Chris Cooley - FTN Midwest Research Thanks. Good morning. Can you heart me okay? James V. Mazzo - Chairman of the Board, President and...
- Earnings calls 2007-10-25
- Kinetic Concepts, Inc. Q3 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator [Operator Instructions]. And our first question comes from the line of Tao Levy with Deutsche Bank. Please proceed. Unidentified Analyst Yes, good morning. This is Seth [ph] in for Tao. Congrats on a good quarter. Catherine M. Burzik - President and Chief Executive...
- Earnings calls 2007-10-23
- Schering-Plough Corporation Q3 2009 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions Your first question comes from Tim Anderson - Sanford Bernstein Tim Anderson - Sanford Bernstein I wanted to wish you, Fred, and the others well in your next endeavor whatever that’s going to be. The first question is whether you can give us an inkling...
- Earnings calls 2009-10-22
- Access Pharma Looking for Smooth U.S. MuGard Launch in 2010
- Mike Havrilla submits:Access Pharma (ACCP.OB) provided an update Wednesday on the status of its FDA cleared treatment for oral mucositis, MuGard. The drug's North American commercial launch is expected to occur during 1Q10 in conjunction with the availability of initial product inventory by its liquid contract manufacturing partner, Accupac. In...
- External links 2009-11-11
- GE Healthcare Selects Fusion as Exclusive Sales Partner for New Senographe Essential Mammography System; Dedicated, Ready-for-Action Team to Drive National Sales
- BALTIMORE -- Fusion Sales Partners, a leading provider of high-performance sales teams to the Fortune 1000 and Global 500, today announced that GE Healthcare has selected Fusion as their exclusive sales partner for their new Senographe Essential Mammography System. The new SenographeR Essential, recently approved by the U.S. Food and...
- Research articles 2006-05-24
- Pfizer District Sales Manager Guilty of Altering Off-Label Celebrex Documents
- Thomas Farina, a former district sales manager at Pfizer, was found guilty of obstruction of justice after he was found altering documents on his computer during a federal investigation of off-label sales of Bextra and Celebrex. He faces a possible 20 years in prison and a $250,000 fine. ...
- Blog posts 2009-03-19
- Top 10 Weirdest Pharma Stories of the Month
- Sometimes I come across items that aren't important enough to count as news but are nonetheless too strange to ignore. Thus, I give you the top 10 weirdest drug stories for August: The connection between O.J. and Preparation H. Ever wonder why the orange juice in your...
- Blog posts 2008-08-29
- Haemacure's Hemaseel APR™ First Commercial Application Successful
- MONTREAL--BUSINESS WIRE--July 7, 1998--Haemacure(ME:HAE.) (TSE:HAE.) Haemacure Corporation today announced that the first commercial application of its fibrin sealant Hemaseel APRTM was successfully completed during a surgical procedure at the University of Virginia earlier this week.Hemaseel APRTM is now being distributed in the U.S. market by ...
- Research articles 1998-07-07
- Abbott Laboratories Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions Our first question today is from Mike Weinstein. And please state your company name. Mike Weinstein - J.P. Morgan Thank you. It's J.P. Morgan. Excuse me, a couple questions if we could start-off. There was during this quarter, there was that Barron's article and there...
- Earnings calls 2007-07-18
- EXACT Sciences' Key to Future Earnings
- Mike Havrilla submits: The stock research section of BioMedReports.com has been updated on 8/1/09 for my new report on EXACT Sciences (NASDAQ:EXAS), which provides a more comprehensive and global earnings model for the company's next-generation stool DNA sDNA screening test (V3) for colorectal cancer (CRC) since my previous article in...
- External links 2009-08-02
- Applera Corporation F1Q08 (Qtr End 9/30/07) Earnings Call Transcript
- Question-and-Answer SessionOperator Thank you sir. [Operator’s instructions.] One moment while we compile a list of questions. Our first question will come from the line of Ross Muken of Deutsche Bank, please proceed. Ross Muken – Deutsche Bank Good morning everyone. Mark P. Stevenson –...
- Earnings calls 2007-10-25
- Alcon Incorporated Q3 2007 Earnings Call Transcript
- Question-and-Answer Session Operator Thank you. [Operator Instruction] please stand by for your first question. Your first question will be from the line of Peter Bye of Jefferies & Co. Peter Bye – Jefferies & Co Thanks and good morning. I apologize if you’ve already...
- Earnings calls 2007-10-25
- EXACT Sciences: 8 Points Following Q2 Earnings
- Mike Havrilla submits: The stock research section of BioMedReports.com has been updated on 8/14/09 to reflect new developments following the 2Q09 conference call and business update for EXACT Sciences (NASDAQ:EXAS) as the company prepares for a Phase 3 study next year to obtain FDA marketing clearance for its next-generation stool...
- External links 2009-08-16
- Pfizer to Pay $2.3 Billion in Fraudulent-Marketing Suit
- NEW YORK (AdAge.com) -- Pharmaceutical giant Pfizer agreed today to pay $2.3 billion to settle the largest fraudulent-health-care-marketing case in the history of the Department of Justice. The settlement stems from government charges that Pfizer falsely marketed and promoted four of its drugs -- pain medication Bextra, anti-epilepsy drug Lyrica,...
- News items 2009-09-02
- Cadence Pharmaceuticals, Inc. Q3 2008 Earnings Call Transcript
- Question-and-Answer Session Operator Thank you. Operator instructions Our first question will come from Charles Duncan with JMP Securities. Charles Duncan – JMP Securities Hi, guys. Good afternoon and congratulations on a good quarter of progress. Ted Schroeder Thanks, Charles. Charles Duncan – JMP Securities I had...
- Earnings calls 2008-11-19
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