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FDA, industry announce game-changer on medical device reviews
Jeffrey Clark - Posted: 2/3/2012
The New England Patriots and New York Giants will both be looking for game-changing plays this weekend in Super Bowl XLVI.  It seems the medical device industry may have a game-changer of its own in the works. The FDA and representatives from the med[...]
Sebelius steps outside her comfort zone on The Daily Show
Jeffrey Clark - Posted: 2/3/2012
Secretary of Heath & Human Services Kathleen Sebelius discusses the benefits and challenges of implementing the Affordable Care Act or Obamacare as the media has tagged last years healthcare legislation.   As one TEDMED presenter pointed out last wee[...]
Roche CEO comments on Illumina, reviews 2011 results
Jeffrey Clark - Posted: 2/2/2012
Roche CEO Severin Schwan is bullish, stating overall I am very pleased with our results, we achieved a solid performance, both of our businesses pharma and diagnostics are growing in a challenging environment and as far a profitability is concerned a[...]
Congress debating future of FDA with PDUFA hearing
Jeffrey Clark - Posted: 2/1/2012
Today, the House Committee on Energy and Commerce will begin debating the renewal of PDUFA.  Technically, this is a reauthorization of the Prescription Drug User Fee Act IV (PDUFA), which is set to expire later this year.  This bill will essentially [...]
FDA approving drugs at light speed this week
Jeffrey Clark - Posted: 1/31/2012
After taking Amylin’s Bydureon approval down to the wire this weekend, the FDA has stepped up their approval notifications in the past two days.  Amylin’s PFDUFA date was January 28th, a Saturday. When Friday afternoon came and went on the East Coast[...]
Amylin CEO discusses future following FDA approval
Jeffrey Clark - Posted: 1/30/2012
CEO Daniel Bradbury explains how Amylin will catch up with rival Novo Nordisk and pricing pressures for new diabetes treatments. Maria Bartiromo from CNBC asks all the right questions in her attempts to get to the core of Amylins strategy moving forw[...]
Pharmaceutical parody has its own YouTube channel
Jeffrey Clark - Posted: 1/30/2012
This is an odd bit.  On Youtube, you can find the home of Trustus Pharmaceuticals.  The entire YT channel is devoted to a crude, if not clever, animation parody of a fictional pharmaceutical company.   The company is described as A collection of scie[...]
AdvaMed responds to Obamas State of the Union address
Jeffrey Clark - Posted: 1/30/2012
FDA regulation and the forthcoming medical device excise tax remain significant issues for medical device makers.  Now they have the attention of the President of the United States. President Barack Obama specifically mentioned medical devices in his[...]
AdvaMed 2012: The MedTech Conference calls for presentations
Jeffrey Clark - Posted: 1/27/2012
The premier medical device and technology event of the year, AdvaMed 2012: The MedTech Conference has officially launched its new website and opened the call for program panel proposals. Annually one of the strongest events of the year, Advamed 2012 [...]
The End of Illness: Devices That Could Change Medical Care
Jeffrey Clark - Posted: 1/25/2012
Dr. David Agus, the former oncologist for the late Steve Jobs, is all over the news, following the release of his book The End of Illness last month According to Agus, we can do better analyzing the human body and using more advanced technologies to [...]
Illumina corporate structure moves Roche to checkmate
Jeffrey Clark - Posted: 1/25/2012
With a poison pill provision and staggered Board elections, Illumina seems to be well-protected from unruly suitors during a time when its stock price is so undervalued.  So, how will Roche win the chess match with Illuminas Board and its shareholder[...]
Roches deal for Illumina a potential boon for San Diego, hurts Indy
Jeffrey Clark - Posted: 1/25/2012
Roche has its sights set on Illumina, the San Diego based sequencing company.  Roche CEO Severin Schwan has repeatedly emphasized the the need for new and better targeted drugs.  Illumina would complement Roche beautifully both with Genentechs focus[...]
President Obama on FDA regulatory structure, in plain English
Jeffrey Clark - Posted: 1/24/2012
Just days ago, President Obama authored an article in the Wall Street Journal entitled, Toward a 21st-Century Regulatory System. While not wholly specific to the life sciences industry, he does address government regulatory process in general as inef[...]
Sanofi CEO speaks out toward FDA on behalf of PhRMA
Jeffrey Clark - Posted: 1/24/2012
Chris Viehbacher has become an outspoken voice since taking the helm at chairman of the board for PhRMA.   His latest comments are aimed at the FDA, claiming that the pharmaceutical industry may stop investing in medicines to treat diseases like diab[...]
Inside Boston Scientifics CEO Transition
Jeffrey Clark - Posted: 1/23/2012
Hank Kucheman, Boston Scientific Interim CEO, and Michael Mahoney, Boston Scientific Icoming CEO, shed insight on a pro-longed CEO transition and pricing pressures in the device industry. Remember that Mahoney was the Group Chairman of J&Js Medical D[...]
Alkermes and Amylin come down to the wire
Jeffrey Clark - Posted: 1/20/2012
Richard Pops, Alkermes chairman & CEO, discusses the challenges facing the health care industry; FDA approval of a once weekly diabetes drug, and other promising new drug candidates. These are nervous times at Alkermes and Amylin. Bydureon is a long-[...]
FDAs User Fee Agreement heads to Congress
Jeffrey Clark - Posted: 1/19/2012
A final agreement between the FDA and the pharmaceutical industry on user fees for prescription, generic and biosimilar drugs was submitted for approval by Congress. At a time of greater budgetary constraint, user fees provide a critical way for leve[...]
Report: Medtech market in China to reach $5 billion this year
Jeffrey Clark - Posted: 1/18/2012
The medical device market in China will rise 17% to $5 billion this year, according to a report from Citigroup.   Chinas growth is no secret, yet medical device spending will be boosted by growing demand from hospitals as they modernize and improve t[...]
Johnson and Johnson CEO opines on the state of healthcare, economy
Jeffrey Clark - Posted: 1/17/2012
We are seeing a slow recovery in the U.S. and while there are challenges there are opportunities to take advantage of the slow recovery, says William Weldon, Johnson & Johnson chairman/CEO.
Seattle life sciences companies ready for massive snowstorm
Jeffrey Clark - Posted: 1/17/2012
Rarely is weather a big topic on Beaker.  In fact, places like Chicago, Minneapolis and Boston may not blink in the face of 12-18 inches of snow in January. But for Seattle, what is set to unfold is being described as a crippling blizzard that will b[...]
Baxter recruits key executive from Medtronic
Jeffrey Clark - Posted: 1/17/2012
Baxter International has recruited a key member of Medtronic CEO Omar Ishraks team.   Jean-Luc Butel has been appointed Corporate VP & President, International reporting to Robert L. Parkinson, Jr., Chairman and CEO at Baxter. Butel, 55, will be resp[...]
Celgene & Gilead CEOs review earnings, emerging markets, and more
Jeffrey Clark - Posted: 1/16/2012
Gilead Sciences makes a big move into hepatitis C treatment with its acquisition of Pharmasset. Insight with John Martin, Gilead Sciences CEO/president. Robert Hugin, Celgene chairman & CEO, explains why Celgenes 2012 earnings will top expectations o[...]
Vertex & Biogen CEOs Talk Business
Jeffrey Clark - Posted: 1/16/2012
Jeffrey Leiden, incoming CEO of Vertex Pharmaceuticals, and George Scangos, CEO of Biogen Idec, discuss Biogens restructuring and Vertexs Hepatitis C drug.
Medical Device Titans on Obamacare, excise tax and JPM12
Jeffrey Clark - Posted: 1/13/2012
CEOs of Stryker, Medtronic and Edwards Life Sciences make a joint appearance to discuss how Obamacares new 2.3% tax on the biggest medical device makers is impacting business. This has to be the first time these guys have shared a panel: Omar Ishrak,[...]
Onyx, Seattle Genetics and Dendreon CEOs predict outlook at JPM12
Jeffrey Clark - Posted: 1/13/2012
Dr. Tony Coles, President & CEO of Onyx Pharmaceuticals, discusses his outlook for the new year. Dendreons revenues for its solo product, Provenge, has more than tripled from a year ago. Insight on the drugs treatment of prostate cancer and an outloo[...]
 
Beaker.com
BeakerBeat - 01-30-12
In this week’s BeakerBeat, Roche makes a multi-billion dollar pass at Illumina, but gets no love in [...]
BeakerBeat - 01-23-12
In this week’s BeakerBeat, to quote Rodney King, ”Can't we all just get along”?. Apparently they ca[...]
BeakerBeat - 01-16-12
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BeakerBeat - 01-09-12
In this week’s BeakerBeat, it’s not as fun as a fantasy sports draft, but the FDA releases more draf[...]
BeakerBeat - 01-04-12
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