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Jan. 27, 2012 |
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Biopharma
Trends In Diagnostics 2011 /
In the 1967 movie classic The Graduate, Dustin Hoffman gets a one-word piece of career-planning advice from a family friend: “plastics.” In diagnostics, as it was last year, that word would have to be sequencing. But unlike last year, when the first item in our diagnostics trends piece cited the successful IPOs of next-generation sequencing companies Pacific Biosciences of California Inc. and Complete Genomics Inc., owing to the downturn in government funding and a slow economy, the tone in 2011 was more nuanced. [See Deal][See Deal] (See"Personalized Medicine In 2010: Welcome To The Esta... / IN VIVO January 2012
The A-List: The Trend-Shaping Series A Financings Of 2011 / The capital drought that hit life science companies the past three years worked its way upstream in 2011, as several venture firms said they wouldn’t either continue in the life sciences or raise new funds. But our annual tally of life science Series A rounds presents a surprising twist: Series A rounds are up, not in blockbuster numbers by any stretch, but the downward trend of the recession years has finally been reversed. / START-UP January 2012
Mutual Reliance Blossoming Among FDA, EMA, Other Inspectorates / FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe. Inspection coordination remains somewhat ad hoc, with EMA keeping a spreadsheet for some and PIC/S enabling others. / “The Gold Sheet” January 2012
Consumer
CMP Therapeutics Readies EU Launch With An Eye On The U.S. / CMP Therapeutics talks with large and small pharmas about distributing its micronized nasal spray, branded as Atlantic Secret. EU regulatory approval came seven years after the firm’s launch, but CEO Neil Moray Mackenzie expects much less time before a U.S. launch. / “The Tan Sheet” Jan. 23, 2012
Valeant Includes OTCs In Bid For Dramatic Growth By 2013 / The Ontario-based firm has its sights set on becoming a top-15 pharma company with a $50 billion market capitalization by the end of 2013. Emerging markets and consumer health products, including the recent iNova and Fleming deals, play a big part in Valeant’s plans. / “The Tan Sheet” Jan. 23, 2012
FDA Will Take GMP Inspections To The Next Level / If supplement firms thought FDA inspectors were tough on GMP compliance last year – they ain’t seen nothing yet. FDA investigators are ready to delve into more complex and technical GMP areas after focusing primarily on “surface level areas of GMP compliance” to date, FDA officials warn. / “The Tan Sheet” Jan. 23, 2012
Medical Devices
Top Device Stories Of 2011: Living In A State Of Transition / EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry. / IN VIVO January 2012
Bioventus Spin-out Creates New Leader In Orthobiologics / The spin-out of Smith & Nephew’s Biologics and Clinical Therapies division into a privately held entity, Bioventus LLC may serve as a model for other large publicly held device companies seeking to maximize the performance of non-core businesses. / IN VIVO January 2012
Next Step On the Innovation Pathway: Renal Disease Devices / FDA issued an “innovation challenge” Jan. 12 asking companies developing devices for end-stage renal disease to volunteer for a pilot program designed to assess new statistical tools and collaborative processes that the agency hopes will accelerate product development. / “The Gray Sheet” Jan. 23, 2012
Biopharma
Biopharma
Trends In Diagnostics 2011 /
In the 1967 movie classic The Graduate, Dustin Hoffman gets a one-word piece of career-planning advice from a family friend: “plastics.” In diagnostics, as it was last year, that word would have to be sequencing. But unlike last year, when the first item in our diagnostics trends piece cited the successful IPOs of next-generation sequencing companies Pacific Biosciences of California Inc. and Complete Genomics Inc., owing to the downturn in government funding and a slow economy, the tone in 2011 was more nuanced. [See Deal][See Deal] (See"Personalized Medicine In 2010: Welcome To The Esta... / IN VIVO January 2012
The A-List: The Trend-Shaping Series A Financings Of 2011 / The capital drought that hit life science companies the past three years worked its way upstream in 2011, as several venture firms said they wouldn’t either continue in the life sciences or raise new funds. But our annual tally of life science Series A rounds presents a surprising twist: Series A rounds are up, not in blockbuster numbers by any stretch, but the downward trend of the recession years has finally been reversed. / START-UP January 2012
Mutual Reliance Blossoming Among FDA, EMA, Other Inspectorates / FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe. Inspection coordination remains somewhat ad hoc, with EMA keeping a spreadsheet for some and PIC/S enabling others. / “The Gold Sheet” January 2012
For Novartis, 2012 Is Set To Be A Bumpy Ride / With the loss of exclusivity for its blockbuster heart drug, Diovan, coming in September, management focused on the company’s long-term prospects during a fourth quarter financial update. / “The Pink Sheet” DAILY Jan. 25, 2012
Ranbaxy Must Withdraw Several ANDAs Under DoJ Consent Decree; Will Lose 180-Day Exclusivity On Others / Three executives are named in the complaint, which the government calls “groundbreaking in its international reach.” The complaint cites GMP problems at four Ranbaxy facilities, three in India and one in New York, and says the company submitted false data in drug applications. / “The Pink Sheet” DAILY Jan. 25, 2012
Pressure Mounts For Amylin As Bydureon PDUFA Approaches / With declining sales of Byetta, Amylin has staked its near-term future on the performance of Bydureon, a long-acting formulation of the active ingredient in Byetta. / “The Pink Sheet” DAILY Jan. 25, 2012
Eli Lilly, Jubilant JV Called Off; Untimely Split Points At Rough Ride / Jubilant will absorb the joint venture as Lilly steps down, despite enthusiasm for Indian partnerships. / “The Pink Sheet” DAILY Jan. 25, 2012
J&J’s Incivo Shows “Hints” Of Added Benefit, Says Germany’s IQWiG / IQWiG concludes that J&J/Vertex’s new Hep C drug Incivo might be helpful in certain patient groups, but the German HTA body questions the validity of a widely-used surrogate efficacy measure. / “The Pink Sheet” DAILY Jan. 25, 2012
Medical Devices
Medical Devices
Top Device Stories Of 2011: Living In A State Of Transition / EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry. / IN VIVO January 2012
Bioventus Spin-out Creates New Leader In Orthobiologics / The spin-out of Smith & Nephew’s Biologics and Clinical Therapies division into a privately held entity, Bioventus LLC may serve as a model for other large publicly held device companies seeking to maximize the performance of non-core businesses. / IN VIVO January 2012
Next Step On the Innovation Pathway: Renal Disease Devices / FDA issued an “innovation challenge” Jan. 12 asking companies developing devices for end-stage renal disease to volunteer for a pilot program designed to assess new statistical tools and collaborative processes that the agency hopes will accelerate product development. / “The Gray Sheet” Jan. 23, 2012
ClinicalTrials.gov: NIH Busy Educating Sponsors On Mandates While Regs Remain In The Works / Draft rules are still being developed to fully implement ClinicalTrials.gov, but the law has been in effect for some time and officials say they are making a consistent effort to ensure study sponsors are educated on their new responsibilities. / “The Gray Sheet” Jan. 23, 2012
The A-List: The Trend-Shaping Series A Financings Of 2011 / The capital drought that hit life science companies the past three years worked its way upstream in 2011, as several venture firms said they wouldn’t either continue in the life sciences or raise new funds. But our annual tally of life science Series A rounds presents a surprising twist: Series A rounds are up, not in blockbuster numbers by any stretch, but the downward trend of the recession years has finally been reversed. / START-UP January 2012
Emboline Inc. / While the focus of aortic embolic protection has previously been limited to stroke prevention, Emboline Inc. believes the concern should be broader because there are other complications that can be caused by emboli moving downstream, resulting in diminished function or failure of other organs, such as the kidneys. The company’s Emboline CAP device provides complete protection of the arterial system from these emboli, thanks to a central filter enabled by an access port that allows for tool access through the filter. / START-UP January 2012
Laser Cataract Surgery: Sorting Out The Business Case / The once staid US cataract surgery market has evolved considerably over the past several years. A trio of conferences this fall provided updates on the latest developments. / Medtech Insight December 2011
A Bright Future For Optical Imaging / One bright spot emerging in this otherwise lackluster economy is the market for optical imaging technologies. Optical imaging encompasses a wide array of current and emerging techniques that use light as the primary imaging modality to characterize local anatomy down to cellular and molecular levels. / Medtech Insight December 2011