IN VIVO from Elsevier Business Intelligence

Out Of The Blocks, May 2013

Thu, 23 May 2013 00:01:31 -0400

Brief profiles of these recently formed companies: advanceCOR, Aegis Women’s Health Technologies, dBMEDx, Exscien, OsteoVantage, and Trice Orthopedics.

Acquisitions Signal Smith & Nephew’s Emerging Market Strategy

Thu, 23 May 2013 00:01:08 -0400

Smith & Nephew’s recent purchases of two trauma businesses in Brazil and India (Pró Cirurgia Especializada and Adler Mediequip Pvt. Ltd.) reflect its broader strategy to find growth in emerging markets, an attempt to offset the losses and disappointing quarters the company is seeing in established markets like Europe.

Start-Up Previews, May 2013

Thu, 23 May 2013 00:01:04 -0400

This Month's Profile Group: Women’s Health: Moving Beyond Gynecology To Sexuality, features profiles of Evestra Pharmaceuticals, S1 Biopharma, and Sprout Pharmaceuticals. Plus these Start-Ups Across Health Care: AgPlus Diagnostics, MitaMed, Respinova, and ViroCyt.

Maximizing An Innovative Device Launch: Going Slow To Go Fast

Thu, 23 May 2013 00:00:55 -0400

Contrary to conventional wisdom, a gradual product rollout, as opposed to a full-court press, may be the best way for device companies to generate maximum value from innovative products.

Edwards’ Success With Go-Slow Sapien Launch

Thu, 23 May 2013 00:00:50 -0400

Transcatheter heart valves (TAVI) arrived in Europe in 2007 with the introduction of Medtronic Inc.’s CoreValve, followed shortly thereafter by Edwards Lifesciences Corp.’s Sapien. (See"CoreValve: A Surgeon Moves Heart Valves to the Cath Lab" — IN VIVO, March 2007, "Edwards’ High Wire Act In TAVI: An Interview With Mike Mussallem" — IN VIVO, September 2012 and"Edwards: Transcatheter Valve Leader Proves You Can Go Home Again " — IN VIVO, November 2010.) Designed to treat patients with severe, symptomatic aortic stenosis, these innovative therapies have the potential to treat inoperable pat...

A New Direction For Alzheimer’s R&D: FDA Outlines Early Disease Pathway

Thu, 23 May 2013 00:00:45 -0400

Alzheimer’s R&D has suffered multiple failures over the last decade, with no drug found to slow or halt the underlying progression of the disease. Industry’s focus is now on patients at the very earliest stages of the disease, and FDA is meeting sponsors halfway, with a draft guidance outlining approval requirements.

Biopharma Dealmaking Quarterly Statistics, Q1 2013

Thu, 23 May 2013 00:00:29 -0400

Biopharma financing reached $4.6 billion in Q1 2013, exceeding Q4 2012’s $4.2 billion total, mostly through follow-on public offerings, which made up 47% of the total funding. Conversely, M&A was on the decline with 18 completed transactions together valued at $4.8 billion, the lowest quarter since 2009.

Execs On The Move, May 2013

Thu, 23 May 2013 00:00:25 -0400

Recent executive-level company changes and promotions in the biopharma, medical device, and diagnostics industries.

Deals In Depth: March 2013

Thu, 23 May 2013 00:00:02 -0400

AstraZeneca paid $240 million for rights to Moderna’s RNA therapeutics. Argon Medical acquired Angiotech’s interventional business for $362.5 million.

Russian IP Status: Adequate, But Flawed For Pharma

Fri, 17 May 2013 14:40:00 -0400

In recent years, Russia has adopted IP reforms that bring its patent provisions closer to international standards, but enforcement remains problematic, as are dispute proceedings, in part because there’s a lack of trained judicial experts.

Priming Russia’s Pharma Industry For Innovation

Fri, 17 May 2013 14:35:08 -0400

The Russian government’s aggressive plan to modernize the country’s pharmaceutical industry is stimulating entrepreneurial activities, as well as a flurry of deal activity between local and foreign companies. Many uncertainties remain about the potential opportunities, however, as foreign companies try to sort out changing regulatory and business dynamics.

CircuLite: Treating Heart Failure’s Lost Patients

Thu, 16 May 2013 13:05:01 -0400

Even with all of the advances and options in heart failure therapy, there remain no real options for a large number of patients who are seriously ill but not yet at the end-stage of the disease. CircuLite hopes to change that with a partial support device for patients who don’t need a VAD.

Rituximab: A Popular But Problematic Biosimilar

Wed, 15 May 2013 13:05:07 -0400

Roche/ Biogen Idec’s $7 billion oncology and rheumatoid arthritis monoclonal antibody rituximab has been a far more popular target than infliximab for biosimilar developers.

Biosimilar Remicade Will Pit Rising Cost Pressures Against Prescriber Caution

Wed, 15 May 2013 13:05:00 -0400

If approved in Europe this year, as expected, Celltrion/Hospira’s biosimilar infliximab will provide a compelling test of whether and how quickly budgetary pressures can override physician caution. It will also set the stage for the $70 billion worth of copycat antibodies in development.

Life Technologies Extends Thermo Fisher’s Reach Into Clinical Practice

Wed, 08 May 2013 11:55:00 -0400

Thermo Fisher’s $13.6 billion bid for Life Technologies is a blockbuster move within the instrumentation and consumables space, and also has implications for clinical practice. It’s another sign of the growing recognition that integrating clinical workflow is an important potential area for innovation and growth, along with the desire to move genomics tools into clinical use and the development of test content by nontraditional players in diagnostics.

Robot Wars Brewing In Orthopedics

Tue, 07 May 2013 08:10:02 -0400

Robotic-controlled surgical tools – led by market leader MAKO Surgical Inc. – are beginning to take root in the knee surgery market, at least in partial knees. Perhaps the truest measure of the potential of this market is the growing competition that MAKO is facing: just over the past five months, Blue Belt Technologies and Stanmore Implants Worldwide received FDA approval for rival robotic surgical systems.

IN VIVO: Deals Shaping The Medical Industry, May 2013

Fri, 03 May 2013 11:45:06 -0400

Derived from Strategic Transactions, Elsevier Business Intelligence’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment –In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type –Acquisition, Alliance, or Financing.

Out Of The Blocks, April 2013

Mon, 22 Apr 2013 00:00:10 -0400

Brief profiles of these recently formed companies: Neurotrope Bioscience, scPharmaceuticals, Syros Pharmaceuticals, Taragenyx, TeVido BioDevices, and Tyrosine Pharmaceuticals.

Start-Up Previews, April 2013

Mon, 22 Apr 2013 00:00:05 -0400

This Month's Profile Group: Using Quantified-Self Data To Enhance Fertility And Pregnancy, features profiles of Fertility Focus, Ovuline, and Unifvy. Plus these Start-Ups Across Health Care: Actium Biosystems, MacuLogix, Novan, and Presage Biosciences.

Execs On The Move, April 2013

Mon, 22 Apr 2013 00:00:00 -0400

Recent executive-level company changes and promotions in the biopharma, medical device, and diagnostics industries.

AZ’s Make Or Break Moment Comes Down To Business Development

Wed, 17 Apr 2013 10:50:02 -0400

AstraZeneca needs new assets to change investors’ dismal outlook for the company. With a new CEO installed, an R&D shakeup underway, and a new portfolio strategist joining in May, AstraZeneca will embark on an ambitious acquisition and partnering strategy in 2013.

At AAOS Knee Implant Makers Pitch Better Fit, Precision

Wed, 17 Apr 2013 09:45:00 -0400

Once beyond reproach, knee replacement surgeries are getting a long, hard look by surgeons, researchers, and companies trying to determine whether success rates that exceed 90% can be improved upon by using customized implants or surgical robots.

Covidien 2.0 – A Conversation With Joe Almeida

Wed, 17 Apr 2013 09:30:00 -0400

Covidien President and CEO Joe Almeida is positioning the company to continue its dynamic growth. Having run up an impressive track record over the past several years, where will – where can-- Covidien go from here?

Overcoming The Bias Against Medtech Entrepreneurship In Europe: An Interview With Martin Rothman

Tue, 16 Apr 2013 10:00:00 -0400

Why are European physicians so far ahead of the curve when it comes to innovative clinical practice and so far behind when it comes to creating companies? Interventional cardiologist and serial entrepreneur Martin Rothman offers some answers.

When Opportunity Knocks: Eisai Turns To Business Development

Mon, 15 Apr 2013 17:00:00 -0400

Starting in 2006, Eisai embarked on a bold campaign to reorient the company around cancer – with an emphasis on externally sourced innovation – that put aggressive business development front and center. Now as Eisai prepares to launch what may be its most transformative in-licensed product, the weight-loss therapy Belviq, signs of trouble have appeared in its trophy cancer franchise.

Matchmaking And Integration In The New World Of Diagnostics M&A

Tue, 09 Apr 2013 19:45:00 -0400

Nontraditional buyers, including Big Pharmas, life science tool companies, diversified conglomerates, and even food companies, are snapping up molecular diagnostics assets with increasing frequency, applying a variety of models to enhance their businesses.

Owning The Disease II: Adapting Strategy Into Successful Business Tactics

Tue, 09 Apr 2013 09:00:00 -0400

Owning the Disease represents a powerful new business model for medical technology companies as they seek to adapt to health care reform and a changing environment. Organizations that successfully own a disease align their incentives with those of other stakeholders in the market by developing the capabilities to deliver compelling new value propositions.

Deals In Depth: February 2013

Thu, 04 Apr 2013 10:25:01 -0400

Biogen paid over $3 billion to buy out Elan’s share of Tysabri. Mylan and Cardinal Health made two billion-dollar-plus acquisitions.

Deals Shaping The Medical Industry, April 2013

Mon, 01 Apr 2013 13:00:00 -0400

Roche CEO Severin Schwan: Fueled By Innovation, Emerging Markets

Wed, 27 Mar 2013 13:00:00 -0400

Roche’s CEO Severin Schwan says the Swiss group’s recent revamps, lack of patent expiries, and ongoing drug innovations give the world’s largest maker of cancer drugs a strong position to expand its sales globally, helped by new cutting-edge therapies and creative business approaches.

Start-Up Previews, March 2013

Fri, 22 Mar 2013 00:00:12 -0400

This Month's Profile Group: Nanomedicine: Will It Get Big?, features profiles of Blend Therapeutics, Kala Pharmaceuticals, Qualiber, and Uroboros Technologies. Plus these Start-Ups Across Health Care: Ceterix Orthopaedics, Flux Medical, Neuros Medical, and Tunitas Therapeutics.

Out Of The Blocks, March 2013

Fri, 22 Mar 2013 00:00:08 -0400

Brief profiles of these recently formed companies: CliniCast, CoCoTherapeutics, Jounce Therapeutics, MetaMed, Prevacus, and Saphena Medical.

Execs On The Move, March 2013

Fri, 22 Mar 2013 00:00:01 -0400

Recent executive-level company changes and promotions in the biopharma, medical device, and diagnostics industries.

Volcano: Learning To Thrive In A Declining PCI Market

Tue, 19 Mar 2013 17:00:00 -0400

Long used to a growing market driven by favorable demographics, cardiovascular companies are facing a declining PCI market, in the US and Europe at least, and are forced to shift their strategies to adapt. Volcano, for one, is articulating a new way to approach this declining market.

Building On Bayer

Tue, 19 Mar 2013 13:40:14 -0400

Onyx has learned a lot in its almost twenty year history with Bayer, managing through the upside and downside of having a Big Pharma partner.

Avinger: Finally, Seeing Through Total Occlusions, But Will Clinical Value Generate Economic Return?

Tue, 19 Mar 2013 13:35:00 -0400

Noted physician/entrepreneur John Simpson is back. His latest company, Avinger, has finally achieved his long-sought goal: combining imaging and therapeutics in catheter technology for crossing CTOs.

Onyx’s Transformative Year: From Productive Partner To Big Cap Contender?

Tue, 19 Mar 2013 13:35:00 -0400

Onyx Pharmaceuticals is working to execute on two launches and produce late-stage data that will enable it to add more indications to its growing roster of marketed drugs. If it succeeds, it could eventually rival competitor Celgene as one of the few biotechs to move from a small cap into the big cap ranks, but any stumbles could slow or eliminate Onyx’s evolution.

Reinventing Flexion For The World Beyond Proof-Of-Concept

Fri, 15 Mar 2013 17:30:00 -0400

Flexion Therapeutics had the pedigree, determination, and corporate connections to source and speed to clinical proof-of-concept its in-licensed pharma assets, and it planned to build a business around getting paid to do so. But a funny thing happened on the way to the bank.

DexCom: The Beauty Of Open Architecture

Fri, 15 Mar 2013 15:00:00 -0400

Today the fight for the continuous glucose monitoring market isn’t so much about a large company and a mid-sized one battling for market share as about acceptance of the entire category of CGM, which remains low after more than a decade. DexCom believes that CGM should be a first-line blood glucose management tool to help diabetes patients keep their blood glucose levels within a healthy range, and now with the launch of a stellar fourth-generation product, the company is closer than ever to realizing that goal.

Rigel’s High Science Bet

Wed, 13 Mar 2013 11:00:01 -0400

In an era in which biotechs focus on specialty drugs in niche populations, Rigel has been building a portfolio that looks different from other biopharmas in terms of what goes in and how it goes out. Although the company is currently valued on the performance of fostamatinib, investors might do well to take notice of Rigel’s pipeline.

Baxano Acquisition Could Transform TranS1

Wed, 13 Mar 2013 10:30:00 -0400

In a uniquely structured deal, TranS1 is merging with privately held Baxano to form a new minimally invasive spine company.

Lessons From Generic Launches: About The Study

Wed, 13 Mar 2013 09:30:06 -0400

IMS Consulting Group studied 4,564 generic launches dating between July 1, 2005 and July 31, 2010, in order to gauge key criteria for success.

Entering The Generics Business In Mature Markets: Lessons Learned From 4,500 Launches

Tue, 12 Mar 2013 20:00:00 -0400

In response to major market challenges, Big Pharmas have or are considering entering the small-molecule generics business. An IMS Consulting Group analysis of more than 4,500 generics launches between 2005 and 2010 tracks key attributes would-be branded company players need to know for success.

Deals In Depth: January 2013

Thu, 07 Mar 2013 17:00:00 -0500

Gilead licensed rights to four preclinical antibodies from MacroGenics. Stryker bought Chinese device company Trauson for $751 million.

Device/Diagnostics Quarterly Deal Statistics, Q4 2012

Thu, 07 Mar 2013 10:00:00 -0500

Device firms closed the final quarter of 2012 with $1.1 billion in financing, led by Volcano’s debt offering. Takeovers of Gambro and PSS Medical topped the device M&A list.

Deals Shaping The Medical Industry, March 2013

Mon, 04 Mar 2013 17:00:01 -0500

Debating Veracyte’s Data

Tue, 26 Feb 2013 16:35:00 -0500

The imprecision of cytology is an opportunity for Veracyte Inc., but until sufficient real-world experience backs up the data from its validation trial of its Afirma thyroid test, that imprecision could prove to be a double-edged sword. As with any test predicated on cytology, a statistical analysis of sensitivity and specificity of Afirma will depend on the accuracy and nuances of classification of the cytology samples.

Start-Up Previews, February 2013

Tue, 26 Feb 2013 00:00:29 -0500

This Month's Profile Group: Medtech Start-Ups Battle Advanced Skin Cancer With Innovative Technologies, features profiles of OncoSec, Sensus Healthcare, and Siva Therapeutics. Plus these Start-Ups Across Health Care: Avillion, CardioLogical Solutions, Fixes 4 Kids, RenovoRx, and Savant HWP.

Out Of The Blocks, February 2013

Tue, 26 Feb 2013 00:00:24 -0500

Brief profiles of these recently formed companies: ArthroCAD, Carmenta Bioscience, Helmedix, MediBeacon, SulfaGENIX, and ViroCyt.

Four Firms Vie For Medicare 2014 New-Tech Add-On Payments

Tue, 26 Feb 2013 00:00:19 -0500

CMS held its annual new-technology Town Hall February 5, hearing from applicants for a drug-eluting peripheral artery stent, a neurostimulator system for epilepsy seizures, a transcatheter mitral valve repair system and a retinal prosthesis system.