Industry news

The 2014 Numbers Are In: FDA’s Orphan Drug Program Shatters Records

Kurt R. Karst / FDA LowBlog

FDA’s agency-wide performance management system, known as FDA-TRACK, provides some information on orphan drug designations and approvals, that system is not up-to-date.  So we have to get our data from other sources – primarily (though not exclusively) from FDA’s Orphan Drug Designations and Approvals database.  

Artificial heart sees most patients to donor heart within a few years

Stacy Lawrence / Fierce Medical Devices

Artificial, mechanical hearts are effective in getting almost three-quarters of patients to a donor heart transplant, recent data on the SynCardia Total Artificial Heart suggest. But that feat doesn't contain SynCardia's ambitions--it recently started a trial for permanent use of its artificial heart that's ultimately designed for FDA submission.

Apple Meets With Mexican Regulators Ahead of Smartwatch Debut

Patricia Laya, Tim Higgins / Bloomberg

Apple Inc. representatives met with Mexican regulators this month ahead of the debut of its smartwatches, indicating that the iPhone maker is stepping up efforts to make the new product available internationally.

Russia’s regions create modern Nuclear Medicine Centers

MarchMont Innovation News

The Orel region in Central Russia is ready to launch this coming spring its Nuclear Medicine Center for early diagnostics of cancers and cardiovascular diseases, the website of the Russian Agency for Medical and Social Information reported.  The new Center is said to be supplied with “most up-to-date high-tech equipment,” including a state-of-the-art PET/CT scanner. 

19 February 2015

Atlas Genetics Aims to Bring io Platform to Market This Year after Long Delay

Tony Fong / GenomeWeb

Initially planned for a 2011 launch, Atlas Genetics' multiplex, molecular diagnostics system, called io, will hit the market four years later if the company is successful in launching it this year.

Why Eastern Europe May Be The Best Location For Your Next Clinical Trial

Gail Dutton / Life Science Leader

Eastern Europe is becoming the new bright spot for clinical trials by offering significant opportunities and the fewest challenges of any of the emerging regions, according to a recent IQPC survey of pharmaceutical executives.

Cutting-edge Russian solutions for mobile medicine

Marchmont Innovation News

The Russian government has named pharma and biomed as a priority sector for innovation, and set a fairly ambitious strategic goal of increasing the share of domestic medical equipment products in the Russian market to at least 40%. It is a priority area for Marchmont to cover, too, and we have highlighted for you an ever-growing number of high tech medical projects pushed by innovators across the country. 

Microsoft, Cambridge University team up on blood cancer simulation model

Nick Paul Taylor / Fierce BiotechIT

Researchers at Microsoft ($MSFT) and the University of Cambridge have created a computer model to simulate blood cell development. The model can simulate the activity of genes tied to blood cancers, giving researchers a quick way to map the pathways that play out in leukemia and other diseases.

Russia to make its first vacuum vials

Marchmont Innovation News

Eiliton, a resident company of the Dubna special economic zone outside Moscow, is launching later this month the production of Russia’s first vacuum vials called UniVac to draw venous blood, Nanonewsnet.ru  reported . 
 

Eastern Europe Top Region for Healthcare Investments

PharmExecutive

With a population of 420 million generating $4660 billion in GDP, Eastern Europe is swiftly gaining momentum as a key area for private and public investment in healthcare and health services, according to a new Frost & Sullivan Insights report.