Industry news

FDA finalizes accelerated approval pathway for critical devices, aims to get med tech to market faster

Varun Saxena / FierceMedicalDevices

Almost a year after its proposal, the FDA finalized plans for an accelerated review program for critical medical devices, and said it will begin accepting applications to participate in the new pathway on April 15. The program applies to devices that "demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions." Examples include of previous devices that would meet the condition include the first drug-coated balloon catheter to treat vascular disease.

Report: Supply chain efficiency can boost both top- and bottom-line results

Eric Palmer / FeircePharmaManufactoring

Pharma puts so much emphasis on top line that drugmakers give scant consideration to what their supply chains are costing them. But a new report suggests that making a supply chain more efficient is not only going to save costs, but it will also help drive greater sales.

The largest biopharma layoffs of 2014

Eric Palmer / FeircePharma

The pharma industry has taken like none other to the notion of controlling costs by laying off employees. And so every year there will be some substantial number of displacements. But how substantial will depend on lots of factors in any given year. The layoff roller-coaster ride also has lots of ups and downs. And so while the top 10 announced layoffs in 2011-2013 averaged nearly 30,000 a year, there were far fewer in 2014. In fact, so few that this year we tallied only 10,691 among 7 companies.

Private health exchange an attractive option as enrollment doubles

Michael Johnsen / Drug Store News

Based on its research, Accenture forecasts that enrollment in private health insurance exchanges will grow to 12 million in 2016 and 22 million in 2017. As previously forecasted, Accenture expects total enrollment in private exchanges to ultimately surpass state and federally funded exchanges, reaching 40 million by 2018.

FDA recalls fall more than 50% in Q1 2015 after reaching record high in 2014

Varun Saxena / FierceMedicalDevices

There were 426 medical device recalls in the first quarter of this year, according to the FDA's recall database, down from a record high of 968 in Q4 2014.

Mid-cap biotech beats most of the big dogs with 21.9% revenue growth

Carly Helfand / FiercePharma

Who says bigger is better? According to a new report, mid-cap biotech companies are doing pretty well for themselves, thank you very much. Combined revenues for 35 mid-sized biotechs shot up by 21.9% last year, according to new research from GlobalData. The cohort hiked its revenue haul to $26.5 billion last year, up from $24.8 billion in 2013.

Second-quarter pharma market outlooks for pan-Asia mixed, India promising

EJ Lane / FeircePharmaAsia

The 2015 second quarter bodes well for India, Taiwan, Malaysia and others, while Australia, Kuwait and Iran are not looking as healthy, according to the latest forecasts covering 11 countries of Asia and the Pacific region.

In a quiet move, India ends free drugs, diagnostics to public health units

EJ Lane / FeircePharmaAsia

No fanfare, no press releases for this government action: India has decided to drop its three-year-old practice of providing free drugs and diagnostics in the nation's public health facilities. States instead would have the option of providing them on their own, a news report indicates.

South Korea struggles with healthcare needs of elderly

EJ Lane / FeircePharmaAsia

South Korea has a wealth of statistics about the near future of healthcare needs in the country, but no apparent solutions for how to deal with an elderly population about to drain its coffers.

Use of Multivariate Data Analysis in Bioprocessing

Anurag S. Rathore, Sumit K. Singh / BioPharm International

The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motivated biotech manufacturers to focus on process optimization. Of a variety of approaches, use of advanced sampling techniques, new sensor technologies, and analyzers has emerged as a topic of interest to the scientific community at large. Implementation of these tools, however, inadvertently results in large complex datasets with underlying multivariate interactions.