Roche Holding AG said US health regulators have approved its Ebola test for emergency use in response to the world’s worst outbreak of the disease in West Africa.
The US Food and Drug Administration (FDA) has approved Roche’s LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection, the Swiss drugmaker said in a statement.
In 2014, wearable health tracking devices continued to get more creative, going far beyond simple fitness tracking. The K-Goal, a “Fitbit for your vagina,” promised to help women do kegel exercises correctly, while the Emotiv EEG headset offered the prospect of mental acuity, measured by a device that tracks the brain’s concentration.
The year in biotechnology began with a landmark event. A decade after the first human genome was decoded at a cost of about $3 billion, the sequencing-machine company Illumina, of San Diego, introduced a new model, the Hyseq X-10, that can do it for around $1,000 per genome.
A new business incubator in Baltimore’s Inner Harbor will cater to startup companies launched through universities.
The Institute of Marine & Environmental Technology in January is opening a 4,300-square-foot incubator in its offices at the Christopher Columbus Center in Baltimore’s Inner Harbor.
Medical technology developer Medtronic, Inc. recently completed an application submission to the U.S. Food and Drug Administration (FDA) regarding the pre-market approval of their SynchroMed II implantable drug infusion system, which includes a new catheter design. The system is intended to be used by pulmonary arterial hypertension (PAH) patients for the intravenous delivery of the drug Remodulin (treprostinil), which is being developed by the United Therapeutics Corporation.
Here are my 10 crucial pieces of advice for students who aspire to a career in pharmaceutical labs:
1. You need a solid foundation in science. Master the basics, and learn how to apply that knowledge.
Biotechnology will have a strong year in 2015, but it can’t get any better than 2014, biotech investor G. Steven Burrill says in his annual year-end report.
“The unprecedented IPO (initial public offering) and M&A (mergers and acquisitions) activity this year will make 2014 one for the record books and unlikely to ever be surpassed,” Burrill said.
Faced with diminishing returns on R&D investments, large pharmaceutical companies are searching for innovative ways to successfully identify, develop, and market products with financial viability. Yet small discovery companies and biotechs continue to outpace large pharma in the approval of NMEs (new molecular entities).
Rampaging animal spirits have given birth to a biotechnology unicorn. It’s apt that a stellar year for initial public offerings in the sector will be capped by its biggest float ever. Juno Therapeutics is a year old and revenue free, but its cancer fighting technology is hot. At nearly a $2 billion valuation, the company shows capitalism’s ability to catalyze investors’ hopes and resources.
Whether a startup makes or breaks depends on if you have the right people on the team. How can you know? During my start-up journey as an early employee of an online education startup, co-founder of a social enterprise, and sole founder of my health technology company, ClickMedix, I’ve been through and witnessed the birth, growth, decline, and eventual end of startups.
