Source: FierceBiotech 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…...
St. Jude releases promising data on its heart failure system
Source: FierceBiotech St. Jude Medical released new data from a trial that showed patients using its CardioMEMS HF system had a 57% reduction in mortality and 43% fewer hospitalizations related to heart failure compared to patients treated only by guideline directed medical therapy. The St. Paul, MN-based devicemaker said the…...
Business deaths are hampering job growth
Source: Gallup Small businesses and startups are the crux of economic growth in the United States. Gallup continually collects and analyzes data to understand the attitudes of small-business owners and the current barriers to job growth and startups. On March 4, I testified before Congress about our ongoing efforts in…...
Actavis beats on top and bottom lines, will change name to Allergan
Source: The Street NEW YORK -- Specialty pharmaceutical company Actavis (ACT) reported fourth-quarter and full-year earnings results Wednesday that beat analysts' estimates. And the company, which late last year inked a deal to acquire Allergan (AGN), maker of anti-wrinkle treatment Botox, for $66 billion, said it will adopt Allergan as…...
Hiring in 2015? 5 trends to prepare for
Source: Business News Daily If you're looking for a new job, you should have better luck finding one this year, new research finds. Overall, 36 percent of employers plan to increase their full-time, permanent head count in 2015, up from 24 percent last year, according to a new study from…...
Why great managers are so rare
Source: Gallup Management talent exists in every company. It's often hiding in plain sight. Gallup has found that one of the most important decisions companies make is simply whom they name manager. Yet our analytics suggest they usually get it wrong. In fact, Gallup finds that companies fail to choose…...
Court ruling against FDA enables more combination products to be classified as devices
Source: FierceBiotech In victory for industry, FDA's second attempt to classify Prevor's skin wash as a device is vacated once again. The U.S. District Court for the District of Columbia rejected the FDA's attempt to classify Prevor's Diphoterine Skin Wash as a drug rather than a device for the second…...
AbbVie partners with Google’s Calico on $1.5B R&D operation focused on aging
Source: FierceBiotech Hot on the heels of its $805 million development deal with Infinity, AbbVie Pharmaceuticals ($ABBV) has followed up today with a plan to partner with Google's ($GOOG) closely watched biotech upstart Calico on a new research operation that will cost up to $1.5 billion to get started. Google-backed…...
Big Pharma doesn’t win the margin stakes. That’s Jazz, Celgene, Regeneron and Alexion
Source: Margins, margins, margins. That's an inevitable mantra among top investors and analysts. Just ask Novartis ($NVS) CEO Joe Jimenez, who's pledged big improvements in the Swiss drugmaker's spread. Or Eli Lilly ($LLY) CFO Derica Rice, who's had to explain why his company can promise to maintain margins as its…...
Cubist Pharmaceuticals: Ripe For Acquisition?
Source: Bidness ETC Threats from the increase in drug-resistant germs, and the subsequent rise in demand for more effective and high-impact antibiotics has spurred interest in companies such as Cubist Pharmaceuticals Inc (CBST). The Massachusetts-based drug developer has announced that it plans to introduce four new medicines to the market…...