Originally posted on MedCity News The patent protection landscape’s been turned on its head in the past couple years, ever since the Leahy-Smith America Invents Act went into effect. A discussion at trade group Biocom’s DeviceFest in San Diego this week addressed some of these changes and subtleties as they apply to medical device companies:
Marathon Pharmaceuticals, LLC today announced Dave Bradshaw has joined the company as executive director of manufacturing. In this role, Bradshaw will oversee the manufacturing and supply operations for Marathon Pharmaceuticals’ rapidly growing portfolio of treatments.
ARCH Venture Partners, one of the largest U.S. technology venture firms investing in the development of seed and early-stage advanced technology companies, today announced that its eighth venture fund closed with more than $400 million in subscriptions. ARCH Venture Fund VIII exceeded its $250 million subscription target by more than $150 million.
Originally posted on MedCity News by Stephanie Baum What’s the difference between an extrovert and introvert in the world of principal investigators? Answer: Are they staring at your shoes or their shoes? The joke Steve Blank told during a fireside chat hosted by NYCBio illustrates the uphill challenge SBIR grant applicants face when they’re asked to break away from the insulated world of…
Truly innovative devices that do not have a “substantially equivalent” predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply…