I will be at the Cleveland Clinic Medical Innovation Summit next week. Cleveland Clinic, ranked America’s Top Heart Hospital, will host the 2007 Medical Innovation Summit, October 1-3 2007. Cleveland Clinic’s Medical Innovation Summit is an international gathering of health care, business and media leaders, all offering insight into what drives medical innovation. The 2007 […]

Ironically, within hours of President Bush signing the FDA Amendments Act of 2007 into law, a report is released finding the U.S. Food and Drug Administration doesn’t do enough to ensure the safety of patients who help test drugs in clinical trials The New York Times quotes Daniel Levinson, the inspector general of the Department […]

The FDA’s Office of Generic Drugs posted a letter requesting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues.  This concerns an ANDA submitted to the FDA containing a paragraph IV patent certification requesting FDA approval for a generic version of Bayer Pharmaceuticals’ PRECOSE (acarbose) Tablets. Before marketing a new branded drug, […]

President Bush has signed the FDA Amendments Act of 2007 into law. The Senate passed the bill, H.R. 3580, by unanimous consent on Sept. 20, a day after the House approved it in a 409-17 vote. The massive 422-page FDA bill, the biggest overhaul to the FDA in the last decade, renews device and drug […]

A newly formed nonprofit corporation unites industry, academia and government in first large-scale study of genetics and drug safety. The Serious Adverse Event Consortium (SAEC) will work to identify genetic markers that may help predict which individuals are at risk for serious drug-related adverse events (SAEs). Pharmacogenetics and pharmacogenomics deal with the genetic basis underlying […]

About Biotech talks about Biotech Business Models this week, such as the Platform, Product and Vertical models for early-stage biotech companies. In all cases, patents and IP rights are noted to be at the core of any venture. Noteably is that the Platform business model has persevered, combined with contract research and services for the […]

In an appeal from a summary judgment of noninfringement of U.S. Patent 6,054,482, the Fed Circuit concluded that the district court erred in determining that there were no genuine issues of material fact concerning whether Warner Lambert failed to meet its burden of proof that the accused products infringe the asserted claims of the ’482 […]

We currently have a client interested in making an acquisition in the U.S.  The criteria are listed below: Location: Anywhere in the 48 Contiguous States, excluding California Size in Sales: $5,000,000 to $15,000,000 Type of Business: Manufacturing, Non-Union, with a successful history Type of Ownership: Privately Owned/Held or a Division/Subsidiary of Public Company Type of […]