2012 came and went, leaving many investors and emerging growth biotechs still waiting for the opportunities promised in the Jumpstart Our Business Start-ups (JOBS) Act, as the SEC has missed its deadlines for implementing major provisions of the legislation, which was passed last year to provide new fundraising options and ease the burden of complying with securities laws.
With the clock ticking away on a two-month reprieve from the deficit-reducing sequestration, the White House is warning the FDA, National Institutes of Health (NIH) and other government agencies to prepare to be chopped.
LEBANON, N.H. – Despite its roots in small town USA, Adimab LLC is becoming the belle of the global biopharmaceutical ball, with a dance card that includes partners from all over the world.
Hoping to beef up its arsenal against drug-resistant bacteria, the FDA is taking the first steps to blaze a new approval shortcut for drugs, both small molecules and biologics, that narrowly focus on serious or life-threatening diseases in which there's an unmet need.
The only thing that was clear in a roundtable discussion the Patent and Trademark Office (PTO) held Thursday on gene-based diagnostics is that a consensus on the value of patents for the diagnostics, and DNA in general, is as out of reach as ever.
The FDA's end-of-the-year approval of Janssen Therapeutics' Sirturo rang in a new year of hope for patients with multidrug-resistant pulmonary tuberculosis (MDR-TB). And it brought good cheer to other biopharma companies developing their own cocktails intended to make the deadly form of TB toast.
In what's being called the largest settlement ever for a biotech company, Amgen Inc. finalized a $612 million agreement Tuesday to resolve federal civil claims stemming from 10 whistleblower suits alleging off-label marketing of several of its top-selling drugs.
Amgen Inc. began to close the book Tuesday on several federal investigations and whistleblower suits involving its marketing practices when it pleaded guilty in federal district court to a misdemeanor charge of off-label marketing of Aranesp, which posted global sales of $2.3 billion in 2011.
With one piece of the budget puzzle about to be put in place, at least temporarily, the FDA, National Institutes of Health (NIH) and other federal agencies can start planning for fiscal 2013, which begins in two weeks.
