Whether the nation's budgetary glass for the next few years is half empty or half full is more a question of "ifs," rather than perspective, according to the Congressional Budget Office's (CBO) latest outlook for fiscal 2013-2023. A number of those ifs depend, to some extent, on health care spending.

Hoping to gain some ground in an all-out war against superbugs, the FDA is taking the first steps toward creating an approval shortcut for new antimicrobials with a public hearing Feb. 4.

When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The article “Biotech Firms, Billions at Risk, Lobby States to Limit Generics” slams biotechs for encouraging states to adopt legislation limiting the automatic substitution of biosimilars, which the Times repeatedly called “generics.” As BioWorld Today reported, most of the bills being considered by states would require physician notification of what was substituted, enhanced recordkeeping and an opportunity for doctors (and, in...

While the FDA is still waiting for its first biosimilar application to be submitted, a few states – with the encouragement of patient advocacy groups and the biopharma industry – are already casting a safety net for when interchangeable biologics hit the U.S. market.

Even with grade inflation, the Department of Health and Human Services (HHS) and other federal agencies earned a "D" average for their efforts to request and respond to public comments when making major new rules. The grade dropped to an "F" for other rules.

With exclusivity assuming a bigger role in the life cycle of a drug, Gilead Sciences Inc. wants more for its Stribild HIV drug than the three-year exclusivity the FDA typically grants to new fixed-dose combination (FDC) drugs.

Stress levels for companies working on medical countermeasures (MCMs) took a welcome nosedive this week as the House overwhelmingly approved a bill to reauthorize the Biomedical Advanced Research and Development Authority (BARDA) and Project BioShield.

I recently took a few months off from daily deadlines to explore the evolving world of biosimilars for the newest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies. It was quite an eye-opening adventure. Even though I’ve been covering biosimilars for BioWorld for a few years now, I was surprised at the impact these follow-on biologics (FOBs) are having throughout the world, given that the European Union (EU) is continuing its two-year approval slump and no biosimilar candidates have stepped up to bat yet in Canada or the U.S. Some of my surprise undoubtedly...

With Congress searching for ways to reign in the federal deficit, the Congressional Budget Office (CBO) has a suggestion: Change the way offshore profits of multinational companies are taxed.

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.