A House effort to reopen the National Institutes of Health (NIH) as the government shutdown continued into its third day hit a Senate brick wall.

Don’t bother to submit new drug and supplemental applications (NDAs) during the government shutdown, the FDA is telling drugmakers.

With both the House and Senate refusing to be the first to flinch in their ongoing game of chicken Tuesday, the rest of America was getting a feel for how the first government shutdown in 17 years might affect their day-to-day businesses.

What’s in a biosimilar name? That depends on whether the vial is half empty or half full. Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities, they say biosimilars and their reference product should share the same international nonproprietary name (INN) – as is the practice with traditional generic drugs. That’s the argument the Generic Pharmaceutical Association (GPhA) made in the citizen petition it submitted to the FDA earlier this month. Used to cashing in on the success of a small molecule brand drug by sharing...

As the U.S. House and Senate continued their down-to-the-wire game of chicken Monday, government departments dusted off and updated their contingency plans in preparation for what threatened to be the first shutdown in nearly two decades should neither side give on a continuing resolution to fund federal programs after 12:01 a.m. (EDT) Tuesday, the dawn of fiscal 2014.

A national track-and-trace system that would preempt the expanding patchwork of state regulations involving the drug supply chain may soon move a step closer to reality.

Prioritizing 505(q) petitions asking the FDA to take or stay action in pending approvals of biosimilars, generics and 505(b)(2) drugs is delaying action on more important matters, the agency told Congress in a recently submitted annual report.

When it comes to health care, money really does talk – especially if it’s in the form of Medicare reimbursement.

Given the devil in the details of the SEC’s amendments implementing Title II of the Jumpstart Our Business Startups (JOBS) Act, some angels fear that what Congress intended as a way to help start-ups raise money before going public could make participating in Rule 506 private offerings even riskier.

What’s in a name? Marketability. That’s part of the sales pitch the Generic Pharmaceutical Association (GPhA) made in a citizen petition in which it asked the FDA to give biosimilars the same international nonproprietary name (INN) as their reference biologic.