Biopharma regulators across Asia are undergoing major restructuring as China, India and other countries seek to protect their share of drug exports in the face of stiffer manufacturing compliance demands in the West and pressure to adopt international standards.

All the hurdles in developing drugs to fight cancer in children came to the fore this week as the Pediatric Oncology Subcommittee of the FDA’s Oncology Drugs Advisory Committee (ODAC) grappled with the unknowns of science and a pressing unmet need as they discussed global pediatric development plans for Bristol-Myers Squibb Co.’s (BMS) nivolumab, Merck Sharp and Dohme’s MK-3475 and Novartis Pharmaceuticals Corp.’s LEE011.

Opting for an ounce of prevention rather than a pound of cure, the FDA unveiled a proposed rule and strategic plan Thursday to keep drug shortages from happening.

Several lawmakers have put aside their political differences to come together on the Innovation Act, a sequel that takes up where the 2011 America Invents Act (AIA) left off in its reform of the U.S. patent system.

The regulatory experts who gathered in Europe from all over the world to consider a global standard for naming biosimilars got such an earful of contradictory views that they’re likely to hold at least one more public forum before they recommend an international nonproprietary naming (INN) scheme for the follow-on biologics.

The SEC took the first step toward opening the door to the crowds that may be waiting to put their money where their heart is, proposing rules to implement the crowdfunding provision of the Jumpstart Our Business Startups (JOBS) Act.

The question is no longer should clinical trial data be shared but, rather, how can it best be shared. Hoping to answer that question, an Institute of Medicine (IOM) committee heard from a range of experts Wednesday on strategies to responsibly share raw trial data.

No big worries appear to be on the agenda for Thursday’s advisory committee meeting on Janssen Pharmaceuticals Inc.’s simeprevir, which is seeking a limited hepatitis C virus (HCV) label.

Given the power of a name and the fact that more biosimilars are moving through the global pipeline, the World Health Organization (WHO) is facing increased pressure this week to come up with a new international nonproprietary naming (INN) scheme for the follow-on drugs.

The good news is that the government is up and running again and a default on federal bills has been averted for at least another few months. The bad news is that government agencies, including the FDA and National Institutes of Health (NIH), are once again pinned to last year’s sequestered spending levels.