Recognizing that an initial public offering (IPO) isn’t the best route for all small companies in need of capital, the Equity Capital Formation Task Force is pushing the SEC to lift the barriers on Regulation A offerings immediately.

Now that generic drugs are a fully grown industry in the U.S., the FDA said it’s time for generic drugmakers to take responsibility for the labeling of their products and face the same liability as the makers of brand drugs and biologics.

Just in time for the holidays, the FTC is gifting itself on the biopharma industry by finalizing a change to its premerger notification rule that makes transfers of “all commercially significant rights” to drug, biologic and in vitro diagnostic patents subject to antitrust review under the Hart Scott Rodino (HSR) Act.

What could be the first chapter in a sequel to the Jumpstart Our Business Startups (JOBS) Act was unveiled Wednesday with the hope that it soon will become a congressional best-seller that will stimulate investment in groundbreaking R&D.

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.