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.
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.
With the Supreme Court beginning its next session later this month, drugmakers are looking to the justices for guidance in shareholder, whistleblower and patent infringement cases while seeking protection from punitive damages and some civil suits.
In the wake of the Jumpstart Our Business Startups (JOBS) Act, more than 230 initial public offerings (IPO) are expected this year, with small biotechs and other emerging growth companies (EGCs) accounting for much of the resurgence in IPO interest.
A rule change restricting access to prescription drugs under the new expanded Medicaid programs has a group of 81 patient advocacy organizations demanding some changes of their own.
The FDA is getting ready to take its Secure Supply Chain Pilot Program (SSCPP) out for a two-year test flight, and it's looking for up to 100 drugmakers to sign on for the ride.
An attempt to lift California's 6-year-old ban on compensating women for donating human eggs for medical research ended this week with a veto by Gov. Jerry Brown.
