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Galena Biopharma agreed to pay more than $7.5 million to settle a whistleblower suit alleging the drugmaker violated the False Claims Act by paying doctors to prescribe its fentanyl-based drug Abstral. Read More
Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
The FDA’s Pediatric Advisory Committee voted overwhelmingly that the risks outweigh the benefits of using opioids to treat coughs in children. Read More
FDA commissioner Scott Gottlieb highlighted the agency’s efforts to improve clinical trials during a keynote address Monday at the RAPS’ 2017 Regulatory Conference. Read More
Biocon plans to re-submit applications for European approval of two biosimilars as soon as it corrects serious GMP deficiencies found at a Bangalore manufacturing plant. Read More
The FDA finalized 48 guidances for generics manufacturers, outlining the recommended studies for demonstrating bioequivalence for dozens of active ingredients and combinations, to assist the industry with generating evidence to support ANDA approvals. Read More
The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by Hospira. Read More
Coherus BioSciences filed a petition with the PTO for an inter partes review of a patent on production methods for Amgen’s Enbrel (etanercept), saying the claims are obvious and unpatentable. Read More
Hedge fund investors are suing generics manufacturer Teva for not being forthcoming about a federal price-fixing investigation — saying the company’s false statements before the eventual reveal of a subpoena resulted in losses of billions in shareholder value. Read More