May 6th 2024
Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.
States Take the Lead in Advancing US Biopharma Industry Development
June 15th 2017States have taken the lead in advancing strategic policies and programs to attract, retain, and grow an innovative biopharmaceutical presence in the United States, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents leading US biopharmaceutical research companies.
Legal Experts Grapple With Implications of Sandoz v Amgen at the Summit on Biosimilars
June 15th 2017News of the landmark Supreme Court ruling in the case of Sandoz v Amgen broke during the Monday session of the 8th Annual Summit on Biosimilars, a meeting of legal and pharmaceutical industry professionals convened in New York City. In a previously scheduled—and swiftly updated—discussion of the case, a panel of attorneys grappled with the ruling and its implications for the industry.
ICER Report Recommends Patient Access to Dupilumab for Atopic Dermatitis
June 13th 2017The Institute for Clinical and Economic Review (ICER) has issued a report recommending that dupilumab (Dupixent) offers good long-term value and important clinical benefit for patients with moderate-to-severe atopic dermatitis.
PhRMA Report a Call to Action on the Global Challenge to US Leadership in Biopharma
June 9th 2017The US biopharmaceutical industry faces mounting global competition from countries in the developing world and Europe that are increasingly implementing pro-innovation programs and strategies in the sector, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA)
FDA Commissioner Gottlieb Focusing on Generics to Address High Drug Prices
June 7th 2017FDA Commissioner Scott Gottlieb, MD, said that the agency is examining how to push drug applications to “the front of the line” when there are fewer than 3 competing manufacturers for generic versions of a particular medication.