US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
This article was originally published in Scrip
Executive Summary
This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included a new brief submitted to the Supreme Court in which Amgen Inc. argued the Zarxio biosimilar lawsuit is a "poor vehicle" for interpreting the Biologics Price Competition and Innovation Act, and therefore, Sandoz Inc.'s petition to hear the case should be denied; another eye-opener involving Valeant Pharmaceutical International Inc.'s pricing practices, which this time involved Seconal, a drug used off-label in physician-assisted suicides; a decision by the Patent Trial and Appeal Board of the US Patent & Trademark Office to institute an inter partes review petition from hedge fund manager Kyle Bass challenging a patent held by Biogen Inc. on its 480mg dose of its multiple sclerosis drug Tecfidera (dimethyl fumarate); and the FDA's approval of Pine Brook, NJ-based Elusys Therapeutics Inc.'s Anthim (obiltoxaximab) in combination with appropriate antibacterial drugs to treat inhalational anthrax and prevent the disease when alternative therapies are not available or are not appropriate; plus other Washington news.
You may also be interested in...
Moderna's Valera Takes mRNA Approach To Combat Zika
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan's Price Reform Pledge: Will Others Follow?
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.
Clinton's Drug Price Plan: Threat Or Flash In The Political Pan?
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.