Understanding Multinational Regulatory Filings: New Chemical Entity
By Jim Springer, Steve Halpin, and Megan Kuikstra, Albemarle FCS
Finding the right long-term CDMO partner for development and commercial launch of a new chemical entity (NCE) presents sponsors with a uniquely challenging scenario. First, “right” must be defined in quantifiable metrics, then the search begins for a CDMO exhibiting those qualities. The challenge is magnified when a multinational launch is planned.
For many sponsors, the search for a CDMO partner begins in earnest during phase two of clinical trials: the new chemical compound, chemical structure, or mechanism of action (MOA) is producing positive results, and the sponsor is actively evaluating the patient population and dose. They are trying to estimate volumes for launch and predict where growth might take the product in five or ten years.
04.08.21 Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
On this episode of the
Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company s approach to process development and manufacturing. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C.
This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020, transition date, as well as the FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic.
Hall of Famers Coached by a Hall of Famer; 1950s Golden Era of Gustie Men’s Hoops Posted on January 11th, 2021 by CJ Siewert
The 1950s truly was the golden era of Gustavus men’s basketball. Head Coach
Gus Young guided the Gusties to three consecutive runner-up finishes in the MIAC before dethroning Jon Hutton’s Hamline Pipers for conference championships in 1954, 1955, and 1956.
The makeup of those championship teams was extraordinary. The lineup for the 1956 squad that won a third-straight MIAC title and advanced to the quarterfinals of the NAIA tournament included four future Gustavus Athletics Hall of Famers under the direction of a Hall of Fame coach. 1956 graduates
martha: there is some serious new concerns about the safety of the new boeing 787 dreamliner. officials are still trying to figure out what caused a battery to fail earlier this month. there are multiple systems to protect against a system fire like this. those systems did not do not work as intended. we need to understand why. martha: yes, we do. jim springer joins us now. that s right, this problem did not sneak up on us. a fire was sparked over six years ago that exploded during a test. this was an arizona company called that was a boeing contractor. they make a charter for the 787 boeing plane. during some testing, 60-pound
massive killings to be carried out again and again and again in our country. bill: she says no guns are being taken away. people that have assault rifle will have to secure them. but the bill is facing tough opposition. tucker carlson, editor, daily caller. fox news contributor. good morning to you. good morning, bill. bill: in a word do you expect it to go anywhere? i do not. for the reason it doesn t address the core problem. it is silly. most people are horrified by series of school shootings all of which were carried out by the mentally ill. the question is how do you keep firearms away from people with mental problems? this bill does not address that at all. instead it addresses law-abiding citizens who have guns for self-protection or hunting, who pose no threat to anyone. it is an attack on people who are not the problem. for that reason it will not make it through the senate much less the whole congress. bill: we l see what harry reid does. he says he is cautious