Search Results for Lilly

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FDA Denies Amneal Petition Seeking to Block Generic Versions of Osteoporosis Treatment By Zachary Brennan - Published 09 January 2018

Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide).

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Forteo, osteoporosis, Amneal, Lilly, citizen petitions

Trump: Former Eli Lilly Exec to be Nominated as Next HHS Secretary By Zachary Brennan - Published 13 November 2017

President Donald Trump on Monday morning announced via Twitter his intention to nominate Alex Azar, former senior vice president at Eli Lilly and deputy HHS secretary under President George W. Bush, to be the next HHS secretary.

Categories: News, US, Drugs, Reimbursement

Tags: Azar, HHS Secretary, Eli Lilly

Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US By Zachary Brennan - Published 11 December 2017

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars

FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics By Zachary Brennan - Published 07 February 2017

The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which was first approved by FDA in 1986.

Categories: News, US, FTC, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Vancocin, c. difficile, Eli Lilly, Shire, citizen petitions

Why Don’t People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss By Zachary Brennan - Published 01 December 2016

At the end of Thursday's Forbes healthcare summit in New York, some of the pharmaceutical and biotech industries’ top executives – from Pfizer, Regeneron, Eli Lilly, Gilead and Astellas – sat down and were presented with a simple question: Why don’t people like you?

Categories: News

Tags: Regeneron, Eli Lilly, Pfizer, Astellas, Gilead, Forbes

TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators By Zachary Brennan - Published 29 June 2016

The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Clinical, Crisis management, Drugs

Tags: TransCelerate, Lilly, Pfizer, AstraZeneca, Amgen

FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions By Zachary Brennan - Published 16 June 2016

The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs, Research and development

Tags: Viekra Pak, Eli Lilly, AstraZeneca, generic drug draft guidance, generic drug development

European Regulatory Roundup: Lilly May Move API Production Outside EU Due to REACH Regulations (17 March 2016) By Nick Paul Taylor - Published 17 March 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: EU Regulatory Roundup, Eli Lilly, API manufacturing, REACH, CHMP, DMD

Case Study: Regulatory Advertising and Promotion From a Fellow’s Perspective By John Riehl - Published 16 October 2015

This article discusses three components of Purdue University’s Regulatory Pharmaceutical Fellowship from a current fellow’s perspective followed by a candid interview.

Categories: Features, US, FDA, Advertising and Promotion, Business Skills, Drugs

Tags: drug advertising and promotion, FDA, Purdue University, Johnson & Johnson, Eli Lilly, regulatory pharmaceutical fellowship

Warning Letter to Eli Lilly Focuses on Use of Color Images in Marketing Materials By Alexander Gaffney - Published 10 September 2012

Categories: FDA

Tags: Alzheimer's Disease, OPDP, NOV, Amyvid, Eli Lilly, warning letter, Latest News, marketing

Companion Diagnostic Test, Drug Get Concurrent Approval from FDA By Alexander Gaffney - Published 09 July 2012

Categories: FDA, CDER, CDRH

Tags: CRC, Erbitux, Companion Diagnostic, BMS, Eli Lilly, Latest News, approval

Suspects Nabbed in Record-Setting Pharmaceutical Heist By Alexander Gaffney - Published 08 May 2012

Tags: Cymbalta, Prozac, Zyprexa, Robberies, Villa, Thieves, Robbery, Heist, Eli Lilly, GSK, Latest News, pharmaceutical, drug

NIH Launches New Program to Share Drug Compounds By Alexander Gaffney - Published 04 May 2012

Tags: Compounds, Library, Eli Lilly, AstraZeneca, Pfizer, Combine, Translational Science, Thomas Insel, NCATS, NIH, Latest News, pharmaceutical, drug

Eli Lilly's Lechleiter Replaces Sanofi's Veibacher as PhRMA Chairman By Alexander Gaffney - Published 16 April 2012

Tags: Chairman, Lechleiter, Veihbacher, Castellani, Board, Eli Lilly, PhRMA, Sanofi, Latest News

FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism By Alexander Gaffney - Published 12 April 2012

Categories: FDA

Tags: NRDC, Taylor, Eli Lilly, antibiotics, Pfizer, Merck, Veterinary, CVM, Latest News, draft guidance, guidance

Eli Lilly Gets Approval for Brain Plaque Test Published 09 April 2012

Categories: FDA

Tags: Amyvid, Alzheimer's, Eli Lilly, Latest News

NIH, Eli Lilly Creating Public Drug Database By Alexander Gaffney - Published 13 March 2012

Categories: FDA

Tags: Phenotypic Drug Discovery, Discovery, Eli Lilly, NCATS, NIH, Latest News, partnership, database, pharmaceutical, drug