BusinessWeek Says " Why Cheaper Insulin Today Risks Higher Costs Later " . We should want that!
On April 4, 2023,Bloomberg BusinessWeek magazine published an article entitled " Why Cheaper Insulin Today Risks Higher Costs Later " (seehttps://www.bloomberg.com/news/articles/2023-04-04/cheaper-insulin-from-lilly-and-sanofi-risks-raising-costs-later for the article). Unfortunately, Americans have grown much too accustomed to seeing prescription drug prices being artificially manipulated from behind-the-scenes by entities who rig the system to line their own pockets that today, we instinctively view higher prices in the future as a direct assault. Don ' t play that game!But if the market was working properly to begi...
Source: Scott's Web Log - April 7, 2023 Category: Endocrinology Tags: glucose responsive insulin 2023 Amphastar Biocon bloomberg BusinessWeek Civica insulin prices Lannett Sandoz the Business of Diabetes Source Type: blogs

More Insulin Biosimilars Are Forthcoming; The Market Outlook for Them
During the past few weeks, in both SEC-mandated (for publicly-held companies) earnings reports and investor presentations, plus in the business news and pharmaceutical industry trade press, we received several important, relevant updates on not one, but on FOUR insulin biosimilars currently in development from two different companies. We also know that in addition to them, insulin biosimilars are in development from at least three additional companies, plus as the " innovators " , the traditional " Big Three " insulin-makers of Lilly, Novo Nordisk and Sanofi continue making their bestsellers (for the time being, anyway).&n...
Source: Scott's Web Log - September 12, 2022 Category: Endocrinology Tags: 2022 Biosimilar Biosomilars generic insulin Source Type: blogs

Lilly Pulls the Plug on Mix-and-Inject Glugagon Rescue Kits
For those who didn ' t hear the news when it broke, diaTribe news reported (seehttps://diatribe.org/glucagon-options-expand-lilly-discontinues-emergency-kit for the news) that Lilly announced that the company intends to discontinue manufacturing its traditional Glucagon Emergency Kitshttps://www.lillyglucagon.com/ by the end of 2022. The kits are old-school, mix& inject kits that many patients (and caregivers alike) really despise because they are rather cumbersome and inconvenient to use when time is of the essence. Having an unpopular product works in the absence of competition, but when newer, more convenient produc...
Source: Scott's Web Log - August 17, 2022 Category: Endocrinology Tags: Eli Lilly and Company glucagon PBM rebates Source Type: blogs

PROP s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences
ConclusionDespite being turned back from an effort to bluntly reduce opioid prescribing by the FDA in 2013 based on a lack of scientific evidence for its position (17,18), PROP has had a disproportionate effect on opioid policy in the Untied States for almost a decade. PROP found a willing federal regulatory partner in the CDC, and while PROP may not have secretly written the 2016 CDC Pain Guidelines (75), they certainly enjoyed disproportionate representation on CDCs review panels and Core Expert Group (23-25) in a process that lacked transparency (22, 23, 26, 27). When the CDC admitted that its Pain Guideline had been...
Source: Pallimed: A Hospice and Palliative Medicine Blog - May 3, 2021 Category: Palliative Care Tags: CDC health policy kollas opioids pain prop Source Type: blogs

PROP ’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences
ConclusionDespite being turned back from an effort to bluntly reduce opioid prescribing by the FDA in 2013 based on a lack of scientific evidence for its position (17,18), PROP has had a disproportionate effect on opioid policy in the Untied States for almost a decade. PROP found a willing federal regulatory partner in the CDC, and while PROP may not have “secretly written” the 2016 CDC Pain Guidelines (75), they certainly enjoyed disproportionate representation on CDC’s review panels and Core Expert Group (23-25) in a process that lacked transparency (22, 23, 26, 27). When the CDC admitted that its Pain Guideline ha...
Source: Pallimed: A Hospice and Palliative Medicine Blog - May 3, 2021 Category: Palliative Care Tags: CDC health policy kollas opioids pain prop Source Type: blogs

More on clinical trials
Previously, I discussed the basic concept of randomized controlled trials, but didn ' t go into all the complexities. Actually, I can ' t go intoallthe complexities without writing a very big book, and that ' s not the book I want to write. However, there are some important points I ' d like to cover here.First, there ' s the question of what drugs (or possibly other kinds of interventions) even get into clinical trials in the first place. In order to conduct trials, the sponsor needs to get approval of what ' s called an Investigational New Drug Application from the FDA. This requires a reasonable expectation of safety an...
Source: Stayin' Alive - February 18, 2021 Category: American Health Source Type: blogs

This treatment could save your life – COVID-19 and Convalescent Plasma Therapy
Ajay Kohli Vinay Kohli Chitra Chhabra Kohli By CHITRA CHHABRA KOHLI MD, AJAY KOHLI MD, and VINAY KOHLI MD, MBA With a doubling time of cases estimated between 3 days within the U.S. and about 6 days globally (at the time of this writing) COVID-19 is demonstrating its terrifying virulence as it spreads across the world. What’s perhaps equally terrifying, if not more, is the absence of a known cure or treatment plan for COVID-19. While there has been a lot of attention focused on Hydroxychloroquine and Azithromycin, there has been debate on the scientific validity of these treatment options, either as thera...
Source: The Health Care Blog - March 30, 2020 Category: Consumer Health News Authors: Christina Liu Tags: COVID-19 Patients Physicians Ajay Kohli Azithromycin convalescent plasma therapy coronavirus COVID-19 treatment hydroxychloroquine Pandemic Vinay Kohli Source Type: blogs

Keep using sunscreen while FDA updates recommendations on safety of sunscreen ingredients
This study is called an exploratory maximal usage trial (MUsT), because the sunscreen products were applied according to the maximum limit of the products’ directions for use, which likely far exceeds use by the average consumer. Furthermore, while the FDA recommends that active ingredients in sunscreen that exceed 0.5 ng/ml should undergo toxicology testing to check for harmful health effects, this number is somewhat arbitrary, as it is not known what the significance of this blood level means. The FDA acknowledges that without further testing, we do not know what degree of absorption should be considered safe. What is ...
Source: Harvard Health Blog - July 31, 2019 Category: Consumer Health News Authors: Kristina Liu, MD, MHS Tags: Cancer Skin and Hair Care Source Type: blogs

Fight Aging! Newsletter, April 22nd 2019
Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to online resources, and much more. This content is...
Source: Fight Aging! - April 21, 2019 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs

A Few of the Many Interviews Conducted at the Undoing Aging 2019 Conference
The Life Extension Advocacy Foundation (LEAF) volunteers were at the recent Undoing Aging conference in Berlin, and spent much of their time interviewing a selection of the attending scientists and entrepreneurs. The interviews are being published at the LEAF blog as they are made ready, and here I'll point out the latest. The research and development communities focused on treating aging are becoming very diverse. A wide range of activities are underway, driven by an equally wide range of views on the nature of aging and where best to intervene. Most work at the present time, well represented in these interviews, involves...
Source: Fight Aging! - April 17, 2019 Category: Research Authors: Reason Tags: Healthy Life Extension Community Source Type: blogs

Alcohol Clinical Trial Continues to Crumble: Anheuser-Busch Pulls Its Funding
In another setback for the NIAAA ' s and alcohol industry ' s study of the " health benefits " of encouraging people to drink, Anheuser-Busch has pulled its funding from the clinical trial because recent controversy over how the research funding was solicited has undermined the study ' s credibility.According to anarticle by Roni Caryn Rabin in theNew York Times:" Brewing giant Anheuser-Busch InBev, one of five alcohol companies underwriting a $100 million federal trial on the health benefits of a daily drink, is pulling its funding from the project, saying controversy about the sponsorship threatens to undermine the study...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - June 10, 2018 Category: Addiction Source Type: blogs

A Tale of 2 FDAs
By ANISH KOKA Frances Oldham Kelsey by all accounts was not mean to have a consequential life.  She was born in Canada in 1914, at a time women were meant to be seen and not heard.  Nonetheless, an affinity for science eventually lead to a masters in pharmacology from the prestigious McGill University.  Her first real break came after she was accepted for PhD level work in the pharmacology lab of a professor at the University of Chicago.  An esteemed professor was starting a pharmacology lab and needed assistants, and the man from Canada seemed to have a perfect resume to fit.  That’s right, I said man.  France...
Source: The Health Care Blog - June 4, 2018 Category: Consumer Health News Authors: anish_koka Tags: Uncategorized Source Type: blogs

Making Progress Toward Healthier Pharma Markets
By MICHAEL J. ALKIRE Pharmaceuticals play a major role in today’s population health era – they can prevent and cure disease, improve or maintain wellness and slow progression of existing conditions. Yet, their promise can also be a curse if high prices limit patient access and bankrupt the healthcare providers and insurers bearing significant financial risk for patient care. The proactive new leadership at the FDA is promoting competitive markets by combatting the abuse of well-intentioned programs and market share monopolies. Commissioner Scott Gottlieb has ramped up the FDA’s efforts to prevent drug manufacturers f...
Source: The Health Care Blog - March 27, 2018 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized Source Type: blogs

FDA Issues New Draft Guidance on Submitting Formal Meeting Requests
A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how FDA can respond, how long the agency can take to respond, and how the sponsor and FDA can go about conducting efficient, consistent, timely and effective meetings. Meeting Types FDA describes four types of meetings. Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important safety issue. Before submitting a Typ...
Source: Policy and Medicine - March 6, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Releases Guidance on IND Sponsors
In December, the FDA issued a guidance describing best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs. The guidance applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD). Guidance Communications between FDA and industry are often opportunities to share information on clinical trials and for the agency to provide ...
Source: Policy and Medicine - February 5, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs