The union representing Canada Post workers said it will be in a legal strike position on Friday, exactly one year after talks on a new contract began. But the union is holding back on deciding whether a job action will take place immediately.

Mike Waltz, the man reportedly tapped for the top international role inside the Trump White House isn’t just predicting the impending defeat of Canada’s Trudeau government: He’s celebrating it.

Former B.C. premier John Horgan has died at the age of 65, CBC News has confirmed. In June this year, Horgan told CBC that he had been diagnosed with cancer for the third time during a routine followup appointment for his previous throat cancer.

Canada's intelligence agency amassed a sizable file on Abousfian Abdelrazik's suspected terrorism ties in the early 2000s, although the validity of that intelligence was called into question during the Montreal man's Federal Court case.

Prime Minister Justin Trudeau sounded an upbeat note Tuesday on the prospect of working with U.S. president-elect Donald Trump, saying Canada has dealt with his trade threats before and can do so again.

BROCK Lesnar was allowed to dodge an anti-doping policy to make his megastar comeback at UFC 200 but what’s happened since is remarkable.

La vedette colombienne du reggaeton Karol G s’est excusée pour des paroles de son nouveau single «+57» jugées offensantes.

Elle tiendra la vedette de l’adaptation québécoise du succès mondial Ménopause aux côtés de Claudine Mercier, Catherine Sénart et Geneviève Charest.

ONE of the world’s most spectacular clouds made a dramatic entrance for passengers on an Adelaide-bound jet.

The Arctic territory hopes that three new airports will pave the way for direct flights from the US and Europe.

As Americans prepare to vote in the presidential election, Canadians and Mexicans mull the likely impact. 

Canada has launched a tourist drive but will tensions with China doom it to fail?

They can cost hundreds of pounds, but are these products actually worth the money?

Thousands of drivers on ride-hailing and food delivery app Bolt have won a legal claim to be classed as workers.

Office for National Statistics data suggests homeworkers get more sleep and exercise on average.

Centrelink’s controversial data-matching program will be ‘refined’ as pressure mounts for it to be suspended.

Ces produits se démarquent par leurs valeurs nutritives, surpassant celles d’options similaires.

The secretary of the Union Ayush Ministry, Dr Rajesh Kotecha, will inaugurate the 61st Ayurveda Seminar organized by the Kottakkal Aryavaidyasala (Kottakkal AVS) on November 10 at Kottakkal in

Public Sector Enterprises Selection Board (PSEB) is seeking qualified candidates for the post of managing director at the Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) in Bengaluru. The candidate will be

The Indian healthcare industry is looking to invest further in computational infrastructure as data integration frameworks and regulatory compliance are pivotal to ensure intelligent clinical support

Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the FDA has granted clearance of the first 3D-Printed PEEK Interbody System made from PEEK-OPTIMA.

Regulatory experts LFH Regulatory have announced their attendance at MEDICA 2024 to provide insights and support to healthcare innovators facing the complexities of the UK and EU markets.

Peytant has announced that the U.S. Food and Drug Administration (FDA) granted marketing authorisation (clearance to market in the United States as a Class II device) for the AMStent Tracheobronchial Covered Stent System, a therapy platform.

A strange supernova remnant first appeared as a “guest star” seen in 1181 by sky watchers in China and Japan

It is difficult to disentangle Russian and Chinese scientists from international science cooperation. That is a good thing

Outside groups often offer their solutions for climate adaptation in Africa. But the best people to manage the climate crisis are the people in those communities themselves. For climate adaptation to succeed in Africa, let communities and local leaders show the way

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Last week, the Federal Trade Commission (FTC) released the redacted version of administrative complaint against the three largest pharmacy benefit managers (PBMs). The FTC rightly calls out how the gross-to-net bubble can raise patients’ out-of-pocket costs, while also acknowledging how rebates can reduce a plan's (but not the patient’s) costs. Apparently, the FTC believes that PBMs’ customers are pretty dumb, because PBMs are able to prevent plans from “appreciating” such healthcare financing dynamics.

Section V.E. of the complaint (starting on page 23) focuses on the PBMs’ alleged unlawful conduct related to preferring high-list/high-rebate insulin products over versions with lower list prices. I thought it would therefore be fun to take the Wayback Machine to November 2021, when I wrote about this specific topic.

Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus. Much of the FTC’s description of the drug channel aligns with my commentary. But before you fist pump too hard for Ms. Khan’s FTC, you should pause to reflect on the agency’s legal theories in light of plans’ revealed preferences.

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The Food & Drug Administration (FDA) recently approved the first interchangeable biosimilar insulin product: the insulin glargine-yfgn injection from Viatris. Read the FDA’s press release.

Alas, I’m sad to report that the warped incentives baked into the U.S. drug channel will limit the impact of this impressive breakthrough.

Viatris is being forced to launch both a high-priced and a low-priced version of the biosimilar. However, only the high-list/high-rebate, branded version will be available on Express Scripts’ largest commercial formulary. Express Scripts will block both the branded reference product and the lower-priced, unbranded—but also interchangeable—version. Meanwhile, Prime Therapeutics will place both versions on its formularies, leaving the choice up to its plan sponsor clients.

Consequently, many commercial payers will adopt the more expensive product instead of the identical—but cheaper—version. As usual, patients will be the ultimate victims of our current drug pricing system.

Below, I explain the weird economics behind this decision, highlight the negative impact on patients, and speculate on what this all could mean for biosimilars’ future. Until plan sponsors break their addiction to rebates, today’s U.S. drug channel problems will remain.
Read more »

Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats:

• Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy

• Vampiric! Prior authorization sinks its fangs into providers’ time

• Wicked! How the IRA will put a stake through specialty physician practices

• Eerie! Google’s monstrous AI podcasts leave me petrified

• Zoinks! Join the vampire hunters at Drug Channels Institute

Plus, Dr. Glaucomflecken tells us a frightening tale of copayments.

P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community.
Read more »

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a photo:

Catherine Dasenbrock, director of the U.S. Food and Drug Administration’s National Forensic Chemistry Center, speaks to guests prior to officially reopening the center during a ribbon-cutting ceremony, Sept. 24, 2024, celebrating the completion of the 64,000-square-foot expansion and renovation of the facility in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

U.S. Food and Drug Administration officials and General Services Administration leaders officially reopen the National Forensic Chemistry Center during a ribbon-cutting ceremony, Sept. 24, 2024, highlighting the completion of the 64,000-square-foot expansion and renovation of the center in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

(From left)
Marie Maguire, Assistant Special Agent in Charge, Headquarters Operations, Office of Criminal Investigations, FDA
James Sigg, Deputy Commissioner for Operations and Chief Operating Officer, Office of the Commissioner, FDA
Catherine Dasenbrock, Director, National Forensic Chemistry Center, Office of Inspections and Investigations (OII), FDA
Duane Satzger, Associate Director, Office of Medical Products and Specialty Laboratory Operations, OII, FDA
Katy Kale, Deputy Administrator, GSA
Douglas Stearn, Principal Deputy Associate Commissioner, OII, FDA

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more progressive environment at the agency: continuity of leadership, presidential support, and increased funding. For FDA in 2013 (as the saying goes): 2 out of 3 ain’t bad. In particular, medical innovation seems poised to flourish in an FDA environment where there is continuity of policy and leadership, instead of a new team learning the ropes. I explore this and other themes in the latest issue of Pharmaphorum.com. You can read my thoughts at: http://www.pharmaphorum.com/2013/01/29/fda-post-election-continuity-and-progress-likely-to-mark-2013/.

FDA is the only federal agency that touches the lives of every American several times every day. Despite this, FDA will probably not be mentioned when President Obama delivers his State of the Union (SOTU) address to Congress on February 12. Instead, FDA Matters provides its third annual “State of the FDA.” As reflected in last week’s column, I think that FDA did well in 2012. And 2013 is very promising. Potential funding cutbacks are the primary impediment to future successes.

FDA’s mission is “at risk” because of inadequate funding. So says Alliance for a Stronger FDA President Diane Dorman, testifying before the FDA Science Board. Her remarks come 5 years after the Science Board made a similar declaration, concluding that decades of underfunding had left FDA without the resources to fulfill its mandate and make science-based decisions. Congress responded with more monies for the agency, but since then the FDA’s workload has increased even faster. The current threat to FDA comes from two sources: four major new laws to implement since 2009; and changes in the environment in which FDA operates, notably acceleration of globalization and increasing scientific complexity. Ms. Dorman’s remarks are reprinted below. If you care about FDA, FDA Matters urges you to read her testimony, go to the Alliance’s site (www.StrengthenFDA.org) and join.

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Altogether, FDA will lose about $209 million between now and September 30, 2013. This will reduce inspections, slow drug and device approvals, and restrict implementation of the Food Safety Modernization Act and other recent legislation. Because of the many questions about the process and outcome, this is FDA Matters’ primer on the sequester of FDA funds.

The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives. And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights. Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law.