As people gather to remember those who fought and died to protect this country in past wars, a new poll suggests many Canadians know little about their country's history.

Donald Trump's former commerce secretary says he 'can't imagine' the U.S. president-elect would want to tax Canadian energy, despite campaign promises about imposing a global tariff when he takes office in January.

Thousands of veterans, military personnel and their supporters gathered at Canada's National War Memorial in Ottawa to remember those who have fought and died to protect this country and its freedoms.

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.

Ontario Premier Doug Ford appears to be dipping his toe into new territory — talking about removing Mexico from the North American trade agreement.

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.

Don’t trust yourself to stop nibbling? Shut those tempting treats away in a time-locked safe.

AFTER suffering an NBA Finals defeat to ruin the best regular season in history, Golden State’s owner promised to be “very aggressive”.

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.

Gros succès en France, le drame biographique est présenté samedi au Festival Cinemania.

Geoff Molson, Kent Hughes et Martin St-Louis avaient promis que le Canadien de Montréal serait dans le «mix» cette saison.

IF you buy a large cappuccino you may find it is quite cold by the time you get to the bottom. Thankfully, there is now a solution to this.

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?

The deal secured by the Hull facility is for the East Anglia TWO project off the Suffolk coast.

Former Liberal senator Sean Edwards has continued to fuel speculation he is set to make a bid to enter state politics.

Those who work in public administration and defence operate in the most heavily unionised sector of the labour market.

LEGENDARY Ironman champion and long-serving swimming coach Barry Rodgers died yesterday aged 74 after battling cancer. He is remembered as “the embodiment of grit and determination”.

La présence de lésions intestinales serait associée à une hausse importante du risque de développer la maladie de Parkinson.

The National Commission for Allied Health Professionals (NCAHP), constituted by the Union ministry of health and family welfare in the beginning of this year, will have its official representative in the National

Indian and multinational pharma companies are leading the charge by investing in digital transformation and aligning Indian operations with global standards. Essentially, pharmaceutical water systems are

Oversimplification about integration of traditional and modern treatment systems often creates confusion among the stakeholders, and nobody understands the reality of the integration and what it is meant for, said Dr.

Two exclusive conferences focusing on "Reference Material (RM) Producers" organized by National Accreditation Board for Testing and Calibration Laboratories (NABL) are scheduled to be held on January 10,

Syensqo, previously part of Solvay Group and a global provider of advanced performance materials and chemical solutions, is making its debut at Compamed 2024.

In this episode of The MedTalk Podcast, we're bringing you something a little different. One of our sister publications, European Pharmaceutical Manufacturer, secured an interview with Thermo Fisher Scientific's Urmi Prasad Richardson.

Scientific American staff and sleep experts share advice on how to get better sleep in the stressful days leading up to the U.S. presidential election—and those that come after

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

Analysis of a strain of the virus circulating in Central Africa shows genetic mutations indicative of sustained human-to-human spread

Famous people who die at age 27, such as Janis Joplin, Jimi Hendrix and Amy Winehouse, get even more famous because of the mythology surrounding that number—an example of how modern folklore emerges

“Going viral” appears to be more than just a catchphrase when it comes to the rampant spread of misinformation

Is your kid in trouble? Blaming their friends is ill advised

The new Trump administration is likely to reduce subsidies for Affordable Care Act insurance plans and roll back Medicaid coverage. Public health authorities worry that antivaccine activist Robert F. Kennedy, Jr., will be empowered

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

A fee created to push oil and gas companies to plug methane leaks could be axed by the incoming Trump administration, hampering efforts to curb the potent greenhouse gas

Researchers at the Wyss Institute at Harvard University have developed a microfluidic chip that can recreate some of the features of radiation-induced lung injury. The lungs are very sensitive to radiation, and this can limit the application of radiotherapy to treat cancer. Accurately modeling radiation-induced lung injury could assist in developing new methods to prevent […]

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.

The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. Last night, I posted an updated analysis showing that the volatility in seniors' coinsurance rates continues. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. What's more, rates for 17 drugs returned to their original 20% level. Click here to see our original post from May 2024.

---

Contrary to what you may have heard, the Inflation Reduction Act’s (IRA) inflation rebates for Medicare Part B drugs do not always save money for seniors.

As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing, not declining. In many cases, the coinsurance rate declines only briefly before rebounding back to the standard 20% rate. What’s more, these fluctuations have triggered huge jumps in patients’ out-of-pocket obligations for some drugs—even when a drug’s costs were falling.

Chalk off these coinsurance surprises to yet another unintended consequence of the IRA. Seniors who are expecting to see costs drop may find they are instead being taken for a rollercoaster ride.
Read more »

Informa Connect’s Trade and Channel Strategies
December 10-12, 2024 at the W Hotel in Philadelphia, PA
Drug Channels readers save 10% with code 24DC10*

Pharmacy and distribution models are growing increasingly complex. Stop running in circles—It’s time to unlock proven strategies to propel market access.

What is the secret to success? Trade and Channel Strategies is bringing together industry experts to deliver specific strategies and talk best practices in tackling the latest industry challenges.

As the landscape rapidly evolves, there are only two choices—Adapt or risk falling behind. With policy changes and market fluctuations, specifically surrounding the DSCSA and IRA, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of innovations within the pharmacy sector, there has never been a more important time for industry to unite. A program driven by market dynamics and led by champions of channel strategy, join your peers now to master the complexities of pharmacy and distribution models to accelerate market access—It's all happening December 10-12.

Why do trade and channel professionals choose this pivotal event?

The challenge of staying viable among shifting market dynamics while meeting business objectives is heavy. Professionals are left with many questions, including:

• How will the new administration affect the distribution channel?
• Is my organization haemorrhaging money to stay afloat with the shift to alternative distribution and pharmacy models?
• Does the DSCSA deadline change affect my organization? Am I still prepared?

Join the experts for three dedicated days of collaborative discussions that will give you the answers to these questions and so many more. Leaders in the landscape are uniting and will dive into the top trends for innovative distribution, integrated pharmacy models and talk the truth about the future of trade.

WHAT CAN YOU EXPECT?

Vital insights from industry’s leading pharmacy and distribution experts, including:

• Bill Roth, Senior Vice President of Consulting, Blue Fin Group, An IntegriChain Company
• Patrick Lupo Group Vice President, Pharmacy Trade and Specialty, Walgreens
• Amanda Salindong, Associate Director, Channel & Distribution, Alnylam Pharmaceuticals
• Chris Rocco, Senior Director, Market Access Data, Reporting & Analytics, GSK
• Eliane Maalouf, Director Trade and Fulfillment, Mass General Brigham Specialty Pharmacy
• Stephanie Wirkes, Head of Distribution and Strategy Execution, Bayer
• John Harlow, Chief Commercial Officer, Melinta Therapeutics
• Aria Cohen, Vice President, Head of Market Access, Alkeus Pharmaceuticals, Inc.
• Elizabeth Cherry, Program Director for Trade Relations, Vanderbilt Specialty Pharmacy
• Danielle Bryan, PharmD, CSP, Program Director, Specialty Pharmacy Trade Relations, Vanderbilt University Medical Center
• Thomas Scalone, Director, Trade Strategy and Operations, Bristol Myers Squibb
• Dina Lynch, VP, Market Access and Reimbursement, Renibus Therapeutics
• And more!

Tackle the hottest topics facing industry right now, including:

• Keynote Address: Access and Channel 2024 In-Review and Preview of 2025
• Pharmacy Evolved—Aligning Commercialization to the Changing Pharmacy Channel
• Advanced Trade Leaders Executive Session
• Navigate and Operationalize the IRA
• Focused Multi-Track Offerings:
  • Supply Chain, Distribution and Logistics
  • Pharmacy Models and Reimbursement Strategies
  • Data, Innovation and Analytics
  • Health Systems and Pharma Partnering Symposium
• Balancing the GTN Bubble with Market Access Priorities
• What’s Happening in Retail—Brick and Morter, Home Delivery and Cash Pay Pharmacies
• Navigating Post Deadline Challenges—DSCSA Compliance and Serialization Updates
• Four Roundtable Breakout Discussions:
  • What Good Looks Like in a 3PL/Manufacturer Partnership
  • Optimizing Healthcare Partnerships
  • Women in Trade
  • GLP-1s and New Product Archetypes
• Actions Needed to Mitigate and Prevent Drug Shortages
• Case Study: Master Your Organization Chart—Ensuring Higher Cross Functional Interactions
• Three Interactive Workshops:
  • Trade 101
  • Advanced Trade Leaders Executive Session
  • Health Systems Fundamentals
• And more!

Exclusive Offer—Download the agenda and register today—Be sure to use your exclusive promo 24DC10 to save 10% off* of your registration.

See you there!

* Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply.

---

The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net).

Disclosure: I sit on the Planning Committee for the FDLI Ad-Promo conference. This is an unpaid, volunteer position. The contents of this post were not discussed with or influenced by any member of the FDLI staff.

This post provides some of the highlights from FDLI's ad-promo conference. An on-demand version of the conference presentations is available on-demand at: https://www.fdli.org/2023/11/advertising-promotion-for-medical-products-conference-on-demand/

The Food and Drug Law Institute's (FDLI) Advertising & Promotion for Medical Products conference wrapped up last week. I attended the conference and also moderated a panel on data privacy and concerns about the use of health data for the targeting of advertising.

The first day kicked off with a fireside chat with Arun Rao from the Department of Justice (DOJ), Lauren Roth from the Food & Drug Administration (FDA), and Serena Viswanathan from the Federal Trade Commission (FTC), led by Christine Simmon of FDLI.

FDA and FTC both noted their recent guidance updates. For FDA, that means the new Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Guidance for Industry (SIUU) and the newly finalized Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements. 

FTC has also been busy, providing updated guidance on endorsements, reviews and testimonials, and a distinct Health Products Compliance Guidance.

DOJ, FDA, and FTC also mentioned the extent to which they are still very much digging out from the backlog created by the pandemic. More than three years after COVID-19 first came to our shores, its effects are very much still being felt.

Rao also mentioned a new policy from DOJ to create a safe harbor for self-reported disclosures made in connection with a merger or acquisition. Under this new policy, companies that learn of wrongdoing at a company they have acquired can be protected from later liability if they report the wrongdoing to DOJ within six months of closing the merger or acquisition. This is as Rao described it a "very big juicy carrot" to encourage self-reporting of wrongdoing, and it also ramps up the need for effective due diligence during the M&A to ensure that all wrongdoing is uncovered and can be reported.

One final point mentioned by Roth is the importance to FDA of combatting misinformation about medical products. Commissioner Califf has repeatedly warned about the need to combat misinformation, and it is not a stretch to see FDA's SIUU guidance as one small step in that direction. By providing further guidance about exactly how sponsors can share truthful, not misleading information about unapproved uses, FDA is enabling efforts to get good information from the people who should be seen as the most reliable source of that information, the product's sponsors.

The next session of the day included an update from OPDP, APLB, CDRH, and CVM related to advertising and promotion.

Katie Gray from OPDP gave a detailed presentation on the Recorlev enforcement action from earlier this year and an overview of the SIUU guidance. Lisa Stockbridge from APLB provided a reminder on reminder advertising, indicating that this well-established category of communication continues to cause firms difficulties. Debra Wolf of CDRH emphasized that although there has not been a significant amount of publicly available enforcement actions from CDRH, the Agency continues to have many private communications with firms about their marketing efforts.

The next plenary session covered scientific exchange and pre-approval communications. Elisabethann Wright of Cooley provided particular insight into the EU's approach, which of course varies widely by country, and has been especially active on platforms such as LinkedIn. Of note is the extremely active role played by the industry's own associations in not merely promulgating guidance and establishing codes of conduct but in regularly enforcing violations of those codes against member companies.

After lunch, the first set of breakout sessions occurred including the panel I moderated on data privacy. I found the discussion very lively and enjoyed hearing from Elisa Jillson from the FTC, Lyra Correa from HHS's Office of Civil Rights, and Nancy Perkins from Arnold & Porter. I have previously opined that the 2020s will be most known for its focus on privacy, and while the cookie-less future we keep hearing about gets pushed back once again, there's growing awareness and concern about how much deeply personal information has been given up and on how companies are using (or misusing) that data.

Simultaneous sessions looked at the recently finalized guidance from the FDA on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements while another session looked more into the promotion of veterinary products. Because I was leading another session, I couldn't attend either, but I'm looking forward to using that link provided earlier to view the recordings. 

The afternoon plenary sessions resumed with a look at FTC's role in enforcement of healthcare advertising and closed out with a session on that perennial chestnut of social media usage.

Day two of the conference kicked off with an enlightening discussion of so-called CFL (Consistent with FDA-Labeling) claims. Torrey Cope of Sidley Austin provided an insightful look not just at FDA's enforcement post-guidance for claims that failed to meet the CFL standard, but also for taking the time to examine the nature and wording around the acceptance by FDA of so-called Real-World Evidence (RWE) in the context of product approvals. RWE is not the sole source of CFL claims, but Cope was able to provide some valuable lessons.

The afternoon's breakout sessions included one on artificial intelligence (which I attended), promotional challenges in rare disease treatments, and navigating accelerated approval promotion.

The closing session focused on other avenues for enforcement, including of course, the Better Business Bureau National Advertising Division's (NAD), as well as general counsel to general counsel complaint letters, filing complaints with the FDA, and perhaps even bringing a Lanham Act case.

The NAD's finding against Novartis earlier this year was of course a hot topic. But it is worth noting that in a more recent case, Viiv simply declined to participate in the NAD process. NAD referred the matter to FDA and FTC noting that decision, but as of the writing of this post, no further action by the government has been seen.

Alan Minsk of Arnall Golden Gregory noted the importance of determining your goal when looking at the appropriate path. If your goal is get a competitor in trouble then you really need to rely on the government or the courts, but if your goal is primarily to just get the company to stop the use of misleading promotion, then NAD or a direct complaint letter might be a far more cost-effective solution.

Overall, the conference was a huge success, though my opinion should be viewed as biased because I sit on the conference planning committee. FDA is definitely digging itself out from the pandemic backlog. I fully expect we'll see more from the Agency, as a very active 2023 has already demonstrated.

Chicken was once an expensive delicacy. In 1928, America’s quest for a better diet and a better standard of living was summarized by the campaign promise of “a chicken in every pot.” Today, chicken is a ubiquitous, low-cost source of protein, which we largely take for granted. Despite depletion of ocean-based stocks, fish hold similar potential. To begin this transformation, FDA must approve a scientifically-based innovative product—a faster growing genetically-engineered (GE) Atlantic salmon. When FDA Matters wrote about this subject 18 months ago, I believed the agency was near to approval of this first-ever food product from a GE animal. It is still not resolved and there are implications for all innovations that require FDA approval.

On May 24, Governor Tim Walz signed into law Minnesota’s new comprehensive data privacy law, the Minnesota Consumer Data Privacy Act (HF 4757 referenced as the MCDPA). The MCDPA goes into effect on July 31, 2025, with some exceptions for colleges and universities (who have until 2029). The MCDPA is similar to other state privacy laws, […]

The New York legislature passed two bills on June 7, 2024 directed at children’s use of online technologies – the Stop Addictive Feeds Exploitation (SAFE) for Kids Act (S7694) that restricts access to addictive algorithmic feeds and the New York Child Data Protection Act (S7695) that bans sites from collecting, using, sharing or selling personal […]

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>

Starting COVID-19 patients on prophylactic anticoagulation within 24 hours of being admitted to hospital has been linked to a reduced risk of mortality.

The type 2 diabetes mellitus drug semaglutide is effective for weight loss in non-diabetic overweight or obese adults, when taken alongside a reduced-calorie diet and exercise, researchers have found.

A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.