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

The Department of Foreign Affair­s and Trade has renamed its meeting rooms in honour of pionee­ring female diplomats.

Japanese PM Shinzo Abe will arrive in Sydney tomorrow for a weekend meeting with Malcolm Turnbull.

MORE than 100 defibrillators will be placed in all sport venues in Blacktown making it the first council in the state to roll out the life-saving machines.

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

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

Raising deep concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model, the All India Organization of Chemists and Druggists (AIOCD) has apprised the Drug Controller

The Department of Pharmaceuticals (DoP) has upheld the retail price fixation of National Pharmaceutical Pricing Authority (NPPA) for Mumbai─based Aristo Pharmaceuticals for its multivitamin tablets with

The Federation of Pharmaceutical Entrepreneurs (FOPE) has identified potential opportunities for Indian pharmaceutical companies to expand in Australia. Further, the India─Australia Economic Cooperation and Trade

The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for

The Indian Council of Medical Research (ICMR) has issued a call for proposals for its Centre for Advanced Research (CAR) initiative under the Extramural Research Programme, inviting experienced research teams to

The Indian Council of Medical Research─National Institute of Cancer Prevention and Research (ICMR─NICPR) is set to launch its first─ever DHR─funded National NICPR─ECHO online certificate course on cervical

In an effort to strengthen the regulatory activities for medical devices in the country, the Union health ministry has framed and finalised rules regulating the method of recruitment to various posts under the Central

Whilst the timeline set for adhering to the revised Schedule M of the Drugs and Cosmetics Act ends on December 31 for pharmaceutical companies with a turnover of less than Rs. 250 crore, the union ministry's

The Department of Pharmaceuticals (DoP) has released the operational guidelines for the newly announced central sector scheme for Strengthening of Medical Device Industry (SMDI), aiming at providing

The Directorate General of Trade Remedies (DGTR), under the Ministry of Commerce and Industry, has issued a notice to all interested parties involved in the sunset review of the anti─dumping investigation

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

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,

An inter─ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of

Finding regulatory violations in two private hospitals operating in the twin cities of Hyderabad and Secunderabad, the Telangana drugs control administration (DCA) has issued advisories to all the private hospitals in the state mandating strict obtainment of NDPS licence (NDPS Form II) from the DCA to purchase and sell NDPS drugs.

The centrally sponsored scheme for strengthening of medical devices industry (SMDI), launched by the Central government last week, was widely welcomed by the medical devices industry in the country.

The Indian pharmaceutical industry is advocating for enhanced fire safety measures and improved insurance coverage for employees working in pharmaceutical facilities.

TekniPlex Healthcare is set to unveil its strongest-ever reinforced paper for medical device packaging applications at Pack Expo 2024, 3-6 November in Chicago.

The Association of British HealthTech Industries (ABHI) is excited to unveil a diverse delegation of UK HealthTech innovators at MEDICA 2024, one of the world's largest and most influential medical trade fairs.

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.

Rob Pitts, sales manager at Tri-Tech 3D, UK provider of Stratasys 3D printing solutions, explores how additive manufacturing (AM) can help speed up surgical workflows and reduce costs by transforming anatomical modelling.

Global temperatures through September point to 2024 besting 2023 as the hottest year on record. How many future years set records depends in part on the outcome of the 2024 U.S. presidential election

Pesky leaks on the International Space Station aren’t the most serious issue facing U.S. human spaceflight

In medieval times, astrology was considered a serious science, a branch of astronomy. Curator Larisa Grollemond of the Getty Museum, walks us through the medieval zodiac and how someone’s sign decided their day-to-day life.

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

Droughts in 48 of 50 U.S. states, evidence of microplastics mucking up wastewater recycling and the science of a baseball mud bath in this week’s news roundup.

A Biden administration proposal that would require employers to provide cooling measures under extreme heat conditions may be scuttled by the incoming Trump administration

A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer […]

A research team at the University of California San Diego have developed a smartphone attachment that can provide information on changes in pupil size, which can be used to assess neurological phenomena, such as traumatic brain injury and Alzheimer’s disease. Such changes in pupil size have been difficult to characterize in the past in those […]

Engineers at the University of British Columbia have collaborated with the Japanese automotive company Honda to develop an e-skin for robotic prostheses that allows such devices to sense their environment in significant detail. The soft skin is highly sensitive, letting robotic hands to perform tasks that require a significant degree of dexterity and tactile feedback, […]

On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry.

9 chapters, 350+ pages, 178 exhibits, 750+ endnotes: There is nothing else available that comes close to this valuable resource.

We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2024-25 edition at special discounted prices. This means that you can be among the first to access our new report. Those who preorder will receive a download link before October 8.

• Review pricing/license options and place a preorder

• Download a free pre-publication report overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits)

You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Special preorder and launch pricing discounts will be valid through October 23, 2024.

Read on for more details.
Read more »

Today’s guest post comes from Josh Marsh, Vice President and General Manager, Sonexus™ Access and Patient Support at Cardinal Health

Josh discusses challenges manufacturers may face when outsourcing patient support programs. He outlines a process that smoothly transitions hubs and minimizes disruptions for patients and healthcare providers.

To learn more, download the 3-step guide to patient hub transitions.

Read on for Josh’s insights.
Read more »

Informa Connnect's Pharma/Biotech GTN Summit
November 18-20, 2024 | W Philadelphia Hotel, Philadelphia, PA
Drug Channels Readers Receive 15% Off* with Code 24DGC15.

View the Complete Agenda

Informa Connect's Copay, Reimbursement and Access Congress
November 18-20, 2024 | Hilton Penn’s Landing in Philadelphia, PA
Drug Channels readers save 10% with code USAVE24*

The access and affordability landscape is undergoing a seismic shift. Evolving legislation, disruptive market forces and the ever-growing complexities of cost sharing programs threaten patient adherence and commercialization strategies. Are you ready?

A program driven by marketplace insights and led by industry trailblazers, Copay, Reimbursement and Access Congress is back November 18-20 and will deliver up-to-date insights necessary to enhance patient affordability, ensure program sustainability and navigate the regulatory landscape. In a time where remaining compliant has never been more complex and program innovation has never been more important, be sure to join your industry counterparts to drive adherence, access and commercialization forward.

Why attend the Copay, Reimbursement and Access Congress?

Keeping up with shifting market dynamics in the midst of maximizing access, while also meeting business objectives is a challenging task and brings about many questions for access professionals.

• Is your program sustainable and innovative to better support patients?
• Accumulators, maximizers, AFPs – What are your next steps to ensure effective reimbursement strategies?
• In an election year, what is the future of health policy?

Experts will tackle these questions and more as the industry comes together to benchmark best practices to accelerate access and commercialization. Do not miss your chance to join seasoned leaders, your peers and leading solution providers as they navigate marketplace trends and dive into the impact coupons, benefit design, accumulators, maximizers, alternative funding programs and drug pricing legislation have on patient affordability and out-of-pocket costs. This is your chance to gain critical insights on industry standards, forward-thinking strategies to optimize your copay and cost sharing programs and so much more.

Content highlights:

• Over 20 hours of content, including 7+ dedicated sessions to help decipher copay legislation
• Crucial perspectives from Pfizer, Sanofi, Janssen, Teva, Ascendis Pharma, Melinta Therapeutics, GSK, HIV + Hepatitis Policy Institute and more
• Insights direct from enforcement agents on the top trends and actions within the copay and patient services space
• Illuminating case study, Navigating the Patient Journey in a Shifting Copay Landscape from Spark Therapeutics
• 465 minutes of valuable in-person networking with colleagues and counterparts to expand your network and establish powerful partnerships
• Additional content access through Streamly, a platform that gives you 12-month access to all of the available conference content** to review at your leisure
• And more!

Download the agenda and register today—Be sure to use your exclusive promo USAVE24 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.
**Pending speaker permissions

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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).

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 »

Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx.

Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

To learn more, register for AssistRx's free webinar on October 8: Meet Your Patients Where They Are & Gain Visibility: Even at Retail.

Read on for Timothy’s insights.
Read more »

Informa Connect’s PBM Contracting Summit
December 10-11, 2024 | Chicago, IL
Drug Channels readers save 10% with code 24DRCH10*

Experts from across the US come together each year at the PBM Contracting Summit to gain innovative and practical contracting strategies, master PBM innovation and design, improve patient care management and rising costs, understand the current legislative issues impacting contract negotiations and more. Join us in Chicago (or virtually) where you’ll benefit from two days of learning, education and networking, and will return to the office having mastered the complex PBM landscape.

You’ll hear from Matthew Gibbs, Pharm.D., Pharmacy Transformation Leader of Blue Shield of California as he leads a comprehensive discussion on the PBM landscape over the last year, and delves into the evolving trends and emerging challenges shaping the current industry today.

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions:

• What are the latest legislative updates and proposed federal bills impacting PBM operations?
• What's on the horizon for alternative PBMs? What are the top intricacies of rebate eligibility? What are the market impacts of innovative models such as Mark Cuban's Cost Plus Drugs and Amazon's pharmacy model?
• What can be learned from the J&J lawsuit? Review the expansion of data access and the importance of employer's fiduciary duties.
• What are the challenges of vertical integration?
• How do PBMs manage their contracting processes with plan sponsors to create successful contracts?
• What are the most effective strategies for spread pricing and reimbursement models?
• What is the best solution to navigate the challenges of the 340B drug pricing program and PBM contracting?
• What is the best way to design and optimize benefits for covering GLP-1s?
• How can I ensure compliance with ERISA requirements?
• What are the latest developments in copay maximizer and accumulator programs?
• What market dynamics and barriers are impacting pricing and demand?
• What can be learned from the economic landscape of biosimilars and specialty therapeutics?
• And much more!

View the agenda for the PBM Contracting Summit to see the complete picture – the program, speakers, and more, visit www.informaconnect.com/pbm-contracting for further details and to register. Drug Channels readers will save 10% off when they use code 24DRCH10 and register prior to November 8, 2024.*

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category rates or other offers. Other restrictions may apply.

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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).

Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA

Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure,  combined with clinical and reimbursement support specialists, can improve  patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes.

Click here to learn more about EVERSANA’s Direct-to-Patient care model.

Read on for Greg and Faruk’s insights.
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.

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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).

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