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 Embassy of India in Iraq has extended an invitation to Indian businesses to participate in the "Medico Expo," officially known as the Erbil International Health Exhibition. This prestigious event, set to be the

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

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

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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

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.

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

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 National Accreditation Board for Testing and Calibration Laboratories (NABL), under the Quality Council of India (QCI), has announced a collaborative effort with Man─Made Textile Research Association (MANTRA) in Surat to deliver a specialized technical training programme on medical textiles testing.

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

Asahi Kasei Medical has launched the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics, in October 2024.

Founded in 1924 as J&G Hardie, Hardie Polymers, the Glasgow-based polymer supplier, celebrates its 100th anniversary.

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.

Placon, an innovator in the medical packaging market, announced the release of a new stock line of BargerGard TPU pouches and tip protectors.

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.

WITTMANN BATTENFELD will present the latest solutions for time and cost optimisation in the production of parts with nano structures at Compamed, booth No. F03-1 in hall 8b.

PolyNovo UK – a UK medical devices company specialising in the development of surgical solutions using the patented polymer technology NovoSorb will be exhibiting at MEDICA 2024.

Schultz Medical, a single use instrument company based in Southport, Merseyside have announced they will be exhibiting at MEDICA 2024 in Germany and on the UK Pavilion in Hall 15 hosted by Medilink UK.

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.

Brightmark CEO Bob Powell discusses Plastics Renewal technology and how to bring sustainability into the medical industry.

Ampacet has introduced ProVital+ Gamma-Protect, a medical-grade additive designed to preserve mechanical and optical properties of polypropylene-based medical and pharmaceutical articles during gamma and e-beam sterilisation processes.

Accumold, with over 40 years of experience in micromoulding technology, is set to participate at Compamed, taking place in Düsseldorf, Germany, from 11-14 November. The company will highlight its small and complex parts for medical device OEMs.

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.

Mike Hodgin, director of strategic applications, Meridian Electronics Division discusses enabling and protecting vital medical implants with epoxies.

Surgical Holdings, a British manufacturer and repairer of medical devices, will return to MEDICA 2024 for the third consecutive year, focused on strengthening its partnerships across Europe and expanding its reach in key markets.

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

Gerresheimer, an innovative system and solution provider, received a Red Dot Design Concept award for its Gx Inbeneo autoinjector platform.

Dr Euan McBrearty, head of commerical & innovation, Wideblue shares five steps to successful medical device development.

Trelleborg Medical Solutions showcases its comprehensive polymer-based solutions and capabilities for the medical technology and biopharmaceutical industries at Compamed 2024 in Dusseldorf from November 11 to 14, at stand F02 in hall 8A.

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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 […]

Researchers at the University of Waterloo in Canada have developed plant-based microrobots that are intended to pave the way for medical robots that can enter the body and perform tasks, such as obtaining a biopsy or performing a surgical procedure. The robots consist of a hydrogel material that is biocompatible and the composite contains cellulose […]

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 »

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.

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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 »

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 »

Today’s guest post comes from Kimberley Chiang, Vice President of Biopharma Commercial Solutions at CoverMyMeds

Kimberley highlghts the crucial roles of field reimbursement managers in removing access and reimbursement barriers. She then identifies the keys to successful implementation of field reimbursement services.

To learn more, register for CoverMyMeds' November 13, 2024, webinar: Specialty Therapies & Field Reimbursement Services: Driving Better Outcomes for Brands and Patients.

Read on for Kimberley’s insights.
Read more »

Prepare to witness the convergence of strategy and science at the highly anticipated the DIA 2024 Global Annual Meeting! Immerse yourself in four days of conversations that don’t happen anywhere else, where strategic thinking seamlessly intertwines with scientific innovation: Elevate Your Professional Profile Expand your knowledge base with continuing education opportunities available virtually from June […]

The post Science Meets Strategy at DIA 2024 first appeared on ACRO.

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:

¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars

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