Wednesday, August 14, 2024

Mark Cuban Says He's 'F****** Up' Healthcare On 'The Daily Show'

(8/13, Hayley DeSilva, Modern Healthcare) ...Mark Cuban plans to increase healthcare price transparency by making all future Mark Cuban Cost Plus Drug Co. partnership contracts public. During a conversation with Jon Stewart on "The Daily Show" Monday night, Cuban pivoted the conversation from the Dallas Mavericks to discuss his main priority: shaking up healthcare... Sub. Req'd

Mark Cuban Dishes On Politics, Health Care in Daily Show Appearance

(8/13, Irving Mejia-Hilario, The Dallas Morning News) ...On his Monday television appearance, Cuban said if hospitals want to work with him, they'll have to be public about it. Cuban said he's received the green light to publish the contracts of companies such as hospitals that work with Cost Plus Drugs. "We're just getting it approved today. We're going to publish all contracts," Cuban said. "Never before has it be done where, for my companies, we're saying if you want to do business with us, if this hospital system wants to work with my companies, we're going to publish them and put them online for anybody to see all of our pricing."... Sub. Req'd

Celltrion Receives Go-Ahead for P3 Study for Cosentyx Biosimilar in US

(8/14, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it has obtained approval from the U.S. Food and Drug Administration for an investigational new drug application to conduct a global phase 3 clinical trial for CT-P55, its Cosentyx (ingredient: secukinumab) biosimilar... Full

Alembic Pharma Gets Approval from US FDA to Market Generic Medication

(8/13, Press Trust Of India) ...Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing... Full

Lilly Opens Huge New Boston Research Center, With a Focus On Genetic Medicines

(8/13, Ryan Cross, Endpoints News) ...The building was originally billed as the Lilly Institute for Genetic Medicine but is now called the Lilly Seaport Innovation Center...Roughly two-thirds of the 346,000 square-foot building are devoted to lab space where scientists will work on drugs for several diseases, including diabetes, obesity, cardiovascular diseases, chronic pain and neurodegeneration — including Alzheimer's... Full

Amgen Sues Samsung Biotech Unit Over Bone Drug Copies

(8/13, Blake Brittain, Reuters) ...Amgen has sued Samsung's biologics unit in New Jersey federal court over its proposed biosimilar versions of Amgen's blockbuster bone drugs Prolia and Xgeva. Amgen's lawsuit against Samsung Bioepis, filed on Monday, said the biosimilars would infringe 34 patents covering Amgen drugs. It requested an order blocking Samsung from making and selling the drugs and an unspecified amount of monetary damages... Full

Store-Brand Mucinex Maker to Move Away from Using Cancer-Causing Chemical

(8/13, Anna Edney, Bloomberg) ...Amneal Pharmaceuticals Inc. plans to submit testing data on its new formulation to the US Food and Drug Administration by the end of the year, the company said in a statement. The company expects to bring the products to market before August 2025. Bloomberg reported Monday that, according to an analysis of government data, store-brand generic versions of extended-release Mucinex made by Amneal contain an ingredient called a carbomer that is made with the potent carcinogen benzene. Brand-name Mucinex, made by Reckitt Benckiser Group Plc, uses a carbomer without benzene... Sub. Req'd

Fed. Cir. Nixes Sun Pharma's Win Axing Allergan IBS Drug Patents

(8/13, Lauren Castle, Bloomberg Law) ...The Federal Circuit overturned Sun Pharmaceutical Industries Ltd.'s win invaliding five patents linked to Viberzi, the irritable bowel syndrome treatment produced by AbbVie Inc.'s Allergan unit... Sub. Req'd

Data Show Fremanezumab Converts Chronic Migraine to Episodic, Improves Quality of Life for Patients

(8/13, Alok Sharma, PhD, Pharmacy Times) ...Individuals with chronic migraine (CM) experience severe headaches for a minimum of 15 days per month for at least 3 months, leading to significant detrimental effects on physical, personal, and professional aspects of life. Episodic migraine (EM) manifests as less frequent headaches, is less disruptive, and is easier to manage and treat. Over time, however, EM can progress to CM and CM can remit to EM, but researchers do not currently know why or how this occurs. Health care professionals therefore strive to convert CM to EM and prevent EM progression to CM... Full

Blue Cross Cuts 64 Jobs Due to Rising Drug Costs

(8/13, Dustin Walsh, Crain's Detroit Business) ...The Detroit-based insurer eliminated the positions this month in response to its $544 million underwriting loss, largely attributed to a $1.8 billion rise in pharmacy costs. "Our company sits in an uncomfortable position between two extraordinary pressures — the skyrocketing increase in health care costs and the desire of our customers to maintain the affordability of their health insurance plans," BCBSM said in a statement to Crain's... Sub. Req'd

How GoodRx's Low-Cost Humira Biosimilar Could Affect the Market

(8/13, Maia Anderson, Healthcare Brew) ...And despite losing patent exclusivity in 2023 and facing competition from 10 biosimilars, Humira has held onto roughly 85% of the market share (though US sales have fallen about 32% in the past year), according to Divya Iyer, SVP of pharma manufacturer solutions at GoodRx...This lower-cost version from GoodRx and Boehringer Ingelheim could drive the uptake of the biosimilar, according to Iyer... Full

Can Rite Aid Recover?

(8/13, Adam J. Fein, Ph.D., Drug Channels) ...To get a comprehensive look at the company's ever-declining fortunes, DCI rummaged around the compnay's numerous bankruptcy filings. Below, you'll find our review of Rite Aid's current financial situation, shrinking store footprint, changing relationship with key wholesaler McKesson, surprisingly optimistic projections, and more... Full

Hot Summer Threatens Efficacy of Mail-Order Medications

(8/13, Emily Baumgaertner, The New York Times) ...Dr. Mike Ren, a primary care physician and an assistant professor in the department of family and community medicine at the Baylor College of Medicine, said that liquid medications like insulin or AUVI-Q, the epinephrine injection for allergic reactions, are often at heightened risk of degradation because excessive heat exposure can cause the evaporation of liquid components that were compounded at precise ratios. Aerosolized medications, too, are uniquely vulnerable because of the risk of pressure changes in the canister... Sub. Req'd

Sanders Calls On GSK to Cap Price of Authorised Flovent Generic

(8/13, Anna Bratulic, FirstWord Pharma) ...Over eight months after GSK took its Flovent (fluticasone propionate) inhaler off the shelves, US Senator Bernie Sanders (I-Vt.) is calling on the company and its partner Prasco Laboratories to cap the cost of the authorised generic version at $35. "No child in America should be sick or die because their parents cannot afford or access the inhalers they need to breathe," Sanders said in a statement Tuesday... Full

IRA Price Negotiation Results to Be Released Thursday — Report

(8/13, Drew Armstrong, Endpoints News) ...The Biden administration plans to share at least some results of IRA drug price negotiations on Thursday, according to a Politico report that cited anonymous sources. Negotiations were scheduled to end on Aug. 1, and many drugmakers whose products were picked for the negotiations have said in recent weeks that they expect to absorb the impact of the law when the new prices go into effect in 2026... Full

What to Watch When Medicare Releases First Negotiated Drug Prices

(8/14, Maya Goldman, Axios) ...What information will CMS release about the final drug prices? Analysts, policy experts and industry groups told Axios they're watching for whether Medicare officials announce specific levels of savings they achieved on each drug. If Medicare does announce levels of savings, it'll matter whether they measure those against drugs' current list prices, which are typically higher than what patients actually pay, or another figure that takes into account existing rebates and discounts, said TD Cowen analyst Rick Weissenstein... Full

Biden Admin to Spend Billions to Blunt Spike in Medicare Drug Premiums

(8/13, Robert King and David Lim, Politico) ...One of President Joe Biden's signature domestic achievements is set to cause a significant spike in Medicare premiums for millions of Americans just ahead of the November election. Now, his administration is preparing to dole out billions of dollars to private insurance companies to blunt the impact of the increase. The jump in premiums is a consequence of efforts to reduce what older Americans pay for prescription drugs, part of the 2022 Inflation Reduction Act... Full

Stelara's Shift From Medicare B To D Was Costly, OIG Finds, How Much Will IRA Reforms Help?

(8/13, Cathy Kelly, Pink Sheet) ...A new report by the Health and Human Services Department's Office of Inspector General found that Medicare paid 80% more, on average, for Johnson & Johnson's Stelara for the same conditions in 2021 when it was obtained under Part D instead of Part B..."Our findings illustrate how differences in the methods used to set drug payment amounts under Part B, i.e., manufacturers' sales prices, versus under Part D, i.e., negotiations between plan sponsors, manufacturers, pharmacy benefit managers, and pharmacies, result in widely different payment amounts for the same drugs," the report concludes... Sub. Req'd

Decoding Low-Income Subsidy Prescription Drug Plans: Policy And Market Realities

(8/13, Tomas Bednar, Health Affairs) ...A combination of government policies and market trends is causing significant turmoil in the Prescription Drug Plan (PDP) market, especially for plans that serve beneficiaries who receive the Medicare low-income subsidy (LIS)—assistance under the Medicare Part D Extra Help program that supports individuals in need of financial assistance to afford their prescription medications... Full

The Poorly Managed 340B Program Will Be Even Worse With The Inflation Reduction Act

(8/13, Kirsten Axelsen, RealClearHealth) ...The 340B program is not just a wasteful policy, it is harmful. Program evaluations have noted that it has contributed to higher drug prices, that 340B facilities use higher-priced drugs (which costs consumers more), and that it has reduced competition by fueling consolidation. It is time to put in sensible oversight and reforms to 340B before the Inflation Reduction Act prices in 2026 continue to fuel its growth... Full

Eli Lilly: FDA Must Intervene Against Mass Compounding Of Unapproved Weight-Loss Drugs

(8/13, Maaisha Osman, InsideHealthPolicy) ...Eli Lilly told Inside Health Policy that FDA and state regulators must intervene to stop compounders from mass producing unapproved replicates of its weight-loss drugs, Mounjaro and Zepbound, and, without specifically naming Hims & Hers Health Inc. (HIMS), argued potential legal actions by brands against compounders are not enough... Sub. Req'd

Industry Calls for Revisions of FDA's REMS Draft Guidance

(8/13, Joanne S. Eglovitch, Regulatory Focus) ...Industry stakeholders say the US Food and Drug Administration's draft guidance calling for a REMS logics model requires major changes to make it workable, claiming the guidance is too broad and lacking clarity. The Pharmaceutical Research and Manufacturers of America (PhRMA) offered the most strident criticism of the guidance and said FDA is exceeded its statutory authority in the guidance and misread the law establishing the REMS program... Full

Past and Present FDA Adcomm Members Weigh in On Potential Reforms

(8/13, Nicole DeFeudis, Endpoints News) ...A majority of former and current FDA advisory committee members surveyed in July supported remote participation in meetings and better communication, as the FDA considers reforms to its committees of outside experts...The FDA told Endpoints on Tuesday that it relies on "many advisory committees to help us make sound decisions based on the best science available." "FDA advisory committees give our own agency experts outside, independent, and professional advice on various complex scientific, technical, and policy issues," an agency spokesperson said in an email... Full

State Policy Experts Offer Model Health Care Consolidation Bill

(8/13, Gabrielle Wanneh, InsideHealthPolicy) ...Hensley-Quinn said that because states have already put in work across the country to rein in other ways PBMs’ business practices keep drug costs high for the state and consumers, it feels like a natural transition for states to tackle consolidation and how the issue may be raising drug costs and impeding care... Sub. Req'd

EMA Considers Changing Scientific Advice Briefing Doc To Enhance Patient Input

(8/13, Vibha Sharma, Pink Sheet) ...The European Medicines Agency is considering changing its "briefing document" template that companies use to request scientific advice (SA) or protocol assistance (PA) for the drugs they are developing, with the aim of better capturing patient input in these procedures...The EMA told the Pink Sheet that it anticipates providing further details on the changes being considered and their impact on companies later in the year. It said the revised SA/PA briefing document needed to be "discussed further internally."... Sub. Req'd

Mexican Regulators Approve Zydus' Herceptin Biosimilar

(8/13, Adam Zamecnik, Generics Bulletin) ...Doubling down on its Latin American strategy, Zydus has managed to snap up a second biosimilar approval in Mexico, paving the way for future launches. Mexico's health agency COFEPRIS has approved Zydus Lifesciences' Herceptin (trastuzumab) biosimilar, doubling down on the Indian pharma's efforts in the North American nation after a recent approval of the firm's bevacizumab biosimilar... Global Sub. Full

Japan Recommends Donanemab, Sets Raft Of New And Reduced Prices

(8/13, Lisa Takagi, Pink Sheet) ...A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review... Sub. Req'd

Shortage of Drugs in Russia is Deepening

(8/13, The Pharma Letter) ...The shortage of drugs in Russia is deepening, and is currently being observed in almost 70 regions throughout the country and forcing the local state to consider ways to resume stable supplies to local market, reports The Pharma Letter's local correspondent. Probably the biggest problems are currently seen in case of drugs against cancer and diabetes, stocks of which in Russian pharmacies have significantly declined in recent months. At the same time the situation in state segment of the market is better... Sub. Req'd

Active Component to Build One of Largest Facilities in Russian North West

(8/14, The Pharma Letter) ...The new plant will have the range of up to 40 active pharmaceutical ingredients (APIs), that will be supplied to different parts of Russia and primarily the North West, according to recent statements made by the Governor of St Petersburg Alexander Beglov. The range of products will be drugs against cancer and for the treatment of cardiovascular diseases along with diabetes... Sub. Req'd

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