Friday, September 27, 2024

Attorney General Mayes Announces Naloxone Allocation in Fight Against Opioid Epidemic

(9/26, Arizona Attorney General Kris Mayes) ...Attorney General Kris Mayes today announced the latest quarterly allocation of naloxone as part of the state's ongoing efforts to combat the opioid crisis in Arizona. This initiative is the result of Arizona's settlement with Teva Manufacturing to address the harms caused to Arizonans by the opioid epidemic...The naloxone units will be distributed to the following organizations, totaling 7,000 units for this quarter... Full

Alvotech Enters Next Stage For Entyvio Rival

(9/26, David Wallace, Generics Bulletin) ...As it announced the start of trials for its AVT16 proposed rival to Takeda's Entyvio, Alvotech reiterated that it is one of just two publicly-disclosed biosimilar developers targeting vedolizumab...And with Takeda's Entyvio (vedolizumab), Alvotech seems confident that it has chosen a product that not only holds significant commercial potential, but will also have relatively few rivals fighting it out for market share... Global Sub. Full

Formycon and Fresenius Kabi Receive European Commission Approval for FYB202/Otulfi® (Ustekinumab) for the Treatment of Serious Inflammatory Diseases

(9/27, Formycon AG) ...FYB202/Otulfi® received European Commission approval for both subcutaneous and intravenous formulations, providing a high-quality treatment option for European patients treated with ustekinumab. FYB202/Otulfi® is approved in the indications of moderately to severely active Crohn's disease, moderate to severe plaque psoriasis and active psoriatic arthritis... Full

AbbVie's Dopamine-Focused Parkinson's Treatment Reduces Disease Burden in Phase 3 Trial

(9/26, Darren Incorvaia, Fierce Biotech) ...The phase 3 TEMPO-1 trial tested two daily doses (5 mg and 15 mg) of tavapadon, an oral dopamine receptor agonist. Both arms beat placebo at improving disease burden at Week 26 as measured by a combined score using parts of an industry scale dubbed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, according to a Sept. 26 release... Full

Alembic Pharma Gets USFDA Nod for Paliperidone Extended-Release Tablets

(9/27, Business Standard) ...Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Paliperidone extended-release tablets... Full

FDA Approves a Novel Drug for Schizophrenia, A Potential ‘Game Changer'

(9/26, Daniel Gilbert, The Washington Post) ...The new drug, Bristol Myers Squibb's Cobenfy, targets a different area of the brain than traditional antipsychotic drugs to relieve symptoms like delusions without causing patients to gain weight, fall asleep and experience involuntary muscle jerking...Wall Street analysts say clinical trials suggest that Cobenfy is at least as effective as other blockbuster antipsychotics, like Risperdal and Zyprexa, and project that it could eventually generate billions of dollars a year in sales... Sub. Req’d

Biocon Inks Deal with Tabuk Pharma to Commercialize GLP -1 Products in Middle East

(9/27, Business Standard) ...Biocon said that it has signed a licensing and supply agreement with Tabuk Pharmaceutical Manufacturing Company to commercialize its GLP-1 products for treating diabetes and chronic weight management, in select countries of the Middle East... Full

Slow Progress On Pfizer's Plan to Sell Drugs to Low-Income Nations at Not-for-Profit Price, Says CEO

(9/26, Jennifer Rigby and Michael Erman, Reuters) ...The programme, which Pfizer called "An Accord for a Healthier World," launched in 2022 and was expanded to cover more products in 2023. It aims to provide 45 low-income countries affordable access to Pfizer's entire portfolio of drugs and vaccines, including bestsellers like blood thinner Eliquis and cancer drug Ibrance, as well as new products... Full

Expert: Biosimilars and Generics Lower Cost of Cancer Care

(9/26, Pharmacy Times) ...Pharmacy Times® interviewed Clayton Irvine, PharmD, MBA, MS, senior manager, oncology cancer care at Mayo Clinic, about the cost of cancer care. Irvine discussed how advancements in health care technology can contribute to the overall costs for cancer care, and that biosimilar or generic treatments can be helpful for lowering costs; however, it is difficult for health systems to quickly implement these products on such a large scale... Full

The Ozempic Dilemma: Balancing Demand, Supply, and Patient Safety in a Viral GLP-1 World

(9/26, Eloise McLennan, Pharma Phorum) ...Joining the ranks of Viagra, Xanax, and Botox, a new superstar has emerged: Ozempic...Despite the drug's viral fame, actually obtaining Ozempic is no easy task...Many are discouraged by the high price tag, even with insurance coverage, and some struggle to afford the copays. Persistent drug shortages add to the complexity, leaving patients unable to fill their prescriptions, even after navigating the insurance maze. These barriers have created a complex landscape wherein demand outstrips supply, fuelling frustration for legitimate patients and encouraging the rise of a dangerous black market for counterfeit drugs... Full

AAM, PhRMA To Continuing Battling Over Interchangeability Bill After Markup Delayed

(9/26, Jessica Karins, InsideHealthPolicy) ...The generic drug lobby plans to continue its push for passage of a bill opposed by brand drug makers that would automatically designate all biosimilar drugs as interchangeable with the reference products after a planned Thursday (Sept. 26) markup of the measure was postponed, the organization confirmed, with Congress' lame duck period rapidly approaching... Sub. Req’d

FTC Chair Signals Possible Lawsuits Against Drug Companies, Continues Orange Book Probe

(9/26, Maaisha Osman, InsideHealthPolicy) ...FTC Chair Lina Khan confirmed that the commission is exploring possible lawsuits against drug manufacturers and will continue working to stop "junk" patent listings in FDA's Orange Book, despite a former commissioner questioning FTC's expertise in patent law...But Alden Abbott, former general counsel at FTC and currently a research fellow at Mercatus Center, tells IHP that the commission does not have expertise on patent law... Sub. Req’d

Sanders Mulls Generic Possibilities As He Blasts Novo Over High Ozempic And Wegovy Prices

(9/26, Adam Zamecnik, Generics Bulletin) ...Senator Bernie Sanders has blasted Novo Nordisk's CEO Lars Fruergaard Jørgensen over the high cost of Ozempic and Wegovy in the US in a September 24, Senate hearing, with Jørgensen stating that the firm was open to potential talks with pharmacy benefit managers after Sanders suggested that generic rivals could step in at a much lower price... Global Sub. Full

Novo Nordisk CEO Agrees to Work With PBMs to Negotiate Lower Semaglutide List Prices

(9/26, Lauren Biscaldi, Drug Topics) ...During Tuesday's hearing, Sanders informed Jørgensen that representatives from all 3 major PBMs had committed—in writing—that if Novo Nordisk reduced semaglutide's list price, they "would not limit access to Ozempic and Wegovy, and would not take these drugs off of their formularies." When pressed by Sanders, and later by Senator Maggie Hassan (D, New Hampshire), to commit to PBM negotiations, Jørgensen agreed that he would be happy to look into anything that would help patients access affordable medications... Full

Survey Finds Payers are Looking for Change in Pharmacy Benefits

(9/26, Denise Myshko, Formulary Watch) ...Customers of the Big 3 PBMs report lower satisfaction across most measures, including overall satisfaction, and they are less likely to recommend their PBM. Additionally, employers remain more satisfied with PBMs than health plans on nearly all measures of satisfaction. The survey found that there have been moderate declines in satisfaction with PBMs across the board, Morgan Lee, Ph.D., MPH, CPH, senior director of Research & Strategy at PSG, said during an interview... Full

Editorial: The FTC's Anti-PBM Suit Could Mean Higher Health Premiums

(9/25, The Wall Street Journal) ...Lina Khan claims she's trying to lower prices, but the Federal Trade Commission Chair's attacks on business often do the opposite. Consider her new charge against pharmacy benefit managers (PBMs), which could result in higher healthcare premiums for all Americans... Sub. Req’d

A PBM Amicus Brief

(9/26, Peter J. Pitts, RealClearHealth) ...The FTC has filed an antitrust and consumer-protection lawsuit against the three largest pharmacy-benefit managers, or PBMs, and affiliated businesses over their tactics for negotiating prices for drugs. I'm no fan of FTC Chair Lina Kahn, but healthcare policy makes for strange bedfellows. Bravo. It's about time that the silent middlemen of healthcare are called to account over their, shall we say, muscular behavior when it comes to building stockholder value on the backs of the patients they profess to serve. That being said, and in the spirit of professional courtesy, allow me to offer some pointed questions that counsel for the defense can ask potential jurors... Full

The IRA's Unconstitutional Drug Price Controls

(9/26, Roger D. Klein, RealClearPolicy) ...Millions of Americans depend on lifesaving prescription medications. These drugs are developed with enormous investments made at great financial risk. Policies that encourage competition among drugmakers will best achieve optimal pricing, maintain the supply of essential therapeutics, and encourage the development of novel medicines. The phony "negotiation" program forced on drug makers, the strain placed on Part D insurers, and other noxious provisions of the Inflation Reduction Act will do the opposite... Full

Biden Administration Axes Proposal to Mandate More Drug Price Transparency in Medicaid

(9/26, Bob Herman, STAT Plus) ...Pharmaceutical companies and lobbying groups heavily pressured the Centers for Medicare and Medicaid Services to abandon the little-noticed idea to create "drug price verification surveys" — they indirectly threatened to sue if the government moved forward with it. Industry lobbyists even wielded dictionaries in their complaints, incensed over how federal officials defined the word "verify."... Sub. Req’d

Legal Challenge to Medicaid Drug Rebates Rule Seen as Likely

(9/26, Ganny Belloni, Bloomberg Law) ...The rule from the Centers for Medicare and Medicaid Services (RIN: 0938-AU28) seeks to strengthen oversight and transparency around how drug companies negotiate prices with Medicaid. The CMS clarified several statutory ambiguities that the it says have allowed drug companies to pay lower rebates to states and ultimate increase the cost of prescription drugs. The agency had expressed concerns that manufacturers were misclassifying their drugs in the Medicaid Drug Rebate Program, leading to lower rebates to state Medicaid programs and higher drug prices overall... Sub. Req’d

CMS Holds Back Drug Verification Survey, Select Definitions In Final MDRP Rule

(9/26, Gabrielle Wanneh, InsideHealthPolicy) ...In addition to not finalizing a proposal to have drug makers "stack" all manufacturer price concessions to determine a drug's final best price under the Medicaid Drug Rebate Program (MDRP), a final rule released this month to address misclassification of drugs in the MDRP shows CMS will also not move forward with implementing a proposed annual verification survey process, nor will the agency finalize its proposals to broaden the program's definition of a "manufacturer" or provide a definition of a "vaccine" in the program... Sub. Req’d

Crossing The Floor: Ex-PhRMA And BIO Exec Murphy Moves To Head Up AAM

(9/26, David Wallace, Generics Bulletin) ...[AAM CEO John Murphy] "My goal I think initially is to really start to get out there and be a very loud voice for the value and importance of this industry to the US health care system." "Washington and drug pricing policy, it's not a magic formula," he added. "Really it's about bringing constructive dialogue and amplifying those voices across the hosts of constituencies to really drive that policy change."... Global Sub. Full

BIOSECURE Act: Potential Supply Chain Hits And Pharma's Path Ahead

(9/26, Vibha Ravi, Pink Sheet) ...With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate data to highlight the likely holes in pharma's supply chain... Sub. Req’d

Kentucky Attorney General Sues Express Scripts Alleging Company's Actions Fueled Opioid Crisis

(9/26, Sarah Ladd, Kentucky Lantern) ...Kentucky Attorney General Russell Coleman has sued a pharmacy benefits manager he says played a "role in worsening the deadly opioid crisis in Kentucky." The complaint, filed in Jessamine County Circuit Court Wednesday, names Express Scripts and affiliates as defendants and targets alleged practices over the last two decades... Full

Getting Ready For The Windsor Framework: Ensuring Continuity Of UK Medicines Supply Beyond January 1, 2025

(9/26, Rick Greville, Pink Sheet) ...There are increased complexities associated with potential regulatory divergence between the UK and the EU when the Medicines and Healthcare products Regulatory Agency takes over responsibility for UK-wide new drug approvals from January 2025, writes the ABPI's Rick Greville...The agreement seeks to resolve some of the issues with the Northern Ireland Protocol identified by businesses and communities, but the new framework does not entirely replace all the protocol's provisions... Sub. Req’d

Novo Nordisk Scolded by UK Drug Marketing Watchdog Over Sponsorship of Weight Loss Services

(9/26, Nick Paul Taylor, Fierce Pharma) ...An anonymous complainant, who described themselves as a health professional, triggered the latest of a series of assessments of Novo's promotional practices. The complainant made claims related to Novo's alleged promotion of Saxenda, its older GLP-1 weight-loss drug, and sponsorship of pharmacy chains. Novo largely denied its activities breached the marketing code but copped to wrongdoing in one area... Full

WHO Homes In On Best Practices For More Effective And Equitable Clinical Trials

(9/26, Vibha Sharma, Pink Sheet) ...The WHO has issued new guidance to improve the design, conduct and oversight of clinical trials in countries of all income levels. The guidance addresses a raft of issues affecting the current clinical trials landscape, such as limited participant diversity, insufficient infrastructure and bureaucratic inefficiencies...The WHO is working on several implementation tools to support the guideline's practical implementation, such as toolkits and checklists... Sub. Req’d

50 New Plants Will Be Completed in Two Years Under the PLI Scheme: Govt

(9/26, Financial Express) ...Dr. Arunish Chawla, Secretary Department of Pharmaceuticals said, many reforms have been done in both the regulatory framework and in the schemes. We are working very hard to upgrade the quality framework for all pharma and drug units. We want to make India not just a pharmacy of the world, but a reliable pharmacy of the world. The all-big pharma companies, global and multinational companies are now expanding their footprint and their business in India and also locating their value chains here... Full

Pharma Industry Urges Government to Prevent Price Cuts to Stabilize Drug Supply

(9/27, Yang Hyeon-su, Korea Biomedical Review) ...The pharmaceutical industry has called for the government to take measures to prevent drug price cuts to stabilize drug supply and demand. It made the demand during a policy debate on "Fostering the Pharmaceutical Industry and Stabilizing the Supply and Demand of Drugs" held at the National Assembly on Thursday. Rep. Kim Mi-ae of the ruling People Power Party hosted the debate, which was co-organized by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the Korea Pharmaceutical Association... Full

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