Tuesday, September 24, 2024

New Teva Data Support Switching to Uzedy

(9/23, The Pharma Letter) ...Israeli drugmaker Teva Pharmaceuticals has announced new findings from research that could shape treatment strategies in schizophrenia and tardive dyskinesia (TD)...Teva's vice president and head of medical affairs in Europe, Pinar Kokturk, said that despite Austedo's approval in several markets, TD remains underdiagnosed and poorly treated across Europe... Sub. Req’d

Teva Reports Positive Phase III Data for Schizophrenia Treatment

(9/23, The Pharma Letter) ...The long-acting injectable formulation of olanzapine is being tested for adults with schizophrenia. Teva said the trial met its primary endpoint, showing significant improvements in a commonly-used efficacy metric after eight weeks, compared to placebo...Chief medical officer Eric Hughes said: "PDSS is a major barrier to the utilization of intramuscular olanzapine long-acting injectables that exists today, and our SOLARIS findings fuel the continued development of TEV-749."... Sub. Req’d

Teva Touts Safety Profile of Once-Monthly Schizophrenia Therapy

(9/23, Phalguni Deswal, Pharmaceutical Technology) ...Pharmaceutical Technology‘s parent company GlobalData expects Teva's olanzapine extended-release product to reach annual sales of $145m by 2034 in the US..."Developing a long-acting olanzapine formulation that poses potentially no risk of PDSS is crucial in preventing these dangerous episodes that otherwise limit the use of olanzapine to daily oral options," said Dr Christoph Correll, professor of psychiatry at the Zucker School of Medicine... Full

Teva Pharma Announces Long Term Efficacy and Safety of Deutetrabenazine in European Patients with Debilitating Movement Disorder Tardive Dyskinesia

(9/24, Pharmabiz.com) ...Co-author and presenter of the data, Dr Krzysztof Duma, associate medical director, Teva Pharmaceuticals Europe, said, "Tardive Dyskinesia is a complex disorder that is difficult to treat and remains broadly underdiagnosed. Treating this condition still often results in dose reductions of antipsychotic medication that can impact the underlying psychiatric condition and lead to higher hospitalisation rates. The positive outcome of the study in the European cohort is similar to what we have observed in the overall and US population and gives us further evidence that deutetrabenazine can provide an effective treatment option."... Full

13 Drugs Expected to Be Included in CMS Negotiations: Study

(9/23, Alexandra Murphy, Becker's Hospital Review) ...Researchers have aimed to predict which drugs would be selected by analyzing Part D spending from 2020 to 2022 and applying selection criteria from the Inflation Reduction Act and CMS guidelines. The 13 drugs most likely to be chosen for CMS negotiations, according to the study...Austedo (deutetrabenazine): A drug from Teva Pharmaceuticals for treating chorea associated with Huntington's disease and tardive dyskinesia... Full

Sanofi CEO Believes Company Poised for Growth from New Drugs

(9/23, Michael Erman, Reuters) ...Sanofi's chief executive, Paul Hudson, said in an interview on Monday that the company is poised for strong growth from a variety of new drugs and is not facing imminent, costly patent expirations of top-selling products as are some rivals...Sanofi has said it is considering a spinoff, initial public offering or sale of the unit. Hudson said more value can be achieved via an independent company run by executives with greater focus on the consumer healthcare sector... Full

Is Sanofi Making a Move into Obesity? French Pharma Invests $27M into Ventyx

(9/23, Kyle LaHucik, Endpoints News) ...On Monday, however, the French pharma giant made what could be an early move. It made a $27 million investment in small, San Diego-based Ventyx Biosciences, and the deal comes with exclusive right of first negotiation on the biotech's drug VTX3232, an NLRP3 inhibitor being tested in obesity as well as neuroinflammatory conditions...If Sanofi moves forward with VTX3232 in obesity, it could mark the drugmaker's first significant foray into the area in many years... Full

Celltrion Dodges Omalizumab Preliminary Injunction In Fledgling UPC Decision

(9/23, Dean Rudge, Generics Bulletin) ...Celltrion has seen denied a bid for a preliminary injunction that would block the potential sale of its Omlyclo (omalizumab) biosimilar to Novartis/Genentech's Xolair in many European countries, after the Düsseldorf local division of the Unified Patent Court ruled against the originators... Global Sub. Full

Amgen Gets Early Win in Regeneron Lawsuit Over Eylea Biosimilar

(9/23, Blake Brittain, Reuters) ...Regeneron cannot immediately block U.S. sales of rival Amgen's proposed copy of its blockbuster eye-care drug Eylea, a federal judge in West Virginia said on Monday...Spokespeople for Regeneron did not immediately respond to a request for comment on the decision. The company said in a court filing on Monday that it had appealed. An Amgen spokesperson said in a statement that the company was pleased with the decision and will announce its timeline for launching its biosimilar Pavblu "in due course."... Full

Viatris Gets Shareholders' Biosimilars Class Action Thrown Out

(9/23, Daniel Seiden, Bloomberg Law) ...Investors in Viatris Inc. can no longer proceed with a proposed class action alleging that the global health-care company made misstatements or omissions about its biosimilar drugs and finances, in part because the challenged statements were accompanied by words of caution, a federal district court said... Sub. Req’d

Amneal Asks Court to Block Colorado's Free Allergy Pen Program

(9/23, Brendan Pierson, Reuters) ...Amneal Pharmaceuticals has sued Colorado in an effort to block a state law requiring it to provide free generic EpiPens to pharmacies. In a complaint filed on Friday in federal court in Denver, Colorado, New Jersey-based Amneal said that the law, which was passed last year and took effect in January, was an illegal taking of its property under the 5th Amendment of the U.S. Constitution... Full

Eli Lilly's Alzheimer's Drug Approved in Japan

(9/24, Puyaan Singh, Reuters) ...Eli Lilly said on Tuesday Japan's health ministry has approved donanemab, its drug for Alzheimer's disease, providing patients with another treatment option after Eisai and Biogen's Leqembi received the nod in September last year... Full

Baltimore Sues Biogen Over Generic Drug Entry Plan, High Prices

(9/23, Nyah Phengsitthy, Bloomberg Law) ...A class action filed by the city of Baltimore is alleging Biogen Inc. unlawfully orchestrated a scheme working with the nation's largest pharmacy benefit managers to impair competition from generic versions of its brand-name drug Tecfidera. Biogen "crafted a market-switch strategy" to stall generic competition for Tecfidera—a drug used to treat multiple sclerosis—when it developed a "next generation" version of its drug called Vumerity, the city of Baltimore wrote Sept. 20 in a complaint filed in the US District Court for the Northern District of Illinois... Sub. Req’d

Opioid Abuse Treatments Don't Reach Areas Most in Need

(9/24, Adriel Bettelheim, Axios) ...Nearly 1 in 5 U.S. counties lacked opioid treatment programs or any office-based providers of buprenorphine, which reduces the risk of future overdoses, according to a federal review of whether drugs for opioid abuse are reaching areas of greatest need... Full

Opioid Deaths Fell in Mid-2023, But Progress Is Uneven and Future Trends are Uncertain

(9/23, Heather Saunders, Nirmita Panchal, and Sasha Zitter, KFF) ...Initially driven by prescription opioids and heroin, the epidemic has shifted in recent years, with illicit synthetic fentanyl—a substance 100 times more potent than morphine—now dominating most markets. Even a small amount of fentanyl can be lethal, and in 2023, 7 in 10 counterfeit opioid pills contained a deadly dose...This analysis examines opioid overdose deaths from the last two decades (2003-2023), with a particular focus on the decline in deaths observed in the last six months of 2023... Full

Novo CEO Blames Ozempic's High Cost On Drug Middlemen's Tactics

(9/23, Madison Muller, Bloomberg) ...Novo Nordisk A/S Chief Executive Officer Lars Fruergaard Jorgensen will use a familiar argument to defend the US prices of blockbuster drugs Ozempic and Wegovy when he appears Tuesday before a congressional committee led by Senator Bernie Sanders: It's the middlemen... Sub. Req’d

$50 Billion in Sales Make Ozempic and Wegovy Prices Tougher to Justify

(9/23, Robert Langreth and Tanaz Meghjani, Bloomberg) ...Ozempic and Wegovy are making so much money for Novo Nordisk A/S that their cumulative sales will soon surpass the drugmaker's entire research budget for the past three decades, undercutting a key argument for their unusually high prices. The pair of medicines for diabetes and obesity have sold nearly $50 billion as of the second quarter and are on track to make $65 billion by the end of this year, according to a Bloomberg News analysis of regulatory filings and analyst estimates... Sub. Req’d

Warren, Others Urge Government to Allow Generics to Novo's Blockbuster GLP-1s Ahead of CEO Hearing

(9/23, Zoey Becker, Fierce Pharma) ...Sen. Elizabeth Warren, D-Massachusetts, Rep. Lloyd Doggett, D-Texas, and other legislators penned a letter to secretary of the Department of Health and Human Services (HHS), Xavier Becerra, urging the agency to use its authority to dole out licenses to generic semaglutide makers in order to promote competition and bring down prices... Full

Analysts Say Market Forces Will Lower Cost of Obesity Drugs

(9/23, Lia DeGroot, Roll Call) ...Lindsay Allen, a health economist at Northwestern University, said while the hearing could lead to renewed calls from lawmakers for price controls, the market is already moving toward lower costs. She pointed to Eli Lilly's direct-to-consumer platform that launched last month, LillyDirect, where it will sell its obesity medication Zepbound for $399 a month. "What's going to be the most effective lever in the short term is the market dynamics of what's going on with competitors," she said. Allen said Novo charges such a high price tag in the United States because consumers are largely willing to pay that price... Full

Dose of Reality: Big Pharma's GLP-1 Price-Gouging Unsustainable for American Patients and the U.S. Health System

(9/23, The Campaign for Sustainable Rx Pricing) ...On Tuesday, September 24, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) is scheduled to hold a hearing examining the high price of blockbuster diabetes and GLP-1 weight loss drugs manufactured by Novo Nordisk...Ahead of the hearing, get a Dose of Reality on how Big Pharma is applying a playbook of price-gouging and blocking competition honed on diabetes drugs to this category of GLP-1 drugs for weight loss... Full

Sen. Cassidy Questions Lilly and Amgen On 340B Restrictions On Contract Pharmacies

(9/23, Zachary Brennan, Endpoints News) ...As the federal government is threatening Johnson & Johnson with fines related to its unilateral alterations to the 340B drug discount program, Sen. Bill Cassidy (R-LA) is continuing his ongoing investigation into the program with two letters sent Monday to the CEOs of Eli Lilly and Amgen. The letters question the pharma companies' restrictions on certain pharmacies that contract with hospitals under the program, even as the number of those pharmacies has ballooned from 789 in 2009, to 25,775 in 2022, according to Cassidy... Full

Sen. Bill Cassidy On Drug Prices: There's a Tension Between Innovation and Affordability

(9/23, CNBC) ...Senate Health, Education, Labor and Pensions Committee ranking member Sen. Bill Cassidy (R-La.) joins 'Squawk Box' to discuss the state of drug pricing in the U.S., what to expect from the weight-loss drug price hearing today, fixing social security, and more... Full

PCMA Statement On Senate HELP Committee Hearing

(9/23, PCMA) ..."In the HELP Committee hearing Tuesday, the drug company executive testifying will redux Big Pharma's favorite messaging tactic of pointing the finger at pharmacy benefit managers (PBMs). This blame game is meant to shift attention, avoid accountability, keep drug prices high, and advance an agenda that would mean even higher profits for Big Pharma at the expense of patients, employers, and taxpayers."... Full

‘Alternative' PBMs Say Vertical Integration Unfairly Carving Them Out Of The Game

(9/23, Sarah Karlin-Smith, Pink Sheet) ...Vertical integration between health insurance companies and PBMs is leading to anticompetitive practices that make switching to alternative benefit managers unaffordable or impossible for self-funded employer health plans, the newer PBMs argue. The alternative PBMs are pushing for federal policy solutions, such as a ban on data integration fees among health care companies... Sub. Req’d

PBMs Are Committed to Helping Clients Navigate the GLP-1 Coverage Journey

(9/24, JC Scott, RealClearHealth) ...Few issues in health care have received more attention over the past year than the breakthrough weight loss treatments, GLP-1s. The potential for these medications to help millions of Americans is extremely exciting. However, the promise of GLP-1s is associated with interconnected challenges of high price tags, a lack competition in the market, and unprecedented consumer demand... Full

Fifth Circuit Remands PhRMA, Infusion Provider Case Against Medicare Drug Price Negotiation

(9/23, Gabrielle Wanneh, InsideHealthPolicy) ...The drug industry notched its first initial win at the appellate level when the Fifth Circuit on Friday (Sept. 20) partially reversed a Texas district court's decision to dismiss the brand drug lobby's lawsuit against further implementation of the Inflation Reduction Act's Medicare drug negotiation program... Sub. Req’d

Harris, Trump Must Tackle the Root Causes of High Drug Prices

(9/23, Gabi Hanna, RealClearHealth) ...Addressing the root causes of high drug prices demands a comprehensive approach. Lowering development costs, de-risking innovation, and extending the effective patent life of new drugs are critical steps in this process. It will take more than a line in a campaign speech... Full

Gaetz: CMS Must Release Preliminary 2025 Part D Premium Data

(9/23, Sigi Ris, InsideHealthPolicy) ...Rep. Matt Gaetz (R-FL) is demanding the Biden administration release Medicare Part D preliminary premium data for 2025 -- data typically released every year in July, but which CMS put off releasing as it launched a last-minute demonstration aimed at stabilizing expected premium increases... Sub. Req’d

Patent Bills Could End Up Costing Patients More at the Pharmacy Shelves

(9/23, PIRG) ...In the week leading up to an important meeting of the Senate Judiciary Committee on September 19, PIRG and our allies worked to educate lawmakers about how two pieces of legislation could undermine some of Congress' previous work to address the high costs of prescription drugs... Full

Senate Panel To Consider Automatic Biosimilar Interchangeability, PRV, Food Bills

(9/23, Luke Zarzecki, Jessica Karins, InsideHealthPolicy) ...The Senate health committee plans to consider six health bills Thursday (Sept. 26), including legislation that would automatically deem all biosimilar drugs interchangeable with their reference counterparts and that would reauthorize FDA's pediatric priority review voucher program through 2028. Several of the changes were requested by FDA in the agency's legislative requests for fiscal 2025... Sub. Req’d

40th Anniversary of the Generic Drug Approval Pathway

(9/23, U.S. Food & Drug Administration) ...In this CDER Conversation, Darby Kozak, PhD, deputy director for CDER's Office of Generic Drugs, talks about the impact of the Hatch-Waxman Amendments on the generic drug industry, FDA's work, and patients and consumers... Full

40 Years of Hatch-Waxman: How Does the Hatch-Waxman Act Help Patients?

(9/23, Jocelyn Ulrich, PhRMA) ...Unfortunately, patients often still have issues accessing and paying for the medicines they need, despite expansive generic competition thanks to Hatch-Waxman. Instead, patients are often steered by insurers and pharmacy benefit managers towards higher priced drugs to further pad profits as they make more money off a higher list price medication... Full

The U.S. Has Relied On Cheap, Effective Generic Drugs for 40 Years. Now that Promise is Under Threat

(9/24, Leslie Walker and Dan Gorenstein, STAT Plus) ...Researchers and industry executives say intense price pressures have forced some generic manufacturers to exit markets while pushing those that stay to slash costs, including spending on redundancies that keep the supply chain resilient... Sub. Req’d

Happy 40th Birthday, Hatch-Waxman!

(9/23, Bob Pollock, Lachman Consultants) ...When Hatch-Waxman passed in 1984, the generic substitution rate was at 19% (remember, there were generic products before 1984; however, they were permitted only for copies of NDA products approved prior to 1962). Today, generics and biosimilars account for "a whopping 90 percent of all U.S. prescriptions" and the total generic and biosimilar savings in the commercial market in 2022 was $194 billion, with $2.9 trillion saved by patients over the past ten years... Full

Addressing the Mounting Threat of Antimicrobial Resistance

(9/23, Jocelyn Ulrich, PhRMA) ...On Thursday, September 26th, the United Nations General Assembly will host a meeting on the growing threat that antimicrobial resistance (AMR) poses to people around the world. This marks an important moment in the fight to address AMR, which the World Health Organization (WHO) has deemed "one of the biggest threats to global health, food security and development today."... Full

BIOSECURE Act Faces Senate Roadblocks, Alabama Aims To Fill The Gaps

(9/23, Maaisha Osman, InsideHealthPolicy) ...The House-passed BIOSECURE Act is facing a setback in the Senate after it was excluded in the chamber's initial version of the National Defense Authorization Act (NDAA), with an industry lawyer saying House leadership may need to make a strong push to incorporate the bill into its own version of the must-pass defense legislation... Sub. Req’d

Inflation Continues To Rear Head At US FDA User Fees

(9/23, Derrick Gingery, Pink Sheet) ...Inflation accounted for a larger portion of user fee revenue target increases for fiscal year 2025, compared to previous years, according to a Pink Sheet analysis...Deflation and its potential effect on fees in the years after the Great Recession also sparked conversations about changing the inflation adjustment formula. Some worried the adjustment may not properly fund future personnel agency needs. And with renewal negotiations for the three user fee programs set to begin in 2025, questions already are being asked about whether program funding should continue to increase... Sub. Req’d

New York State Lawmaker Proposes No-Cost Inhalers

(9/24, John Whittaker, Observer) ...Assemblywoman Jessica Gonzalez-Rojas, D-East Elmhurst, has introduced legislation (A.10692) that would require the state Insurance Law to require every insurance policy include coverage for inhalers for the treatment of asthma. That coverage would not be allowed to include a deductible, copayment, coinsurance or any other cost-sharing requirement... Full

Generic Drug Group Defends Suit Challenging Illinois Pricing Law

(9/23, Celine Castronuovo, Bloomberg Law) ...Generic and biosimilar maker Sandoz, Inc. plans to increase the price of one of its generic drugs this year—an action that will likely result in a violation of the now-challenged Illinois law, the Association for Accessible Medicines said Sept 20 in its opposition to Illinois Attorney General Kwame Raoul's (D) motion to dismiss the case... Sub. Req’d

EU HTA Regulation: Expect The Unexpected When It Comes To PICOs

(9/23, Eliza Slawther, Pink Sheet) ...Manufacturers should undertake scenario planning exercises and simulations to prepare for questions that will be asked under the upcoming EU HTA Regulation, but unpredictable questions are likely to arise, experts from Cencora caution in this first of two articles on the new EU joint clinical assessments... Sub. Req’d

EMA Explains How To Make Risk Minimization Measures Robust & Effective

(9/23, Vibha Sharma, Pink Sheet) ...Pharmacovigilance experts speaking at an event organized by the European Medicines Agency discussed the rationale behind revised requirements relating to how drug sponsors must develop and evaluate risk minimization measures and thereby improve the safety of their medicines... Sub. Req’d

Pharma Package Improvements Are Needed, Says Belgian Medicines Agency

(9/23, Nicole Verbeeck, Euractiv) ...The Belgian medicines agency, an important stakeholder in revising the European pharmaceutical legislation, is proposing improvements to the EU Pharma Package. "A reform of the pharmaceutical legal framework was more than necessary. Overall, we are satisfied with the Commission's proposal, which moves in the right direction on many issues," Hugues Malonne, CEO of the Belgian Federal Agency for Medicines and Health Products (FAMPH), told Euractiv... Full

Greek Pharma Report Lays Bare Industry's Impact

(9/23, The Pharma Letter) ...The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry's importance. The first is an annual report, The Pharmaceutical Market in Greece: Facts and Figures 2023, while the other study is entitled The Contribution of the Pharmaceutical Sector to the Greek Economy... Sub. Req’d

Dose of Uncertainty: Drug Industry Warns Pharmacare Bill Could Upend Economic Balance

(9/23, Chris Hannay, The Globe and Mail) ...Industries that make, sell and insure drugs say the federal pharmacare bill will deliver a major dose of uncertainty to their sectors if it passes in the coming weeks. The legislation aims to create the beginnings of a national public insurance plan for pharmaceuticals that starts with contraceptives and diabetes medication... Sub. Req’d

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