Wednesday, June 12, 2024

NJ Federal Judge Rules Teva Inhaler Patents are 'Improperly Listed' in Orange Book

(6/11, Nicole DeFeudis, Endpoints News) ...Five of Teva's inhaler patents are "improperly listed" in the FDA's Orange Book, a federal judge ruled Monday, in a win for Amneal Pharmaceuticals' efforts to market a generic version of one of Teva's drugs...Teva told Endpoints that it stands behind its intellectual property and will appeal the ruling... Full

Judge Orders Teva To Delist Inhaler Patents From FDA's Orange Book

(6/11, Maaisha Osman, InsideHealthPolicy) ...U.S. District Judge Stanley Chesler of New Jersey agreed with Amneal and FTC, concluding an order Monday (June 10) that Teva's patents solely pertained to inhaler device technology. He ordered the removal of these patents from FDA's Orange Book, eliminating a hurdle for Amneal's proposed generic version of the inhaler product. Teva argued that despite its Orange Book patents not specifically claiming the drug substance albuterol sulfate as listed in its new drug application for the product, its patents should still be considered properly listed... Sub. Req'd

Court Orders Teva Patents to Be Delisted from Orange Book

(6/12, The Pharma Letter) ...A New Jersey, USA, federal judge has ruled that five patents covering Israel-based Teva Pharmaceutical Industries-brand asthma inhalers were improperly listed in the Food and Drug Administration's Orange Book, in a win for US drugmaker Amneal Pharmaceuticals... Sub. Req'd

Court Orders Teva to Remove Asthma Patents from Orange Book

(6/11, Marisa Woutersen, Life Sciences Intellectual Property Review) ...The court found that Teva's patents only covered parts of an inhaler device technology, as opposed to its ProAir HFA drug, and ordered their removal from the Orange Book, clearing the way for Amneal's proposed generic. The ruling, issued by the US District Court for the District of New Jersey, revolves around Teva's ProAir HFA (albuterol sulfate) Inhalation Aerosol and allegations of patent infringement under the Hatch-Waxman Act. Judge Stanley Chesler, in his June 10 decision, also denied Teva's attempt to dismiss Amneal's claims that Teva violated state and federal antitrust laws... Full

FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy

(6/11, Kevin E. Noonan, Patent Docs) ...It must be recognized that the District Court's decision was based, inter alia, on Teva's assertion that these patents were listed as reciting the drug rather than reciting methods for administering the drug. (Perhaps more troubling is that the District Court denied Teva's motion to strike Amneal's counterclaim that improper listing can amount to an antitrust violation under 21 U.S.C. § 355(j)(5)(c)(ii)(II))... Full

Court Invalidates Teva's Improper Patents that Keep Inhaler Prices High, Embracing FTC Amicus Brief

(6/10, American Economic Liberties Project) ...Following a decision from the United States District Court for the District of New Jersey ordering Teva Pharmaceuticals to correct or delete five improperly listed Orange Book patents for its ProAir Inhalers, the American Economic Liberties Project released the following statement. "This is a major victory for patients facing artificially inflated drug prices, and it's another validation of the Federal Trade Commission's campaign against sham Orange Book patents," said Lee Hepner, Senior Legal Counsel at the American Economic Liberties Project."... Full

Taiwan's Lotus Pharma Acquires Teva Pharma Thailand, Expanding Footprint in Southeast Asia

(6/12, BioSpectrum Asia Edition) ...Taiwan-based Lotus Pharmaceuticals has announced the acquisition of Thailand business and commercial entity of Teva pharma. The acquisition is targeted for completion by Q3 2024. Upon finalisation, Teva Pharma Thailand will transition into a wholly owned subsidiary of Lotus and Lotus will undertake the sales and marketing of existing products of Teva Pharma Thailand... Full

Amneal Launches Six Injectables With Some To Aid US Drug Shortage

(6/11, Urte Fultinaviciute, Generics Bulletin) ..."The persistent shortage of quality injectables is driven by multiple factors, including unstable market economics, supply chain disruptions and the need for supply redundancy," said Andy Boyer, Amneal's executive vice president and chief commercial officer for generics. ASHP currently lists 323 drugs as being in shortage, with about half representing injectables. With these additional launches, Amneal will now commercialize 13 injectables that are on the ASHP shortage list... Global Sub. Full

Stada Bags European Rights from Alvotech to Biosimilar of Amgen Blockbusters

(6/11, Nick Paul Taylor, BioSpace) ...Alvotech and Stada are preparing to provide patients and physicians with biosimilar alternatives to Prolia and Xgeva. Tuesday, Alvotech said Stada has gained semi-exclusive commercial rights for its proposed biosimilar copy of the Amgen drugs in Europe, including Switzerland and the U.K. Stada has also secured exclusive rights to the biosimilar candidate in some markets in Central Asia and the Middle East... Full

Glenmark Receives USFDA Approval for Esomeprazole Magnesium Delayed-Release Capsules

(6/12, Business Standard) ...Glenmark Specialty SA has received final approval by the United States Food & Drug Administration for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent1 to Nexium2 24 HR Delayed-Release Capsules, 20 mg (OTC), of Haleon U.S. Holdings LLC... Full

Lilly Exec Points to Medicare As More Pay Full List Price for Zepbound Than Mounjaro

(6/11, Max Bayer, Endpoints News) ...Patrik Jonsson, president of Lilly USA, said Monday at the Goldman Sachs 45th Annual Global Healthcare Conference that while access to Zepbound has been good, "it's not 100 percent." He added that because of a Medicare provision excluding coverage of anti-obesity medications, more patients have had to pay the full list price than patients receiving type 2 diabetes treatment Mounjaro... Full

After M&A Stretch, Pfizer CEO Says Company Needs 'Breathing Period' from Large Deals

(6/11, Fraiser Kansteiner, Fierce Pharma) ...Though not for lack of business development capacity, Pfizer is currently taking a large dealmaking "breathing period," CEO Albert Bourla told investors this week at Goldman Sachs' 2024 annual Global Healthcare Conference in Miami. After spending tens of billions of dollars on Arena Pharmaceuticals, Biohaven Pharma, Global Blood Therapeutics and, most recently, Seagen, "[w]e need to catch our breath and make sure that we execute well on those [companies] that we have right now," Bourla explained... Full

New Pharma Will Crowd Out Big Pharma

(6/11, Aimee Donnellan, Reuters) ...Big Pharma is under threat from tech-driven upstart rivals. The values of large, established players like $159 billion Pfizer, $230 billion Novartis and $216 billion Roche are converging with newer players like $121 billion Vertex Pharmaceuticals. As drugmakers wrestle with the need to constantly replenish their stocks of remedies via deals, big names may struggle to remain relevant... Full

This Startup Helps Americans Get Ozempic and Adderall by Using Overseas Freelancers

(6/11, Bruce Gil, Quartz) ...A startup is working to help Americans navigate ongoing shortages of highly-coveted drugs like Adderall and Ozempic. Their solution is to outsource the detective work of finding which pharmacies have these medicines in stock to freelancers abroad. Insito Health's medicine finding service Medfinder was launched in January by co-founders Peter Daggett and Parth Shah, both of whom have ADHD. They told 404 Media that they came up with the idea after joking that they would be willing to pay someone $100 to help them find where to they could fill an Adderall prescription. Since then, they have helped thousands of people locate hard-to-find medications... Full

Takeda Extends Partners in Health Collab to Improve Access to Care in Massachusetts

(6/11, Andrea Park, Fierce Pharma) ...The duo will work toward breaking down systemic barriers to care, especially along the racial, ethnic and socioeconomic lines that often play a role in preventing access to effective healthcare. In Massachusetts, according to data cited by Takeda, communities of color are estimated to spend an extra $1.5 billion per year in avoidable healthcare costs caused by poorer health—an annual economic burden that's forecast to reach more than $11 billion within the next 30 years... Full

BIO's New CEO Takes a Patriotic Pivot to Win Back Congress, Pushing Industry to Rethink China Relationship

(6/11, Andrew Dunn, Jared Whitlock and Max Bayer, Endpoints News) ...."Biosecure does not help the international environment or the US public," said James Sapirstein, the CEO of Entero Therapeutics and a longtime friend of Crowley, who sits on a governing board of BIO. "It does not help. It hurts it. But we realize why we had to do it, again, to live to fight another day."... Full

Drug Shortages Are Killing Our Patients

(6/11, Robert D. Glatter, MD; Peter J. Papadakos, MD, Medscape) ...More and more, patients are being subjected to ongoing critical shortages of all classes of medications, leading to a major break down in the way we usually treat patients. These drug shortages have had an impact on not only individual patients but also the entire healthcare system... Full

A Top Inhaler for Children Was Discontinued. Families and Doctors Are Scrambling to Fill the Gap

(6/12, Amanda Gokee, The Boston Globe) ..."We know families who are rationing their kids' inhalers because they can't afford it," said Robyn Cohen, a pediatric pulmonologist and director of Boston Medical Center's Pediatric Pulmonary and Allergy Clinic. But Cohen said rationing a needed preventative medication can make it more likely children will need to see a doctor or end up hospitalized for asthma attacks, especially during pollen season. She said the issue is further taxing an already burdened health system... Sub. Req'd

Ahold Delhaize USA Enters into Agreement with Mark Cuban Cost Plus Drug Company

(6/11, Zachary Russell, Chain Store Age) ...The grocery retail group has entered into a new agreement with Mark Cuban Cost Plus Drug Company, PBC involving the Team Cuban Card. Under the agreement, customers can now use the Team Cuban Card at each Ahold's local brand pharmacies, including Food Lion, Hannaford, Giant Food, The Giant Company and Stop & Shop... Full

Sanders Pushes Subpoena Vote to Force Testimony of Novo Nordisk Exec On GLP-1 Prices

(6/11, Lia DeGroot, Endpoints News) ...Senate HELP Committee chair Bernie Sanders (I-VT) is moving to subpoena Doug Langa, Novo Nordisk's EVP of North America operations, to testify, following an investigation by the committee this spring over what he calls "outrageously high" prices for the company's diabetes and obesity treatments. Sanders said he's planning to hold the vote next Tuesday on issuing the subpoena and would like to hold a hearing on July 10. Specifically, Sanders is upset that Novo charges significantly more for its drugs Ozempic and Wegovy in the US than in other countries... Full

Sanders Wants to Subpoena Novo Nordisk Exec to Answer Questions On Wegovy, Ozempic Pricing

(6/11, Kevin Dunleavy, Fierce Pharma) ...Industry association PhRMA criticized the committee's pursuit of a subpoena. "Senator Sanders continues to use his position to exploit the popularity of revolutionary new medicines and attack one company, who is cooperating and already agreed to testify, to further his own political agenda," Alex Schriver, PhRMA's SVP of public affairs said in a statement. "This isn't a good-faithed effort to address the challenges patients are facing; it's a political crusade."... Full

Novo CEO Willing To Testify On Weight-Loss Drugs After Sanders Threatens To Subpoena Novo President

(6/11, Maaisha Osman, InsideHealthPolicy) ...A Novo Nordisk spokesperson tells Inside Health Policy that its global CEO Lars Fruergaard Jørgensen, who is better versed in reference pricing, is willing to testify, and the subpoena is unnecessary. "Every time the chairman has made a request to Novo Nordisk we have responded and cooperated. On multiple occasions, we have communicated our CEO's willingness to testify and offered several dates for a hearing," the spokesperson says. "Based on our continued cooperation, we feel that issuing a subpoena is unnecessary."... Sub. Req'd

Spanberger Joins AARP Virginia Town Hall, Backs Bills to Lower Drug Costs for Seniors, Expand Medicare Coverage, & Support Caregivers

(6/11, Congresswoman Abigail Spanberger) ...According to the Center for Medicaid and Medicare Services, nearly 1.6 million Virginians are enrolled in Medicare. Yesterday evening, Spanberger took questions from Virginia seniors who are contending with high prescription drug costs, who are caregivers for loved ones, and who are worried about unaffordable coverage. She provided direct answers to their questions and provided updates about how the Inflation Reduction Act — which Spanberger voted to pass and President Biden signed into law — is continuing to lower prescription drug costs for Virginia seniors. Beginning on January 1, 2025, the Inflation Reduction Act will cap out-of-pocket costs at $2,000 for Medicare Part D... Full

Merith Basey Advocates for Transparency in PBM Practices | AHIP 2024

(6/11, Peter Wehrwein, Managed Healthcare Executive) ...Merith Basey, M.Sc., executive director of Patients for Affordable Drugs, discusses her group's focus on the monopoly pricing of pharmaceutical companies and bills in Congress addressing patent reform and "pay for delay" strategies, in an interview with MHE previewing the presentation she's co-presenting on June 11 at the AHIP 2024 meeting in Las Vegas... Full

AHIP 2024: The Hurdles to Widespread Biosimilar Adoption

(6/12, Paige Minemyer, Fierce Healthcare) ...Biosimilars hold significant promise in reducing pharmacy costs, and pharmacy benefit managers have touted them for years as being the key to introducing competition to some of the most in-demand branded products...Vin Gupta, M.D., chief medical officer at Amazon Pharmacy, said just the word "biosimilar" has an unclear meaning for a physician who may not have an extensive knowledge of the pharmaceutical space. And, to encourage patients to explore these options, docs need to able to talk to them about it. Again using generics as an example, patients initially were skeptical as they were concerned that these products were lesser than the branded drugs they may have already been taking. Biosimilars face a similar knowledge gap, he said... Full

Watch: The Role of PBMs, Patents, and Public Health in Drug Pricing

(6/12, Anna Yeo, STAT) ...In this video series, we take you behind the pharmacy counter to explore the factors involved in pricing prescription drugs. We look at how a complex relationship between drugmakers, insurers, and pharmacy benefit managers contributes to increasing drug costs. We also do a deep dive on drug patents — how they're obtained, how they're used, and how they can mean the difference between a drug costing hundreds of dollars or the equivalent of a cup of coffee... Full

Watch: How Pharmacy Benefit Managers Influence Drug Pricing

(6/12, Anna Yeo, STAT) ...The video outlines what pharmacy benefit managers, or PBMs, are; how formularies and rebates work; and how PBMs use them to mediate with drugmakers, health insurers, and pharmacies in ways that influence the cost of drugs... Full

Expert: Manufacturers Making ‘Great Progress' Towards DSCSA Compliance

(6/11, Joanne S. Eglovitch, Regulatory Focus) ...Most drugmakers are actively transmitting serialized data under the Drug Supply Chain Security Act and will be in compliance with the law when it takes effect this November; however, much work still lies ahead in getting those companies who are not sending serialized data up to speed, Gregg Gorniak, vice president of manufacturer operations and data services at drug wholesaler Cencora, told Focus... Full

Interesting Facts from Fiscal Year 2023 Report On The State of Pharmaceutical Quality

(6/11, Bob Pollock, Lachman Consultants) ...Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year's report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different... Full

FDA Funding Would Stay Flat Under House Bill Scheduled for Markup

(6/11, Lia DeGroot, Endpoints News) ...Under the proposal, the FDA would receive a total budget of $6.75 billion, the same amount it received in the prior fiscal year. That falls well short of the requested $7.2 billion that the agency proposed in its budget request earlier this year...Steven Grossman, executive director of the Alliance for a Stronger FDA, predicted it could be a long process to get the appropriations packages to completion, warning in a blog post last week that it might not be until December that the process gets ironed out... Full

House Lawmakers Spar Over Proposed FDA FY 2025 Budget

(6/11, Ferdous Al-Faruque, Regulatory Focus) ...Democrats and Republicans on the House Appropriations Committee are already sparring over a proposed FY 2025 budget that falls almost 10% short of President Joe Biden's request for certain agencies, including the US Food and Drug Administration (FDA). While Republicans argue the bill is fiscally responsible, Democrats say it jeopardizes food security and FDA's ability to do its work... Full

FDA Drafts Rules for Fair Biosimilar Promotion

(6/11, Tony Hagen, Managed Healthcare Executive) ...In its updated draft guidance, the FDA concludes that promotional materials that suggest a biosimilar or reference product is superior "are likely to be false or misleading." Therefore, the FDA is advising companies to avoid making these types of comparisons. The FDA based this guidance on the fact that when it approves a biosimilar for use, it has already made the determination that there are "no clinically meaningful differences" between the biosimilar and the reference product... Full

Colorado Drug Review Board Finds J&J's Stelara Unaffordable, Teeing Up Potential Statewide Price Cap

(6/11, Zoey Becker, Fierce Pharma) ...Colorado's Prescription Drug Affordability Review Board isn't waiting for the Inflation Reduction Act to lower prices on certain drugs starting in 2026. After the board previously voted to enforce an upper payment limit on Amgen's Enbrel in the state, Johnson & Johnson's Stelara could be next in line... Full

Minnesota AG Pushing for U.S. Supreme Court Review On Pharmacy Benefit Manager Rules

(6/11, Christopher Snowbeck, Star Tribune) ...Minnesota Attorney General Keith Ellison is leading a bipartisan group of 32 attorneys general asking the U.S. Supreme Court to review a case that could otherwise limit state regulation of pharmacy benefit managers..."Review by this court is therefore necessary to ensure that states continue to be able to enforce needed consumer protections and prevent the blatant abuses that PBMs would otherwise engage in," the attorneys general said in an amicus brief filed Monday with the Supreme Court. The Pharmaceutical Care Management Association said it would continue to defend the appellate court's decision... Full

States Urge Supreme Court to Review PBM Case

(6/11, Nona Tepper, Modern Healthcare) ...Federal law fails to hold PBMs accountable for rising drug costs, retail pharmacy consolidation and lower professional standards among pharmacists, the attorneys general allege in the amicus brief. Their claims echo those made by the National Association of Attorneys General in February when it called on Congress to pass wide-ranging PBM legislation but that effort failed. Separately, the Federal Trade Commission is investigating PBMs' influence on drug costs... Sub. Req'd

ICH Cuts Burden Of Assessing Drug-Drug Interactions; Argentina Gains Membership

(6/11, Neena Brizmohun, Pink Sheet) ...New guidance from the International Council for Harmonisation is designed to tackle problems companies face by having to meet different requirements around the world when evaluating the potential of DDIs for their investigational products... Sub. Req'd

Ahead of UK Election, Life Sciences Trade Group Pushes Politicians to Boost Local Industry

(6/11, Fraiser Kansteiner, Fierce Pharma) ...The Association of the British Pharmaceutical Industry (ABPI) is challenging all U.K. political parties to blueprint their plans to unlock the nation's healthcare industry potential, according to a press release issued Monday. ABPI laid out a series of objectives in its "Manifesto for Investment, Health and Growth," which aims to deliver better health and equity for National Health Service (NHS) patients, boost access to new drugs through clinical trials, bring more manufacturing roles to the U.K. and create more highly skilled and well-paid jobs across the... Full

UK Pharma Industry Delivers Election ‘Wish List'

(6/11, Phil Taylor, Pharma Phorum) ...The trade organisation launched its own manifesto to coincide with the release of the manifestos of the main parties, setting out a plan to "drive better health and fairness to patients in the NHS, boost patient access to new medicines via clinical trials, bring more manufacturing jobs and value to the UK, and create more highly-skilled well-paid jobs in all parts of the country." The document lays out three key ‘asks' of the next government, headed by efforts to strengthen the framework for the development, regulation, and adoption of new medicines and vaccines by the NHS... Full

Press Release: Off-Patent Medicines Industry Marks 30 Years of Delivering Public Health Impact

(6/12, Medicines for Europe) ...These medicines account for 70% of medicines dispensed in Europe, for the most serious conditions like cancer, auto immune diseases and cardiovascular disease. The revision of the European pharmaceutical legislation and the reform of the Supplementary Protection Certificate system are a unique opportunity to support companies providing the majority of medicines to European patients... Full

EFPIA Sets Out Targets for Pharma Environmental Sustainability

(6/11, Catherine Eckford, European Pharmaceutical Review) ...The European Federation of Pharmaceutical Industries and Associations and its members has declared its commitment to a set of science-based targets to help decarbonise the pharmaceutical sector, supporting environmental sustainability. The organisation asserted that it is "essential to move away from traditional methods and adopt innovative practices that reduce our environmental impact."... Full

Warsaw Reallocates Drug Production Funds, Provokes Pharma Industry Criticism

(6/11, Paulina Mozolewska, Euractiv) ...The KPO funds, intended to launch new production lines in pharmaceutical plants in Poland, were also seen as an opportunity for economic growth and industry development. "Abandoning the funding for activities aimed at improving Poland's drug security under the KPO is primarily bad news for Polish patients," Krzysztof Kopec, president of the Polish Association of Pharmaceutical Industry Employers – National Drug Producers, explained to Euractiv... Full

New Czech Medicines Act Takes Force, Boosting Pharma Efficency, Tackling Shortages

(6/11, Aneta Zachová, Euractiv) ...A new amendment to the Czech Medicines Act, designed to bolster patient protection, improve market transparency, and tighten the rules for exporting medicines abroad, is now in force. This legislation represents significant overhauls of pharmaceutical regulations in recent years, making the Czech pharmaceutical market more resilient to disruptions, argues the Czech health ministry... Full

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