Monday, March 25, 2024

FTC Files Amicus Brief in Asthma Inhaler Patent Dispute

(3/22, FTC) ...The Federal Trade Commission filed an amicus brief explaining that pharmaceutical maker Teva has improperly listed patents in the Food and Drug Administration's Orange Book and urged the court to order those listings removed. Improper Orange Book listings can harm competition by delaying the entry of cheaper generic products, according to the FTC's brief. The FTC's amicus brief relates to a case brought by Teva against drugmaker Amneal after Amneal sought FDA approval to bring a generic version of asthma inhaler ProAir HFA to market... Full

Bernie Gets Mostly Pharma-Friendly Drug Pricing Results

(3/22, Sarah Karlin-Smith, Pink Sheet) ...Teva Pharmaceuticals USA Inc., the only inhaler manufacturer Sander's targeted who hasn't announced any pricing moves, Sanders said he talked to the company the other day and "they are considering it," suggesting Teva's size and role as primarily a generic company is impacting its actions. Teva took another hit on March 22, however, as the Federal Trade Commission filed an amicus brief in a lawsuit pitting Teva against Amneal Pharmaceuticals, Inc. over patents for Teva's ProAir HFA... Sub. Req'd

Inhaler Cost Cap Trend Could Help Avoid Lawsuits, Expert Says

(3/22, Maaisha Osman, InsideHealthPolicy) ...FTC Chair Lina Khan applauded GSK's move and asked companies that have chosen not to delist their patents from Orange Book to reconsider their stance. "I urge the other firms whose patent listings FTC challenged--including Teva--to withdraw their improperly listed patents and reduce how much Americans have to pay for essential medicines," Khan wrote in a social media post... Sub. Req'd

The Cost of Inhalers is Going Way Down

(3/22, U.S. Senator For Vermont Bernie Sanders) ...Teva, the smallest of the four companies that manufacture inhalers, has not yet made that commitment. We hope they will in the very near future...During the last few months, I have had the opportunity to talk to the CEOs of Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, and Teva. My impression is that these companies, as well as many others in the pharmaceutical industry, are beginning to catch on to the fact that the American people are sick and tired of paying astronomical prices for the prescription drugs they need to stay alive or ease their suffering... Full

VIDEO: Baldwin Celebrates Capping Inhaler Prices at $35, Brings Relief to Wisconsin Families

(3/22, U.S. Senator For Wisconsin Tammy Baldwin) ...Today, U.S. Senator Tammy Baldwin (D-WI), a member of the Senate Committee on Health, Education, Labor, and Pensions, celebrated the progress made to lower health care costs for Wisconsin families and hold big drug companies accountable. Less than three months after Senator Baldwin launched an investigation into the four major manufacturers of inhalers, three of the companies have made commitments to cap the out-of-pocket costs of their inhalers at $35 for patients at the pharmacy counter...In the past five years, AstraZeneca, GSK, and Teva made more than $25 billion in revenue from inhalers alone. That is part of a broader pattern: between 2000 and 2021, manufacturers of all inhaler products in the U.S. brought in more than $178 billion in revenue... Full

The Obviousness Hurdle

(3/25, Dennis Crouch, Patentlyo) ...The U.S. Supreme Court is weighing whether to grant certiorari in Vanda Pharmaceuticals v. Teva Pharmaceuticals. I have been closely watching this obviousness case that could have significant implications beyond the pharmaceutical industry. The following essay provides an overview of the key legal issues at stake and introduces Teva's recent briefing... Full

Eli Lilly Warns of Temporary Short Supply of Two Insulin Products

(3/22, Meg Tirrell, CNN) ...Drugmaker Eli Lilly warned this week that two of its formulations of insulin would be temporarily out of stock through the beginning of April, citing a "brief delay in manufacturing." The 10-milliliter vials of Humalog and insulin lispro injection will be in short supply at wholesalers and some pharmacies, Lilly said in a statement posted online Wednesday...Tarsis Lopez, a spokesman for Lilly, told CNN that the "dynamic nature of insulin supply and demand, coupled with a brief delay in manufacturing, led to the temporary supply constraint."... Full

Sandoz Maintains Lead On Denosumab With First EU Recommendations

(3/22, Dean Rudge, Generics Bulletin) ...Weeks after obtaining the first US Food and Drug Administration approvals, Sandoz has become the first player to scoop positive opinions in the EU recommending the granting of pan-European marketing authorizations for its biosimilars to Amgen's Prolia/Xgeva products, Jubbonti and Wyost respectively. The recommendations came from European Medicines Agency's Committee for Medicinal Products for Human Use, which will now forward its recommendations to the European Commission... Global Sub. Full

Alvotech Willing And Able To Go Stride For Stride On Pembrolizumab Manufacturing

(3/22, Dean Rudge, Generics Bulletin) ...Alvotech stepped into its 2023 annual financing results call bursting with positive news and momentum, on the back of obtaining USFDA approval for its biosimilar Humira product and a bullish outlook for its strong pipeline of biosimilar candidates...[Anil Okay, Alvotech's CCO] enthused about the approval in particular, he highlighted, because of Teva's potential to grab material market share given Simlandi's unique product characteristics..."I know that Teva is very well reminding that [interchangeability] to the relevant industry stakeholders. This will really be one of the fundamental advantages of Alvotech's product profile to move the market in 2024.”... Global Sub. Full

Hyloris Reports 44% Revenue Growth Driven By Royalties In 2023

(3/22, Adam Zamecnik, Generics Bulletin) ...Belgian company Hyloris Pharmaceuticals has reported a 44% revenue increase in its 2023 results while doubling down on its long-standing ambition to have 30 portfolio assets in the near future...In its commercial highlights, the company underlines new agreements signed in 2023, such as the out-licensing of the Canadian commercial rights to the liquid oral formulation of the ADHD treatment atomoxetine to Kye Pharmaceuticals, which was finalised in October 2023. Beyond this, the company managed to sign further licensing agreements for the antifibrinolytic treatment tranexamic acid, which cover several Asian countries alongside a major European state... Global Sub. Full

Celltrion's Xolair Biosimilar CT-P39 Gets Approval Recommendation in Europe

(3/25, Korea Biomedical Review) ...Celltrion said Monday it has received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use to grant the marketing authorization for the full-label application of CT-P39, a biosimilar to Xolair (omalizumab)...Celltrion added that it would focus on product development and investment to expand its biosimilar portfolio to 11 products by 2025, in addition to the six already commercialized products... Full

Samsung Begins New Drug Development for Rare Diseases

(3/24, Dae-Kyu Ahn and Jeong Min Nam, The Korea Economic Daily) ...Samsung Bioepis Co., a biosimilar development unit of South Korea's top conglomerate Samsung Group, has begun its new drug development business with gene therapy pipelines to spur the company's long-term value creation...The conglomerate is eyeing the niche market for rare diseases as some countries offer benefits on clinical research, allowing speedy procedures for development, and there is a big growth potential of treatment for uncommon illnesses. The group is expected to face limited growth of its current bio businesses, contract manufacturing of drugs and biosimilar development and production, amid intensifying global competition... Full

Sam Chun Dang Pharm Inks Deal to Supply Eylea Biosimilar to 9 European Countries

(3/25, Lee Han-soo, Korea Biomedical Review) ...Sam Chun Dang Pharm said it secured an exclusive contract to supply its Eylea biosimilar to nine Western European countries, including the U.K., Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland, and Finland. Under the accord, Sam Chung Dang will receive 55 percent of the total sales from its partner. However, the company did not disclose the name of the partner, citing contractual reasons... Full

Meitheal Prepares For Major US Injectables Push

(3/25, David Wallace, Generics Bulletin) ...Meitheal Pharmaceuticals says a recent deal to expand its generic injectables portfolio will allow the firm to launch "up to 20 new products" this year in the US "to support a sustainable US drug supply." The firm intends to build on its recent launch of multiple presentations of bupivacaine hydrochloride injection to supply further products that have recently experienced shortages... Global Sub. Full

Lupin to Sell Trade Generics Business in India to Lupin Life Sciences for 100-120 Crore

(3/22, Jomy Jos Pullokaran, CNBC TV18) ...Pharma major Lupin Ltd on Friday (March 22) said the company is planning to carve out its trade generics business in India and transfer it to Lupin Life Sciences Ltd, a wholly-owned subsidiary of the company, for 100-120 crore...The business transfer agreement between Lupin and LLSL is expected to be finalised in Q1 of FY25... Full

Mark Cuban Has Compelling Words About Ozempic and Cost Plus Drugs

(3/22, Jeffrey Quiggle, TheStreet) ...Asked by TheStreet through email about his company's plans for weight-loss drugs such as Ozempic, Cuban explained his thoughts. "Our mission is to sell any FDA approved drug. Right now the manufacturer won't sell through us," Cuban told TheStreet..."Novo Nordisk continuously explores innovative ways to make our products available and accessible to more patients," wrote Allison Schneider, Novo Nordisk's director of media relations and issues management. "New additions to our distribution channels are always fully and responsibly explored, including evaluation of critical factors such as compliant cold-chain medicine delivery requirements (i.e., for medicines that require refrigeration) and more."... Full

The Role of the Pharmacist in Long-Acting Injectable Therapies for Schizophrenia and Bipolar Disorder

(3/24, Alana Hippensteele, Pharmacy Times) ...Long-acting injectables (LAIs) are an essential component of care for patients with schizophrenia and bipolar disorder, explained Megan J Ehret, PharmD, MS, BCPP, professor and co-director, Mental Health Program, University of Maryland School of Pharmacy, during a presentation at the American Pharmacists Association (APhA) 2024 Annual Meeting & Exposition in Orlando, Florida...Second generation antipsychotic LAIs currently available include...risperidone (Uzedy; Teva Pharmaceutical). The most common feature of these second generation LAIs is they antagonize the 5-HT2 and DA receptors... Full

Antitrust Lawsuits On Increasing Biosimilar Accessibility

(3/24, Cameron Santoro, The Center For Biosimilars) ...In an interview with The Center for Biosimilars®, intellectual property lawyer, Ha Kung Wong, JD, partnered with Venable LLP, discusses the impact of lawsuits on biosimilar accessibility. He mentions a recent lawsuit by Johnson & Johnson, aiming to delay biosimilar competition and other relevant legal cases...While these lawsuits might have discouraged the use of exclusionary contracts, their effectiveness remains debatable due to relatively small settlements compared to the drugs' revenue... Full

The Aftermath of COVID-19 Has Sparked a Widespread Mental Health Crisis Causing An Uptick in Prescription Medications and Treatment

(3/22, Sara E. Teller, Legal Reader) ...A recent analysis of Medicaid data sheds light on the escalating demand for mental health treatment and medication...This surge highlights the profound impact of the pandemic on mental well-being, as individuals struggled with heightened levels of anxiety, depression, and emotional distress. The analysis further highlights a significant rise in prescriptions for psychiatric drugs, including antidepressants and ADHD medications. The relentless toll of the pandemic, coupled with heightened awareness of mental health issues, has propelled a growing number of individuals to seek pharmaceutical interventions to alleviate their symptoms and regain stability... Full

Senators Push HHS On ‘Inadequate' Response to Change Healthcare Cyberattack

(3/22, Lia DeGroot, Endpoints News) ...Lawmakers on the Senate HELP committee are putting pressure on HHS to amp up its response to the recent cyberattack on Change Healthcare, the fallout from which has widely disrupted payments across the US healthcare system...The letter underscores that Change Healthcare first reported the cyberattack on Feb. 21, though HHS didn't respond publicly until March 5. The senators gave Becerra until April 3 to reply to a list of almost a dozen questions, including whether HHS has identified any breach of federal systems as a result of the cyberattack and what the agency is doing to ensure that providers have adequate flexibilities to submit claims for reimbursement to private payers... Full

U.S.-China Decoupling Poses Supply-Chain Risks for Drug Companies

(3/23, David Wainer, The Wall Street Journal) ...Targeting Chinese threats to supply-chain resilience has become a bipartisan effort in Washington these days, but the approach to each industry has been notably different...Driving business away from China would probably drive up drug-development costs for biotech companies. And punishing Chinese biotech companies could also lead China to retaliate against similar businesses providing services there...Protecting the drug supply chain is a real national-security concern, just not one with simple solutions... Sub. Req'd

SCOTUS' Abortion Pill Mifepristone Case is Really About The FDA

(3/25, Sarah Owermohle, STAT) ...The case has obvious ramifications for reproductive rights across the country, as 21 states have instituted some form of abortion ban, leading to spikes in out-of-state travel and, advocates say, dependence on telemedicine and mifepristone prescriptions for the procedure...But pharmaceutical companies and former health officials have also mounted the argument that reversing FDA's decisions would upend and politicize otherwise routine regulatory review processes. And it could not come at a worse time for public trust in medicine... Full

Philadelphia DA Larry Krasner Sues Insulin Makers, Pharmacy Benefit Managers, Over High Prices

(3/25, Sarah Gantz, The Philadelphia Inquirer) ...Philadelphia District Attorney Larry Krasner is suing some of the largest pharmaceutical countries and pharmacy benefit managers in the country over the cost of insulin. He contends that the leading insulin manufacturers — Eli Lily, Novo Nordisk, and Sanofi-Aventis — colluded with top pharmacy benefit managers, including CVS Caremark, Express Scripts, and OptumRx to keep insulin prices artificially high and price gouge consumers. In a lawsuit filed without fanfare in October, Krasner said he wants the companies to end unfair pricing and pay unspecified monetary damages... Full

Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

(3/25, Faraz Siddiqui, FDA Law Blog) ...As drug manufacturers battle the Health Resources and Services Administration in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state... Full

EMA Says Yes To 12 New Drugs Including Pfizer/AbbVie's Antibiotic Combo

(3/22, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency has recommended in favor of pan-EU marketing authorization for a new batch of drugs, including Pfizer/AbbVie's antibiotic for infections caused by multidrug-resistant bacteria, Emblaveo (aztreonam-avibactam). Awiqli (insulin icodec), Novo Nordisk's once-weekly treatment for diabetes, and Fabhalta (iptacopan), Novartis's oral treatment for paroxysmal nocturnal hemoglobinuria, also received the thumbs up from the EMA, as did Outlook Therapeutics's Lytenava (bevacizumab) for wet age-related macular degeneration... Sub. Req'd

Leqembi's EU Approval Process Delayed Over Advisory Group COI Considerations

(3/25, Lisa Takagi, Pink Sheet) ...The European approval process for Eisai Co., Ltd./Biogen, Inc.'s Alzheimer's disease drug Leqembi (lecanemab) has been delayed due to the unprecedented impact from a recent court ruling related to the European Medicines Agency's conflict of interest policy...The decision was not related to Eisai or the drug, but rather based on the EMA's recent finding that a member of SAG-N had a potential conflict of interest, the Japanese firm told the Pink Sheet... Sub. Req'd

Leqembi Authorization in EU is Delayed for Procedural Issues

(3/22, Katherine Lewin, Endpoints News) ...The EU review of Eisai's Alzheimer's drug lecanemab was delayed this week because of a procedural issue at the European Medicines Agency...Eisai reported disappointing fiscal third quarter sales for the Biogen-partnered drug. It has previously projected the drug could hit $7 billion in global sales by 2030, but in the final quarter of 2023 only sold $7 million. Eisai has shared a goal of getting 10,000 patients on the drug by the end of 2024, but now expects it may take one to three months longer to reach that... Full

Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee

(3/22, Francesca Bruce, Pink Sheet) ...A new bill going through the legislative process in Germany aims to make the country a more attractive location for clinical research by streamlining the system governing ethics committees and reorganizing the competencies of Germany's two regulators, BfArM and the Paul-Ehrlich-Institute. The bill could reduce bureaucracy and bring more simplicity to the processes for authorizing clinical studies, said Adem Koyuncu, a Frankfurt-based partner at the law firm Covington & Burling. However, there is some concern that the regulator reorganization will lead to confusion and a "loss of energy," he told the Pink Sheet... Sub. Req'd

Spurious Drugs: Maiden Pharma Blacklisted, All Contracts Cancelled

(3/23, Bhartesh Singh Thakur, The Tribune India) ...Haryana has blacklisted Maiden Pharmaceuticals Ltd, based at Sonepat, for three years, thereby debarring the firm from participating in state tenders. All rate contracts issued to the firm have also been cancelled...Though the HMSCL policy is to blacklist a firm only if more than three products fail quality tests, it decided to act in the case of Maiden Pharma in view of public safety and after receiving the CM's approval... Full

Health Ministry to Publish Up-to-Date Drug Supply Data from April

(3/25, The Japan Times) ...The health ministry is gearing up to address persistent drug shortages in the pharmaceutical industry by publishing up-to-date information on its official website from April regarding supply or any suspension of prescription drug shipments. The move aims to equip medical institutions and pharmacies with timely information on drug shortages, enabling pharmacies to take proactive measures, such as preparing alternative medications... Full

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