Wednesday, February 21, 2024

Teva CEO: It's a Long Way Back to Being 'Share of the Nation'

(2/20, Shiri-Habib-Valdhorn, Globes) ...Teva Pharmaceutical Industries Ltd. CEO Richard Francis believes that the Israeli drug-maker is entering an era of growth, is bullish about its ability to achieve good value for the sale of its active pharmaceutical ingredients division and sees a change in market sentiment towards its stock. Frances was speaking today at a press conference at the company's headquarters in Tel Aviv. Francis, who became Teva CEO in January 2023, believes that the company's market cap will rise with the market appreciating Teva's performance and the value it is creating but he concedes it will be a journey of many years... Full

Teva CEO Says Production and Distribution in Israel Remain Largely Unaffected by War

(2/20, The Times of Israel) ...Israel's Teva Pharmaceuticals Industries Ltd. said Tuesday that manufacturing has not been affected despite the country being more than four months into a war with the Hamas terror group, and many of the company's employees having been absent from work. "We were not prepared for something of this incident happening, [but] at the same time we had plans in place to make sure that our manufacturing and our distribution could function," Teva CEO Richard Francis said at a press briefing in Tel Aviv... Full

Teva Presents Data Confirming Target Engagement o TEV-'574 at ECCO Meeting

(2/20, The Fly) ...Teva Pharmaceuticals announced positive safety, tolerability, and pharmacokinetic data for its anti-TL1A or TEV-'574 asset, a potentially best-in-class human IgG1 monoclonal antibody that targets the tumor necrosis factor,TNF-like ligand 1A, TL1A, and is designed to offer both anti-inflammatory and anti-fibrotic effects... Full

Teva Pharmaceuticals Announces Positive Data For Anti-TL1A Asset

(2/20, RTT News) ...Dr. Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva said, "We are currently investigating the efficacy and safety of anti-TL1A (TEV-'574) in IBD through the RELIEVE UCCD Phase 2 trial, which features an innovative and efficient basket study design allowing the inclusion of patients with either type of IBD"... Full

Teva and Sanofi Forge Ahead in IBD Treatment with Promising TEV-574 Drug Trials

(2/20, BNN) ...In a significant leap towards innovative treatment for inflammatory bowel diseases (IBD), Teva Pharmaceutical Industries Ltd., in collaboration with Sanofi, unveils groundbreaking safety and efficacy data for its investigational drug, TEV-574. This novel anti-TL1A agent shows promise in the battle against debilitating conditions such as ulcerative colitis (UC) and Crohn's disease (CD), marking a hopeful horizon for patients and the medical community alike... Full

New Data Supports Development of Teva and Sanofi's Anti-TL1A IBD Therapy

(2/20, Abigail Beaney, Clinical Trails Arena) ...Teva Pharmaceuticals and Sanofi have revealed new data that further bolsters their $1.5bn co-development deal of an anti-tumour necrosis factor-like ligand 1A (anti-TL1A) therapy...Teva will lead commercialisation of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialisation in North America, Japan, other parts of Asia and the rest of the world. Sanofi will be leading development of the Phase III program... Full

10 Drugs Now in Shortage

(2/20, Paige Twenter, Becker's Hospital Review) ...Fluvoxamine maleate extended release capsule: No solutions of the obsessive-compulsive disorder medication are available as Par Pharmaceuticals and Teva Pharmaceuticals report shortages. Teva said it expects supply to rebound in early March...Topotecan injection: There isn't enough supply for the usual ordering of five solutions from Accord, Fresenius Kabi, Pfizer and Teva Pharmaceuticals. Most drugmakers could not estimate a release date for the chemotherapy, and Pfizer predicts resupply in February... Full

Rick Gonzalez Defended AbbVie's Empire. The Next CEO Will Have to Build A New One Beyond Humira

(2/20, Andrew Dunn, Endpoints News) ...As AbbVie's CEO, Rick Gonzalez took Humira from a megablockbuster into something singular: a politics- and competition-defying product that became the best-selling drug of all time. In his final act, he has prepared AbbVie for life after its signature product. When Gonzalez retires as CEO in July, he'll hand the top spot to Robert Michael, AbbVie's president and chief operating officer, who will inherit a high-flying stock and two new major deals meant to set up AbbVie for the future... Full

Healthcare Group Fresenius Tops Q4 Profit Forecast, Shares Rise

(2/21, Tristan Veyet, Reuters) ...German healthcare firm Fresenius beat expectations with a 13% jump in fourth-quarter operating earnings on Wednesday after it exceeded its costs savings target for 2023. CEO Michael Sen, who took the helm a year ago, has been restructuring the group to cut costs and debt after it was hit by a decline in earnings at its former dialysis unit Fresenius Medical Care. The restructuring plan will bring Fresenius Kabi, a maker of generic hospital drugs, and Helios with its German and Spanish hospital chains to the forefront, while other parts of the business will be run as investments... Full

AION Labs, In Continued Partnership with BioMed X, Launches First 2024 Global Call for Applications: AI/ML Platform for Targeting RNA with Small Molecules

(2/20, AION Labs) ...AION Labs, the first-of-its-kind venture studio spearheading the adoption of AI technologies and computational science to solve therapeutic challenges, and German independent research institute BioMed X, announced today the launch of its latest global call for applications to identify computational biologists, biomedical scientists and inventors to form a new startup at AION Labs' headquarters in Rehovot, Israel...AION Labs is a first-of-its-kind venture studio comprising AstraZeneca, Merck, Pfizer, Teva, the Israel Biotech Fund, Amiti Ventures, and Amazon Web Services, powered by BioMed X with the support of the Israeli Government via the Israel Innovation Authority... Full

Chinese API Manufacturer Receives FDA Warning Letter After QC Employee Says Test Results 'In My Mind'

(2/20, Anna Brown, Endpoints News) ...The FDA last week sent a warning letter to China-based Sichuan Deebio Pharmaceutical after a September inspection led to data integrity and other quality control questions...The letter notes that QC personnel admitted to inspectors that they had not written down some test results and were relying on their memory, with one employee noting: "It's in my head." Another team leader delayed the inspection after providing "misleading" information, according to the warning letter... Full

‘Fourth Wave' of Opioid Epidemic Crashes Ashore, Propelled by Fentanyl and Meth

(2/21, Colleen DeGuzman, KFF Health News) ...The United States is knee-deep in what some experts call the opioid epidemic's "fourth wave," which is not only placing drug users at greater risk but is also complicating efforts to address the nation's drug problem. These waves, according to a report out today from Millennium Health, began with the crisis in prescription opioid use, followed by a significant jump in heroin use, then an increase in the use of synthetic opioids like fentanyl... Full

Updated: NJ Court Says Drugmakers Can Coordinate Their Legal Fight Against The Government's Price Negotiations

(2/20, Nicole DeFeudis, Endpoints News) ...Despite opposition from the federal government, the companies — Bristol Myers Squibb, Novartis, Novo Nordisk and J&J's Janssen — convinced a federal judge in New Jersey to hear all of the cases over four hours on March 7, given the "overlapping nature" of their claims. "Industry is throwing everything at the government hoping something will stick," professor Robin Feldman with the University of California Law told Endpoints News... Full

Coalition of AGs Wants Congressional Action to Reform Pharmacy Benefit Managers

(2/20, Rebecca Barnabi, Augusta Free Press) ...A bipartisan coalition of 39 attorneys general is encouraging Congress to take decisive action to reform the way pharmacy benefit managers conduct business and bring more transparency to their work... Full

AG Yost Leads Bipartisan Coalition Urging Congressional Action on PBM Reform

(2/20, Ohio Attorney General Dave Yost) ...Ohio Attorney General Dave Yost is leading a bipartisan coalition of 39 attorneys general in urging the U.S. Senate and House of Representatives to engage in meaningful debate and reform of the current practices of pharmacy benefit managers..."PBMs were originally intended to reduce the financial burden on Americans for prescription drugs, the reality today is starkly different," Yost said. "Instead of prioritizing the interests of patients, PBMs have shifted their focus to maximizing profits and marginalizing local pharmacies from the marketplace."... Full

‘You Step Up, You Bring Things Back To Market': CDER's Corrigan-Curay On Shortages

(2/20, Dean Rudge, Generics Bulletin) ...Taking to the stage on day one to provide the US Food and Drug Administration's viewpoint, the principal deputy director of the agency's Center for Drug Evaluation and Research, Jacqueline Corrigan-Curay, told attendees during her keynote address: "While everyone says that the shortages are in generics, it's also the generic drug industry that helps get us out of this."... Global Sub. Full

Trends Impacting the Long-Term Sustainability of Biosimilars

(2/20, Brian J. Miller, Melissa Andel, Nick Adolph, and Pramod John, AEI) ...Brian Miller recently took part in a panel hosted by the Association for Accessible Medicines to discuss the long term sustainability of biosimilars... Full

Medicare Plans Increase Patient Costs for Generic Medicines

(2/20, AAM) ..."Avalere's analysis demonstrates that Medicare Part D Plans continue to deny patients the full value of low-cost generic drugs," said David Gaugh, Interim President & CEO of AAM. "Fewer than half of all generic drugs are on generic formulary tiers. Plans are profiting from patients using generic drugs through higher copays and placement on brand formulary tiers, even as generic prices continue to fall. AAM encourages the Administration and Congress to ensure that Medicare beneficiaries receive the full value of low-cost generics."... Full

Surprise! Thanks to the IRA, Part D Plans Will Prefer High-List, High-Rebate Drugs

(2/21, Adam J. Fein, Ph.D, Drug Channels) ...Making manufacturers pay 20% of Part D catastrophic coverage costs probably seemed like a great idea when the IRA was rushed through Congress. Alas, this new structure will create an unintended formulary tension. The government and brand-name manufacturers will do better with low-list-price products, while plans will do better with high-list-price products. While I have changed my views on the outlook for the gross-to-net bubble in Part D, my assessment of the IRA remains the same: Legislate in haste, repent at leisure... Full

Copay Accumulator Lawsuit Comes To An End; Will Ruling Be Enforced?

(2/20, Angela Maas, Pink Sheet) ...The ball is now in the federal government's and state insurance commissioners' courts to enforce a district court ruling after HHS stops its appeal. As groups that brought the suit press CMS for guidance, they also eye complaints with DOL and class-action suits...Groups that brought the suit want government to issue guidance that manufacturer assistance must be counted toward patients' out-of-pocket responsibility except for brands with generics. Many states already have banned accumulator programs, but those that haven't could begin enforcement based on the third... Sub. Req'd

Part 1: Dr James Robinson On The Impact of 340B Programs and Drug Pricing Policies

(2/16, Maggie L. Shaw and Mary Caffrey, AJMC) ...In the January issue of The New England Journal of Medicine, James Robinson, PhD, MPH, and his fellow investigators published their findings from an analysis of how insurer drug expenditures on infused drugs influenced price markups at hospitals...In part 1 of our interview with Robinson-the Leonard D. Schaeffer Professor of Health Economics and the Director of the Berkeley Center for Health Technology, University of California, Berkeley-he expands on why he and his team took up this investigation, their reaction to the degree of markup they saw, and the contributing role of diversion... Full

Part 2: Dr James Robinson On The Impact of 340B Programs and Drug Pricing Policies

(2/20, Maggie L. Shaw and Mary Caffrey, AJMC) ...In part 2 of our interview with Robinson, he addresses the potential for exacerbated health care disparities in the aftermath of hospital price markups and how insurance plan design often disadvantages the patients who most need expensive infusion therapies but cannot afford them... Full

TX Judge's Dismissal Of IRA Case Put New Argument In Legal Fray

(2/20, Maaisha Osman, Gabrielle Wanneh, InsideHealthPolicy) ...A Texas district court's recent dismissal of a case against drug price negotiation in Medicare inserts a new argument into the ongoing legal fray against implementation of the Inflation Reduction Act's most notable drug price control: Providers who claim they will also suffer from the lower Part B prices CMS negotiates with drug makers will need to take their complaints directly to Medicare before going to court... Sub. Req'd

Rocky Rollout for Colorado's New EpiPen Price Cap As Some pharmacies Aren't Honoring $60 Limit

(2/20, Meg Wingerter, The Denver Post) ...Colorado's EpiPen cost cap has proven trickier to implement than the state's limits on insulin expenses, with some families struggling to find a pharmacy that will sell them the medical devices for the required $60. One of the law's main sponsors and some pharmacies point the finger at manufacturers, who they allege are refusing to follow the law as insulin makers did... Sub. Req'd

French Agency Sets Up New Body To Advise On Biosimilar Substitution

(2/20, Ian Schofield, Pink Sheet) ...The French regulatory agency, ANSM, has set up a new temporary scientific committee to advise it on the conditions under which pharmacists can substitute a biosimilar medicine in place of the originator drug. The move is part of ongoing government efforts to increase the number of biosimilar products and help curb drug spending... Sub. Req'd

French Proposals On Supply-Chain Security ‘Could Aggravate The Situation'

(2/20, David Wallace, Generics Bulletin) ...Proposals outlined in French draft legislation to address medicines shortages by strengthening supplier obligations to hold security stocks – while also bolstering potential sanctions – would be counter-productive and could "aggravate the situation", local generics industry association Gemme has warned...However, the proposals suggested by the French government to increase volumes – which Gemme said included strengthening security stock obligations in terms of both duration and sanctions – were "not the solution and could aggravate the situation," the association insisted... Global Sub. Full

Pooled Procurement Of Cancer Drugs In India: Is Pharma Game For More?

(2/20, Anju Ghangurde, Pink Sheet) ...India's National Cancer Grid pilots pooled procurement for 40 drugs including trastuzumab, imatinib, and pemetrexed, delivering median savings of over 80%. Experts discuss with Scrip the prospects of scaling the initiative and what it may mean for pharma's margins and go-to-market strategy... Sub. Req'd

India Pharma Giants and Global Big Pharma Join Forces for NMEs Commercialisation in India: GlobalData

(2/21, Express Pharma) ...The pharma landscape has undergone a significant shift towards collaboration and partnership between global big pharma and Indian pharma firms in recent years to drive innovation and expand market reach. This strategic alliance brings together the strengths and resources of both parties to accelerate commercialisation. The focus is on introducing new molecular entities into India, with both parties contributing to accelerate commercialisation and address evolving healthcare needs, finds GlobalData... Full

Sandoz Receives Health Canada Approval for Jubbonti®, First and Only Denosumab Biosimilar for Treatment of Osteoporosis

(2/20, Sandoz Canada) ...Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti® (denosumab subcutaneous injection, reference medicine: Prolia*). Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass...Jubbonti® is Sandoz Canada's seventh biosimilar, demonstrating the company's ongoing commitment to grow its portfolio to respond to patient needs. Sandoz Canada remains committed to delivering affordable and high-quality medicines, with a plan to introduce 24 new biosimilars... Full

Korea Faces Antibiotics Shortage As Drugmakers Halt Production

(2/21, Shim Woo-hyun, The Korea Herald) ...South Korea is confronting a deepening shortage of cephalosporins, a commonly prescribed class of antibiotics used to treat a range of bacterial infections, as pharmaceutical firms discontinue product lines due to unprofitability and growing raw materials costs...Among the main producers of cephalosporins, Hanmi Pharmaceutical and Azu Pharm have reportedly downsized their cephalosporin businesses, or have withdrawn from them, according to the source... Full

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