Thursday, September 5, 2024

Teva Provides Update On Olanzapine LAI Trial

(9/5, The Fly) ...Teva Pharmaceuticals announced during the 22nd Annual Global Healthcare Conference held yesterday that confidence interval 99% of the targeted injections for submission have been performed. Teva also confirmed that the full submission safety results are expected to be available in the second half... Full

Medincell's Partner Teva Provides New Update on Pivotal Clinical Phase 3 of Investigational Olanzapine Long-Acting Injectable (LAI)

(9/5, Medincell) ...Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced during the 22nd Annual Global Healthcare Conference held yesterday that c.99% of the targeted injections for submission have been performed as of today. Teva also confirmed that the full submission safety results are expected to be available in H2 24...It has the potential to be the first long-acting Olanzapine with a favorable safety profile as other LAIs of Olanzapine have been associated with a FDA black box warning for PDSS that limits their use... Full

DEA Raises Production Limits On Takeda's ADHD Drug Vyvanse and Generics as Shortages Continue

(9/4, Kevin Dunleavy, Fierce Pharma) ...Less than four months after Teva's Adderall was erased from the FDA shortage list, supply problems with another attention-deficit/hyperactivity disorder treatment, Takeda's Vyvanse and its generic versions, are such that the U.S. Drug Enforcement Administration has increased production quotas on the drug by 24%... Full

Lupin Marks Its Second Canadian Biosimilar Approval With Pegfilgrastim

(9/4, Urte Fultinaviciute, Generics Bulletin) ...Health Canada has given its nod to Lupin's second biosimilar. This time, the agency approved a pegfilgrastim rival to Amgen's Neulasta. Marketed under the name Armlupeg, the biosimilar was approved to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs... Global Sub. Full

Henlius Reports Near 10% Revenue Growth In First Half Of 2024

(9/4, Adam Zamecnik, Generics Bulletin) ...Shanghai Henlius Biotech has reported a 9.8% growth in total revenue in the first half of the 2024 financial year compared to last year as the company edges closer to being fully acquired by its parent company Shanghai Fosun Pharmaceutical...At the same time, the company's net profit in the first half increased by RMB146.3m to RMB386.3m. According to Henlius' analysis, this is largely due to the commercialization of its core products and a constant sales expansion... Global Sub. Full

Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal

(9/4, Kevin Grogan, Pink Sheet) ...Ipsen SA appears to have reset the market for US Food and Drug Administration priority review vouchers after selling its voucher to an unnamed company for $158m..."The sale of the PRV generates further firepower for our ongoing medicine launches and external-innovation strategy, which has seen multiple additions to our portfolio at every stage of development in 2024," Chief Business Officer Philippe Lopes-Fernandes said... Sub. Req’d

Lilly, Pfizer Take Meds Straight To Consumers in Renewed DTC Push

(9/4, Annalee Armstrong, BioSpace) ...Big Pharma has finally gotten its arms around something advocates have wanted for a long time: direct-to-consumer sales. Eli Lilly and Pfizer are leading the way...The two programs connect patients to telehealth care and a third-party service for the delivery of medicine. "It does just make the full digital telehealth pharmacy experience online really seamless," Dedham Group Principal Manny Jurado told BioSpace. "It's like you're able to integrate everything into almost more or less a one-stop shop."... Full

China Detains AstraZeneca Staff in Data, Drug-Import Probes

(9/5, Bloomberg) ...Police in China have detained five current and former employees of British drugmaker AstraZeneca Plc for questioning about potential illegal activities, according to people familiar with the matter. The individuals being held are all Chinese citizens who marketed cancer drugs in AstraZeneca's oncology division, the people said, asking not to be identified discussing private information...One probe is related to the company's collection of patient data, and whether that infringed China's data-privacy laws, according to the people... Full

AstraZeneca, Samsung Biologics Settle Soliris Biosimilar Lawsuit

(9/4, Christopher Yasiejko, Bloomberg Law) ...An AstraZeneca Plc unit settled a federal patent-infringement lawsuit with a Samsung Biologics Co. subsidiary after failing to block its biosimilar version of the $500,000-per-patient drug Soliris... Sub. Req’d

Walgreens Hit with Lawsuit Claiming Generic Cold Medicine Has Cancer-Causing Chemical

(9/4, Diana Jones, Reuters) ...Walgreens is facing a proposed class action lawsuit brought on Wednesday by customers who say they weren't warned that the pharmacy chain's generic version of cold medicine Mucinex contains a cancer-causing chemical... Full

Biosimilar of Xolair Shows Similarity in Reducing Asthma Exacerbations

(9/4, Ashley Gallagher, Pharmacy Times) ...Investigators found that P043 (Zerafil; CinnaGen), a biosimilar of omalizumab (Xolair; Genentech, Novartis), was equivalent to the reference product for the management of asthma by reducing exacerbations. Further, they found no significant differences in any other efficacy or safety outcomes in the 28-week studay (NCT05813470)... Full

Evernorth's Accredo to Make Stelara Biosimilar Available at $0 Out-of-Pocket

(9/5, Paige Minemyer, Fierce Healthcare) ...Evernorth's Accredo specialty pharmacy will offer biosimilars for the popular immunotherapy Stelara at $0 for eligible patients, the company announced Thursday. The interchangeable biosimilar will be produced by Evernorth's affiliate private label distributor, Quallent Pharmaceuticals, and will be available in early 2025, according to the announcement. The $0 out-of-pocket cost will be part of Quallent's copay assistance program, and Cigna expects that it will save patients about $4,000 per year on average... Full

The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings

(9/4, Skylar Jeremias, The Center For Biosimilars) ...Although biosimilar competition has led to significant price reductions across all product families, originator products with sole preferred coverage strategies maintained market share, suggesting that biosimilar uptake alone may not fully capture the competitive dynamics and cost-saving potential of the biosimilar market, according to a recent study... Full

Biosimilar and Innovator Co-Promotions: The Changing Tide of Biosimilar Strategy

(9/4, Aanam Mahmood and Ruthy Glass, PhD., IQVIA) ...Early reports showed Hyrimoz share rapidly increased after Caremark's announced formulary change, particularly within new prescriptions, instigating many conversations around the changing tide among pharmacy biosimilars in the U.S. Though these events are still recent, much can be learned from the early months of the evolving adalimumab landscape... Full

Humira Biosimilar Price War Update: Should We Be Glad that CVS Health and Express Scripts Are Using Private Label Products to Pop the Gross-to-Net Bubble?

(9/4, Adam J. Fein, Ph.D., Drug Channels) ...Below, we review the 18 products competing with Humira—including four private-label products marketed by in-house subsidiaries owned by CVS Health and Cigna. As you will see below, CVS Health's formulary actions led to rapid uptake of a low-list-price biosimilar. Express Scripts' 2025 strategy will also drive biosimilar adoption, although its pricing strategy is more problematic...MedImpact's formulary includes Humira, the unbranded adalimumab-adaz from Sandoz, and Teva's low-list-price Simlandi... Full

FTC Applauds FDA Draft Proposal To Speed Interchangeable Status For Biosimilars

(9/4, Gabrielle Wanneh, InsideHealthPolicy) ...The Federal Trade Commission is applauding draft FDA guidance released earlier this summer that calls for removing a longstanding agency policy requiring switching studies to demonstrate the interchangeability of biosimilars -- a move that could allow biosimilars to be switched with brands without completing the more stringent requirements the agency had earlier required for formal interchangeability designations... Sub. Req’d

U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars

(9/4, Alliance for Safe Biologic Medicines) ...U.S. physicians overwhelmingly support maintaining the Food and Drug Administration's current data standards for interchangeable biosimilars and oppose treating all biosimilars as interchangeable with the originator biologic medicines they copy, according to a recent survey of 270 U.S. physicians...88% of physicians agree that switching studies increase their confidence in the safety of switching patients from an originator medicine to an interchangeable biosimilar... Full

Biosimilars Take Bigger Role in Drug Price Debate

(9/4, Victoria Knight, Axios Pro) ...The push in Congress to address high drug prices increasingly features calls for expanded access to biosimilars...There's been action on a variety of bills this Congress aimed at making it easier to swap biosimilars for brand-name biologics... Sub. Req’d

Drug Pricing Overhaul Sparks Tension with Industry

(9/5, Ben Hargreaves, Pharma Phorum) ...Up until recently, political rhetoric targeting the pharma industry had been largely all bark and no bite. Ben Hargreaves finds that the Biden-Harris Administration has finally shown its teeth and major players in the industry are facing the prospect of losing drug revenue in the coming years... Full

Study: Medicare Coverage Of Novo Nordisk's Semaglutide For CVD Could Reach $145 Billion Annually

(9/4, Maaisha Osman, InsideHealthPolicy) ...As Congress debates expanding Medicare coverage to include a new class of weight-loss drugs, a recent study reveals that CMS' decision to already cover Novo Nordisk's blockbuster drug Wegovy under Medicare Part D for cardiovascular risk reduction in specific patients could cost the U.S. government up to $145 billion annually... Sub. Req’d

Glenmark to Pay USD 25 Mn as Part of Settlement with US Authorities

(9/5, Press Trust Of India) ...Glenmark Pharmaceuticals has agreed to pay USD 25 million as part of a settlement with the US Department of Justice regarding a case related to the pricing of a generic drug. Glenmark Pharmaceuticals Inc, USA, a wholly-owned subsidiary of the Mumbai-based drug maker, has agreed to pay the amount in six installments over five years, with interest on the settlement amount at a rate of 4.25 per cent per annum from May 28, 2024, the company said in a late night regulatory filing on Wednesday... Full

CSRxP Launches Seven-Figure Advertising Campaign to Hold Big Pharma Accountable for Egregious Drug Prices, Anti-Competitive Tactics and False Rhetoric

(9/4, The Campaign for Sustainable Rx Pricing) ...The Campaign for Sustainable Rx Pricing (CSRxP) launched a new seven-figure advertising campaign Wednesday. The campaign will highlight Big Pharma's egregious pricing practices and rampant abuse of the patent system that are the root cause of high prescription drug prices in America — and encourage lawmakers to pass bipartisan, market-based solutions to hold Big Pharma accountable in order to lower prices for patients... Full

CSRxP Launches New Campaign To Expose Drug Companies' Patent Manipulation

(9/4, Maaisha Osman, InsideHealthPolicy) ...Some experts argue that reforming patent laws would be a more effective solution for lowering drug costs than relying on Medicare negotiations...Lawson Mansell, a health policy analyst at Niskanen Center, told IHP, "Competition from generics and biosimilars are much more impactful way to lower drug costs ... you'll see a lot more savings from that sort of competition than you will from sort of the price-setting in the drug negotiation program."... Sub. Req’d

ICYMI: Senate Judiciary Committee Got It Right On Big Pharma's Patent Abuse As Root Cause Of High Rx Prices

(9/4, PCMA) ...The most effective way to lower drug prices is by cracking down on patent abuse by drug companies. Big Pharma continues to try to avoid culpability for high drug prices by pushing for policies targeting pharmacy benefits. Misguided policies targeting PBMs would jeopardize employer-sponsored prescription drug coverage and raise costs for everyone. Congress must reject Big Pharma-backed policies targeting Americans' pharmacy benefits and start to hold Big Pharma accountable... Full

Advocates Rush to Congress, White House to Extend Telehealth Prescribing for Two Years, After DEA's Plans Leaked

(9/4, Emma Beavins, Fierce Healthcare) ...The agency's rule, which is under review at the White House, is a far cry from the unfettered access telehealth advocates were hoping for, a former DEA official told them, according to an anonymous source who spoke to Fierce Healthcare...The unpublished rule reportedly restricts schedule II substances, like Adderall, from being prescribed at all unless an in-person visit has occurred. Schedule III-V substances can be prescribed based solely on a telehealth visit... Full

FDA Revises Final Guidance On Nitrosamine Impurities

(9/4, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration on Wednesday issued a revised final guidance to assist manufacturers in detecting and controlling nitrosamine impurities in pharmaceutical products...These changes include the addition of a new section on nitrosamine drug substance-related impurities, as these novel nitrosamines were not addressed in the earlier guidance, as well as expanded information on FDA's August 2023 guidance establishing acceptable intake limits for NDSRIs... Full

Landmark Guidance For Curbing Antibiotic Pollution Considers Impact On Pricing & Supply

(9/4, Neena Brismohun, Pink Sheet) ...The World Health Organization says its new 98-page guidance dealing with wastewater and solid waste management for antibiotic manufacturing is a first of its kind and addresses an important but neglected issue...It builds on industry-led initiatives to improve practices on this front, "but recognizes the need to independently develop guidance to be used for regulatory activity such as inspections," the organization said... Sub. Req’d

New WHO Guidance to Support Manufacturers to Reduce AMR Risk

(9/4, Catherine Eckford, European Pharmaceutical Review) ...The WHO's new report follows launch of the BSI Minimized Risk of Antimicrobial Resistance certification for antibiotic manufacturing in June 2023. By certifying, companies (such as Sandoz and Teva), can help to "mitigate the risk of the development and spread of AMR in the environment," shared Courtney Soulsby, Global Director of Healthcare Sustainability at BSI and Steve Brooks, Manufacturing Working Group Chair at the AMR Industry Alliance... Full

Europe Reliant On Chinese Drugs After Local Products Priced Out

(9/5, Jen Kastner, NIKKEI Asia) ...Paris-listed pharmaceutical manufacturer Euroapi is phasing out production of 13 medical ingredients, leaving Europe dependent on cheaper Chinese imports for its most commonly used drugs such as paracetamol. As part of the pullback, Euroapi, formerly a unit of industry major Sanofi, will sell its manufacturing plants in the Italian city of Brindisi and the U.K. town of Haverhill by the end of 2027. A spokesperson told Nikkei Asia the moves were necessary because of "decreasing or stagnant markets and increasing competition from Asian players."... Full

Swedish Medicines Agency Wants State-Run Pharma Production to Prevent Shortages

(9/4, Monica Kleja, Euractiv) ...The Swedish Medical Products Agency is pushing for the creation of a state-run pharmaceutical production company to deal with shortages of critical medicines. If the proposed law revisions pass, in future, a state-owned firm and private manufacturers could receive state orders to produce medicines to be reserved on standby. Sweden needs to have a stable contingency function for the national supply of drugs, the nation's Medical Products Agency says in a recent article, outlining its positions on how to deal with medicine shortages... Full

Clarity Needed On EU Health Data Sharing Rules For Trial Sponsors

(9/4, Eliza Slawther, Pink Sheet) ...Clinical trial sponsors could find themselves in hot water with EU regulators if they share data from non-EU patients under the upcoming European Health Data Space, warns a life sciences lawyer from Sidley Austin. Enhanced health data sharing is a key aim of the European Health Data Space, a new regulation that aims to make anonymized health data from EU citizens available to certain entities for secondary purposes, such as in medical research... Sub. Req’d

The AI Act: Help or Hindrance to the Pharma Industry?

(9/4, The Pharma Letter) ...With the right approach, the EU AI Act can serve as a catalyst, driving pharma to adopt AI in a way that balances innovation, patient safety and fundamental rights. By embracing this challenge, the industry can pave the way for a future where cutting-edge technologies and rigorous compliance go hand in hand, ushering in a new era of breakthroughs in healthcare... Sub. Req’d

Cluster Wars: Korea's Challenges In Shaping a Boston Style Biopharma Hub

(9/4, Jung Won Shin, Pink Sheet) ...South Korea has yet to come up with detailed plans for a major national biopharma cluster, but is considering a virtual approach to connect existing industry hubs nationwide. At a recent policy forum, experts discussed related issues including governance and insufficient investment, as well as the need to attract foreign firms and capital to compete with rival clusters in Asia... Sub. Req’d

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