Thursday, June 20, 2024

Teva Pulls Out Its Digital Inhaler GoResp From UK Market

(6/20, Urte Fultinaviciute, Generics Bulletin) ...Commercial reasons led Teva to withdraw its innovative GoResp Digihaler from the UK market, asking healthcare professionals to stop supplying the inhaler immediately..."The decision to discontinue the products is business-related and is grounded in Teva's company strategy. Teva continues to maintain a portfolio of respiratory products that includes generic and branded inhalers," confirmed Teva's spokesperson to Generics Bulletin... Global Sub. Full

Formycon's Keytruda Biosimilar Enters Phase I Clinical Trial

(6/19, Urte Fultinaviciute, Generics Bulletin) ...One of the self-proclaimed frontrunners in the pembrolizumab biosimilar race, Formycon, has initiated the first clinical trial for its FYB206 candidate. Meanwhile, Celltrion submits a Phase III trial application to the FDA, expecting "limitless" sales potential for its CT-P51 version...Formycon will have to wait a few years before it can reach the market. The firm expects to launch the product at the earliest in 2029 in the US and a year later in Europe after Keytruda loses its market exclusivity in both regions... Global Sub. Full

Unichem Signs A Near Two-Decade Truce On Sleeping Disorder Drug Sunosi

(6/19, Dean Rudge, Generics Bulletin) ...Unichem has bowed to Axsome Therapeutics' IP portfolio and strategy, signing a settlement agreement that will keep the Indian firm's US generic version of Sunosi from the market until the beginning of the 2040s..."Similar patent litigation brought by Axsome against other parties remains pending," the originator confirmed, following its settlement deal with Unichem. Central nervous system specialist Axsome markets another drug, Auvelity (dextromethorphan/bupropion) for the treatment of adults with major depressive disorder. In March and December last year, the firm sued Teva for patent infringement under two separate actions in a New Jersey district court. Both actions are currently pending... Global Sub. Full

India's Biocon Seeks Partner to Test Generic Wegovy, Ozempic in China

(6/20, Andrew Silver, Reuters) ...Biocon, which aims to eventually launch generic versions of the injectible drugs globally, wants to find a Chinese partner for clinical trials on 500-plus patients so they can be sold in the world's second-biggest economy, said Amit Kaptain, Biocon's head of commercial active pharmaceutical ingredients business. "We will find it challenging to do it by ourselves because it's at least about a $12 to $15 million investment," Kaptain said, referring to a clinical trial required in China... Full

Celltrion Secures Supply Contracts for 3 Biosimilars in France

(6/20, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it has successfully won bids to supply three key biopharmaceutical products—Remsima (ingredient: infliximab), Herzuma (ingredient: trastuzumab), and Vegzelma (ingredient: bevacizumab)—to Union des Hôpitaux pour les Achats (UniHA), France's largest pharmaceutical procurement group...As a result of this bid, Celltrion will be the exclusive supplier of these three products until June 2027... Full

Adalvo Secures First EU Approval For Victoza Rival

(6/19, Adam Zamecnik, Generics Bulletin) ...Adalvo has snatched up the first ever EU approval of a rival to Novo Nordisk's GLP-1 agonist Victoza (liraglutide), getting ahead of other companies in a key international market. Secured through a decentralized procedure, the drug serves as an equivalent to the type 2 diabetes treatment Victoza, rather than to Novo Nordisk's weight-loss product Saxenda. Adalvo cited a global market for the product "exceeding $4.8bn in 2023" according to IQVIA data... Global Sub. Full

Sun Pharma's Dadra Unit Gets USFDA Warning Letter

(6/20, Hormaz Fatakia, CNBC TV 18) ...India's largest drugmaker, Sun Pharmaceuticals Ltd., informed the exchanges on Wednesday that it has received a warning letter from the United States Food & Drug Administration for its Dadra facility..."We are concerned about the negative outcomes in the audit and I think its our job to find a way to ensure that we come out of whatever the learnings that we have so that we perform better in subsequent audits," Sun Pharma Chairman and Managing Director Dilip Shanghvi had said during its recent earnings call with analysts... Full

Looking Ahead to Cardinal Health's Biosimilar Pipeline

(6/19, Nicholas Saraceno, Pharmaceutical Commerce) ...In an interview with Pharma Commerce Editor Nicholas Saraceno, Fran Gregory, PharmD, Vice President of Emerging Therapies, Cardinal Health, discusses what to expect from Cardinal Health's biosimilars pipeline... Full

Part 2: Unlocking the Potential of Biosimilars to Improve Health Equity

(6/19, Cameron Santoro, The Center For Biosimilars) ...Biosimilars hold immense potential for increasing patient access to life-saving medications at lower costs, especially for underserved communities, but their path to widespread adoption is riddled with obstacles. While part 1 of this series addressed the issue of medical mistrust in underserved communities, part 2 dives deeper into the health care system itself, revealing financial hurdles that limit biosimilar access and ultimately hinder health equity... Full

Express Scripts by Evernorth Members Paid Less for Prescriptions in 2023 Despite Drug Price Increases

(6/20, Express Scripts) ...On average, members with employer-sponsored drug coverage paid $15.10 out-of-pocket for a 30-day prescription in 2023, a decrease of about 1% compared to 2022. While drug manufacturers raised prices for 60% of branded drugs in 2023, data confirm that Express Scripts lowered out of pocket costs for these members as a result of its negotiations with pharmaceutical manufacturers and innovative solutions, even as consumer prices for goods and services increased in the United States from 2022 to 2023... Full

Politicians Can Aid Patients By Protecting Patents

(6/19, David Williams, RealClearMarkets) ...Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) have urged government agencies to invalidate patents, allowing rivals to profit off drugs they did not create. And now, the Biden administration wants to (mis)use the Bayh-Dole Act to "march-in" and seize the IP of drug makers. Policymakers can protect patients by rejecting these anti-IP efforts and reaffirming patent rights. Innovation suffers when these researchers are stripped of their patents and cannot continue to recoup their costs... Full

Video: Congressional Perspectives: Evolution of PBMs

(6/19, Richard Payerchin, Medical Economics) ...Rep. Buddy Carter (R-Georgia), a career pharmacist, discusses his experiences with pharmacy benefit managers, drug discounts that are not helping patients, and vertical integration in health care... Full

Video: Congressional Perspectives: PBM Reforms

(6/19, Richard Payerchin, Medical Economics) ...Rep. Buddy Carter (R-Georgia) discusses the Protecting Patients from PBM Abuses Act, which aims to lower prescription drug prices by regulating pharmacy benefit managers (PBMs)... Full

Guest Column: How to Address America's Historic Drug Shortage Crisis

(6/19, Nick Iacovella, The Mercury) ...Much of America's current dependence on drug imports has been driven by the Indian government's massive subsidies for its generic pharmaceutical industry. It's a major factor in the offshoring of domestic production, leaving the U.S. dangerously reliant on Indian drug factories that frequently violate FDA regulations. The FDA's failure to adequately inspect and regulate many of these overseas facilities has also exacerbated the drug shortage crisis... Full

Business Leaders Push Back On Rising Health Plan Costs

(6/19, Christian M. Wade, The Salem News) ...The state Division of Insurance is reviewing proposals from large commercial insurers to increase premium rates by an average of 8.4% next year for merged group health plans offered to businesses with 50 or fewer employees. The insurance rate hikes, if approved by regulators, would far exceed the 3.6% benchmark for health care costs set by the Massachusetts Health Policy Commission, an agency that tracks health care spending. But business leaders say the higher rates would add to mounting financial pressure on private employers that already includes rising labor and energy costs, as well as a paid family and sick leave law... Sub. Req'd

Curiouser and Curiouser! Late-Cycle Amendments Under GDUFA III Part 2

(6/19, Jennifer Leaming, Lachman Consultants) ...Since the introduction of the LCA in October 2023, the use of LCAs and their effect on Abbreviated New Drug Application (ANDA) goal dates has been inconsistent, at best, and, at worst, a frustrating process of attempting to guess the approval date... Full

Europe Must Not Squander Potential Of Reformulation

(6/20, David Wallace, Generics Bulletin) ...At a panel on value added medicines at Medicines for Europe's 30th annual conference in Dublin last week, Pharmanovia CEO and value added medicines sector chair James Burt set out the case for expanding the scope of current EU pharma legislation proposals to reward reformulation alongside repurposing... Global Sub. Full

‘We Tried It, It Does Not Work' – The Problems With The EU's SPC Manufacturing Waiver

(6/19, David Wallace, Generics Bulletin) ...While the European SPC manufacturing waiver was once seen as a triumph for the region's off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe's legal affairs conference in Dublin last week heard the latest...Voicing industry frustrations during the Q&A section of the panel, Corinna Sundermann – senior vice president of IP at Fresenius Kabi – highlighted from the conference floor the urgency of making the SPC manufacturing waiver workable for developers, especially given the need to convince firms to retain generic and biosimilar manufacturing within Europe... Global Sub. Full

EMA Explains How To Draw Up Shortage Prevention & Mitigation Plans

(6/19, Ian Schofield, Pink Sheet) ...The shortage prevention plan (SPP) should be part of companies' pharmaceutical quality system and will be open to inspection, while shortage mitigation plans (SMPs) should be proportionate to the level of risk for each medicine in line with ICH guideline Q9, the EMA says...The agency says that the implementation of such plans for each marketed product will help companies fulfil their "obligations to ensure, within the limits of their responsibilities, an adequate and continuous supply to the market."... Sub. Req'd

Indian Pharmaceutical Industry at a Crossroads

(6/19, Vladislav Vorotnikov, Contract Pharma) ..."The incidents regarding contaminated cough syrups in Gambia and Uzbekistan impacted the reputation of the Indian pharma industry," commented Nakul Pasricha, MD, CEO of Pharma Secure, a local GS1 solution provider. India's drug manufacturers meet around 20% of the global demand for drugs and 60% of vaccines. Its biggest success story has been in the export of generics. However, the deadly cough syrup scandal raised strong doubts over the safety of drugs of Indian origin... Full

Suspension of Humalog Supplies to Russia May Cause Problems

(6/19, The Pharma Letter) ...According to Swixx BioPharma, which is distributing the drug in Russia, the remaining stocks of the drug are now being sold out, and new supplies are not expected. That may pose a threat to the shortage of the drug in the Russian market. In accordance with the existing Russian legislation, drugmakers must warn the Russian drug regulator Roszdravnadzor about the cessation of supplies a year before the planned date... Sub. Req'd

Russian Drugmakers Aim to Focus On Design of Original Drugs

(6/18, The Pharma Letter) ...According to recent statements by Yuri Zubov, head of the Russian Patent Service (Rospatent), the current balance in the number of patent applications in the Russian pharmaceutical market is gradually shifting in favor of Russian drugmakers. However, according to him, while global drugmakers mainly patent new active ingredients – the so-called primary patents - most of Russian companies are focused on secondary patents, improving already known formulas and technologies... Sub. Req'd

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