Friday, February 28, 2025

Teva Targets Schizophrenia to Build On Innovative Medicines Growth

(7/28, Meagan Parrish, PharmaVoice) ..."We know 80% of patients relapse from their medications," said Heather DeMyers, Teva's vice president of U.S. innovative medicines. "So when we look at different types of innovative solutions, we look at adherence."...DeMyers said Teva expects to evaluate full results from the study later this year and then assess if and when it will file for regulatory approval. Teva has yet to offer potential sales guidance for TEV-'749, but DeMyers noted that the oral version of olanzapine currently has about 20% market share in schizophrenia... Full

Teva Resumes Scarce Epilepsy Drug Finlepsin Retard Deliveries to Russia

(2/28, The Pharma Letter) ...An official spokesman of the company said in an interview with the Russian RBC business paper, in 2025, the company plans to import more than 1 million packages of the drug. Earlier some Russian media reported that parents of disabled children complain about the lack of this drug. As Teva explained, the suspended deliveries are due to the registered price of the drug, which did not cover production and logistics costs. "The resumption of deliveries became possible thanks to the mechanism for re-registering the maximum selling price, determined by Government Resolution No. 1771 of October 31, 2020," Teva said in a statement... Sub. Req’d

Mandatory Drug Stock Monitoring Empowers EU to Tackle Shortages

(2/27, Frankie Fattorini, Pharmaceutical Technology) ...Since February 2, this year, EU Member States are required to report critical medicine shortages to the MSSG via the European Shortages Monitoring Platform (ESMP). In turn, companies holding marketing authorisation for the concerned drugs must use the platform to inform the MSSG of their stocks. Thomas Thoma, Head Managed Access Programs at Teva Pharmaceuticals, outlined the potential impact of this platform at the Clinical Trial Supply Europe 2025 conference in Barcelona, which took place from 25–February 26... Full

Drugmaker Viatris Forecasts Weak 2025 Results After Import Curbs On India Plant

(2/27, Kamal Choudhury, Reuters) ...The company estimated on Thursday that the FDA action will reduce its 2025 total revenues by about $500 million, and adjusted core earnings by about $385 million. "Although in the past we and investors had assumed a minimal impact from Indore warning letter, today's guidance shows a significant negative impact," said Ashwani Verma, an analyst at brokerage UBS. Restrictions on a generic version of Bristol-Myers Squibb's blood cancer drug Revlimid was driving the hit, company executives said... Full

Fresenius Kabi Eyeing €1Bn Revenues From Biopharma Within Three Years

(2/27, Dean Rudge, Generics Bulletin) ...Fresenius Kabi expects its Biopharma unit to break through €1bn ($1.05bn) in sales in the coming years, being accretive to its newly improved EBIT margin band of 16%-18%, as the firm enters the ‘rejuvenate' chapter of its strategic roadmap marked by increased productivity and focused capital allocation, particularly on organic opportunities like in-licensing deals... Global Sub. Full

Amneal Reports Fourth Quarter and Full Year 2024 Financial Results

(2/28, Amneal Pharmaceuticals) ...Net revenue in the fourth quarter of 2024 was $731 million, an increase of 18% compared to $617 million in the fourth quarter of 2023. The increase was driven by Affordable Medicines(3) revenues growing 21% due to new product launches, biosimilars and multiple other complex products, AvKARE revenues growing 14% due to new product launches and Specialty revenues growing 16% driven by key branded products including CREXONT... Full

BeiGene Fleshes Out Global Ambition as Brukinsa Surpasses AstraZeneca's Calquence in Quarterly Sales

(2/27, Angus Liu, Fierce Pharma) ...In a heated competition among BTK inhibitor treatments for blood cancer, BeiGene's third-to-market Brukinsa has for the first time surpassed AstraZeneca's Calquence in quarterly sales. In the fourth quarter of last year, Brukinsa doubled its sales year over year, generating $828 million and edging out Calquence's $808 million during the same period... Full

Biocon Introduces Glucagon-Like Peptide-1, Liraglutide in United Kingdom

(2/28, Pharmabiz.com) ...Biocon Limited, an innovation-led global biopharmaceutical company, announced the launch of its GLP-1 peptide, Liraglutide, for diabetes and obesity, in the United Kingdom (UK). The drug-device combination will be marketed in the UK under the brand names Liraglutide Biocon for diabetes (gVictoza) and Biolide for chronic weight management (gSaxenda)... Full

Celltrion Expands Subcutaneous Pipeline as Herzuma SC Heads to Trial

(2/28, Kim Ji-hye, Korea Biomedical Review) ...Celltrion isn't slowing down. Just a day after announcing that Remsima (infliximab) had officially become Korea's first blockbuster biopharmaceutical, the company made another bold move by pushing further into the high-stakes market for subcutaneous (SC) biosimilars. On Thursday, the Ministry of Food and Drug Safety (MFDS) greenlit a phase 1 clinical trial for CT-P6 SC, Celltrion's SC version of Herzuma, its biosimilar to Roche's Herceptin (trastuzumab)... Full

UK Health Regulator Approves Moderna's RSV Vaccine for Adults Aged 60 and Older

(2/28, Sriparna Roy, Reuters) ...Britain's health regulator said on Friday it has approved Moderna's vaccine for respiratory syncytial virus in adults 60 years and older. The shot, branded as mRESVIA, is for the prevention of lower respiratory tract disease in older adults, the Medicines and Healthcare products Regulatory Agency (MHRA) said... Full

MSN Says Novartis Is Using Bad Patent to Stall Entresto Copies

(2/27, Christopher Yasiejko, Bloomberg Law) ...MSN Laboratories Pvt. Ltd. urged a federal judge to order Novartis AG to delist a revived Entresto patent from the FDA's Orange Book, arguing it doesn't cover the blockbuster heart drug's active ingredient and unlawfully blocks competition. The request came in MSN's brief supporting its motion for summary judgment to delist US Patent No. 8,101,659 from the US Food and Drug Administration's registry of approved drugs, both of which were filed Wednesday in the US District Court for the District of Delaware. MSN also filed a response brief opposing Novartis' motion to dismiss its delisting counterclaim... Sub. Req’d

Trump Plans Tariffs On Mexico and Canada for Tuesday, While Doubling Existing 10% Tariffs On China

(2/28, Josh Boak and Fabiola Sanchez, Associated Press) ...Trump indicated Wednesday that European countries would also face a 25% tariff as part of his reciprocal tariffs. He also wants separate tariffs on autos, computer chips and pharmaceutical drugs that would be levied in addition to the reciprocal tariffs... Full

Pharma Braces for Tariffs as Trump Threatens to Buck Trade Convention

(2/28, Mari Eccles, Politico) ...Generic drugmakers say that will lead to price increases for American patients, while analysts believe tariffs could also disrupt the delicate drug supply chain at a time when both the U.S. and the EU are trying to boost domestic medicine production after years of relying on cheaper Asian drugs. "Tariffs would affect both sides of the ocean," Elisabeth Stampa, board chair at Spanish generics and active pharmaceutical ingredients firm Medichem, told POLITICO, underlining that Europe, which is a major supplier of medicines and their ingredients to the U.S., would experience export disruptions... Full

HHS Lays Off Lawyers Executing the Medicare Drug Price Cuts

(2/27, Rachel Cohrs Zhang and John Tozzi, Bloomberg) ...However, firing attorneys leaves HHS fewer resources to continue implementing and defending the law, the person familiar said. Beyond the lawsuits, pharmaceutical companies have pressured the Trump administration to pause the drug price negotiations that began during the Biden administration... Sub. Req’d

Drug Policy Veteran at CMS to Depart On Friday

(2/28, Zachary Brennan, Endpoints News) ...John Coster, CMS' senior technical advisor for the Medicare drug rebate and negotiation group, told Endpoints News that he's leaving his agency on Friday. Coster, who has been at CMS for more than a decade, said he's retiring from the government, but may continue to work outside the agency. He told Endpoints that he doesn't "know what, if anything, I am doing next." He didn't respond to a further request for comment... Full

Trump Blog: CMS Reiterates Drug Negotiation Guidance Ahead of Participation Deadline

(2/28, Nicole DeFeudis, Endpoints News) ...The agency published an infographic explaining the drug selection process, including how current guidance allows it to group together different products with the same active molecule (like Ozempic and Wegovy). Some legal and policy experts say the announcement could signal how the Trump administration intends to carry out negotiations going forward. The second round of negotiations is scheduled to kick off next week...Selected drugmakers have until Friday to decide if they are participating in the second round of negotiations... Full

1 Big Thing: Fighting Inevitability

(2/28, Caitlin Owens, Axios) ...The more public sentiment sours on any one particular group, the easier it is for policymakers to make changes that group doesn't like. And in a world where patients are enraged with insurers for care denials or hospitals for their billing practices, those groups may not be as protected as they used to be if lawmakers decide to turn their attention to prices... Full

E&C Panel Holds First PBM Hearing Weeks Ahead Of CR Deadline

(2/27, Gabrielle Wanneh, Inside Health Policy) ...Like the several hearings held across both chambers throughout the last Congress to investigate PBM practices, the focus was on the impact PBMs have on patients, payers, pharmacies and drug market competition through spread pricing, vertical integration and other business practices -- but Democrats made frequent attempts to redirect and call out a recent budget resolution vote by House Republicans that could significantly slash Medicaid funding... Sub. Req’d

FTC Nominee Pledges PBM Crackdown, Backs Increased WH Control

(2/27, Maaisha Osman, Inside Health Policy) ...Federal Trade Commission nominee Mark Meador told senators he's committed to enforcing competition laws in the health care sector, vowing to crack down on pharmacy benefit managers and anti-competitive practices like product hopping if confirmed. Meador also said he believes the White House should control independent agencies during his Senate confirmation hearing, arguing such control enhances democratic accountability... Sub. Req’d

House Hearing on PBMs a Tale of Two Discussions

(2/27, Joyce Frieden, MedPage Today) ...A House hearing on a topic that both Republicans and Democrats agree on -- the need to more heavily regulate pharmacy benefit managers (PBMs) -- nonetheless devolved into two separate discussions: one on PBM reform and the other on stopping potential cuts to the Medicaid program...Rep. Frank Pallone (D-N.J.), ranking member of the full Energy and Commerce Committee, said that although he agreed with the need for PBM regulation, it was pointless to discuss it at a time when a bill passed Tuesday by the House would cut $880 billion from federal spending in order to finance tax cuts for wealthy Americans, with many of the spending reductions likely to come from the Medicaid program... Full

Confirmation Hearing For FDA Nominee Makary Set For March 6

(2/27, Luke Zarzecki, Inside Health Policy) ..Legal experts are weighing the possibilities for sweeping FDA shakeups under Kennedy including a shift in FDA center director roles from career civil servants to political appointees, vaccine restrictions, the potential elimination of user fees, and more. In an exclusive interview with Inside Health Policy, former FDA Commissioner Robert Califf said it will be a difficult time at the FDA with workers needing resilience to stand up for legal and ethical principles... Sub. Req’d

Turning Back The Clock At The US FDA

(2/27, Michael McCaughans, Pink Sheet) ...The agency now largely embraces the idea that its mission includes accelerating the availability of effective treatments for unmet medical needs at least as much as it involves protecting Americans from unsafe or ineffective medicines. Kennedy sees an agency that has lost trust over time... Global Sub. Full

Trump Is Looking for Drugmakers to Come Through for Him. They Have a Wish List for Him, Too

(2/28, STAT+) ...Even if several other large drugmakers take the same step as Lilly, there is no immediate impact on what Americans will pay for medicines nor is there any reason to think prices would later drop. Although the domestic supply chain may be more efficient, labor costs in the U.S. may also be higher than if the same work was performed in other countries, [Craig Garthwaite, an economist and who heads the health care program at the Northwestern University Kellogg School of Management,] noted. "I don't think that locating production here will bring costs down," he told us... Sub. Req’d

As Trump Targets DEI Practices, 4 Pharmas Reaffirm Commitment to Diversifying Clinical Trials

(2/28, Darren Incorvaia, Fierce Biotech) ...Spokespeople for Eli Lilly, Bristol Myers Squibb, Sanofi and Roche's Genentech confirmed in emails to Fierce Biotech that their work on advancing clinical trial diversity remains ongoing. The commitments come after a flurry of Trump actions to end DEI practices across the government, including at the Department of Health and Human Services...In statements to Fierce, Lilly, Sanofi and Genentech explicitly said they will follow all applicable laws and regulations issued by the government... Full

Independent Pharmacists Urge Legislators to Pass Pharmacy Benefit Manager Reform Bill

(2/27, Gwen Dilworth, Mississippi Today) ...A group of independent pharmacists from across Mississippi gathered at the Capitol Thursday to urge lawmakers to increase regulation and transparency of pharmacy benefit managers, who they say are threatening their survival...The Mississippi House of Representatives and Senate have both passed bills that would further regulate pharmacy benefit managers, authored by Speaker of the House Jason White, R-West, and Sen. Rita Parks, R-Corinth, respectively. Both bills prohibit spread pricing, or charging a health plan a higher price for a prescription drug a pharmacy is paid... Full

Pharma Reform Brings New Opportunities for Better Regulation, Access and Security of Medicines Supply

(2/27, Medicines for Europe) ...The review of the EU pharmaceutical legislation provides an opportunity to update the regulatory framework for pharmaceuticals in Europe. The legislation should integrate modern tools to make science-based regulation more digital, agile and efficient. The legislation should be forward-looking and flexible to manage the challenges and opportunities of the next 20 years... Full

Major Public Health Interest? Scholar, Insmed & Soleno Ask EMA To Fast-Track Their Products

(2/27, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency is considering whether apitegromab, brensocatib and diazoxide choline, from Scholar, Insmed and Soleno respectively, are drugs that are of potential major public health interest, particularly from the point of view of therapeutic innovation... Global Sub. Full

Medicines for Ireland Expands Membership with Kora Healthcare and Athlone Pharmaceuticals

(2/27, Medicines for Ireland) ...Commenting on the expansion, Chair of Medicines for Ireland, Paul Neill said: "We are delighted to welcome Kora Healthcare and Athlone Pharmaceuticals as members of Medicines for Ireland. Both companies have a wealth of expertise that will assist the association as we prepare to enter negotiations on a new Framework Agreement with the State. Our goal is to strengthen the agreement to minimise medicine shortages impacting Irish patients while delivering millions in savings for the State."... Full

Faster Innovative Medicines Access for Irish Patients is Possible, Says Pharma Report

(2/27, Brian Maguire, Euractiv) ...Patients in Ireland could access new medicines up to a year earlier, according to a new position paper published yesterday by the Irish Pharmaceutical Healthcare Association (IPHA). The paper, which evaluates access timelines against the Health Act 2013, highlights significant delays in the current system, with patients waiting nearly two years for new treatments. The IPHA's findings underscore the urgency of the government's commitment to ensuring faster and fairer access to medicines... Full

Ukrainian Government to Increase Public Procurements of Drugs

(2/27, The Pharma Letter) ...According to a recent report, prepared by a research company Proxima Research, the current situation in the Ukrainian pharmaceutical market remains generally stable, which is reflected by the ever-growing demand for drugs among local customers and their sales. In accordance with the report, last year sales grew by about 18% in value terms, compared to 2023. Moreover 66.2% of local citizens regularly buy drugs, which significantly exceeds the figures for previous years... Sub. Req’d

National Pharmaceutical Associations Form Partnership and Develop Report

(2/27, Canadian Manufacturing) ...As drug shortages continue to escalate globally and nationally, driven by a complex array of factors such as economic pressures, regulatory barriers, and lean supply chain limitations, the Canadian Generic Pharmaceutical Association (CGPA) and the Canadian Association for Pharmacy Distribution Management (CAPDM) have collaboratively developed a comprehensive report aimed at finding sustainable solutions. This initiative comes in response to Health Canada's call for stakeholder cooperation to strengthen resilience against these shortages... Full

Panel to Suggest Ways to Strengthen Supply Chains, Cut Dependence On China for Pharma Products

(2/28, Teena Thacker, The Economic Times) ...The Department of Pharmaceuticals (DoP) has formed a technical committee to formulate the strategy and a roadmap for an action plan to strengthen supply chains to reduce the dependence on China for pharma products. "This technical committee will support the department of pharma in similar other initiatives related to supply chain resilience," said a person aware of the matter... Full

Central Drug Regulator Creating Guidelines for Gene Therapies, Biosimilars: DCGI

(2/27, Jessica Jani, Mint) ...The Central Drugs Standard Control Organisation (CDSCO) is in the process of creating guidelines to regulate cell and gene therapies and upgrading the framework to regulate biosimilars, as the Indian industry moves towards innovations in the space, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said on Thursday... Full

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