Thursday, February 13, 2025

From Innovation to Access: The Future of Medicine

(1/31, STAT) ...Access to innovative medicines remains a critical issue in healthcare. Teva Pharmaceuticals is tackling this challenge head-on, driving scientific innovation to deliver high-quality medicines that improve the health outcomes of millions. Chris Fox, executive vice president of US Commercial, offers her perspective on the future of medicine and the pivotal role she and her colleagues play in shaping it... Full

Pharmalittle: We're Reading About Pharma Silence On Trump Moves, Lawmakers Eyeing PBMs Again, and More

(2/12, Ed Silverman, STAT+) ...Teva is doubling down on its fight against Medicare after its drugs were picked for price negotiations...Teva claims the agency's implementation guidance rewrote two critical limitations imposed by Congress in the Inflation Reduction Act. The lawsuit adds to the ongoing legal challenges from manufacturers from the first negotiation cycle, although manufacturers so far have been unsuccessful in litigation... Sub. Req’d

Biogen CEO Hails Quartet Of New Launches As Multiple Sclerosis Competition Weighs On 2025 Guidance

(2/12, Fraiser Kansteiner, Fierce Pharma) ...In the fourth quarter, sales for Biogen's multiple sclerosis (MS) franchise—which includes drugs like Tysabri and Tecfidera—declined 9% at constant currencies to a little more than $1 billion. For all of 2024, Biogen's multiple sclerosis sales came in at $4.4 billion, a 7% drop over the sum the business brought home in 2023...The silver lining for Biogen, however, is that sales from four recent launches—Skyclarys, Leqembi, Zurzuvae and Qalsody— "more than offset the decline in our multiple sclerosis product revenue," according to Viehbacher... Full

Apotex Branches Out Into Natural Health With CanPrev Takeover

(2/12, Dean Rudge, Generics Bulletin) ...Apotex has further diversified its offerings by acquiring CanPrev, a Canadian provider of vitamins, supplements, and other natural health products, in a deal that the firm says introduces it into the "strategically attractive and growing Canadian health and wellness sector." Financial details were not disclosed for the deal that Apotex observed would "leverage our existing channel presence in pharmacies and expand our channels to include health food stores, new professional channels including naturopathic doctors, and grocery retail channels."... Global Sub. Full

Natco Pharma Shares Tank 19%, Near 52-Week Low On Weak Q3 Results

(2/13, Deepak Korgaonkar, Business Standard) ...Natco has two business segments, Pharmaceuticals and Agrochemicals. The pharma segment constitutes a major portion of its revenues, where export formulations contribute a major portion of the company's revenues, followed by Active Pharmaceutical Ingredients (API). The company's export formulations business focuses on high entry barriers and complex products and comprises customers in the US, Canada, Brazil, Asia-Pacific region and other countries... Full

Roche Nabs FDA Nod for Evrysdi Tablets, Bolstering Convenience Edge Over Rivals

(2/12, Fraiser Kansteiner, Fierce Pharma) ...The FDA on Wednesday gave the thumbs-up to a 5-mg tablet formulation of Evrysdi (risdiplam) to treat SMA in adults and children ages 2 and older who weigh more than 44 pounds...The two other SMA stalwarts on the market, Biogen's oligonucleotide Spinraza and Novartis' gene therapy Zolgensma, are delivered intrathecally (into the cerebrospinal fluid around the spinal cord) and via a one-time, 60-minute infusion, respectively. Roche says it plans to launch the new Evrysdi tablets—which can either be swallowed whole or dispersed in water—"in the coming weeks."... Full

Psoriasis Biosimilars Saved VA $67 Million in 2023

(2/12, Skylar Jeremias, The Center For Biosimilars) ...The Department of Veterans Affairs (VA) saved $67 million in 2023 through its strong adoption of biosimilars to curb the high costs of biologic therapies to treat chronic disease. By embracing psoriasis biosimilars, the Department of Veterans Affairs (VA) successfully slashed over $67 million in costs in 2023, proving that these lower-cost biologics can deliver on promised cost savings; however, greater education is needed to unlock their full potential, according to an analysis... Full

CVS CEO Defends Pharmacy Middlemen, Accuses Drugmakers of ‘Monopolistic' Practices

(2/12, Annika Kim Constantino, CNBC) ...CVS Health CEO David Joyner on Wednesday defended controversial pharmacy middlemen like his company's Caremark unit, which are widely accused of inflating prescription medication prices, and instead accused manufacturers of "monopolistic tendencies" that keep drug costs high in the U.S...However, the pharmaceutical industry and lawmakers argue that PBMs and insurers pocket those savings from negotiated rebates and discounts rather than passing them to patients. In a statement on Wednesday, PhRMA, the nation's largest lobbying group for the pharmaceutical industry said PBMs are "under intense, well-deserved scrutiny."... Full

‘This Is Not Good For Business': Trump's Workforce Shakeups Could Harm Industry

(2/12, Sarah Karlin-Smith, Pink Sheet) ...Experts worry a new executive order calling for large cuts in the federal workforce, along with new FDA limits on remote work could "decimate" the agency. The pharma industry should be speaking out more proactively about the risks to FDA's workforce, experts said, given the risks to drug approval timelines and other aspects of their businesses. Public trust in regulated products also could be threatened with a smaller and less experienced FDA workforce... Global Sub. Full

Trump Comments On GLP-1 Prices Add To Drug Policy Uncertainty

(2/12, Donna Haseley, Maaisha Osman, Inside Health Policy) ...In the Monday (Feb. 10) interview, Trump promised to fix the situation without providing details other than a reference to his earlier support for drug imports, and he mentioned he might slap tariffs on imported pharmaceuticals...In an exclusive interview with Inside Health Policy, Joe Grogan, the former director of the United States Domestic Policy Council during the first Trump administration, said the United States Trade Representative could get involved in drug pricing policy under Trump. For instance, the Trade Representative could bargain with the drug industry in seeking lower prices in exchange for increased support for domestic manufacturing, Grogan told IHP... Sub. Req’d

Senate Expected to Vote Thursday On Kennedy's Nomination as Health Secretary

(2/13, Liz Essley Whyte, Kristina Peterson and Lindsay Wise, The Wall Street Journal) ...If voted in as expected on Thursday, Kennedy would be in position to apply his unconventional views to U.S. health policy. He would oversee a department with a $1.7 trillion budget and 80,000 employees that regulates vaccines, decides which prescription drugs can be sold, provides health insurance for millions of Americans and responds to breakouts of infectious diseases... Sub. Req’d

Senate Bill Seeks to Make Prescription Drugs More Affordable for Americans

(2/12, Tracey Porpora, Silive.com) ...U.S. Senator Kirsten Gillibrand introduced the "Capping Prescription Costs Act," that would cap the annual out-of-pocket cost of prescription drugs for both individuals and families at $2,000 and $4,000 respectively during a virtual press conference on Wednesday... Full

AAM Stares Into The Biosimilar Void

(2/12, Dave Wallace, Generics Bulletin) ...Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM's Access! 2025 conference heard that the "sobering" findings should act as a "wake-up call for stakeholders."... Global Sub. Full

US FDA Discourages Off-Label Guidance Suits as Challenges To Entire Approval Authority

(2/12, Michael McCaughan, Pink Sheet) ...Recently finalized FDA guidance on communicating scientific information on unapproved uses included a memo arguing the policy allows rather than restricts speech. The language suggests the agency already has prepared the legal briefs for the inevitable court challenges of the policy. Among the many policy alternatives considered, the FDA said the BIO/PhRMA principles were not specific enough... Global Sub. Full

The FDA Must Remove An Unnecessary Barrier to The Use of Clozapine for Treatment-Resistant Schizophrenia

(2/13, Daniel X., STAT) ...Following its approval, the FDA implemented a requirement for patients, providers, and pharmacies to be registered in the Clozapine REMS Registry. This system imposes strict requirements for prescribing clozapine, creating a highly delicate and coordinated process. Patients must navigate a complex system involving prescribers, pharmacies, distributors, lab-testing facilities, and insurers... Full

Diet Drug Boom Weighs Heavily On State Budgets

(2/12, Kelly Hooper, Politico) ...Colorado's spending on highly effective but costly weight-loss drugs for state workers more than quadrupled from 2023 to 2024 — and costs have been doubling every six months. Now, the state wants to scrap the benefit, arguing that it's financially unsustainable. But the potential removal of the popular benefit has sparked blowback among state workers. The state employees' union argues ending coverage will cost the health plan in other ways — increasing spending on obesity-related diseases and leading to a less healthy workforce... Full

US, UK and Canada HTAs Convene The Health Economics Methods Advisory

(2/12, The Pharma Letter) ...The USA-based Institute for Clinical and Economic Review (ICER), England's National Institute for Health and Care Excellence (NICE), and Canada's Drug Agency (CDA-AMC) have formed the Health Economics Methods Advisory (HEMA) initiative. The goal of HEMA is to critically and independently research some of the most pressing topics in global health economics and health technology assessment (HTA) methods... Sub. Req’d

EU Pharma Reform & Reducing Reliance On Asian Imports: What To Expect in 2025

(2/13, Neena Brizmohun, Pink Sheet) ...The European Commission's 100-day countdown to deliver a Critical Medicines Act, aimed at improving the EU's resilience to supply chain disruptions and price volatility, began last December. Meanwhile, negotiations over the proposed package that will reform the over 20-year-old EU pharmaceutical legislation are now in the hands of the Council of the EU. The Pink Sheet examines what to expect for these key pieces of legislation this year... Global Sub. Full

Feedback Sought To Shape Highly Awaited EU Law On Cutting Dependency On Asian Imports

(2/13, Neena Brizmohun, Generics Bulletin) ...The European Commission is intensifying efforts to fulfil its promise of proposing a Critical Medicines Act in March to tackle drug shortages and reduce the EU's overreliance on imports from Asia. It has given stakeholders until February 27, to respond to a call for evidence on the initiative, which aims to create "a more favourable framework for establishing or expanding manufacturing facilities of critical medicines in the EU."... Global Sub. Full

EP Health Chair Jarubas Urges Prioritisation of EU Pharma Sovereignty and Resilience

(2/12, Paulina Mozolewska, Euractiv) ...The newly established Public Health Committee (SANT), with Polish MEP Adam Jarubas at the helm, has rolled up its sleeves to tackle the complex issue of EU autonomy while advocating for the finalisation of the EU Pharma Package. The committee is focusing on the European Union's heavy reliance on pharmaceutical ingredient imports from Asia... Full

Russia Deepening Localization in Domestic Pharma Market

(2/12, The Pharma Letter) ...At least 90% of drugs from the list of vital medicines in Russia will be of domestic origin already by the end of 2025, according to latest predictions by some senior officials of the Russian Ministry of Health, reports The Pharma Letter's local correspondent... Sub. Req’d

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