Monday, July 21, 2025

Congressional Forecaster Says Trump Health Research Cuts Would Lead to Fewer New Drugs

(7/18, Ahmed Aboulenein, Reuters) ...President Donald Trump's proposed budget cuts to the National Institutes of Health would eventually result in fewer drugs on the market, the U.S. Congressional Budget Office said on Friday. The Trump administration's 2026 budget proposal includes deep cuts for scientific research, including $18 billion in cuts from the NIH's funding, a 40% reduction... Full

CBO: FDA Review Delays, NIH Cuts Will Decrease New Drug Availability

(7/18, Jessica Karins, Inside Health Policy) ...In its analysis of the impact of NIH budget cuts, CBO focused on how the cuts would impact preclinical research conducted by external organizations that receive funding from NIH. The office estimated a reduction of 10% would lead to a decrease of about 4.5% in the number of new drugs coming to market, but the decrease would build over time and not fully take effect until the third decade. A reduction in other components of NIH's budget could lead to further decreases, which CBO did not analyze... Sub. Req’d

Republicans Are Ready to Revive Stalled Health Care Legislation. Dems Want the GOP to Pay a Price. (7/21, Benjamin Guggenheim, Politico) ...With the dust barely settled after enacting their party-line domestic policy megabill, GOP lawmakers on the Senate Finance, House Ways and Means and House Energy and Commerce committees are hoping they'll have another shot this year at making policy changes to drug pricing long sought by both parties...But Democrats are also pointing out that Republicans are looking at policies that would reduce drug costs, and expand federal health insurance coverage of drugs, right after they stripped hundreds of billions of dollars from Medicaid...A senior Senate Democratic aide, granted anonymity to speak candidly, added: "Democrats will not be a part of any effort to selectively dismantle the American health care system after Republicans put it on life support."... Full

Medicare Drug Price Negotiation Program: A Litigation Status Check

(7/18, Zachary Baron, Andrew Twinamatsiko, Health Affairs) ...At the district court level, we could soon see three new decisions, two in lawsuits filed in the District of Columbia by Merck and Teva and one in litigation filed in Texas by PhRMA...Briefing is also now complete in the second District of Columbia lawsuit, filed by Teva. As noted above, to date, Teva is the only challenger that has sued over a product's selection for the second round of negotiations (it did not have a drug selected in the first round of negotiations). Teva's drug Austedo/Austedo XR is used to treat chorea in Huntington's disease and tardive dyskinesia...Oral arguments have not yet been scheduled in either the Teva or PhRMA cases, and it is unclear if the courts will do so or decide the case based on the filings... Full

Heath Insurers Are Denying More Drug Claims, Data Shows

(7/18, Sarah Klif, The New York Times) ...The report, compiled for The New York Times by the health analytics company Komodo Health, shows that denial rates rose from 18.3 percent to 22.9 percent. The rejections went up across many major health plans, including the country's largest private insurer, UnitedHealthcare. The data offers a rare look into the largely hidden world of rejected insurance claims. While some government-funded health plans are required to publish their denial rates, most private insurers keep that information confidential. Komodo draws from private databases that collect denial details from pharmacies, insurers and intermediaries... Sub. Req’d

FDA Finalizes Guidance for Efficient Biosimilars Meetings, Per BsUFA III

(7/18, Emily Hayes, Regulatory Affairs) ...The US Food and Drug Administration (FDA) published on July 18, a final, 23-page guidance document clarifying how sponsors may formally meet with the agency regarding the development and review of their biosimilars, including interchangeable products. The latest reauthorization of the Biosimilar User Fee Act (BsUFA III) included performance goals for efficiently and predictably managing formal meetings between FDA and sponsors... Full

FDA to Appoint Biotech Executive as RFK Jr.'s Top Drug Regulator

(7/21, Robert Langreth, Sam Hornblower, Bloomberg) ...Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency's top drug regulator, according to a person familiar with the decision. The naming of Tidmarsh, also a Stanford University-affiliated pediatrician, to director of the Center for Drug Evaluation and Research (CDER) could be announced as soon as Monday, said the person, who asked not to be identified because the appointment wasn't public... Full

Connecticut Wants to Make Generic GLP-1s. Will RFK Jr. Lend a Hand?

(7/20, Anjalee Khemlani, Yahoo! Finance) ...The bill, signed by Gov. Ned Lamont on July 8, focuses on efforts to control drug prices but has a section dedicated to generic GLP-1 drugs, similar to Novo Nordisk's (NVO) Ozempic and Wegovy and Eli Lilly's (LLY) Mounjaro and Zepbound. Combined, the four drugs have been ballooning the state's spending — contributing costs of $140 million in fiscal year 2024 — a problem plaguing many states..."The commissioner may enter into a consortium with officials in other states in contracting with such manufacturer for such drugs," according to the state's new law. State Sen. Matt Lesser, who introduced the bill, told Yahoo Finance that other states, both red and blue, have already expressed interest. He said the state has 30 days to submit the petition... Full

Sun Pharma's Phase 3 Clinical Studies Evaluating ILUMYA in Active Psoriatic Arthritis Met Their Primary Endpoint

(7/21, Express Pharma) ...Sun Pharmaceutical Industries announced top-line results from two Phase 3 clinical studies evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA) administered over 24 weeks for the treatment of active psoriatic arthritis. Treatment with tildrakizumab 100 mg (ILUMYA) resulted in greater improvements in PsA signs and symptoms at Week 24 compared to treatment with placebo... Full

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

(7/18, Dean Rudge, Generics Bulletin) ...Accord/Bio-Thera's BLA filing comes six months after the first one claimed for a golimumab biosimilar in the US by Alvotech and its commercialization partner Teva. "These are the first US BLA filing acceptances announced for a biosimilar candidate to golimumab," the firms indicated, adding that "the FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025." Alvotech handles development and manufacturing of the biosimilars using its "purpose-built end-to-end platform," while Teva is responsible for commercialization in the US, which the companies said "leverages Teva's experience and extensive sales and marketing infrastructure."... Global Sub. Full

Zydus Life's Plans for Cancer Biosimilar Hit a Legal Hurdle

(7/21, Vikas Dandekar, The Economic Times) ...The Delhi High Court has issued an interim injunction against Ahmedabad-based drug maker Zydus Lifesciences after a case filed by the US pharma giant Bristol Myers Squibb alleging patent infringement on its blockbuster anticancer drug Opdyta (nivolumab) branded as Opdivo in other countries. The restraining order comes as a setback for the Indian drug maker which was running clinical trials in India for the launch of the biosimilar versions of nivolumab. The earliest patent for the drug expires in India on May 2, 2026. The next hearing for the case is August 8... Full

Samsung Bioepis Finds New US Partner For Ophthalmic Biosimilars

(7/18, Dave Wallace, Generics Bulletin) ...Samsung Bioepis has announced a fresh ophthalmic biosimilars partnership with Harrow, as the end approaches for a longstanding US commercialization alliance with Biogen on the Korean firm's Lucentis (ranibizumab) and Eylea (aflibercept) rivals Byooviz and Opuviz...As it announced the partnership, Harrow pledged to "leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars."...As for Biogen, while the firm has for many years operated a successful biosimilars business – bringing in sales of $793m in 2024 – it has also made clear its declining interest in the segment as a strategic priority... Global Sub. Full

Study Highlights Filgrastim Savings Potential With Biosimilars

(7/18, Ethan Nolin-Halpern, Pharmacy Times) ...Global cancer medication spending is projected to exceed $409 billion by 2028, highlighting the need for cost-effective solutions. A Saudi Arabian study showed significant savings and increased patient access by substituting filgrastim with its biosimilar, pegfilgrastim. The U.S. could achieve greater savings by adopting biosimilars, necessitating careful selection and formulary integration... Full

Samsung Bioepis Releases Third Quarter 2025 US Biosimilar Market Report Exploring the Most-Favored-Nation (MFN) Policy and its Impact On Biosimilars

(7/21, Samsung Bioepis) ...The report offers insights into recent biosimilar pricing trends, market dynamics such as biosimilars adoption and price erosion, and the latest policy affecting biosimilars such as the Most-Favored-Nation (MFN) policy. "When we first launched this report in Q2 2023, the US market had seen the approval of 40 biosimilars, with 28 products commercially launched. As of this tenth edition, the numbers have risen to 75 approvals and 53 launches, reflecting the market's accelerating pace and growing complexity," said Thomas Newcomer, Vice President, Head of US Commercial Operations, at Samsung Bioepis... Full

Celltrion Eyes Record High Sales in 2025, Fueled by High-Margin Biosimilars

(7/21, Hyun-Ah Oh, The Korea Economic Daily) ...In a preliminary earnings disclosure on Monday, Celltrion projected a consolidated operating profit of 242.5 billion won for the April-June period, marking its all-time high second-quarter profit. Sales rose to a quarterly record of 961.5 billion won, up 9.9% from a year earlier. Operating profit more than tripled, lifting the operating margin to 25%, according to the filing. First-half sales totaled 1.80 trillion won, another record, and up 11.9% from the same period a year ago. The company attributed the stellar performance to accelerating sales of its newer, high-margin biosimilars – Remsima SC (marketed as Zymfentra in the US), Yuflyma, Vegzelma and Stequema... Full

Amphastar Unveils Plans To Quadruple US Manufacturing

(7/18, Dave Wallace, Generics Bulletin) ...Amphastar is planning to quadruple production capacity at its Rancho Cucamonga location in California over the next three to five years. The firm said the move reinforces its "commitment to domestic pharmaceutical manufacturing and strengthening supply chain resilience." The Association for Accessible Medicines celebrated the announcement, which comes in the wake of other off-patent industry commitments to US manufacturing and also takes place against the backdrop of potential pharmaceutical tariffs that have been trailed as imminent by the Trump administration... Global Sub. Full

Viatris' Ophthalmic Drug Flunks Phase 3 Study, Company Mulls Next Steps

(7/18, Ayisha Sharma, Endpoints News) ...Viatris said Friday its treatment candidate for a common form of eye inflammation failed a late-stage trial, casting uncertainty on the program's future. The biotech's pimecrolimus 0.3% ointment did not meet the Phase 3 primary endpoint of "complete resolution of debris" at six weeks versus vehicle, according to a release. The trial enrolled 477 patients with blepharitis, a condition that involves inflammation at the edges of the eyelids. Blepharitis causes swelling, itching, and crusting of the skin near the eyelids... Sub. Req’d

Roche's COPD Drug Flunks Phase 3, Denting Hopes of 2025 Approval

(7/21, James Waldron, Fierce Biotech) ...The Swiss pharma had been evaluating administering astegolimab every two weeks in the phase 2b Aliento trial of 1,301 former and current smokers with a history of frequent COPD exacerbations, as well as the phase 3 Arnasa study of 1,375 patients. The primary endpoint of both trials was the reduction in the annualised rate of moderate and severe COPD exacerbations (AER) over a year of treatment... Full

EURneffy Wins UK Approval

(7/18, The Pharma Letter) ...Danish allergy immunotherapy specialist ALK Abello has announced that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has approved EURneffy 2 mg for anaphylaxis treatment of adults and children (=30 kg). The UK market launch of the product—seen as an alternative to the EpiPen epinephrine auto-injector—is expected within the coming months, once market access negotiations are completed. While its trade name is neffy in the USA, it is EURneffy in the European Union and UK... Sub. Req’d

Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support

(7/18, Lisa Pham and Damian Garde, Bloomberg) ...Otsuka Pharmaceutical Co.'s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers' bid to bring the first new drug for the condition to market in more than two decades. The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established... Full

Sanofi Completes Acquisition of Blueprint Medicines

(7/18, Sanofi) ...Sanofi today announces the completion of its acquisition of Blueprint Medicines Corporation (Blueprint), adding to its portfolio a commercialized medicine, a promising pipeline, and the expertise of a company specializing in systemic mastocytosis (SM), a rare immunological disease, and other KIT-driven diseases. In addition, the acquisition of Blueprint brings Sanofi an established presence among allergists, dermatologists, and immunologists which is expected to enhance Sanofi's ability to advance its growing immunology pipeline... Full

Dr. Reddy's Formulations Plant Gets 7 Observations from FDA

(7/20, The Economic Times) ...In an intimation to the stock exchange the company said, "the United States Food & Drug Administration (USFDA) completed a GMP and a Pre-Approval Inspection (PAI) at our formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh and has issued a Form 483 with 7 observations."...Without disclosing the nature of observations the company in its filing noted that, "we will address them within the stipulated timeline."... Full

UK Drugs Agency Outsources 40% of Applications After Brexit Turbulence

(7/20, Hannah Kuchler and Sarah Neville, The Financial Times) ...Lawrence Tallon, who took over in April, said the regulator is "completely content" to allow normal devices and therapies to be approved through international recognition and not to duplicate the work. Instead it wants to move faster in areas where the UK has "deep expertise". "We aspire to move faster than other countries and really set the standards," he said in an interview with the Financial Times... Sub. Req’d

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

(7/18, Eliza Slawther, Pink Sheet) ...The European medicines regulatory network's "AI Observatory" has released its first annual report providing a snapshot view of how artificial intelligence was used in EU drug regulation processes in 2024. The report shows that most interactions between regulators and drug sponsors regarding AI occurred at the pre-authorization stage, with growing interest in applying AI across all stages of the medicine lifecycle. Drug developers want further clarity on regulatory expectations for AI, especially around risk assessment, automation, and support the development of globally aligned principles to support innovation... Global Sub. Full

Drugs Often Approved for Wider Use Than Tested, Says Swiss Study

(7/20, Swissinfo.ch) ...An international team of researchers, led by Kerstin Vokinger, Professor of Law and Medicine at the University of Zurich and ETH Zurich, has taken a closer look at how medicines are approved. They wanted to find out how often the people tested in clinical trials differ from those who end up being prescribed the drugs. The team analysed all 278 medicines approved between 2012 and 2023 across Switzerland, the European Union (EU), and the United States (US). The findings are striking. Medicines often approved for broader use than tested... Full

Global Pharma Giants Underscore Local Partnerships, R&D at China Supply Chain Expo

(7/21, Xinhua) ...At the expo, French drugmaker Sanofi exhibited its ecosystem, as well as its latest products for conditions such as immunological, cardiovascular, metabolic and other diseases...Meanwhile, Novo Nordisk announced new partnerships with local manufacturing, logistics and tech firms at the expo, as part of its latest efforts to deepen local industrial chain cooperation. Novo Nordisk has continued to increase its investment in China, enhancing its presence throughout the industry chain to better serve patients in China... Full

Exclusive: New Drug Approval Plan Could Make Hong Kong Magnet for Pharma Firms

(7/20, Aiden He, The Standard) ...Hong Kong's plan to independently assess and approve new drugs based on its scientific review of clinical trial data gives it the opportunity to become a very attractive market for pharmaceutical companies, said GSK Hong Kong and Macau general manager Nicholas Teo Zefeng. The new method, also known as primary evaluation, can cut drug approval times by six to 12 months by allowing the SAR to begin reviews simultaneously with globally renowned regulators like the US FDA and the EMA. It could also make the city a possible reference market for other regions' approval processes in the future... Full

Hong Kong Public Hospital Patients to Pay 20% Less for Drugs

(7/20, Elizabeth Cheung, South China Morning Post) ...Hong Kong patients can expect to pay about 20 per cent less for some drugs following negotiations by public hospitals with pharmaceutical companies, as part of government efforts to bring down operational costs and medication prices...Public hospitals are also looking to purchase more generic drugs instead of brand-name ones, in a bid to increase drug supply and introduce price competition...As Hong Kong is placing more importance on clinical trials in its endeavour to become an international medical and innovation hub, the authority would also actively monitor drugs that were in phase three clinical trials and approach developers to explore the possibility of their inclusion for use in public hospitals soon... Full

'Ripped Away': Medicine Crisis Pushing Aussie Families to the Brink

(7/21, Adam Vidler, 9News Australia) ...A shortage of ADHD medicines is putting families in a serious squeeze around the country , with no relief expected for months or even years. Parents are resorting to forgoing their own medication to give to their kids, mixing prescriptions, and travelling hours to try to get a piece of the ever-shrinking supply pool...The Therapeutic Goods Administration lists multiple ADHD medication shortages on its advice page, with warnings the squeeze will continue into the end of 2026 for some. The list of medicines include Concerta modified-release tablets, Teva-XR modified-release tablets, Ritalin LA and Rubifen LA capsules, and Ritalin 10mg immediate-release tablets... Full

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