Friday, July 25, 2025

Rain Free Days: A Migraine App Shaped by Real Experiences

(7/24, PMLiVE) ...Rain Free Days® is a free migraine support app created by Teva, 11 London, and the migraine community. It helps users track symptoms, spot patterns, and access personalised resources like expert articles, treatment videos, and relaxation tools. Developed with real user insight, it even inspired a migraine-friendly paint palette with Dulux...Together with Dulux, the National Migraine Centre and Teva, we carried out a colour survey with over 1,200 people. The results were used by Dulux to develop a migraine-friendly paint palette, designed to support people in creating calming, restorative spaces at home... Full

UK Xtandi Patent Stands Strong As Accord, Sandoz, Teva Lose Appeal

(7/24, Dean Rudge, Generics Bulletin) ...The Court of Appeal of England and Wales has upheld the validity of a UK Astellas patent shielding Xtandi, the $6.2bn prostate cancer treatment, dismissing appeals from Accord Healthcare, Sandoz, and Teva. The generics firms had argued that earlier scientific materials demonstrated the obviousness of the patent, which is set to expire in June 2028. However, the court found that the evidence presented by the generic manufacturers lacked credibility due to hindsight bias... Global Sub. Full

Roche Boss Says ‘Very Easy' To Cut Drug Prices By 50%

(7/24, Hannah Kuchler, Financial Times) ......Thomas Schinecker, Roche's chief executive, said half of all the earnings in the supply chain went to intermediaries, known as pharmacy benefit managers, who take "zero risk" on innovation. "So if the United States would like to cut prices by 50 per cent, it's very easy. We go direct. And this is one of the discussions that we're having with the United States, and that would bring down costs quite quickly," he said... Sub. Req’d

Tariffs, Pricing Policy Changes Bring Industry to a 'Pivotal Moment': Deloitte Survey

(7/24, Kevin Dunleavy, Fierce Pharma) ...Two-thirds of the participants said they expect current or anticipated tariffs and/or pricing policies will have a moderate to major impact on their long-term commercial planning, Deloitte found in its 2025 Tariffs, Pricing and Taxes Survey, which was conducted in late June and before the July 4 signing of the so-called One Big Beautiful Bill Act from the Trump administration. While dealing with one facet of the shifting landscape will require organizations to adjust strategically, negotiating a combination of factors could present "profound operating challenges," Deloitte wrote in a report... Full

EU Pushes US for 15% Cap On Pharma Tariffs

(7/24, Jack Power, The Irish Times) ...The European Union is pushing for any future tariffs on pharmaceutical products sold to the United States to be capped at a blanket 15 per cent rate, in ongoing trade negotiations with US president Donald Trump's administration...The latest outline of a possible deal – the shape of which has shifted several times over recent weeks – would mean the EU accept tariffs of 15 per cent being charged on most goods sold to the US. The European Commission, the EU's executive arm negotiating for the 27-state bloc, wants any tariffs on pharmaceuticals to also be capped at that level... Sub. Req’d

What Pharma Manufacturers Need to Know About US Trade Policy Changes

(7/23, Christopher Cole, PharmTech.com) ...In this first segment of a multi-part interview, Jason Waite, international trade expert at Alston & Bird, outlines how recent United States tariff activity could significantly impact pharmaceutical manufacturers... Full

Tariffs & Trade Policy: What to Watch for, Cost Impacts, and Supply Chain Strategies

(7/24, Christopher Cole, PharmTech.com) ...In Part 2 of our multi-part interview series, international trade expert Jason Waite of Alston & Bird outlines the potential implications of the Trump administration's proposed Section 232 tariffs on imported pharmaceuticals and active pharmaceutical ingredients... Full

Trade Policy Shifts: Compliance and Cost Strategies for Pharma

(7/24, Christopher Cole, PharmTech.com) ...In Part 3 of our multi-part interview series, Jason Waite, an international trade expert at Alston & Bird, outlines how proposed sector-specific tariffs on pharmaceutical products could significantly disrupt the United States drug development landscape... Full

New PRI Brief Warns Trump Drug Price Control Policies Would Lead U.S. Down the Path to European-Style Socialism

(7/25, Sally Pipes and Wayne Winegarden, Pacific Research Institute) ...The report shows how the price control provisions in the Inflation Reduction Act, which are set to begin for 10 drugs under Medicare Part D on January 1, 2026, are already having devastating effects. Since the law's passage, 51 research programs have been shut down and 26 drugs have been discontinued, according to Incubate, a coalition of early-stage biotech investors. Late-stage clinical trials for small-molecule drugs have dropped by 47 percent, and early-stage funding for those treatments has plummeted by 70 percent... Full

PBM Reform Could Save Almost $100 Billion in U.S. Drug Spending

(7/24, Denise Myshko, Formulary Watch) ...Shifting instead to a transparent, fixed payment model for PBMs and other intermediaries in the prescription drug supply chain would reduce annual net drug spending by $95.4 billion (or nearly 15%) without undermining pharmaceutical innovation, according to Schaeffer Center director of Health Policy Geoffrey Joyce, Ph.D... Full

PBMs: Your Friends Behind the Curtain

(7/24, PCMA Blog) ...PBMs are the only actors in the drug supply chain dedicated to lowering costs. The primary way PBMs lower drug costs is by negotiating rebates from drug manufacturers and discounts from drugstores. PBMs also create savings by encouraging the use of generics, biosimilars, and other affordable brand drugs, reducing wasteful and inappropriate drug use, improving patient medication adherence, and managing high-cost specialty drugs. These are real savings, which benefit employers and patients... Full

Two of Biotech's Biggest Champions in the House Want to Counter China's Rise

(7/24, Max Bayer, Endpoints News) ...US lawmakers are slowly coalescing around biotech as a national security imperative, building off a report released earlier this year that industry has touted as a blueprint for future investments and a way to stay ahead of China. The BIOTech Caucus, launched last month by Reps. Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK), is a bipartisan effort to fortify US biomanufacturing and biosecurity. They both spoke with Endpoints News about their effort, and how they plan to inform and generate support among their colleagues... Sub. Req’d

FDA's Drug Chief Pick at Odds With RFK Jr.'s Revolving Door Vow

(7/25, Nyah Phengsitthy, Bloomberg Law) ..."Pharma might be encouraged that he has a lot of experience in drug development," said Genevieve Kanter, a professor at the University of Southern California, but the "concern with Tidmarsh is that he has had no regulatory or FDA experience, unlike previous CDER directors and Gottlieb." "His background doesn't seem to reflect any prior interest or work in public service, so I think it's fair to be concerned that his sources of information may be biased in a way that might not always favor public interests," said Kanter, who published a study that shows about 12% of FDA appointees come from industry... Sub. Req’d

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

(7/24, Sarah Karlin-Smith, Pink Sheet) ...Despite some attempts to protect them from Trump Administration changes, medical reviewers are voluntarily leaving the FDA. Breast and genitourinary reviewers, along with malignant hematology reviewers, are some of the major losses in the cancer space. A source formerly at the FDA said the departing reviewers tend to be more senior and experienced, which will make rebuilding the agency's expertise more difficult... Global Sub. Full

AstraZeneca's Eco-Friendly Version Of Smoker's Lung Inhaler Gets EU Panel Backing

(7/25, Pushkala Aripaka and Unnamalai L, Reuters) ...A panel of the European medicines regulator has recommended approving an eco-friendly version of AstraZeneca's inhaler for the treatment of a chronic lung condition, the drugmaker said on Friday...In this version, Trixeo Aerosphere, also called Breztri Aerosphere in some regions, will use a next-generation, medical-grade propellant from Honeywell to deliver metered-doses to patients' lungs as part of AstraZeneca's green push... Full

Unlike FDA, EC Backs Re-Approval of GSK's Blenrep

(7/25, The Pharma Letter) ...In an import contrast to events in the USA, UK pharma major GSK late Thursday announced the approval of Blenrep (belantamab mafodotin) by the European Commission. This authorizes Blenrep for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide... Sub. Req’d

Sun Pharma Subsidiaries Agree to Pay $200 Million to Settle US Generic Drug Pricing Antitrust Case

(7/24, Jomy Jos Pullokaran, CNBC TV-18) ...Mumbai-based Sun Pharmaceutical Industries Limited on Thursday (July 24) announced that its subsidiaries, Sun Pharmaceutical Industries, Inc. (SPII) and Taro Pharmaceuticals U.S.A., Inc., have entered into a settlement agreement in the ongoing In re Generic Pharmaceuticals Pricing Antitrust Litigation in the Eastern District of Pennsylvania, US. Under the agreement, Sun Pharmaceutical Industries, Inc. and Taro will make a combined payment of $200 million in exchange for a full release of all claims brought against them by the End Purchaser Plaintiffs... Full

Zydus Moves Delhi HC Against Order Restraining, Sale of Its Cancer Drug

(7/25, Indu Bhan, The Economic Times) ...Zydus Lifesciences has appealed a Delhi High Court order. The order restricts it from producing a biosimilar of E.R. Squibb's Nivolumab. Squibb alleges patent infringement of its cancer drug Opdyta. Zydus denies infringement, stating its product ZRC-3276 is biosimilar but doesn't violate patents. Zydus argues the process is known and its subsidiary filed a post-grant opposition... Full

US PE Firms, Aurobindo Said to Zentiva in €5 Billion Deal

(7/24, Dinesh Nair, Swetha Gopinath, Manuel Baigorri, Aaron Kirchfeld, Bloomberg Law) ...US private equity firms GTCR and TPG Inc. are among funds considering bids for generic drugmaker Zentiva in a deal that could value the former Sanofi unit at about €5 billion ($5.9 billion), according to people familiar with the matter. Indian drugmaker Aurobindo Pharma Ltd. is also weighing a bid for Zentiva, now owned by buyout firm Advent, the people said, asking not to be identified because the deliberations are private... Sub. Req’d

Undervalued and Understocked: Are Generics in Crisis?

(7/24, The Pharma Letter) ...For years, generics have been treated as commodities: interchangeable, invisible, and underpriced. The approach has arguably produced a supply chain so lean it can no longer absorb shocks. To turn things around, countries must invest in creating a smarter, more resilient system fit for the future... Sub. Req’d

Indian Drugmaker Cipla Beats First-Quarter Profit On Higher Domestic Demand

(7/25, Kashish Tandon, Reuters) ...The company's consolidated net profit rose 10% to 12.98 billion rupees ($150 million) in the April-June quarter, beating analysts' average estimate of 12.11 billion rupees, per data compiled by LSEG...Cipla said growth in India was led by demand for drugs in therapy areas such as respiratory, urology and anti-infectives. However, delayed approvals for new drug applications and pricing pressure have weighed on the drugmaker's growth in the U.S... Full

Novartis to Pay Matchpoint Up to $ Billion to Develop Anti-Inflammatory Therapies

(7/24, Christy Santhosh, Reuters) ...Matchpoint said on Thursday it will use its technology to develop drugs that block the activity of a specific protein, helping to lower the production of inflammation-causing signals. The company will lead the research and drug development process, using the funding from Novartis. If Novartis exercises its option to exclusively license the program, the drugmaker will have global rights to develop and commercialize all products resulting from the collaboration... Full

Biogen, Zydus Settle Patent Suit Over Copies of MS Drug Vumerity

(7/24, Christopher Yasiejko, Bloomberg Law) ...The agreement, which resolves all claims and defenses involving US Patent Nos. 8,669,281, 9,090,558, and 10,080,733, leaves the door open for the parties to renew their allegations, according to a stipulation and proposed order filed Wednesday in the US District Court for the District of Delaware. The settlement came a day after Judge Gregory B. Williams postponed a bench trial's start from July 28 until Jan. 12, 2026, due to a scheduling conflict. Zydus last August conceded its generic would infringe the patents, a common tactic that allows a party to focus on arguments that each is invalid... Sub. Req’d

Pharma's Turbo Spending Spree On US Manufacturing

(7/24, Meagan Parrish, PharmaVoice) ...Other industry shifts, including the growing GLP-1 market and the demand for skilled workers in pharma's tech-heavy manufacturing environment, are also tipping the scales toward the U.S. Amid the investment boom, tens of billions of dollars are pouring into manufacturing hubs like Raleigh, North Carolina, and generating thousands of job openings for engineers, R&D personnel, operations professionals and more. Here's a look at the latest companies to hop on the U.S. manufacturing bandwagon... Full

Canada is Facing a Nationwide Shortage of These Prescription Painkillers

(7/24, Sean Previl, Global News) ...A national shortage of common prescription pain medications in Canada could last into early August. Health Canada issued a notice last week that drugs containing acetaminophen with codeine or oxycodone that are used to relieve pain are experiencing shortages...Other formulations include Teva-Oxycocet, Teva-Lenoltic No. 1, 2, 3 and 4, and Rivacocet. Some of the companies that manufacture both medication combinations, including Teva Canada Ltd., Laboratoire Riva Inc. and Pharmascience Inc., have reported issues around manufacturing disruptions and increased demands as causes of the shortages...In response to the shortages, the CPA said pharmacists have been limiting amounts given to patients... Full

EMA: Drug Repurposing Efforts Saw Limited Success During Pilot

(7/24, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) said researchers working to repurpose out-of-patent drugs face significant challenges, such as interpreting the available data to support a regulatory application for a new use. They also noted that during clinical trials, they faced challenges developing the right inclusion/ exclusion criteria, isolating the drug's effects in a trial that used combination therapy, and choosing the right primary endpoint... Full

Ireland's ‘Innovation Paradox' is Hurting Pharma Competitiveness

(7/25, Brian Maguire, Euractiv) ..."Right now, from an Irish perspective, our number one priority is access," said Eimear O'Leary, Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association (IPHA), speaking with Euractiv in the heart of Dublin's tech hub. "Patients in Ireland access new medicines later here than those in most other Western European countries due to our slow reimbursement process. The system needs to be reformed to ensure that patients do not continue to wait to access life-enhancing medicines."... Full

Duty Relief to Boost Pharma Companies' Access to UK Drug Stores

(7/24, The Economic Times) ...The India-UK FTA is expected to give a strong tailwind to India's pharmaceutical and medical devices sectors with tariff relief and smoother regulatory pathways acting as critical drivers, industry experts told ET. The agreement will boost exports giving an easier access to the UK market. It is expected to help Indian companies - especially those in generics and biosimilars - to scale their market presence, fast track product approvals, provide a push to cross-border R&D and innovation... Full

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

(7/24, Eliza Slawther, Pink Sheet) ...Australia's Therapeutic Goods Administration is planning to review its clinical trial regulations over the next year, potentially following in the footsteps of the EU and UK. The TGA also announced plans to assess the impact of artificial intelligence on the medicines regulation framework and consider using this technology in its evaluations. Medicines shortages could also be addressed through data collection and legislative measures, the TGA said... Global Sub. Full

Weak Regulation Causing Deaths Due to Contaminated Medicines, WHO Says

(7/24, Sriparna Roy, Reuters) ...The World Health Organization said on Thursday systemic weaknesses in the oversight of the global pharmaceutical supply chain have resulted in medicines formulated with poisonous chemicals claiming lives and compromising the health of patients, mainly children. In a report, jointly released with the United Nations Office on Drugs and Crime, the WHO said there have been more than 300 deaths in Africa, Asia and the Pacific since 2022 linked to syrups containing industrial-grade chemicals such as diethylene glycol and ethylene glycol... Full

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