Tuesday, August 26, 2025

Sandoz CEO On Navigating Trump's Tariffs, "Distorted" U.S. Drug Market

(8/26, Tina Reed, Axios) ...CEO Richard Saynor is telling the Trump administration it should use carrots, not sticks, with generic drug makers that account for more than 90% of U.S. prescriptions but that compete on price and volume — to a point where, as he puts it, antibiotics sell for less than a packet of M&Ms. Sandoz makes about 1,300 generic and biosimilar products, some 150 of which are sold in the U.S. With 2024 annual sales of $10.4 billion, it's part of a cohort of generic drug giants that also includes Teva, Sun Pharma and Viatris...Saynor spoke to Axios about how his message is landing — and the volatility of navigating a second Trump term. The conversation has been edited for length and clarity... Full

Experts: False Premise Underlies Trump's ‘Freeloading' Drug Cost Pitch

(8/25, Maaisha Osman, Inside Health Policy) ...A former FDA associate commissioner and former Republican state senator who oppose importing international reference pricing to lower U.S. drug prices say U.S. trade policy should use economic measures like gross national income (GNI) per capita to crack down on countries that are "freeloading" on American drug innovation. But several drug pricing experts tell Inside Health Policy the proposal rests on a flawed assumption that drugmakers must maintain current profit levels to sustain innovation... Sub. Req’d

US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

(8/25, Laura Helbling, Pink Sheet) ...President Trump ordered the Assistant HHS Secretary for Preparedness and Response to create a list of 26 critical medicines and stockpile their active pharmaceutical ingredients. The effort will be subject to OMB helping repurpose existing funds. ASPR also must develop plans for a second SAPIR repository in the US... Global Sub. Full

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

(8/25, Grace Moser, Pink Sheet) ...AAM CEO John Murphy told lawmakers recently that FDA rehiring employees after the RIF should help expand the pace of domestic and foreign inspections. Murphy said inspection volume still has not reached pre-COVID-19 pandemic levels and the FDA needs the funding for a fully functional inspection force. The FDA's decision to rehire OGD policy staff hopefully will help alleviate the backlog of product-specific guidance development, Murphy said... Global Sub. Full

FDA's CDER Announces Updated Guidance Agenda for 2025

(8/25, Joanne S. Eglovitch, Regulatory Focus) ...This guidance aims to facilitate the development of biosimilar and interchangeable biosimilar products. It was not included in the earlier list issued this year, and this marks the fourth revision of the guidance. The third version of the Q&A guidance was issued in September 2021. The new list includes 87 guidelines scheduled for release, many of which are carried over from the January 2025 agenda... Full

FDA Rolls Out Daily Updates to Adverse Event Dashboard, Plans to Further 'Streamline' System

(8/25, Eric Sagonowsky, Fierce Pharma) ...Starting from last Friday, the FDA plans to update information in its FDA Adverse Event Reporting System (FAERS) on a daily basis. Previously, the FAERS dashboard was updated quarterly. "People who navigate the government's clunky adverse event reporting websites should not have to wait months for that information to become public," FDA Commissioner Marty Makary, M.D., said in a statement. "We're closing that waiting period and will continue to streamline the process from start to finish."... Full

Somewhere in Time: FDA Releases Its FY 2024 Report On Pharma Quality as Industry Looks to 2026

(8/26, John W.M. Claud and Mark I. Schwartz, FDA Law Blog) ...The FDA's fiscal year 2024 Report on the State of Pharmaceutical Quality from CDER's Office of Pharmaceutical Quality (OPQ) provides a look at the agency's efforts under previous leadership to normalize its post-pandemic oversight. But the FDA and the pharmaceutical industry are in transition under the current administration, as new quality challenges have emerged across global supply chains. FY2024 ran from October 2023 through September 2024, so this report does not address the possible impacts of more recent policies, actual and proposed tariffs, and reductions in force at FDA. That said, this look back contains a number of interesting highlights... Full

GSK India Re-Enters Oncology Segment With Launch of Jemperli and Zejula

(8/25, Anjali Singh, Business Standard) ...GSK India has re-entered the oncology segment with the launch of two precision therapies — Jemperli (dostarlimab) and Zejula (niraparib) — targeting gynaecological cancers as part of its strategy to expand its specialty medicines portfolio. This marks GSK's return to the cancer care segment after it sold its oncology portfolio to Novartis around a decade ago... Full

Viatris Locks Cipla Out Of Generic Yupelri Market Until 2039

(8/25, Dean Rudge, Generics Bulletin) ...Cipla is the seventh generic drug maker to settle Hatch-Waxman litigation over a generic version of the long-acting muscarinic antagonist bronchodilator, which is the first and only once-daily, nebulized LAMA approved in the US for the maintenance treatment of chronic obstructive pulmonary disease. Legal action kicked off in January 2023 when Theravance received notice that several generics sponsors – including Accord, Eugia, Lupin, Mankind, Orbicular, and Teva, as well as Cipla – had filed abbreviated new drug applications with paragraph IV certifications challenging five Orange Book patents for Yupelri... Global Sub. Full

Gland Pharma Receives USFDA Nod For Vasopressin In 5% Dextrose RTU Injection

(8/26, Business Standard) ...The company also received tentative approval for the (0.2 Units/mL) RTU vials of the same formulation. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection (0.4 Units/mL) and (0.2 Units/mL) of PH Health... Full

Aurobindo Pharma's Arm Gets UK MHRA Nod for Trastuzumab Biosimilar Dazublys

(8/26, Business Standard) ...Aurobindo Pharma said that its wholly owned subsidiary, CuraTeQ Biologics s.r.o, has received marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Dazublys, its biosimilar version of trastuzumab. Earlier in July 2025, Dazublys was also granted marketing authorisation by the European Commission (EC) for use in the European Union. This marks CuraTeQs fourth biosimilar approval from the MHRA, following the approvals of Bevqolva in December 2024, Zefylti in May 2025, and Dyrupeg in June 2025... Full

Aeon Expects Imminent Data On Botox Biosimilar

(8/26, Dave Wallace, Generics Bulletin) ...Aeon Biopharma expects to complete primary structure and select functional analyses for its ABP-450 proposed biosimilar to Botox by the end of the current quarter. A meeting with the FDA is planned in Q4 in late 2025 to discuss the results of these studies and align on the next steps in the development. Viatris and Revance have for some time partnered on their own biosimilar rival to Botox, although updates on their progress have been thin on the ground recently... Global Sub. Full

ANI Raises Guidance Once More But Admits Generics Sales Will Soften In H2

(8/25, Dean Rudge, Generics Bulletin) ...ANI Pharmaceuticals has quelled expectations for its Generics business, anticipating a decline in sales for the second half of 2025 following a strong first half, largely fueled by its generic prucalopride product. Despite a quarterly revenue increase of 22% to $90.3m, ANI acknowledged that revenue for the rest of the year would be lower compared to the first half due to market competition. ANI has raised its financial guidance for the year once more, with revenues expected between $818m and $843m, reflecting substantial growth compared to 2024... Global Sub. Full

Maker of Pricey Drug Reaches Settlement to Delay Launch of Generic Version

(8/25, Ashley Portero, South Florida Business Journal) ...Catalyst and its licensor SERB sued Lupin after the company filed an abbreviated new drug application with the FDA. Under the terms of the settlement agreement, Lupin will not market its generic version of Firdapse in the U.S. earlier than February 2035 if it receives FDA approval. The case is not Catalysts' first lawsuit surrounding Firdapse. In January, it initiated patent litigation against Teva after the firm submitted an abbreviated new drug application to market a generic Firdapse. The resulting settlement also stipulates that Teva cannot launch its generic version in the U.S before February 2035... Sub. Req’d

AbbVie Targets Psychedelic-Based Depression Drug Market With $1.2 Billion Deal

(8/25, Puyaan Singh, Reuters) ...The deal, which includes an upfront payment and development milestones, could also bolster AbbVie's neurological conditions portfolio after its experimental schizophrenia drug, which it gained access to through an $8.7 billion purchase of Cerevel Therapeutics, failed in two mid-stage studies last year. Gilgamesh's lead candidate for depression, bretisilocin, activates the 5-HT2A serotonin receptor — also targeted by classic psychedelics such as psilocybin, found in magic mushrooms, and LSD... Full

Lilly Will Seek Approval of GLP-1 Pill After Successes in Patients with Both Obesity and Diabetes

(8/26, Elizabeth Cairns, Endpoints News) ...Armed with data from another successful trial in nondiabetic obese patients, the company plans to seek approval for the pill this year. Approval is possible in 2026...Lilly said it is "moving with urgency" to file the drug for approval worldwide. Getting it approved could once again shake up the weight loss market, in which Lilly's injected drugs have stolen the lead from competitor Novo Nordisk. Novo has filed for approval of its own pill, which has shown strong results, and expects an approval decision later this year... Sub. Req’d

EU Industry Welcomes Generics Exemption From US Tariffs

(8/26, Dave Wallace, Generics Bulletin) ...While a 15% tariff is set to be applied to innovative medicines, a Q&A document from the Commission on the EU-US deal specifies that an exemption – in the form of only applying most-favored-nation (MFN) tariffs, which "are effectively zero or close to zero" – will apply to "generic pharmaceuticals and their ingredients and chemical precursors," among other protected categories such as unavailable natural resources and aircraft...Biosimilars are not mentioned on the list of exemptions, leaving it unclear as to whether they will fall under the same rules as generics or will be subject to the 15% tariff on innovative medicines... Global Sub. Full

Building A Biosimilar ‘Launch Machine' For MENA – MS Pharma CEO Sets Out Strategy

(8/26, Dave Wallace, Generics Bulletin) ...MS Pharma's CEO Kalle Känd talks to Generics Bulletin about how the firm is building up its biosimilars business in key markets in the MENA region. The chief executive explains the firm's shift from small-molecule generics, the importance of local manufacturing, and how the company is working to stay ahead of its local rivals. Känd also talks about the firm's ambitions to build up its B2B and CRO businesses in the EU, and potentially acquire front-end European operations... Global Sub. Full

Trump's Tariffs On India: Can Narendra Modi Plug In Act East Policy With China's Belt And Road Initiative?

(8/26, Asit Manohar, Mint) ...However, in the wake of Trump's tariffs and emerging trade war fears, the recent statement by the authorities from both sides has been affirmative, with a clear sign of rapprochement. They said that Donald Trump's tariff dictate has brought India-China-Russia closer, and it won't be a surprise if India joins China's Belt and Road Initiative (BRI), to give the US a Dutch therapy by penalising Pakistan, a medicine that Trump tried with Vladimir Putin by imposing tariffs on India. They said the Indian Prime Minister must integrate his ambitious Act East policy with China's BRI... Full

Safety Violations Found in 20% of Chemical/Pharma Industries in TG

(8/25, V. Swathi, The Hindu) ...Official inspection teams constituted by the government to take stock of industrial safety measures in the high-risk chemical and pharmaceutical factories in the State in the aftermath of the blast in Sigachi Industries on June 30, found serious violations in 20% of the sites visited... Sub. Req’d

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