Wednesday, September 24, 2025

Teva Price Target Raised to $26 from $23 at UBS

(9/24, The Fly) ...UBS raised the firm's price target on Teva to $26 from $23 and keeps a Buy rating on the shares. The stock can continue to see a relief rally as the Austedo IRA price gets revealed by November 30 or earlier, the analyst tells investors in a research note. Payor insights suggest that the potential IRA discount on Austedo could be about 40% off the list price, UBS says... Full

Bausch, Teva Accused of Delaying Generic Version of Diarrhea Drug Xifaxan

(9/23, Mike Scarcella, Reuters) ...Bausch Health and Teva Pharmaceuticals were sued on Monday for allegedly conspiring to delay sales of a generic version of Bausch's blockbuster diarrhea drug Xifaxan, causing buyers to pay inflated prices...Bausch has agreed to allow Xifaxan generics from Teva, Sun Pharmaceuticals and Sandoz starting in 2028 after settling related patent disputes... Full

Bausch, Teva Face Lawsuit for Delay in Generic Version of Xifaxan

(9/23, Nilanjana Basu, Seeking Alpha) ...The case, filed in Rhode Island federal court by the Rhode Island Laborers Health & Welfare Fund, claims Bausch paid Teva in 2018 to postpone selling a generic version of Xifaxan 550 mg, violating antitrust laws. The fund, which covers medical costs for its members, said it will continue paying inflated prices until at least January 2028, when Teva is permitted to launch its generic version... Full

Teva Inks PPA to Back Enery's 122-MW Solar, BESS Project in Bulgaria

(9/24, Sladjana Djunisic, Renewables Now) ...Austrian renewables firm Enery has signed a 15-year power purchase agreement (PPA) with Teva Pharmaceutical Industries, securing an off-taker of electricity generated by a new 122-MW solar farm with integrated battery storage in southern Bulgaria... Full

Enery Signs 15-Year PPA with Teva Bulgaria

(9/24, Radina Veleva, SeeNews) ...A financial PPA is essentially a price hedge rather than a power delivery contract. Instead of receiving electricity, Teva obtains green certificates, allowing it to claim the use of renewable energy. The project is expected to help cut about 15,840 metric tons of CO2 emissions per year, in line with Teva's goal to reduce its Dupnica and Troyan plants' emissions by 46.2% by 2030... Full

Schneider Electric Supports Teva Pharmaceuticals' Long- Term Renewable Energy Goals Through 15-Year VPPA in Bulgaria

(9/23, Schneider Electric) ...The project, one of Europe's first to combine photovoltaic (PV) and battery energy storage systems (BESS), marks a significant milestone in Teva's journey toward 100% renewable electricity by 2035 and net-zero emissions by 2045. Schneider Electric served as Teva's advisor throughout the VPPA process, helping align the agreement with its long-term decarbonization strategy..."This agreement represents another significant step forward in our decarbonization journey," said Josh Decktor, Vice President, Head of Global Environment Health Safety & Sustainability, Teva. By investing in a newly built solar asset with integrated storage, we are not only securing clean energy but also enhancing grid resilience and flexibility—key components of our strategy to meet our science-based targets."... Full

Working Capital Optimisation in Times of Disruption

(9/24, EuroFinance) ...Michael Ben Moshe, VP and head of global working capital and cash optimisation at Teva Pharmaceuticals, an innovative biopharmaceutical company, enabled by a world-class generics business, and Carol Thurnheer, senior manager international treasury for the Americas and M&A at Haleon, a consumer health company, shared their perspectives on the new pressures facing working capital and the evolving role of treasury... Full

Drugmakers Meet Trump Only Halfway On Pricing Plan

(9/24, Peter Sullivan, Axios) ...Bristol Myers Squibb became the latest company to make a pricing move on Monday, when it said it would sell its schizophrenia drug Cobenfy in the United Kingdom at the higher U.S. list price. There was no corresponding move to cut U.S. prices, though...Trump might view higher prices abroad as a win, "but that might not feel like a win for patients who still can't afford their drugs here," said Rachel Sachs, a law professor at Washington University in St. Louis who was a Health and Human Services official in the Biden administration. There are also questions about whether the recent announcements would have much effect, since they affect list prices rather than the net prices that are actually paid... Full

Bristol Myers' US/UK List Price Parity Plan For Cobenfy Leverages Trump's MFN Concerns

(9/23, Kevin Grogan and Cathy Kelly, Pink Sheet) ...BMS cited the Trump Administration's focus on most favored nation pricing as a factor in its plan to charge the same list price for Cobenfy in the UK and US. The announcement is a shot across the bow for price regulators in the UK, in part because other companies likely will follow as efforts to close the price gap in the US and comparable economies continue. Concerns about setting an MFN benchmark abroad that could be implemented in the US likely will remain a factor in foreign price negotiations, health policy expert Alice Valder Curran said... Global Sub. Full

Pharma, Other Stakeholders Urge Lawmakers To Further Tweak Drug Price Negotiation

(9/23, Gabrielle Wanneh, Inside Health Policy) ...On the heels of Congress expanding the orphan drug exclusion in the Medicare drug price negotiation program, a coalition of drug companies, insurers and patient advocacy groups have stepped up efforts to convince lawmakers to pass legislation that would stretch out the timeline for when small-molecule drugs are eligible for price negotiation. But the efforts face strong opposition from congressional Democrats and consumer advocates, who say the orphan drug exclusion expansion included in Republicans' One Big Beautiful Bill law was a giveaway to big pharma and oppose further tweaks to the program... Sub. Req’d

Reported ‘TrumpRx' Plan Seen As Modern Take On Bush's Medicare Drug Card

(9/23, Maaisha Osman, Inside Health Policy) ...A health policy expert told Inside Health Policy the Trump administration's reported exploration of a government-run drug discount website signals an effort to modernize the troubled Medicare drug card program launched under former President George W. Bush. It also comes after a drug discount card idea fizzled under the first Trump administration... Sub. Req’d

How Will Trump's Visa Brick, Rubio's Tariff Fix, Lower Domestic Tax Impact Indian Pharma?

(9/24, Vibha Ravi, Pink Sheet) ...A complex interplay between trade policy shifts and pharmaceutical accessibility is playing out in the Indian market. The Trump administration has begun adding non-tariff barriers like an increase in H-1B visa fees after imposing tariffs on goods on products made in India. While pharma remains exempt, unease grows over the fate of generics as Trump has shown an inclination to deliver on re-election promises irrespective of the cost to industry. US Secretary of State Marco Rubio has hinted at a re-evaluation of tariffs imposed due to India's purchases of Russian oil. India's government has lowered the Goods and Services Tax (GST) on critical drugs, making them more affordable. 36 lifesaving drugs will now face reduced or no GST. Despite these changes, the pharmaceutical industry remains cautious about the long-term impacts, especially regarding potential future tariffs on generic drugs... Global Sub. Full

Countering Trump, European Health Officials Stress that Acetaminophen is Safe to Use During Pregnancy

(9/23, Andrew Joseph, STAT+) ...Regulators in Europe have issued new statements backing the safety of Tylenol use in pregnancy, effectively repudiating claims from the Trump administration that the medicine can cause autism in children. The statements from health authorities in the U.K. and European Union do not mention President Trump's Monday news conference warning about the use of acetaminophen (the active ingredient in Tylenol) in pregnancy, but their publication reflects fears from experts that Trump's assertions could cause unnecessary confusion for families... Sub. Req’d

Tariffs, Pricing, and Regs: Navigating Exponential Complexity

(9/23, Jay Bhatt, Deloitte) ...Tariffs, policies, and pricing are expected to remain in flux through 2026, with changes potentially extending into 2027. A number of proposed regulations could further impact drug manufacturing and the supply chain. Brian noted that the shifting landscape appears to have led to an "intersection of worlds" and a need for company executives to strengthen existing connections and or forge new ones in areas where connections might not have existed in the past. Our panelists suggested that policy in one area is likely to impact stakeholders across the industry and that organizations should consider working together across functions with agility... Full

The Complications of Determining a Drug's Value

(9/24, Mike Hollan, PharmExec.com) ...Peter Rubin, executive director of No Patient Left Behind, spoke with Pharmaceutical Executive about President Trump's Most-Favored Nation (MFN) order and the widespread impact it could have on the industry. While the order seeks to reduce drug costs in the United States by enforcing a rule based on foreign prices, it's likely that this rule could force pharma companies, large and small, to adjust the way they approach innovation. According to Rubin, the ruling is likely to impact more than just pricing. He also believes that it will be hard to even find a fair price for the drugs using the MFN order as determining a drug's true value is more difficult that it first appears... Full

Some New Drugs Aren't Actually ‘New' – Pharmaceutical Companies Exploit Patents and Raise Prices for Patients, But Data Transparency Can Help Protect Innovation

(9/23, Lucy Xiaolu Wang, The Conversation) ...I am an economist studying innovation and digitization in health care markets. My colleague Dennis Byrski and I have focused on how regulatory transparency plays a role in curbing weak patents. Our recently published research found that when clinical trial data become public, this disclosure makes it harder for firms to obtain patents for incremental changes that add little therapeutic benefit for patients...Better aligning patents with genuine innovation is not just a legal concern but a public health imperative. Transparency, paired with smarter review systems, can help raise the bar for drug development and reward the kinds of innovations that truly improve health... Full

GOP Should Stop Big Pharma's Patent Games

(9/22, Scottie Nell Hughes, RealClearHealth) ...When Congress passed the Hatch-Waxman Act in 1984, it was a model of smart policymaking. The law struck a careful balance, maintaining patent protections to reward pharmaceutical innovators for undertaking the risks of drug development, while ensuring that once patents expired, lower-cost generics could quickly reach the market. The framework it established worked for decades, fueling innovation and saving American patients billions. But that framework has been hijacked by Big Pharma's newest innovation: serial patent litigation. A new white paper from the Association for Accessible Medicines and the Biosimilars Council details how... Full

US House Of Representatives Successfully Marked Up Bureaucracy-Cutting Q1/Q2 Generic Drug Bill

(9/23, Urte Fultinaviciute, Generics Bulletin) ...The US House of Representatives has advanced the H.R.1843 bill aimed at increasing transparency in generic drug applications, authorizing the FDA to disclose certain ingredient information. At the same time, the Biosimilar Red Tape Elimination Act, which seeks to remove the interchangeability designation, was again introduced to the chamber. Both bills have companion legislation in the Senate and have received support from US trade groups... Global Sub. Full

Industry Should ‘Lead From The Outside' With US FDA Policy Staff Decimated, Woodcock Says

(9/23, Derrick Gingery, Pink Sheet) ...Janet Woodcock said the FDA policy staff is so depleted that industry should try to lead from the outside. The FDA does not have a lot of time for "extracurricular activities" in policy development, she said. Agency reform efforts should consider near- as well as long-term ideas, said Annie Kennedy of the EveryLife Foundation for Rare Diseases... Global Sub. Full

Gottlieb Calls for FDA Reform, Investment to Counter Chinese Medical Innovation

(9/23, Ferdous Al-Faruque, Regulatory Focus) ..."I think long term, if I was to focus on what I think the biggest challenge is, it's really the secular threat from the ecosystem growing up in China," said Gottlieb. He noted that traditionally, US drugmakers used to outsource the pharmacology of their drugs to companies in China, which would synthesize them based on specifications, and then send them back to the US for use in clinical trials. Gottlieb noted that Chinese labs could synthesize the drugs faster and cheaper, and the division of labor was a win-win for everyone. However, over time, Chinese firms have become very good at designing their own novel drugs, which poses a significant challenge to US medical innovation... Full

FDA's Move to Update Old GSK Drug for Autism Raises Questions On Dose, Supply and Data

(9/23, Zachary Brennan, Endpoints News) ...In an unprecedented move, the FDA is calling on GSK to update the label for a now-generic drug called leucovorin that it stopped selling more than 28 years ago, claiming an agency review of the medical literature shows it might help with autism...GSK told Endpoints that it will update the label for the drug at the FDA's request, but it has no plans to restart manufacturing of leucovorin, which it once sold under the brand name Wellcovorin. There are also questions about what dose of the drug patients would get, since generic companies offer various doses and formulations... Sub. Req’d

FDA Finalizes Device Production and Quality System Software Guidance

(9/23, Jeff Craven, Regulatory Focus) ...The US Food and Drug Administration's (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section clarifying terms used in the guidance. However, the agency did not implement stakeholder suggestions to align it more closely with similar guidances or address some of the concerns regarding the validation of certain kinds of software or tools... Full

Novartis, Abbvie Lose Bid to Block Maine Law On Federal Drug Discount Program

(9/23, Nate Raymond, Reuters) ...A federal judge on Tuesday refused to block Maine from enforcing a new state law requiring drugmakers to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving rural, low-income populations... Full

Youngkin Promises Negotiated Fix for Weight Loss Drugs as Costs Expected to Increase

(9/23, Brad Kutner, Radio IQ) ...Speaking at the announcement of a $5 billion Eli Lilly drug production facility, Governor Glenn Youngkin said 2025 budget language that would have allowed Medicaid recipients more access to blockbuster weight loss drugs would have stifled cost-cutting negotiations between the state's Medicaid agency and drug producers. "We are undertaking that process now and I would expect we'll have a lot to say about that come December in my budget speech," Youngkin said... Full

Eli Lilly to Make Weight-Loss Pill in New $6.5 Billion Texas Plant

(9/23, Patrick Wingrove, Reuters) ...The Houston facility will make the active pharmaceutical ingredients for orforglipron and for some of Lilly's cancer, autoimmune and other advanced therapies, the company said. Lilly Chief Executive David Ricks told Reuters the new plant would be a major hub for orforglipron production, although the drug will also be made at a site in Indiana... Full

Neurocrine Details Phase 2 Results for Depression Drug 

(9/23, Lei Lei Wu, Endpoints News) ...Jefferies analyst Akash Tewari wrote in a note on Tuesday that the placebo-adjusted efficacy continues to look similar to J&J's Spravato. Spravato is a relative of ketamine and is used to treat major depressive disorder. However, Tewari added that there are still questions about whether osavampator's efficacy will hold up in Phase 3 studies, given the lack of dose response and that the measured effect for depression drugs generally shrinks when going from Phase 2 to Phase 3 studies... Sub. Req’d

Alvotech Dominates September CHMP Meeting With First Golimumab Biosimilar

(9/23, Dean Rudge, Generics Bulletin) ...Alvotech has swiftly followed a Japanese approval with a recommendation for approval in Europe for its Gobivaz (golimumab) biosimilar to Johnson & Johnson's Simponi. During the European Medicines Agency's Committee for Medicinal Products for Human Use, a further seven denosumab biosimilars referencing either or both of the Prolia and Xgeva brands were also recommended for approval. Meanwhile, Alvotech's partner Stada has received backing for a further biosimilar to Stelara (ustekinumab)...Teva also scooped a CHMP recommendation for its denosumab biosimilars, Ponlimsi and Degevma, which reference Prolia and Xgeva respectively... Global Sub. Full

Amneal Receives FDA Nod for Generic Lumigan

(9/23, Sandra Levy, Drug Store News) ...The Food and Drug Administration has approved Amneal's bimatoprost ophthalmic solution 0.01% (2.5 ml, 5 ml and 7.5 ml), which is the generic of Allergan's Lumigan. Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension... Full

Alvogen Announces Sale to Lotus, Creating a Leading International Specialized Generics Platform

(9/23, Alvogen Pharma US) ...Alvogen Pharma US, Inc...today announced a definitive agreement by its shareholders to sell its parent company to Lotus Pharmaceutical Co., Ltd. Under the terms of the agreement, Alvogen will become a controlled subsidiary of Lotus, subject to customary closing conditions... Full

Sam Chun Dang Wins Korea and Japan OKs for Eylea Biosimilar

(9/23, Kim Ji-hye, Korea Biomedical Review) ...Sam Chun Dang Pharm said Tuesday it secured approvals in Korea and Japan for SCD411, its Eylea (aflibercept) biosimilar, in both vial and prefilled-syringe formats. The new authorizations add to earlier clearances in Canada and Europe and move global launches closer. Sam Chun Dang said it plans additional filings, targeting first sales in some markets as early as 2026 to 2027... Full

Daewoong, Dongkook Face 2027 Bioequivalence Deadline

(9/24, Heo Ji-yoon, ChosunBiz) ...Daewoong Pharmaceutical and Dongkook Pharmaceutical, which have long led the domestic market for leuprorelin-based precocious puberty treatments, are now undergoing re-evaluation trials for their generic drugs. If they fail to demonstrate biological equivalence to the original drug by the end of 2027, their product approvals will be canceled. Peptron and LG Chem, which entered this market as latecomers, are seeking to reverse the situation by proving equivalence first... Full

Indian Drugmakers Dr. Reddy's, Hetero to Sell Generic HIV Prevention Drug for $40 a Year

(9/24, Rishika Sadam and Jennifer Rigby, Reuters) ...Indian drugmakers Dr Reddy's Laboratories and Hetero Labs said on Wednesday that they will sell generic versions of a new and highly effective HIV prevention drug for roughly $40 per year beginning in 2027..."The ($40) price that we have negotiated... brings the product in parity with the cost of the oral PrEP," Carmen Perez Casas, Unitaid's strategic lead for HIV, told Reuters, using the short phrase for pre-exposure prophylaxis, or preventive, drugs... Full

Celltrion Spends A Billion To ‘Eliminate Tariff Risks' With US Facility

(9/23, Dave Wallace, Generics Bulletin) ...Celltrion has struck a deal to acquire a US biologics manufacturing facility in Branchburg, New Jersey, from Eli Lilly for around $330m. The Korean firm says that including initial operating costs, the outlay will amount to KRW700bn – around half a billion dollars – and has indicated that it plans to spend as much again on expansion. Celltrion said the move offered a "fundamental elimination of US tariff risks, freeing future pipeline products from tariff exposure."... Global Sub. Full

Eli Lilly Boss Brands UK ‘Worst Country in Europe' for Cheap Drug Prices

(9/23, Patrick Temple-West and Hannah Kuchler, Financial Times) ...In an interview with the Financial Times, Lilly chief executive Dave Ricks said the UK would miss out on new drugs if it did not raise prices and scrap a contentious rebate scheme. The country paid less for drugs than other developed countries, Ricks said, "unless that changes, I don't think they will see many new medicines and I don't think they will see much investment". "That's the UK's choice, but we react to those choices."... Sub. Req’d

UK is ‘Worst Country in Europe' for Drug Prices, Says Mounjaro Maker

(9/24, Mark Sweney, The Guardian) ...Ricks's comments come as big pharmaceutical companies have ditched or paused almost £2bn in planned UK investments so far this year, amid a push by Donald Trump for companies to offer comparable medicine prices for Americans as in other countries. Pharmaceutical companies are pushing for the UK government to restart negotiations over VPAG – the voluntary scheme for branded medicines pricing, access and growth – which was created to keep NHS costs down... Full

Open Letter To Coreper: Council's Homeopathic Approach To Critical Medicines Act Will Succeed In Watering Down EU Health Security

(9/24, Medicines for Europe) ...While far from perfect, the Commission's proposed regulation included genuine reforms to generic critical medicine markets, the prioritisation of funds to support manufacturing and rules to ensure that national stockpiling would not harm the supply of medicine in neighbouring countries. We are shocked to see the concerted efforts of some Member States to water down the Act as much as possible and we question how this could be compatible with the political ambition of the European Council to support more strategic autonomy, supply diversification, and EU solidarity... Full

Turning Policy into Progress

(9/23, European Pharmaceutical Manufacturer) ...The UK's ambitious Life Sciences Sector Plan outlines a comprehensive roadmap aimed at strengthening the country's position as a leader in science and innovation by 2030. Its targets are compelling, from cutting clinical trial setup times to building an AI-ready Health Data Research Service. Yet while policy and vision provide critical direction, they alone do not guarantee results. As Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI) puts it, "Without change, the UK will continue the slow slide down international league tables for research, investment, and the availability of new medicines."... Full

China Rolls Out Nationwide 30-Day IND Pathway For Innovative Medicines

(9/23, Xu Hu, Pink Sheet) ...The move aligns with global trends towards streamlining the drug development and approval process and enabling patients to access innovative medicines faster, Qi Li, vice-president and head of Regulatory Affairs, R&D at Bayer China, told the Pink Sheet. Others in the industry in China were also positive, a spokesperson for major Chinese firm Innovent Biologics predicting that the policy will improve the industry's ecosystem and create a more standardized and efficient environment for conducting clinical trials in China. It should also further optimize the country's policy environment for innovative drug R&D and accelerate the process for qualified novel medicines to enter the clinical stage, ultimately benefiting patients, they told the Pink Sheet... Global Sub. Full

Russia Registers its First Generic Version of Canakinumab

(9/23, GxP News) ...Generium has received a registration certificate for the first Russian biosimilar of canakinumab. The drug, Limiris, is presented as a lyophilized powder for subcutaneous injection...However, as experts state, it is not economically justified to produce all drugs in Russia from start to finish. A universal requirement for localization at all stages can lead to supply disruptions and a reduction in the range of available drugs... Full

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