Tuesday, September 23, 2025

Goldman Sachs Reiterates Buy Rating On Teva Pharma (TEVA)

(9/23, StreetInsider.com) ...Goldman Sachs analyst Matt Dellatorre reiterated a Buy rating and $25.00 price target on Teva Pharma... Sub. Req’d

Truist On Teva Pharma (TEVA): 'We See Upside To Mgmt's Schizo Franchise Guide'

(9/23, StreetInsider.com) ...Truist Securities analyst Les Sulewski reiterated a Buy rating and $25.00 price target on Teva Pharma. The analyst commented: "We See Upside To Mgmt's Schizo Franchise Guide; We highlight some additional nuggets following today's recap call on Olanzapine LAI data presentation from this weekend's Psych Congress."... Sub. Req’d

Teva Unveils Promising SOLARIS Results for Olanzapine LAI

(9/23, Indian Pharma Post) ...Professor Christoph Correll, MD, coordinating investigator of the SOLARIS study and Professor of Psychiatry at the Zucker School of Medicine, added: "These encouraging results suggest that olanzapine LAI (TEV-'749) could become a valuable new treatment option for patients who may not prefer or struggle with adherence to daily oral medications. This long-acting formulation builds on the proven efficacy of olanzapine while addressing a long-standing clinical need."... Full

Real-World Data Shows Strong Symptom Relief and Patient Satisfaction with Teva's Austedo XR

(9/23, Indian Pharma Post) ..."The reality of tardive dyskinesia goes beyond clinical symptoms—it affects people's daily lives, their confidence, and their ability to connect socially," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "At Teva, we are deeply committed to understanding the lived experiences of patients and ensuring that treatments like AUSTEDO XR not only manage symptoms but also restore a sense of freedom and well-being."... Full

Birth Control Among US Therapies Most At Risk From Trump's 250% Tariff Threat

(9/22, Satviki Sanjay, Bloomberg) ...Approximately 65% of all birth control pill prescriptions in the US last year were manufactured by just two India-based companies, Glenmark Pharmaceuticals Ltd. and Lupin Ltd., according to a Bloomberg News analysis of data provided by health care intelligence firm Symphony Health. While dependence on Indian imports and a narrow supply base is particularly acute for the birth control pills, some other drug categories are not far behind. Treatments for hypertension and depression are second only to birth control medication, with more than 50% of US prescriptions serviced by Indian generic drugmakers, the data shows... Full

Trump's Tylenol Warning Could Fuel New Lawsuits

(9/23, Maya Goldman, Axios) ...Publicly asserting a connection the way Trump did may also encourage lawsuits around Tylenol use after birth, potentially upending the market for the ubiquitous drug. Kenvue, the Johnson & Johnson spinoff that makes brand-name Tylenol, said in a statement that it strongly disagrees with the connection and that "independent, sound science clearly shows that taking acetaminophen does not cause autism," Axios' Nathan Bomey reported. Still, the company's shares are down 20% in the last month... Full

PhRMA Statement On Autism

(9/22, PhRMA) ..."Parents of children with autism want the best for their kids and ongoing research on the underlying causes and treatments are essential to provide the answers they deserve. Importantly, a vast body of scientific research has thoroughly debunked claims linking vaccines, their ingredients or the childhood immunization schedule to autism, and today's announcement does not change that."... Full

Vaccines and Autism: Decades of Scientific Evidence Find No Link

(9/22, Mike Ybarra, PhRMA) ...With autism, there is a lot we know, there are places we need to study more and there are answers we already have: vaccines and their ingredients are not the cause. Decades of scientific research and peer-reviewed studies have found no connection exists between vaccines or their ingredients and autism. While researchers continue to study its underlying causes, increases in autism diagnoses are better explained by expanded diagnostic criteria, improved screening and greater public awareness – not vaccines... Full

UK Tells Patients to Ignore Donald Trump's Advice On Paracetamol

(9/23, Anna Gross, Financial Times) ...UK health secretary Wes Streeting has told the British public not to "pay any attention" to remarks by Donald Trump claiming that the use of paracetamol during pregnancy was linked to autism in children...He told ITV on Tuesday: "I would just say to people watching, don't pay any attention whatsoever to what Donald Trump says about medicine. In fact, don't take even take my word for it, as a politician — listen to British doctors, British scientists, the NHS." The intervention by a senior British cabinet minister is likely to be poorly received by the Trump administration, who only last week received a warm and conflict-free reception during his state visit... Sub. Req’d

Republicans Should Lead the Charge to Stop Big Pharma's Patent Games

(9/22, Scottie Nell Hughes, RealClearHealth) ...We don't need more bureaucracy or price controls. We just need to restore competition and fairness. Every day of delay costs American patients dearly. It's time to stop Big Pharma's patent games, restore balance to the Hatch-Waxman framework, and deliver the conservative solution: lower costs through real competition... Full

340B Reform Advocates Hail CBO Report, But ‘Scoreable' Savings Still In Doubt

(9/22, Michael McCaughan, Pink Sheet) ...The CBO report on 340B may help advocates who want to curtail the program's spending, but the findings likely will not help pass legislation. The report included several issues increasing federal spending in 340B, but indicated offsetting impacts also were possible. In addition, CBO confirmed the 340B program's size now makes it a significant subsegment of the US market... Global Sub. Full

The Biosimilars Forum Applauds Representative Pfluger (R – TX) and Representative Landsman (D – OH) for Helping Make Lower-Cost Medicines Available to Americans

(9/22, Biosimilars Council) ..."The Biosimilars Forum thanks the Congressmen for their leadership in reducing prescription drug costs, improving access to biosimilars, and encouraging free-market competition," said Juliana M. Reed, executive director the Biosimilars Forum. "Biosimilar development should evolve to reflect current science and available evidence. The Forum and our members look forward to working with Congress and the Administration to continue supporting access to lower-cost medicines for Americans."... Full

Axsome to Settle Class Suit Over Migraine Drug for $7.75 Million

(9/22, Bernie Pazanowski, Bloomberg Law) ...Those suing alleged Axsome committed securities fraud in relation to the rollout of a migraine drug's progress toward US Food and Drug Administration approval. The investors claim Axsome and two of its executives made positive statements about the approval timeline despite knowing about manufacturing equipment problems and the resulting supply issues... Sub. Req’d

EMA Committee Recommends Marketing Authorization for STADA's Denosumab Biosimilars

(9/23, Pharmabiz.com) ...STADA received positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorizations be granted in Europe for its Kefdensis and Zvogra biosimilar denosumab candidates. The CHMP recommended approval for the same indications, route of administration and dosing regimen as the Prolia (bone health) and Xgeva (oncology) reference medicines... Full

Amneal Opens Up Competition To Xyrem In US With First ANDA Nod

(9/23, Dave Wallace, Generics Bulletin) ...Amneal has obtained the first ANDA approval for a rival to Jazz Pharmaceuticals' Xyrem (sodium oxybate) 0.5g/ml oral solution. Xyrem has previously faced only authorized generic competition, including from Amneal as well as Hikma. Settlement deal arrangements around Xyrem have previously faced antitrust scrutiny... Global Sub. Full

Dr Reddy's Biosimilar Gets Nod from European Medical Agency's Panel

(9/22, The Hindu BusinessLine) ...The European Medical Agency's (EMA) committee for Medicinal Products for Human Use (CHMP) has recommended AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab) for marketing authorisation...Dr. Reddy's commercialisation rights are exclusive for the U.S., and semi-exclusive for Europe and the UK. Upon approval Dr. Reddy's will offer the biosimilar under the trade names Acvybra (denosumab) solution for injection in a pre-filled syringe and Xbonzy (denosumab) solution for injection in a vial... Full

Aurobindo Pharma Eyes 'Significant Portion' Of $7 Billion Osteoporosis Drug Market

(9/23, NDTV Profit) ...Following the announcement of successful Phase 3 clinical study results, the company is preparing for regulatory filings in major Western markets and setting its sights on a significant portion of a global market currently valued at $7 billion, according to Satakarni Makkapati, CEO of the biologics, vaccines, and peptides businesses at Aurobindo Pharma. "So the drug has a market potential of around $7 billion globally, with entrants in biosimilars shaping the market probably from late 2025. We just announced a strong Phase 3 result for this biosimilar with regulatory filings planned for the US, EU and other key markets beginning from January 2026," Makkapati said during a conversation with NDTV Profit... Full

Celltrion Achieves European First With Omalizumab Biosimilar Launch

(9/22, Dean Rudge, Generics Bulletin) ...Celltrion has won the race to launch the first biosimilar to Novartis/Roche's blockbuster treatment for chronic spontaneous urticaria and severe persistent allergic asthma in Europe...Other companies known to be either developing or have filed biosimilars to Xolair include Alvotech and Kashiv BioSciences' AVT23/ADL-018 version...Another develop is Teva, which has wrapped up a Phase III clinical trial comparing its TEV-45779 candidate against the reference product in patients with chronic idiopathic urticaria/chronic spontaneous urticaria... Global Sub. 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

Alkem Launches Pertuzumab Biosimilar in India for Treatment of Breast Cancer

(9/22, Viswanath Pilla, Moneycontrol) ...Alkem Laboratories Ltd. on Monday announced the launch of Pertuza injection 420mg/14ml, a pertuzumab biosimilar, in India for the treatment of HER2-positive breast cancer. Alkem's Pertuza is an affordable, indigenously-developed and manufactured biosimilar of pertuzumab. In the pivotal phase 3 clinical trial, Alkem's pertuzumab biosimilar, developed by its biotech subsidiary, demonstrated equivalence in efficacy, safety, and immunogenicity to the reference product of the innovator, the company said in a press release... Full

Henlius Aims to Launch More Biosimilars in US, EU

(9/23, Bloomberg) ...Jason Zhu Jun, Executive Director and CEO of Chinese drugmaker Shanghai Henlius Biotech, says the Hong Kong-listed firm is gaining more confidence among international partners as it focuses on expanding its offerings the US and the EU. He speaks exclusively with David Ingles and Yvonne Man on "Bloomberg: The China Show."... Full

Celltrion Acquires U.S. Biopharma Plant from Eli Lilly to Counter Tariff Threats

(9/23, Choi Kyong-ae, Yonhap News) ...Celltrion Inc., South Korea's leading biopharmaceutical company, said Tuesday its U.S. subsidiary has signed a deal to acquire a U.S. biopharmaceutical production facility, a move it said will "eliminate" risks from looming U.S. tariff hikes. Celltrion USA Inc. will take over the production facility from Eli Lilly for 460 billion won (US$330 million) and aims to complete the deal by the end of this year, the company said in a press release... Full

Threat of US Tariffs Hangs Over Sun Pharma's Specialty Business

(9/23, Ashish Agrawal, Mint) ...Sun Pharmaceutical Industries Ltd expects a limited impact from the US government's most favoured nation (MFN) drug pricing directive, management told analysts at a meeting last week. The directive requires US agencies to ensure that the price of a prescription drug in the US is no higher than its lowest price in other developed countries. Sun faces low MFN risk thanks to its focus on specialty products, which have limited exposure to Medicaid, the US health insurance program that covers individuals and families with low income and resources... Sub. Req’d

'We Have the Will': Roche Unveils Strategy to Become 'Top 3' Obesity Company

(9/22, James Waldron, Fierce Biotech) ...Roche has set its sights on becoming a "top three" obesity company, according to the pharma's long-awaited strategy for cracking the weight loss market. Addressing a conference room full of investors in London this morning, Roche Pharma CEO Teresa Graham emphasized that she was "serious about this goal." The aim is to become a "strong entrant" into the obesity space "before 2030" thanks to "competitive products," Graham explained during her presentation at Roche's Pharma Day... Full

Roche, Muscling into Weight-Loss Drug Race, Advances Obesity Treatment to Late-Stage Trial

(9/22, Maggie Fick, Reuters) ...At an investor day in London, company executives laid out why they believed Roche could seize market share from Novo and Lilly, the first entrants to the obesity drug race, showing their understanding of the market's unique dynamics. This included the fact that much of it remains a cash-payer market, with patients paying out of pocket without insurance reimbursement. Roche pharmaceutical division head Teresa Graham told investors the company planned to secure a strong entry to the lucrative obesity-drug market with competitive products by 2030... Full

Specialty Drugs, Chronic Conditions Drive U.S. Employers to Reevaluate Health Plans

(9/22, Briana Contreras, Managed Healthcare Executive) ...It was found that one in three U.S. employers plans to make significant changes to their healthcare programs within the next three years as costs rise to their highest point in more than two decades, according to a survey published by WTW. The 2025 Best Practices in Healthcare Survey found that U.S. employers project their healthcare costs, before plan changes, will increase by 9.1% in 2026, compared with 8.1% in 2025 and 7.0% in 2024. After planned program adjustments, costs are expected to rise 8.0%, 7.0%, and 6.0% in those years... Full

Belgian Pharma Body Warns Cuts Threaten Access to Innovation

(9/22, The Pharma Letter) ...Belgium's drug industry association has warned that repeated budget cuts are restricting patient access to new medicines and could erode the country's position as a global biopharma hub. In a blog post, pharma.be chief executive Caroline Ven said fewer innovative therapies are being reimbursed and patients face longer waits... Sub. Req’d

Belgium Competition Authority Tackles Reimbursement Barriers For Combination Drugs

(9/22, Francesca Bruce, Pink Sheet) ...New guidance from the Belgian Competition Authority (BCA) clarifies how companies with products included in a combination therapy can exchange information for the purpose of submitting a parallel reimbursement application, without breaking competition rules. According to BCA, information exchanges "must be strictly limited to what is objectively necessary to obtain reimbursement for a combination therapy."... Global Sub. Full

India's Generic Pharma Faces Tariff Uncertainty But Retains Edge in US Market: JPMorgan Analyst

(9/23, Nandini Sanyal, The Economic Times) ...According to Bansi Desai, Healthcare Analyst at JPMorgan, while the US has temporarily exempted Indian generic drugmakers from the Trump administration's tariff measures, the uncertainty surrounding the pending Section 232 investigation still looms large..."Generics play a very pivotal role for the US healthcare economy. They bring down the overall healthcare cost burden, and India has established itself as a reliable and large-scale supplier. That's why, despite tariff discussions, the US government knows the importance of Indian pharma," Desai explained... Full

Beijing Tackles Drug Price Wars with New Tendering Rules in Anti-Involution Push

(9/23, Eric Ng, South China Morning Post) ...Beijing's new rules for state-led bulk tendering of medical drugs are the latest example of its "anti-involution" drive to combat cutthroat competition, a move analysts said would favour more established players. "The centralised bulk procurement rules optimisation is a sign that the National Healthcare Security Administration is proactively pushing Beijing's anti-involution agenda within the pharmaceutical sector as part of efforts to bolster domestic consumption," Guotai Haitong Securities' analysts said in a research note on Monday... Full

Hong Kong To End Reliance On Overseas Drug Approvals

(9/22, Anabel Costa-Ferreira, Pink Sheet) ...Hong Kong is pushing forward with its vision to build an "internationally renowned" regulatory authority of drugs and medical devices. Meanwhile, the Department of Health's 1+ drug registration mechanism has received over 620 enquiries from over 160 pharmaceutical companies... Global Sub. Full

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