Monday, September 22, 2025

Teva Reports Positive Olanzapine Safety Data, Austedo Survey Results

(9/21, Elijah Dale, Alliance News) ...The Tel Aviv-based pharmaceuticals company said new long-term safety data from a phase three trial indicated there were no suspected or confirmed post-injection delirium and sedation syndrome events observed in adult patients treated with the long-acting injectable form of Olanzapine for schizophrenia...In addition to this, Teva presented positive findings from a survey of patients taking Austedo XR, or deutetrabenazine, extended-release tablets for the neurological movement disorder tardive dyskinesia... Full

Teva Presents 10 Posters from its Schizophrenia Medicines Portfolio

(9/21, The Fly) ...Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced the presentation of 10 posters from its schizophrenia medicines portfolio, including long-term safety data from the completed SOLARIS Phase 3 trial showing no incidence of post-injection delirium/sedation syndrome, PDSS, in study participants taking olanzapine LAI, a once-monthly, long-acting injectable, LAI, subcutaneous formulation of olanzapine... Full

Latest Batch of New Meds Backed for Approval by EMA/CHMP

(9/19, The Pharma Letter) ...The committee adopted positive opinions for nine biosimilar medicines: Dr Reddy's Acvybra(denosumab), Teva Pharmaceuticals', Intas' Denosumab Intas (denosumab), STADA Arzneimittel' Kefdensis (denosumab), and Teva's Ponlimsi(denosumab), for the treatment of osteoporosis and bone loss. Teva's Degevma (denosumab) Xbonzy (denosumab), and STADA's Zvograb (denosumab), for the prevention of skeletal-related events in adults and treatment of adults and skeletally-mature adolescents with giant cell tumor of bone... Sub. Req’d

Swiss Drug Giant Looks for Ways to Lower U.S. Prices Amid Tariff Threat and Admits Americans ‘Pay for a Large Part of the Innovations'

(9/20, Agence France Presse) ...Vasant Narasimhan told the Swiss daily Neue Zurcher Zeitung (NZZ) that his company was "working to eliminate the price gap between the US and other industrialised countries". "We are working with the government and trying to find constructive solutions so that Americans pay less for their medicines," he told the Swiss daily...Narasimhan suggested it made sense to bring down US prices. "It is a fact that American patients pay for a large part of the innovations," he acknowledged to the NZZ, insisting that "countries outside the US will have to contribute a larger share in the future"... Full

Novartis Has Stockpiles to Withstand Potential Trump Tariffs, CEO Says

(9/22, John Revill, Reuters) ..."We have significantly increased our stockpiles in the U.S., so they will certainly last until mid-2026," CEO Vas Narasimhan told Swiss newspaper Neue Zuercher Zeitung. Novartis has already announced $23 billion in medium-term investments in the U.S. and aims to manufacture its most important products for the American market locally, he added. "It will likely take three to four years to get there. But I estimate that we can make significant shifts within the next two years, for example, to carry out some of the final filling and packaging in the U.S.," he said. "This should allow us to fully mitigate any tariffs."... Full

CMS To Launch AI-Powered Search Tool For Prescription Drugs

(9/19, Gabrielle Wanneh, Inside Health Policy) ...CMS will soon implement a new artificial intelligence-powered drug searching feature for products sold in Medicare. The tool is due to launch this fall and aims to provide Medicare beneficiaries with a fresh and distinct user experience to get personalized drug pricing information outside of the Medicare Plan Finder... Sub. Req’d

US Weighs Trump-Branded Website to Help Shop for Cheaper Drugs

(9/19, Rachel Cohrs Zhang, Skylar Woodhouse, Bloomberg) ...The proposed website would allow patients to search for specific medicines and be connected with platforms that sell them, the people said. Officials have discussed creating a Trump brand for the website, with "TrumpRx" one name that's been considered, they added. The plan has not yet been finalized, and discussions are ongoing ahead of a Sept. 29 deadline for companies to comply with Trump's demands to lower prices on some widely used medicines... Sub. Req’d

Editorial: A Good Idea to Cut Drug Costs

(9/22, The Wall Street Journal) ...The White House has proposed good and bad ideas to reduce drug costs. Among the better ones is a reform of the obscure 340B drug program, which enriches large hospitals at the expense of patients. Cue the protests from the hospital lobby... Sub. Req’d

'Most Favored Nation' Drug Pricing Is a Bad Deal for Patients

(9/19, Gerard Scimeca, RealClearHealth) ...The problem with MFN is simple: the foreign price control systems it would copy are fundamentally broken. Countries like Germany, Canada, and the U.K. don't pay fair-market rates for drugs. Those governments keep costs artificially low using strong-arm tactics, and their citizens pay the price... Full

A New Shot for Cancer is Convenient, But Poised to Keep Prices High

(9/22, Rebecca Robbins, The New York Times) ...The original version of Keytruda had been expected to have its price cut for Medicare starting in 2028, under a Biden-era law subjecting certain medicines to price negotiations. But in a win for Merck, the Republican policy bill that became law this summer delayed that timetable by one year for Keytruda because of a change in the way it dealt with products originally approved for rare diseases. It is not clear whether the Medicare price cut starting in 2029 will also apply to the new Keytruda shot; the federal government recently hinted that it might... Sub. Req’d

PhRMA Statement On ACIP Meeting

(9/19, PhRMA) ..."Ensuring Americans have access to safe and effective FDA-approved vaccines is vital. We fear the ACIP meeting this week has created more confusion for health care professionals and the public...Simply put, every American should have access to all available tools to protect themselves and their families—including vaccines."... Full

Gillibrand, Scott Demand FDA Investigation Into The Safety Of Foreign-Manufactured Generic Drugs, Request Answers On Ties To Forced Labor In China

(9/19, U.S. Senator for New York Kirsten Gillibrand) ..."Ensuring that all drugs imported into the United States fully comply with our laws and regulations is crucial to keep Americans safe," said Senator Gillibrand. "I am deeply concerned by the FDA's pattern of allowing foreign generic drugmakers to export drugs to America even when their facilities have been found to fall below our standards. This is a threat to our seniors and our national security. We must provide better oversight to ensure that all Americans are protected, and I'm committed to pressing the FDA on this issue."... Full

US FDA Appears To Be Managing MAHA Well By Feeding Instead Of Receiving Priorities

(9/19, Ramsey Baghdadi, Pink Sheet) ...The MAHA strategy report includes directives for the FDA, but they largely align with Commissioner Martin Makary's priorities. The items suggest Makary is setting priorities for the FDA and sending them to HHS, rather than having them dictated to him by the department. Makary also tied several FDA activities to the MAHA agenda, including making complete response letters public... Global Sub. Full

Biosimilar Council Applauds Bipartisan House Legislation to Streamline Biosimilar Interchangeability Designation

(9/19, The Biosimilars Council) ..."...The Biosimilar Red Tape Elimination Act will expand competition and savings for patients and taxpayers, while preserving FDA's ability to ensure the safety and efficacy of medicines for America's patients. The Biosimilars Council and AAM thank Representatives Pfluger and Landsman for their work on behalf of American patients, and we look forward to working with House and Senate cosponsors to eliminate this outdated and unnecessary barrier to lower-priced biosimilar medicines."... Full

Rep. Pfluger Introduces Bill to Lower Prescription Drug Prices for Texans

(9/19, U.S. Congressman August Pfluger) ...The bipartisan, bicameral Biosimilar Red Tape Elimination Act would improve patient access to lower-cost prescription medications and increase competition in the biological drug market by automatically deeming "biosimilar" drugs as interchangeable with their name-brand counterparts upon FDA approval... Full

Medincell Reports Positive Phase 3 Safety Data For Olanzapine LAI; No PDSS Observed

(9/22, RTT News) ...Medincell SA reported that new long-term safety data from the completed Phase 3 SOLARIS trial support the potential of Olanzapine LAI (TEV-749) as the first long-acting olanzapine treatment option for schizophrenia, with no post-injection delirium/sedation syndrome (PDSS) observed. The data were presented by Teva Pharmaceuticals... Full

Medincell: New Pivotal Phase 3 Long-Term Data Supports Olanzapine Long-Acting Injectable (LAI) with Favorable Safety Profile – No PDSS Observed

(9/22, Medincell) ...Olanzapine LAI (mdc-TJK / TEV-‘749) is an investigational, once-monthly, subcutaneous long-acting injection of the atypical antipsychotic olanzapine for the treatment of schizophrenia. This is the second product within the Teva partnership – after UZEDY® approved by the FDA in April 2023 – that uses Medincell's co-polymer technology (licensed to Teva under the name SteadyTeq™) to generate a controlled steady release of drug throughout the dosing interval. Teva is currently preparing for regulatory submission and launch of Olanzapine LAI with NDA submission anticipated in Q4 2025... Full

First Global Golimumab Biosimilar Among Alvotech's Trio Of Japanese Approvals

(9/22, Dean Rudge, Generics Bulletin) ...Alvotech has secured three biosimilar approvals in Japan for golimumab, denosumab, and aflibercept. These approvals mark a significant milestone for the firm, as Alvotech claims to have the first golimumab biosimilar approved in major global markets. Alvotech highlighted the importance of these approvals for enhancing patient access to biologic therapies, while keeping future launch dates and pricing strategies undisclosed... Global Sub. Full

EMA Recommends Approval of ALVO's Gobivaz Biosimilar to Simponi

(9/22, StreetInsider.com) ...The CHMP opinion recommends granting marketing authorization for Gobivaz 50 mg/0.5mL and 100mg/mL in pre-filled syringe and autoinjector forms for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adult patients, plus juvenile idiopathic arthritis across the 27 European Union member states, Norway, Iceland and Liechtenstein... Full

Celltrion Wins Japan Approval for Actemra Biosimilar

(9/22, Lee Han-soo, Korea Biomedical Review) ...Celltrion said Monday it has received marketing authorization from Japan's Ministry of Health, Labour and Welfar for Avtozma, a biosimilar referencing Roche's Actemra (ingredient: tocilizumab). The approval covers the main indications held by the original drug, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman's disease (CD), and cytokine release syndrome (CRS)... Full

Scripius Saw 86% Net Cost Reduction After Switching to Stelara Biosimilars

(9/21, Peter Wehrwein, Managed Healthcare Executive) ...Change can be difficult, but when Scripius switched to Stelara biosimilars this summer, the results were swift and the cost savings, large. Within one month, the pharmacy benefit manager (PBM) saw a 98% conversion rate in its commercial population, a 95% conversion rate in its Medicare population and a 100% conversion rate in its Medicaid population, resulting in an 86% net cost reduction, according to Cody Olsen, Pharm.D., director of pharmacy, PBM formularies at Scripius, the in-house PBM of the Intermountain Health health system in Salt Lake City, Utah... Full

‘New Starts' On Brand-Name Products? Pull Levers to Maximize Biosimilars, Says Scripius Formulary Manager

(9/21, Peter Wehrwein, Managed Healthcare Executive) ..."It's not a 'leaky bucket,' per se, but it is something that you're definitely needing to watch, see where your trends are going, and pull whatever levers you can along the way to maximize the biosimilars," said Cody Olsen, Pharm.D., director of pharmacy, PBM formularies at Scripius during an interview at the 2025 Annual National Conference of the Pharmacy Benefit Management Institute held earlier this month in Orlando, Florida. Scripius is a PBM owned and operated by the Intermountain Health health system... Full

Pfizer Goes Full Speed Ahead On Obesity with $4.9B Acquisition of Metsera

(9/22, Kyle LaHucik, Endpoints News) ...The drug giant said Monday morning it would buy cardiometabolic drug developer Metsera for $4.9 billion upfront, with the potential for another approximately $2.4 billion in milestone payments. Metsera's share price $MTSR skyrocketed 52% on Monday morning following a Sunday evening report from the Financial Times, citing unnamed sources. By snapping up Metsera, Pfizer gets hold of a broad pipeline of long-acting injectables in the hot GLP-1 and amylin categories... Sub. Req’d

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

FDA Extends Review of Sanofi's Tolebrutinib for Progressive Multiple Sclerosis

(9/22, The Pharma Letter) ...The American medicines regulator has delayed its decision on Sanofi's tolebrutinib, an oral Bruton's tyrosine kinase inhibitor in development for non-relapsing secondary progressive multiple sclerosis. The US FDA extended the target action date by three months to December 28, 2025, after receiving additional analyses it deemed a major amendment... Sub. Req’d

Global Biotech Firm Invests $30M in N.J. Facility to Make 2 Billion Pills a Day

(9/19, NJ.com) ...Biocon Limited is launching its first U.S. manufacturing facility in Middlesex County, investing more than $30 million to upgrade an existing plant into a state-of-the-art facility capable of producing 2 billion tablets annually. The facility, located in Cranbury, will be operated by Biocon's subsidiary Biocon Generics Inc., according to a statement... Full

Bayer CEO: Overhaul Is Leading to Pharma Pipeline Boost

(9/22, Patricia Weiss; Kirsti Knolle, Reuters) ...Speaking at a press event in San Sebastian, Spain, Anderson said Bayer had fundamentally redesigned itself and was on track to overcome years of crisis, though a "long way to go" was still ahead. At the briefing, drug unit head Stefan Oelrich said sales of cancer drug Nubeqa and kidney treatment Kerendia were strong, and heart drug Beyonttra, also known as acoramidis, was now seen as generating more than $1 billion in its peak sales year... Full

Bristol Myers Squibb Aligns UK and US Prices for New Schizophrenia Drug

(9/22, Patrick Temple-West in New York and Hannah Kuchler in London, Financial Times) ...US pharmaceutical company Bristol Myers Squibb will sell its new schizophrenia treatment in the UK for $22,500 a year, the same price as its American version, at a time when governments on both sides of the Atlantic are seeking to lower drug costs...In an interview with the Financial Times, Adam Lenkowsky, chief commercialisation officer at BMS, said the company might halt Cobenfy's UK launch if it is not included in guidelines issued by the National Institute for Health and Care Excellence (Nice)... Sub. Req’d

John Whelan: US Drug Price Shake-Up Threatens EU Medicine Access

(9/21, Irish Examiner) ...Because the US is the world's largest pharmaceutical market, accounting for more than half of total global demand for prescription drugs, lowering prices there would hit industry revenues hardest, with a particular impact on profits and state corporate tax incomes here in Ireland. Helmut Brand, professor of European public health at Maastricht University in the Netherlands, stated that some companies may decide to delay launches in low-price markets to avoid price erosion in larger, more profitable markets... Full

Big Pharma Forces Britain to Take Its Medicine

(9/22, Matthew Brooker, Bloomberg) ...Streeting's hardball tactics may make sense in the narrow context of the NHS's monopsony power, but look different if global drugmakers decide to take their investment to bigger or more accommodating ponds. The dilemma for the government is that increased spending on medicines would threaten to blow out a health budget that's already under strain. Losing opportunities to capitalize on an industry where Britain has world-leading capabilities would be worse, though. That opportunity is becoming even greater as artificial intelligence and pharmaceutical research converge — a prospect underlined by the tens of billions of pounds of AI investments pledged during Trump's UK visit. Like it or not, Britain may have to take the medicine Big Pharma is trying to force on it... Sub. Req’d

Fears for Pharma Slump as Labs Stand Empty

(9/22, Pui-Guan Man, Hannah Boland, The Telegraph) ...The vacancy rate across life sciences buildings has more than doubled to a record high of 9.9pc over the past year, according to new figures from property analytics firm CoStar...The abundance of empty space will cast doubt on the Government's pledge to make Britain a life sciences "superpower", while also raising questions over a boom in laboratory building post-Covid...Patrick Scanlon of CoStar Group said the drop in both pharmaceutical investment and laboratory leasing activity was a "double-whammy" for the sector. One pharmaceutical insider said there was no demand for lab space across the UK, adding: "The market is dead." They claimed that companies were shifting their focus to the US after Mr Trump offered tax breaks to companies investing in the sector... Sub. Req’d

VPAG Stalemate – How Can the UK Pharma Market Be Rescued?

(9/22, Janet Beal, Pharmaceutical Technology) ...The prospect of an unamended and punitive VPAG arrangement has already begun to show a damaging impact on the UK pharma market, compounding existing challenges from reduced commercial clinical trial recruitment, post-Brexit distancing from EU regulatory processes, restrictive UK cost-effectiveness appraisals, and external pressures from US tariffs and the Most Favored Nation scheme. Cancelling VPAG membership is an unfavourable option for member companies, since the backup Statutory Scheme carries even more punitive payback rates. Instead, companies have already started to vote with their feet—by scaling back their UK investments and launch plans... Full

Novo Nordisk's Woes Are Slimming Denmark's Economic Growth

(9/22, Eshe Nelson, The New York Times) ...Fueled by millions of American prescriptions for Novo Nordisk's medicines, the Danish economy has outshined those of its European neighbors. The pharmaceutical industry's exports kept the country out of a recession for two years. But now, Novo Nordisk is retrenching and cutting jobs after a big profit warning — and it's casting a shadow over Denmark's economy. "They are growing at a much slower pace," said Jens Naervig Pedersen, an economist at Danske Bank. "And given their size, it's something that means the Danish economy will grow at a slower pace."... Sub. Req’d

Reality of Greek Public Pharma Spending

(9/22, The Pharma Letter) ...On the occasion of a recent article on public pharmaceutical spending in Greece, Michalis Chimonas, general director of the Greek pharma trade group, SFEE, clarified some data about Greece. Talking only about one part of the expenditure (outpatient/Private Pharmacy) and drawing conclusions can be misleading as different countries have different systems and different allocation of state budgets. For example, a country may invest in financing the hospital channel, which it controls more, and reimburse private pharmacy less or vice versa... Sub. Req’d

NPPA Releases Draft Calculation Sheet with Ceiling Price of Six Scheduled Formulations

(9/22, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority (NPPA) has released draft version of calculation of ceiling price for six formulations under the revised Schedule I of Drugs Prices Control Order (DPCO), 2013, including three strengths of human immunoglobulin, denatured ethyl alcohol, peritoneal dialysis solution, and vitamin tablet riboflavin... Full

WHO Publishes Full Guideline Report to Help Countries Ensure Safe, Equitable Access to Controlled Medicines

(9/19, World Health Organization) ...The new WHO guideline calls for balanced national policies that both guarantee uninterrupted, affordable access and prevent harmful non-medical use of controlled medicines. It aims to help countries ensure safe, fair, and affordable access to essential controlled medicines that are vital for managing acute and chronic pain, mental health disorders, substance use disorders, and other serious health problems. The WHO guideline provides governments with evidence-based recommendations covering seven key domains: policy development, pricing and financing, medicines selection, procurement and supply chain, regulation, prescribing and dispensing, and education for both health professionals and the public... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.