Monday, October 13, 2025

Teva's Bipolar Disorder Treatment Uzedy Gets FDA Approval

(10/10, Kelly Cloonan, Dow Jones) ...Teva Pharmaceuticals' Uzedy therapy to treat bipolar I disorder received approval from the Food and Drug Administration. The biopharmaceutical company said Friday the therapy was approved as a once-monthly extended-release injectable suspension, or as an adjunctive therapy to lithium or valproate... Full

FDA Approves Risperidone Extended-Release Injectable for Bipolar I Disorder

(10/10, Chelsie Derman, HCP Live) ..."The FDA's decision to expand the indication for UZEDY may help those living with BD-I," said Craig Chepke, MD, medical director at Excel Psychiatric Associates and scientific director at HMP Global's Psych Congress events and programs, in a statement. "As a clinician, I am excited to now have a new treatment option for this complex disease."... Full

FDA Approves Expanded Indication of Uzedy for Bipolar I Disorder

(10/10, Healio) ...As Healio previously reported, the FDA approved Uzedy (risperidone, Teva Pharmaceuticals, MedinCell) for the treatment of schizophrenia in 2023...Teva stated that existing clinical data for Uzedy, as well as model-informed drug development methodologies leveraging past findings on the safety and efficacy of risperidone formulations already approved for bipolar I disorder, formed the basis of this approval... Full

FDA Approves Teva and Medincell's Bipolar I Disorder Treatment

(10/13, Pharmaceutical Technology) ...Teva Pharmaceuticals and Medincell have gained approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone), a once-a-month extended-release injectable suspension to treat adult patients with bipolar I disorder (BD-I)...Therapeutic blood levels are achieved within six to 24 hours following a single administration. With the FDA's approval, Uzedy now offers three monthly dosing options for BD-I patients: 50mg, 75mg and 100mg... Full

Teva Pharmaceuticals Secures US FDA Approval for Bipolar I Treatment

(10/12, Judy Amaca, Alliance News) ..."Adults living with BD-I experience debilitating manic and depressive symptoms, and today's FDA approval of Uzedy provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps," said Chris Fox, executive vice president, US Commercial at Teva. Psychiatrist Craig Chepke, who also serves as scientific director of Psych Congress noted the clinical significance of the approval and said: "The FDA's decision to expand the indication for Uzedy may help those living with BD-I. As a clinician, I am excited to now have a new treatment option for this complex disease."... Full

Teva : FDA Grants Expanded Approval For UZEDY To Treat Bipolar I Disorder In Adults

(10/10, RTTNews) ...Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd., in collaboration with Medincell, announced that the U.S. Food and Drug Administration has approved UZEDY (risperidone) extended-release injectable suspension for subcutaneous use. The approval covers its use as monotherapy or as adjunctive therapy alongside lithium or valproate for the maintenance treatment of bipolar I disorder in adults... Full

Informa Connect's Pharma/Biotech GTN Summit

(10/13, Adam J. Fein, Ph.D., Drug Channels) ...Featured Thought Leaders Include...Matthew Pellegrini, Sr. Director - Revenue Optimization Contracting & Compliance N.A., Teva Pharmaceuticals... Full

Trump Unveils Deal for AstraZeneca to Cut Medicaid Drug Prices and Join "TrumpRx" Site

(10/10, Joe Walsh, CBS News) ...Under the deal, AstraZeneca will offer its drugs to Medicaid patients at "most-favored-nation" prices, meaning the U.K.-based drugmaker will charge no more than the lowest rate offered in other high-income countries, Centers for Medicare and Medicaid Services Administrator Mehmet Oz said in a Friday afternoon Oval Office event. AstraZeneca also promised to offer new prescription drugs at most-favored-nation rates, Oz said... Full

AstraZeneca DTP Rx Deal With Trump Follows Pfizer Model

(10/10, Maaisha Osman, Inside Health Policy) ...AstraZeneca became the second drugmaker to partner with the Trump administration to sell chronic disease medications directly to patients at discounts of up to 80% through the TrumpRx website, while also securing a three-year exemption from Section 232 tariffs in exchange for onshoring its U.S. manufacturing. The deal, which will also provide "most favored nation" pricing to state Medicaid programs, follows the blueprint of the administration's earlier deal with Pfizer... Sub. Req’d

AstraZeneca Strikes Deal to Lower Drug Costs in Exchange for Tariff Reprieve

(10/10, Patrick Temple-West and Hannah Kuchler, Financial Times) ...Speaking at the White House late on Friday, AstraZeneca chief executive Pascal Soriot applauded the deal as "a big win" for US patients. Trump said: "I'm not sure Pascal would like to say it, but behind the scenes, he would say tariffs were a big reason he came here." AstraZeneca's and Pfizer's deals with the White House have given shareholders some optimism about the future of US drug policy... Sub. Req’d

Banquets and Billions: How AstraZeneca Sealed a US Medicine Deal With Trump

(10/13, Maggie Fick, Reuters) ...That moment at the White House was the culmination of public and private meetings between Soriot and Trump officials, stretching back to November last year when Trump won election, three sources close to the negotiations told Reuters. And it went down to the wire with a last-minute push from AstraZeneca to seal the agreement...The agreement will likely bolster the 66-year-old French-born Australian's reputation as something of a Trump whisperer, even as many CEOs globally grapple with the president's whipsaw tariff changes... Full

US FDA Commissioner's Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions

(10/12, Sarah Karlin-Smith, Pink Sheet) ...FDA Commissioner Martin Makary was credited with helping negotiate the AstraZeneca drug pricing deal with the Trump Administration, raising ethical and legal questions given the FDA's role in determining what drugs are safe and effective for US patients. The Trump Administration has suggested companies who fail to reach drug pricing deals could face reevaluation of their drug applications, a move that doesn't comply with US law. The threat however must be taken seriously given the administration's tendency to meddle politically in FDA's decision, experts said... Global Sub. Full

Trump's Rx for Confusion: How a Push for Tariffs Complicated His Pharma Talks

(10/12, Marc Caputo, Alex Isenstadt, Axios) ...When President Trump announced a new deal Friday to lower prescription drug costs, it was the clearest sign yet that he'd paused his commerce secretary's push to slap 100% tariffs on pharmaceuticals that aren't manufactured in the U.S...Prescription drug policy and tariffs are big priorities of Trump's administration. But after the two issues collided in a conflicting series of White House messages recently, Trump set aside the tariffs idea, which could have made drugs more expensive for many Americans... Full

How Are The Drug Pricing Negotiations Impacting Pharma's Relationship with DC?

(10/13, Mike Hollan, William Soliman, PhD, PharmExec.com) ...[Dr. William Soliman] We've seen Pfizer doing a deal with Trump, and I think other companies will follow. If they can come to a compromise for even just some branded drugs, that's a happy middle-ground. What they're looking for in exchange for dropping prices is for the administration to push back the tariffs. That's part of the Pfizer deal. I do think it will make a difference and pharma companies will concede, even if not fully to what Trump wants. Even if it's a little bit, that's still better than nothing... Full

PhRMA To CMS: Scrap Mandatory Requirement For Chronic Disease CMMI Model

(10/10, Gabrielle Wanneh, Inside Health Policy) ...The country's major brand drug lobby stands against CMS' proposal to mandate participation in a years-long CMS Innovation Center (CMMI) model intended to test whether upstream management of chronic diseases could lead to fewer hospitalizations and unnecessary procedures for seniors with heart failure or lower back pain. The Pharmaceutical Research and Manufacturers of America says drug companies continue to invest in treatments for chronic conditions disproportionately affecting older populations, including over 400 candidates currently in development, and tells CMS the demo proposed in CMS' draft physician fee schedule could discourage such investment... Sub. Req’d

Senate-Passed BIOSECURE Act Would Add Arrow to Trump's Drug-Pricing Quiver

(10/10, John Wilkerson, STAT+) ...The Senate on Thursday passed legislation that would restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies, potentially giving the president another way to pressure the industry into doing what he wants...The Biotechnology Innovation Organization supports the bill, but some industry experts say Chinese companies help them keep drug costs down, and taking away their ability to use cheap contract manufacturing and development services would increase drug prices... Sub. Req’d

Patient Experience Data: US FDA Wants To Know What's Coming In An Application And Why

(10/10, Sue Sutter, Pink Sheet) ...Sponsors needed to explain where patient experience data are in an application and why they were included, FDA's Robyn Bent told the RAPS Convergence 2025 meeting. Although the FDA encourages early interactions so reviewers know PED will be part of an application, timing can be challenging for companies when only preliminary qualitative data are available. Bent's virtual presentations during a government shutdown were notable because other scheduled FDA presentations at RAPS were cancelled, including a virtual address by CDER Director George Tidmarsh... Global Sub. Full

Gavin Newsom Signs CA Bill to Lower Medication Costs, Rein In Insurance Middlemen

(10/11, Kate Wolffe, The Sacramento Bee) ...The new law will, beginning in 2026, limit the amount of money that PBMs can squeeze out of a transaction by prohibiting "spread pricing," whereby they hold onto the difference between what they charge an insurer and what they pay a pharmacy for the drug. It also bans certain noncompetitive practices, and only allows PBMs to charge an administrative fee for services provided... Full

PCMA Statement On California SB 41

(10/11, PCMA) ..."It is a failure of the Newsom administration to fall for Big Pharma's ploy to blame their high list prices on others and to undermine the very mechanisms that actually lower prescription drug costs. Nothing in SB 41 will lower drug costs for Californians. In fact, the legislation will increase drug costs for everyone in California. This is Big Pharma politics and Californian patients, consumers, employers, unions and plan sponsors will be the ones who pay the higher prices delivered by this misguided legislation."... Full

Celltrion Launches Actemra Biosimilar in US

(10/13, Lee Han-soo, Korea Biomedical Review) ...Avtozma is an interleukin (IL)-6 inhibitor that blocks the IL-6 protein responsible for triggering inflammation. The original reference product, Roche's Actemra, generated global sales of 2.645 billion Swiss francs (approximately 4.5 trillion won) last year, with the U.S. accounting for about half—1.331 billion francs (around 2.26 trillion won). The newly introduced Avtozma is an intravenous (IV) formulation, and like Celltrion's other U.S. products, it will be marketed directly through the company's local subsidiary... Full

Natco Launches Generic Of Roche's Evrysdi In India At 97% Discount

(10/13, Dean Rudge, Generics Bulletin) ...Natco Pharma has launched a generic version of Roche's drug Evrysdi, a treatment for spinal muscular atrophy, in India after the Delhi High Court ruled against Roche's appeal. The launch offers a significant discount of approximately 97% to the brand, making it available for INR15,900 (about $179) per bottle compared to the original price of INR620,000. Roche had previously sought a temporary injunction to block Natco, citing patent protections that are still under legal scrutiny. Despite the launch, Roche's patent dispute continues in court, which will address the patent's validity and alleged infringement... Global Sub. Full

Roche Suffers Setback as Court Allows Generic Version of Its Rare Disease Drug to Be Sold in India

(10/10, Ed Silverman, STAT+) ...The case is the latest instance in which patent battles between brand-name and generic companies in India have reflected underlying issues of affordability. Patient advocates have often argued that brand-name drugmakers attempt to extend patent rights for a medicine by using tactics that unfairly claim new innovations but are merely tweaks. This concern is one factor in the battle between Roche and Natco. The generic drugmaker maintained that Roche wrongfully claimed that patented improvements made to its rare disease drug were only minor modifications. This alleged sleight of hand is called "ever-greening" by pharmaceutical industry critics... Sub. Req’d

Investors Look to New GSK Boss to Boost Confidence in Drug Pipeline

(10/11, Hannah Kuchler and Alan Livsey, Financial Times) ...Incoming GSK chief executive Luke Miels is under pressure to boost investor confidence in the pharmaceutical group's drug pipeline, following years of market scepticism under current boss Emma Walmsley. Miels, a 50-year-old Australian, will take over the UK-listed drugmaker at the start of next year when Walmsley steps down. After eight years as chief commercial officer, he is known for his sharp execution and knack for uncovering "hidden gem" acquisitions... Sub. Req’d

Next Medicine Deal After Pfizer? Analysts, Shares Point to AstraZeneca, Eli Lilly

(10/10, Bhanvi Satija and Maggie Fick, Reuters) ...Reuters spoke to seven healthcare analysts and investors. Four said Lilly could be next to make a deal, while three pointed to AstraZeneca. Others mentioned Merck, AbbVie, Regeneron and Bristol-Myers Squibb...Lucy Coutts, a UK-based investment director at wealth manager JM Finn, predicted that AstraZeneca could be next after it broke ground on a $4.5 billion plant in Virginia this week and is planning a U.S. listing of its shares. "I do think AstraZeneca is very well placed, given its revenues lean into the U.S. and it has made already this big financial commitment," she said... Full

The Long Read: Opening The Black Box Of Generic Drug Quality In LMICs

(10/13, Urte Fultinaviciute, Generics Bulletin) ...A recent study has raised concerns over the quality of generic cancer drugs in four African countries, revealing that one out of six drug samples tested did not meet the required active pharmaceutical ingredient standards. Two companies whose products failed the study, Accord and Venus Remedies, contest the findings, attributing quality issues to handling and storage problems during transit. Collaboration and communication between multiple bodies will be needed to tackle the substandard drug quality in LMICs, which has been a problem that has plagued the healthcare space for decades... Global Sub. Full

Direct-to-Patient 2.0: Why Today's DTP Programs Can't Scale—and What Pharma Must Do Next

(10/10, Adam J. Fein, Ph.D., Drug Channels) ...[Deepak Thomas, Founder and CEO of PHIL] explores how demographic shifts and digital expectations are reshaping patient engagement. He argues that to stay competitive, pharmaceutical manufacturers must adopt integrated direct-to-patient (DTP) platforms that streamline access, support insurance coverage, and deliver sustainable commercial impact... Full

Why EU Accelerated Assessments Are Harder To Secure Than US Priority Reviews

(10/10, Neena Brizmohun, Pink Sheet) ...This second of a two-part series of articles on accelerated assessments and priority reviews explores why the EU mechanism remains underused compared to its US counterpart, how it might be improved, and how sponsors can improve their chances of securing an expedited drug review in Europe... Global Sub. Full

38 Versus Just 2: How US Expedites Novel Drug Reviews While EU Falls Behind

(10/10, Neena Brizmohun, Pink Sheet) ...Between August 2024 and August 2025, around 63% of the novel drugs approved in the US received an expedited regulatory review, compared to around just 4% in the EU. Of the 12 drugs that were initially denied an EU accelerated assessment, nine received a US priority review. The sponsors of 15 products that were granted a priority review in the US chose not to request an EU accelerated assessment... Global Sub. Full

Chronic Drug Shortages Frustrate EU Pharmacists, Patients

(10/11, Andrew Zinin, AFP) ...Drug prices differ within the bloc as national authorities negotiate individually with producers, explained Olivier Delaere, CEO of Febelco, a wholesale distributor that serves about 40% of Belgian pharmacies. As a consequence, manufacturers tend to deliver more to countries that pay more, and just enough to those who drove a harder bargain—to avoid drugs being re-exported for profit, he said. Additionally, the ECA said that most medicines are still authorized at national level and packages differ significantly among countries, which makes internal EU trade "more costly and complex"... Full

IPHA Welcomes Govt 30 Million Euros Medicines Budget

(10/13, The Pharma Letter) ...The Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the research-based biopharmaceutical industry in Ireland, welcomes the allocation of 30 million euros ($34.7 million) for new, life-enhancing medicines in Budget 2026. This level of funding is part of 217 million euros allocated to Primary Care Reimbursement System (PCRS) medicines, which supports the availability to tens of thousands of current and new patients of over 100 innovative medicines approved in the last four years, across all the major therapy areas and for rare diseases... Sub. Req’d

CGPA and Biosimilars Canada Welcome the Government of Quebec's Initiative to Improve Access to Cost-Saving Medicines

(10/10, Biosimilars Canada) ...The Canadian Generic Pharmaceutical Association (CGPA) and its Biosimilars Canada division welcome the decision by the Government of Quebec to increase the number of formulary updates to the Régie de l'assurance maladie du Québec (RAMQ) lists of medications from nine to 12 per year beginning in 2026. This initiative, which reflects the recommendations made by CGPA in its 2025-2026 pre-budget submission to the Minister of Finance, will accelerate the market entry of generic and biosimilar medicines and generate substantial savings for Quebec's healthcare system... Full

PRIP Scheme Fuels India's Pharma-Biotech Revolution Through Innovation-Driven Policies

(10/13, Nandita Vijayasimha, Pharmabiz) ...PRIP scheme marks a decisive policy shift, one that redefines India's pharma trajectory from replication to innovation. By actively supporting drug discovery, biosimilars, and complex generics, PRIP scheme sends a clear message that India is ready to lead not just in affordability, but also in invention, said Kiran Mazumdar-Shaw, chairperson, Biocon Group... Full

China's ‘Health Silk Road' in Africa Gets a Boost With Insulin and Other Pharma Projects

(10/11, Jevans Nyabiage, South China Morning Post) ...China is advancing its "health silk road" in Africa by initiating major offshore projects to manufacture essential medicines, such as insulin and antiretrovirals. Nigeria is set to produce Chinese-made insulin, while in the Ivory Coast further west, Chinese giant Shanghai Fosun Pharmaceutical is on track to complete the first part of its three-phase €50 million (US$58 million) facility by the end of the year. The facility near Abidjan, the country's biggest city, will manufacture antimalarial and antibacterial drugs... Full

One in Six Bacterial Infections Now Resistant to Treatment, Says WHO

(10/13, Clive Cookson, Financial Times) ...Drug-resistant bacteria continue to multiply worldwide, with the superbugs behind the most dangerous infections increasing by 5 to 15 per cent annually, the World Health Organization has warned. One in six lab-confirmed bacterial infections globally was resistant to antibiotic treatment, the WHO said in a report on Monday, marking the first time such comprehensive surveillance figures have been published... Sub. Req’d

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