Tuesday, October 14, 2025

FDA Clears Teva's Uzedy For Bipolar I Disorder Maintenance Treatment

(10/14, Dean Rudge, Generics Bulletin) ...Teva is doubling down on its neuroscience ambitions after securing US Food and Drug Administration approval to expand the use of its once-monthly injectable Uzedy (risperidone) to patients living with bipolar I disorder...By securing the approval, Teva has opened the door to a multi-billion-dollar market and gained further momentum behind its transition from a generics-oriented firm to a diversified biopharma player. Sales of Uzedy more than doubled year-over-year to $54m in the second quarter, allowing Teva to hike its annual guidance for the schizophrenia treatment to $190m-$200m... Global Sub. Full

How Much Are Drug Companies Exposed To US Government Programs?

(10/13, Jessica Merrill, Pink Sheet) ...An analysis by the investment banking firm Leerink Partners breaks down drug company exposure to US government programs, which is important as US drug pricing pressure increases under the Trump Administration. Under recent MFN drug pricing agreements, Pfizer and AstraZeneca have agreed to sell products to Medicaid programs at MFN prices, meaning the lowest price from a set of countries. Exposure to Medicaid is generally low across the industry as drug companies already pay the lowest prices to state Medicaid programs... Global Sub. Full

Pharma Companies Shift Towards Direct-To-Consumer Sales in US Amidst Tariff and Pricing Turmoil

(10/13, Nicholas Jacobus, PharmExec.com) ...With ongoing tariff and pricing turmoil, multiple pharmaceutical companies recently announced plans to offer direct-to-consumer (DTC) sales and discounted prices, along with responding to President Trump's call for lowered drug prices and goal to cut "middlemen" such as pharmacies, insurers, and pharmacy benefit managers. A recent survey from ixlayer showed that 94% of pharma leaders were currently running, planning, or assessing DTC programs, with the survey highlighting DTC's increasing popularity across the pharma industry... Full

Compounders Argue US FDA's GLP-1 Green List Validates Legit Practices

(10/13, Aakash Babu, Pink Sheet) ...The compounding industry said the FDA's "green list" of GLP-1 API imports for compounded drugs validates legitimate compounding pharmacies' role in the US health system...The FDA said the "green list" does not prevent the legal import of GLP-1 APIs from compliant manufacturers or create new limits on the legal compounding of GLP-1 drugs. However, the agency remains concerned about dosing errors, counterfeit versions of compounded drugs, illegal online sales and underreporting of adverse events... Global Sub. Full

A New Wave of Middlemen Offer ‘Alternative Funding' for Specialty Drugs. Patients Bear the Risks

(10/14, Anastassia Gliadkovskaya, Fierce Healthcare) ...In interviews, sources most commonly cited the AFPs Payer Matrix, Paydhealth and SHARx as problematic, but the companies might be mentioned more often because of their market size. Jennifer Hoefner, CEO of Payer Matrix, told Fierce Healthcare in emailed comments that Payer Matrix is a "cost-containment company focused on specialty drugs, the fastest-rising driver of pharmacy spend."...By contrast, Paydhealth's chief commercial officer David Galardi told Fierce Healthcare the vast majority of its clients do not carve out specialty drugs. Most members have coverage, but may face prohibitively high deductibles and out-of-pocket costs. Paydhealth helps them navigate the complex world of pharma patient assistance and copay programs, Galardi said, so drugs can reach who they're intended for... Full

Convergence: Experts Look for Greater International Alignment On Combination Products

(10/13, Jeff Craven, Regulatory Focus) ...The experts, who spoke at RAPS Convergence 2025, said there are initiatives in motion—including the launch of a new combination product operational group in Europe next month—but acknowledged the difficulties of aligning combination product regulatory requirements in these two regions... Full

Should FDA Make Drug Pricing Part of the Review and Approval Process? I Don't Think So

(10/13, Bob Pollock, Lachman Consultants) ...This morning, I read an article authored by Sarah Karlin-Smith of the Pink Sheet titled "US FDA Commissioner's Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions" (here, subscription required) that, as a former senior FDA official, made my hair stand on end. She wrote about the current politicalization of the FDA with its latest iteration being directly involved in price negotiations with the pharmaceutical industry. It is not a secret that the pharmaceutical industry is being pressured by the administration to lower drug prices. While that may be a good thing for the American public, placing the Agency that is responsible for drug-approval decisions in the crosshairs of pricing determinations might be a somewhat dangerous path to tread down... Full

Inside FDA, Career Staffers Describe How Political Pressure is Influencing Their Work

(10/14,Lizzy Lawrence, STAT+) ...The disconnect underscores the escalating tension between career scientists and political leaders as Kennedy works through his agenda. STAT interviewed more than 20 current and former agency officials, as well as legal experts, about political influence at the FDA. The conversations offered new insights into the political pressure shaping some of the FDA's most important actions this year, from tackling autism to revisiting vaccine safety. Most requested anonymity to protect against personal and professional repercussions. Employees inside the agency, and regulatory experts on the outside, said they were worried the U.S. is headed toward a new era of drug regulation: one where political decisions lead, and evidence follows... Sub. Req’d

FDA On Pace for Lowest Number of New Drug Approvals Since 2022

(10/13, Zachary Brennan, Endpoints News) ...An FDA spokesperson told Endpoints News that "drug reviews and approvals are not affected by the Democrat-led shutdown and this work continues." This year's approval numbers likely won't hit historic highs if applications continue to be delayed at the same rate as they have been recently. Back in July, FDA Commissioner Marty Makary told CNBC that the agency "could hit a record number of approvals" in 2025. The FDA spokesperson did not comment on whether that prediction still stands... Sub. Req’d

US FDA Eager To Advance Oncology Registries

(10/13, Michael McCaughan, Pink Sheet) ...OCE is eager to advance the use of patient registries for cancer drug development. The FDA also said during a recent meeting on the future of oncology registries that previous efforts in the area have not been sufficient to support regulatory decisions. OCE's Pallavi Mishra-Kalyani said it is in everyone's best interest to discuss registry issues early and often... Global Sub. Full

US Industry Bemoans Colorado Price Controls After Limit Set On Enbrel

(10/13, Dave Wallace, Generics Bulletin) ...Colorado's Prescription Drug Affordability Board has finalized a rule establishing an upper payment limit for Enbrel, ahead of biosimilar entry. The rule – which comes into effect from the start of 2027 – sets an upper payment limit for Enbrel of $600.00 per 50mg/ml unit. Both the AAM and Biosimilars Forum criticized the move, calling instead for action to ensure a competitive market for etanercept biosimilars... Global Sub. Full

California Caps Monthly Insulin Costs in Law Signed by Newsom

(10/13, Andrew Oxford, Bloomberg Law) ...California Gov. Gavin Newsom signed legislation Monday that caps the out-of-pocket costs for insulin at $35 a month per person under many insurance plans. Lawmakers passed the bill (SB 40) without any votes against it, with proponents arguing that rising health-care costs are making the state unaffordable with its already high cost of living... Sub. Req’d

Virginia Voters Overwhelmingly Support Prescription Price Watchdog

(10/14, Zamone Perez, WYDaily) ...The survey by AARP Virginia found nearly 85% of voters in the Commonwealth overwhelmingly approve creating a prescription drug affordability board. A similar percentage of voters support requiring employers to provide paid family and medical leave. Early voting is currently underway across the Commonwealth, as the governor's mansion, House of Delegates and many other statewide offices are up for grabs... Full

Opioid Deaths Suddenly Dominate a Governor's Race. Here's What We Know.

(10/13, Tracey Tully and Joseph Goldstein, The New York Times) ...The latest twist in the race came on Monday when Ms. Sherrill, joined by a substance abuse counselor and a man whose brother overdosed on prescription painkillers, again blamed her Republican opponent, Jack Ciattarelli, for spreading misinformation about opioids...Advanced Studies in Medicine, a component of Mr. Ciattarelli's company, Galen Publishing, received $139,800 in funding from Teva Pharmaceuticals to work on what became known as Living With Pain, according to internal corporate documents compiled by the University of California, San Francisco, and Johns Hopkins University...According to the email from the Teva manager, Mr. Ciattarelli's company was expected to introduce the Living With Pain interactive tool to health care providers, who would be "encouraged to provide their patients with access" to the site... Sub. Req’d

FDA Expands Uzedy Indication to Bipolar I Disorder

(10/13, Megan Brooks, Medscape) ...The FDA has approved an expanded indication for risperidone (Uzedy, Teva) extended-release injectable suspension, allowing it to be used for the maintenance treatment of bipolar I disorder in adults, either as monotherapy or in combination with lithium or valproate... Full

Uzedy: FDA Approves Once-a-Month Subcutaneous Injectable Risperidone for Bipolar I Disorder

(10/13, Joyani Das, PhD, WedMD) ...The FDA has approved Uzedy based on studies with a long-acting risperidone injection (given in the muscle every two weeks) that has already been proven effective. Experts predict that Uzedy, given once a month under the skin, will offer similar benefits. Studies showed that risperidone injection alone helped prevent new mood episodes like mania or depression better than a placebo. In another study where it was added to other treatments like lithium or valproate, patients were less likely to have new mood episodes, compared with those who did not get the shot... Full

FDA Accepts Afrezza sBLA for Pediatric Diabetes

(10/13, Morgan Ebert and Joshua Fitch, Contemporary Pediatrics) ...The FDA has accepted for review MannKind Corporation's supplemental biologics license application (sBLA) seeking to expand the indication of Afrezza (insulin human) Inhalation Powder to include children and adolescents with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026... Full

Celltrion Joins The Eylea Biosimilar Lineup With FDA Approval

(10/14, Urte Fultinaviciute, Generics Bulletin) ...Celltrion has received US FDA approval for its aflibercept biosimilar, marketed under the name Eydenzelt. The Korean firm did not provide a launch date for Eydenzelt, as it is currently involved in litigation with Regeneron, which has also obtained a preliminary injunction. A few weeks ago, Celltrion acquired a biologics manufacturing facility in New Jersey from Eli Lilly to curb potential risks of US pharmaceutical tariffs... Global Sub. Full

Natco Pharma Clears Key Hurdle In Bid for 35.75% Stake In Adcock Ingram

(10/14, Dean Rudge, Generics Bulletin) ...Natco Pharma has inched closer to completing its planned INR20bn acquisition of a 35.75% stake in South Africa's Adcock Ingram, after the latter's shareholders overwhelmingly approved a scheme of arrangement, with 98.66% votes in favor... Global Sub. Full

J&J Raises Sales Guidance, Will Split Off Orthopedics Unit

(10/14, Robert Langreth, Bloomberg Law) ...The move comes as J&J announced third-quarter sales and earnings that beat expectations, and raised revenue guidance for the full year. The pharmaceutical and medical technology company kept its adjusted earnings guidance intact for 2025, saying it was absorbing higher taxes...The separation would also benefit J&J, allowing it to shift its portfolio toward higher-growth, higher-margin markets. The company is coping with the erosion of sales for its big-selling psoriasis drug Stelara, which is facing biosimilar competition after key patents expired. It expects newer drugs including Darzalex for multiple myeloma and Tremfya, a drug for psoriasis and other autoimmune conditions, to help fill the gap... Sub. Req’d

J&J's Billion-Dollar Appeal Aims Spotlight at ‘Litigation Trap'

(10/14, Mike Leonard and Jennifer Kay, Bloomberg Law) ...The decision set for review Wednesday by Delaware's supreme court held the pharmaceutical giant liable for breaching a pledge to prioritize surgical robots it acquired when it bought Auris Health Inc. for $3.4 billion. The ruling was the largest ever in a dispute over the contingent payments known as "earnouts," the focus of a litigation wave flooding the state's elite business tribunal... Sub. Req’d

Novo Plant Hit with FDA's Most Serious Inspection Classification, Portending Possible Delays for Partners

(10/13, Kevin Dunleavy, Fierce Pharma) ...It appears problems at Novo Nordisk's recently acquired manufacturing facility in Indiana aren't going to be solved any time soon. The FDA has tagged the former Catalent facility with an official action indicated (OAI) label, which is the most severe of the three inspection classifications issued by the agency. The OAI designation—which identifies facilities that are at "an unacceptable state of compliance," according to the regulator—is bad news for drugmakers who depend on the massive plant in Bloomington for contract manufacturing... Full

US Biotech Nabla Bio, Japan's Takeda Expand AI Drug Design Partnership

(10/14, Kamal Choudhury, Reuters) ...Nabla said it would use its proprietary AI platform, Joint Atomic Model (JAM), to design protein-based therapeutics for Takeda's early-stage pipeline. The companies will focus on hard-to-treat diseases and include multi-specific drugs and other custom biologics. Comparing to how ChatGPT answers text questions, Nabla CEO Surge Biswas said JAM responds to molecular queries by designing antibodies from scratch that bind targets with desired properties... Full

Three Big Questions Ahead of Third-Quarter Pharma Earnings

(10/13, Max Bayer, Endpoints News) ...A series of buyouts has added wind to investors' sails, and a handful of biotechs are even trying to go public, after a months-long freeze in the IPO market. And China continues to be a feeding ground for new assets — if a potential trade war with the US doesn't ripple through biopharma. Evan Seigerman, head of healthcare research and senior biopharma analyst at BMO, told Endpoints News that the improvement in the macroenvironment does not mean that problems surrounding pharmas' patent cliffs have evaporated... Sub. Req’d

How Brexit and Austerity Shape the UK's Life Sciences Ambitions

(10/14, The Pharma Letter) ...The United Kingdom has long cast itself as a global leader in research and innovation, and government ministers still speak of a future in which the country stands tall as a science superpower...Part of the challenge lies in reconciling two competing imperatives. On one side, the government wants the pharmaceutical and biotech industries to drive growth, attract capital, and foster high-value jobs across the regions. On the other, the National Health Service (NHS), already under enormous strain, has to keep a lid on medicines spending. The balance between incentivizing investment and controlling costs is delicate, and at times the two agendas have pulled in opposite directions... Sub. Req’d

Calls for Greater Budget Rises for New Medicines in Iceland

(10/13, The Pharma Letter) ...Iceland's budget for licensed medicines should takes into account the rapid development of new medicines, the increasing number of people with serious diseases and their access to the best possible treatment. So says a statement from Landspítali, the country's leading hospital. The comment was issued as the 2026 budget bill is being discussed in the Althingi Budget Committee. Landspítali says that there is not enough growth expected, neither in the current 2025 budget nor in the 2026 budget bill, to meet the increased costs of new and costly licensed medicines and the rise in the number of patients diagnosed with malignant diseases... Sub. Req’d

Implementation Date for U.S. Tariff On Singapore Pharma Exports Postponed, Local Media Reports

(10/14, Xinghui Kok, Reuters) ...The implementation of a U.S. tariff on Singapore's pharmaceutical exports has been delayed to allow companies to negotiate possible exemptions with the U.S. administration, the Straits Times newspaper cited a junior minister as saying on Tuesday...The Straits Times did not say if the minister of state for trade, Gan Siow Huang, gave a fresh date for the tariff's introduction. But she said Singapore-based pharmaceutical companies are now waiting to hear from the U.S. administration to determine if their plans to build and expand manufacturing capacity would qualify them for an exemption, the paper reported... Full

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