Monday, December 15, 2025

Teva's Estradiol Approved As The First Generic To Imvexxy By The FDA

(12/12, Urte Fultinaviciute, Generics Bulletin) ...The FDA said that the approval of generic Imvexxy will provide an additional treatment option for women with moderate to severe dyspareunia, or painful sexual intercourse, due to menopause. The generic drug will be available in the same 4mcg and 10mcg strengths as the reference listed drug Imvexxy... Global Sub. Full

House Republicans Unveil Health Care Plan, Set up Vote for Next Week

(12/12, Riley Beggin, The Washington Post) ...The legislation would codify and expand health plans for small businesses, fund reductions of premiums for low-income people in the individual health insurance market, and increase transparency in prescription drug pricing, according to House Republican leadership aides... Full

Unsettled Health Policies Leave Billions in Health Spending Hanging

(12/15, Maya Goldman, Axios) ...There are few public details so far about the Global Benchmark for Efficient Drug Pricing Model and the Guarding U.S. Medicare Against Rising Drug Costs Model, but insiders think they may be used to further align U.S. drug prices with the lowest prices paid in other developed nations... Full

China's Dominance in US Pharmaceuticals Sparks Call for Supply Chain Overhaul

(12/12, Madelaine Panganiban, International Business Times) ...America's growing dependence on China for essential medicines is raising new alarms in Washington, as a new report warns that the US could face serious danger if its pharmaceutical supply chain is disrupted. Lawmakers and security experts say the risk goes far beyond hospitals and pharmacies, especially as senators warn that China-linked groups are helping build a global "Silk Road of crime."... Full

Potential MFN Medicaid Model Participants Face Timing, Rebate Hurdles

(12/12, Gabrielle Wanneh, Luke Zarzecki, Inside Health Policy) ...The GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model is set to start Jan. 1, 2026, and aims to foster lower prescription drug prices in Medicaid through CMS-led negotiations with participating drug companies. Participating companies will provide supplemental rebates to participating states for drugs included in the model to align Medicaid net prices with the lower prices being paid by certain foreign countries. The model is expected to run for five years through 2030... Sub. Req’d

Senate Dems Ask Drug Makers How MFN Deals Mesh With Upcoming Medicaid Pilot

(12/12, Gabrielle Wanneh, Inside Health Policy) ...In a letter to the four companies sent Thursday (Dec. 11) by Wyden and seven other Democratic senators... the lawmakers ask whether the companies will effectuate the most favored nation pricing deals for their products through the new CMS GENEROUS Model and, if so, which calendar years the companies plan to participate in the model or offer to state Medicaid agencies the MFN prices they agreed to in their deals with the Trump administration... Sub. Req’d

Pharmacy Coalition to Congressional Leaders: Enact PBM Reform Now to Protect Patient Access and Reduce Americans' Drug Costs

(12/12, NACDS) ...Citing accelerating pharmacy closures, inflated prescription drug costs, and shrinking patient access to the pharmacy of their choice, the groups warn that the failure to address harmful PBM practices "is no longer a crisis in the making — it now constitutes a crisis unaddressed." They call on Congress to seize a "win within reach" by advancing previously agreed-upon, bipartisan PBM reforms at the next available legislative opportunity... Full

‘We Just Want an Even Playing Field' — Pharmacist Weighs in on Pharmacists Fight Back Act

(12/12, Alexis Barrett, Colby Farris, The Times Leader) ...Representatives James Comer (R-Ky.), Jake Auchincloss (D-Mass.) and Diana Harshbarger (R-Tenn.) reintroduced the "Pharmacists Fight Back Act" Thursday, aiming to lower prescription drug costs by placing limits on Pharmacy Benefit Managers... Full

NCPA Applauds Reintroduced Pharmacists Fight Back Act

(12/12, NCPA) ..."With this legislation and the other legislative proposals introduced in Congress, legislators have many options at their disposal to check the PBMs — and no reason to delay," says NCPA CEO Douglas Hoey. "PBM reform would rein in the big health insurance lobby, make prescription drugs more affordable for consumers, and throw a lifeline to the thousands of small, family-owned pharmacies that are on the brink of closure. We are continuing to push hard, along with our allies, for Congress to finalize PBM reform legislation and send it to the president's desk as soon as possible."... Full

The Pharmaceutical Industry's Frequent Flyers and Empty Promises

(12/13, Christopher Shays, The Hill) ...The real question now is whether voters are ready to demand that lawmakers finally confront the industry's influence-peddling and the outsized profits it protects at the public's expense... Full

Lowering FDA's Drug-Approval Standards Is a Lose-Lose

(12/12, Robert M. Kaplan, PhD, MA, Amanda J Koong, MS, and Veronica L Irvin, PhD, MPH, MedPage Today) ...At a moment when public trust in institutions is fragile, lowering the bar for evidence is exactly the wrong move. Instead, we should strengthen the FDA's commitment to transparency, reproducibility, and multiple, independent trials. Innovation matters. But equally important is the confidence that the medicines we rely on are safe, effective, and worth their extraordinary cost... Full

BsUFA IV: Approval Criteria Shift May Mean US FDA User Fee Changes

(12/12, Derrick Gingery, Pink Sheet) ...Aaron Josephson, a senior director at Teva, suggested BsUFA fees may need to change along with the development process. "The BsUFA fee structure and FDA's organizational structure should reflect this," he said during the Dec. 3 kick-off meeting for the biosimilar user fee reauthorization. "We look forward to discussing with FDA how to ensure the fee structure provides the agency with the resources it needs in the right places."... Global Sub. Full

Can US FDA Balance Inspection Generalists And ‘Simple Reform' With Need For Expertise?

(12/12, Sue Sutter, Pink Sheet) ...The agency risks reversing the gains made with the 2017 "Program Alignment" initiative, where inspectors became more specialized, Michael Rogers, principal of quality and compliance at Canal Row Advisors, said at the Food and Drug Law Institute's recent enforcement, litigation and compliance conference... Global Sub. Full

'California' Brand Insulin Is Hitting The Market

(12/14, Grant Stringer, San Jose Mercury News) ...So far, the state is only offering one type of insulin: glargine, a long-acting medication that isn't the main insulin used by many with the most common form of diabetes, Type 2, and all people living with Type 1 diabetes...Behind the scenes, California and Civica are planning to debut a fast-acting insulin as well, [Andrew DiLuccia, a spokesperson for the California Department of Health Care Access and Information,] said. "Civica is making good progress, and the State of California remains committed to making sure this initiative is successful," he said in an email... Full

Opinion | Minnesota Can't Let Big Pharma Hike Prices Unchecked

(12/13, Kate Lynch, The Minnesota Star Tribune) ...Minnesota has consistently led the way in expanding health care access. PDAB is our chance to lead again, standing up to Big Pharma and ensuring that Minnesotans never have to choose between their health and their livelihood... Full

Louisiana Will Settle Two Lawsuits With CVS in Dispute Over Prescription Drug Prices

(12/12, Meghan Friedmann, Nola.com) ...Louisiana has agreed to settle two lawsuits against CVS Health that were filed earlier this year over the company's treatment of independent pharmacies and its general business practices, court records show. The terms of the settlement were not immediately available. On Friday, a spokesperson for Attorney General Liz Murrill said he could not yet provide details. A spokesperson for CVS declined to comment... Full

States Take the Lead Policing AI in Health Care

(12/13, Adriel Bettelheim, Axios) ...While President Trump demands a single national framework on AI policy, states are going their own way with hundreds of proposals aimed at setting guardrails for how the technology is used in health care. Why it matters: That could set up a clash over who determines how AI models and systems can be deployed in insurer reviews, mental health treatment and chatbots that interact with patients... Full

AC Immune Posts Positive Data for Parkinson's Immunotherapy

(12/11, Jacob Bell, BioPharma DIVE) ...The first part of the experiment includes 34 participants who've been treated for somewhere between 12 and 18 months. According to AC Immune, interim results show that not only is its therapy triggering the desired immune response, but biological markers as well as clinical measures of motor function suggest it may also be stabilizing patients' disease... Full

Sanofi Shares Fall on Twin Trouble for Experimental Multiple Scleroris Drug

(12/15, Reuters) ...Sanofi said that the U.S. Food and Drug Administration's decision on its tolebrutinib drug to treat non-relapsing secondary progressive multiple sclerosis will likely be delayed until the first quarter of 2026. It is the second delay to a decision that was initially expected in September before being pushed to December 28... Sub. Req’d

Lilly Shifts Ambition for Broader Oral SERD Label to Largest Oncology Trial in Company History

(12/12, Angus Liu, Fierce Pharma) ...Instead, the Indianapolis pharma will only pursue a label for the combo covering patients with ER-positive, HER2-negative advanced breast cancer who carry ESR1 gene mutations, the same limited indication that Inluriyo monotherapy recently obtained from the FDA, Jake Van Naarden, president of Lilly Oncology, told Fierce Pharma... Full

Biocon Biologics Inks Settlement and License Agreement to Commercialize Biosimilar Aflibercept Worldwide

(12/15, Pharmabiz.com) ...This agreement clears the way for Biocon Biologics to commercialize Yesafili, a biosimilar aflibercept (40mg/ml), in all countries worldwide... Full

Generics Succeed Against Sanofi Over Cancer Drug Cabazitaxel

(12/12, Konstanze Richter, JUVE Patent) ...Several generic drug companies scored a win at the UPC against Sanofi's second medical use patent for cabazitaxel. In a decision issued today, the local division Munich revoked the patent, which forms the basis of cancer drug Jevtana... Full

Aurobindo Pharma Gets 3 Observations after FDA Scan of Telangana Unit

(12/15, CNBC TV-18) ...At the conclusion of the inspection, the FDA issued a Form 483, citing three observations, described by the company as procedural in nature. Aurobindo Pharma said it will respond to the regulator within the stipulated timelines... Full

Indian Drugmaker Zee Laboratories Promises Cheap Alternatives - but There's a Catch

(12/15, The Economic Times) ...[Rohit] Mukul runs a fast-growing chain of chemists that sells medicines largely made by Zee Laboratories, a company started by his father that manufacturers generic drugs - cheaper copies of medicines that are produced once an original patent expires. Although they are sold at a knock-down price, generics must contain the same key ingredients as the original. But Zee Laboratories' drugs have failed at least 86 quality tests by Indian regulators, and the company has faced multiple court cases, reporting by The Bureau of Investigative Journalism (TBIJ) and the Thomson Foundation found... Full

Biosimilar Patient Experience a Focus at NASP 2025

(12/13, Marcus A. Banks, Specialty Pharmacy Continuum) ..."Most if not all, adalimumab patients have gone through a long journey to find a treatment and dosage that really works for them. It can be a long and frustrating journey to get to that point," Dr. Lockhart said. "Understandably some of them are hesitant about wanting to change," even if a biosimilar is fundamentally the same as the originator product... Full

Updated Biosimilars Statement Anticipates Future Approvals

(12/12, Andrew D. Zelenetz, MD, PhD, AJMC) ...The National Comprehensive Cancer Network (NCCN) Guidelines statement on biosimilars was revised to include any appropriate biosimilar for a therapy vs focusing on rituximab. The revision was designed to make the guidance more generic and broadly applicable across oncology disciplines... Full

Biosimilars in 2025: A Year of Firsts

(12/12, Denise Myshko, Managed Healthcare Executive) ...In 2025, the biosimilar market saw 16 new approvals as of the beginning of December and the launch of a new class of biosimilars... Full

UK's Hikma CEO Steps Down, Chairman Takes Helm until Successor Appointed

(12/15, Reuters) ...Executive Chairman Said Darwazah, who is a former CEO of Hikma, will lead the company while the board searches for a permanent successor. Chief Financial Officer Khalid Nabilsi will join the board and take on expanded management duties to help deliver the group's strategic plans, the company said... Full

Here's The Key to Making GLP-1s More Affordable

(12/15, Roger W. Ferguson Jr., Grant Verstandig, The Washington Post) ...The path forward is clear: Employers need more flexibility in benefits design and a model that eliminates red tape, reduces administrative burden and empowers consumers. This is how we deliver on the clinical promise of GLP-1s and other quality of life therapies and usher in a new era of affordability, access and better health outcomes... Full

How To Successfully Navigate The UK's New Pathway To Get Medicines To Patients More Quickly

(12/12, Anabel Costa-Ferreira, Pink Sheet) ...Seek early joint scientific advice through a revamped service, ensure different departments within pharmaceutical companies are on the same page and make sure products are registered on the relevant horizon scanning database in good time... Global Sub. Full

Switching to Cheapest Generics Could Save 7.9 Trillion Won

(12/13, Cho Seong-ho, The Chosun Daily) ...Research indicates that if patients currently using medications switch to the lowest-priced alternatives with the same active ingredient, annual drug costs could be reduced by nearly 8 trillion Korean won... 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.