Thursday, March 26, 2026

 

 

The Most Favored Nation Policy: Early Insights Into Europe's Response

(3/25, Simran Gurung, Pharmaceutical Technology) ...While the policy may succeed in reducing drug prices in the US, it raises an important question about its broader impact on patient access and affordability across the pharmaceutical landscape. Additionally, if withdrawal rates and supply constraints intensify, policymakers will likely face pressure to make price adjustments to ensure continued access to medicines... Full

 

Senate Deal Reached to Cap Insulin Costs

(3/25, Joseph Choi, The Hill) ...Sens. Jeanne Shaheen (D-N.H.), Susan Collins (R-Maine), Raphael Warnock (D-Ga.) and John Kennedy (R-La.) introduced the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, which would limit out-of-pocket costs for people with diabetes by waiving any deductibles and limiting cost sharing to $35 or 25 percent of the list price per month. If signed, the bill would go into effect at the beginning of 2027... Full

 

Has the United States Bent the Health Care Cost Curve?

(3/25, David M. Cutler and Lev Klarnet, Brookings) ...The authors explore reasons for the slower growth and "conclude that the United States has bent the health care cost curve, though not as much as it could be or will need to be bent." Price declines in some areas, such as for medical imaging and the shift to generic drugs from brand-name drugs, explains some of the slower growth... Full

 

Senator Rand Paul: PBMs Lower Drug Prices, Deliver Value to Consumers & Businesses

(3/25, PCMA) ...At an event with Competitive Enterprise Institute (CEI) economist Jeremy Nighohossian, the senator, a physician, made several important, clarifying comments about PBMs amid a Big Pharma misinformation campaign... Full

 

U.S. Attorney's Office Entered Settlements Exceeding $900 Million and Collected Over $70 Million in Civil and Criminal Actions in Fiscal Year 2025

(3/25, US Attorney's Office District of Massachusetts) ...The ACE Unit also entered into a $425 million resolution with Teva Pharmaceuticals to resolve allegations that Teva paid kickbacks via two co-pay assistance foundations in violation of the Anti-Kickback Statute and FCA. This resolution stands as the largest co-pay assistance settlement to date... Full

 

PDUFA VIII: Industry Questions Increased Spending Despite Staff Cuts, Agreement on RDEA

(3/25, Joanne S. Eglovitch, Regulatory Focus) ...During the finance subgroup discussions on February 19, the industry raised concerns about the increase in PDUFA spending, especially in light of recent significant layoffs. Specifically, they requested more context regarding the rise in PDUFA payroll from FY 2024-2025. These questions were driven by FDA's FY 2025 PDUFA financial report to Congress... Full

 

GDUFA IV: US FDA Worries About Revenue Shortfalls, Industry Does Not

(3/25, Derrick Gingery, Pink Sheet) ...The FDA told industry negotiators during a Feb. 19 GDUFA IV negotiating session that FY 2025 program spending was down. Had the agency spent what was planned and been fully staffed, expenses would have exceeded revenue by $13m, which would have significantly cut into the operating reserve. Agency officials were concerned that the reserve, which the FDA uses to fund the GDUFA program during a government shutdown or if expenses exceed revenue, would have dropped to six weeks of operations... Global Sub. Full

 

‘More Can Be Done' – AAM's Keeton On Reshaping The US Biosimilars Market

(3/25, Dave Wallace, Generics Bulletin) ...Alex Keeton, the new executive director of the AAM's Biosimilars Council, talks to Generics Bulletin for an exclusive interview... Global Sub. Full

 

Trump's Delay In Tapping CDC Nominee Gives RFK Jr. Control Of Some Duties As Bhattacharya Retains Others

(3/25, Jessica Karins, Inside Health Policy) ...The Centers for Disease Control and Prevention, which has been without a Senate-confirmed director since last August, will continue without a nominated replacement, and past the deadline for one that would allow a formal acting director to remain in place, as President Donald Trump still hasn't picked a nominee amid tension over vaccine policy that makes the Senate environment a chilly one for prospective HHS officials. The delay gives HHS Secretary Robert F. Kenney Jr. direct control over some CDC functions like vaccine recommendations while Jay Bhattacharya, who loses his acting director title, retains control of some others as the search continues... Sub. Req'd

                

Louisiana Lawmakers Want to Force Pharmaceutical Companies to Reveal Pricing Information

(3/26, Alyse Pfeil, Nola) ..."We want the truth," state Sen. Kirk Talbot, R-River Ridge, said Wednesday while presenting a proposal that would require drug companies to reveal to the board how much it costs them to make certain prescription drugs and the prices they charge. Under Talbot's legislation, Senate Bill 401, it would be illegal for pharmaceutical companies not to report the price information to the board... Full

 

Kansas Lawmakers Pass PBM Bill, but Drug Pricing Reform Stalls

(3/26, Matt Resnick, The Capital-Journal) ...Senate Bill 20, a related measure, places regulations on the middlemen responsible for negotiating drug prices between pharmacies, manufacturers and insurers. Those influential intermediaries, known as Pharmacy Benefit Managers, also set reimbursement rates for prescription medications... Full

 

Prescription Drug Price Control Bill Passes First Committee Hurdle

(3/25, Jenna Schweikert, Capitol News Illinois) ...The bill would create an independent board with the power to set a maximum price on certain prescription drugs that meet price thresholds. A House committee voted 8-4 along party lines to pass it out of committee Tuesday evening, though its sponsor said it's not a final product... Full

 

 

GH's Psychedelic Alleviates Severe Depression With Repeat Doses

(3/26, Gerry Smith, Bloomberg) ...More than half of patients given the drug, mebufotenin, were in remission after a week, compared with none of those given a placebo, according to results published Wednesday in JAMA Psychiatry. Only 13% remained in remission without needing another dose after six months, and 15 of 20 patients received three to four more treatments... Sub. Req’d

 

 

AEON Biopharma Announces FDA Feedback Following BPD Type 2a Meeting for the ABP-450 Biosimilar Program

(3/25, AEON Biopharma) ...[AEON Biopharma] announced feedback from the U.S. [FDA] following a successful Biosimilar Biological Product Development (BPD) Type 2a meeting...AEON is currently planning to request a BPD Type 2b meeting in 2026 to discuss the next phase of the development program to support approval of ABP-450 as a biosimilar to BOTOX® across all approved therapeutic indications... Full

 

Aurobindo Pharma's CuraTeQ Signs EU Biosimilars Distribution Pact With STADA

(3/25, Jomy Jos Pullokaran, CNBC-TV18) ...Aurobindo Pharma Ltd on Wednesday (March 25) said its wholly owned subsidiary CuraTeQ Biologics Pvt Ltd has entered into a marketing and distribution agreement with European healthcare and pharmaceuticals company STADA Arzneimittel AG for biosimilars in select European Union territories. The company said STADA will market and distribute two biosimilars developed by CuraTeQ that have been approved by the European Medicines Agency (EMA). The agreement covers select EU markets, including France and Germany... Full

 

Celltrion Ramps Capacity To Power Global Biosimilars Expansion

(3/25, Dean Rudge, Generics Bulletin) ...As part of a move that will boost its global drug-substance capacity by more than 80% Celltrion has disclosed plans to invest KRW1.23trn ($820m) to expand its manufacturing footprint in South Korea...More broadly, the company framed the investment as part of a longer-term strategy to "establish a long-term growth foundation" supporting both next-generation biosimilars and innovative drug candidates, as well as its growing CMO business... Global Sub. Full

 

 

Boehringer Ingelheim Plans for Dealmaking, Obesity Pipeline and R&D to Counter US Price Pressure

(3/26, Elizabeth Cairns, Endpoints News ) ...The company's biggest money-makers in 2025 were once again its diabetes and heart drug Jardiance and the lung disease med Ofev. But sales in the US shrank 2% from 2024, hit by "quite substantial reductions in price" in the country. The Medicare prices of Jardiance, Ofev and the diabetes therapy Trajenta are all now negotiated under the IRA. If the impact on pricing in the US were to be excluded, finance chief Frank Hübler said, "we would have also grown there as we did in Europe and other regions." The advent of new products could help... Sub. Req’d

 

Chinese Drugmaker Hengrui's Quarterly Profit Misses Forecasts Amid Generic Drug Business Squeeze

(3/25, Reuters) ...Jiangsu Hengrui Pharmaceuticals, China's biggest drugmaker by market value, reported fourth-quarter profit below market expectations on Wednesday, as income from business development deals has failed to appear. The specialist in oncology, neurology, immunology, respiratory, metabolic and cardiovascular drugs has expanded licensing deals and developed more innovative drugs amid Beijing's centralised bulk buying programmes, which have squeezed generic drug revenues... Sub. Req'd

 

As Strides Pharma Stabilises Balance Sheet, Focus Shifts to Growth Beyond The US

(3/26, Moneycontrol.com) ...After spending years on repairing its balance sheet and recalibrating its portfolio, Strides Pharma Science is now turning its attention to the next phase of growth — one that builds on the strength of its US business while pushing deeper into non-US markets through targeted acquisitions and partnerships... Full

 

How an Outsider Crept into Eli Lilly's Top Ranks — and Plans to Drive its Business Forward

(3/25, Matthew Herper, STAT+) ...Eli Lilly believes that [Jacob] Van Naarden's leadership is set to open up new opportunities for the company in cancer. Daniel Skovronsky, Lilly's chief scientific officer,...calls it "one of the most exciting moments at Lilly for oncology development." Beyond the company's already approved medicines, Skovronsky notes it has four new Phase 3 programs enrolling or about to begin with data expected across lung, breast, ovarian, and urothelial cancer. The deliberate strategy, he said: "Building an oncology portfolio across multiple mechanisms and tumor types, not just one asset or one approach."... Sub. Req’d

 

 

War Exposes Pharma Supply Chain Fragility with Long-term Risks for Generics, Cancer Drugs & Global Prices: Experts

(3/26, Pharmabiz.com) ...Pharma industry expert Vikas Nim informs that there are no widespread US shortages as yet. US distributors hold 30 to 60 days of inventory, and many Indian manufacturers have 3 to 6 months of buffer. Pacific shipping routes remain open. However, cold-chain failures and rerouting are already straining operations. Israel's Teva Pharmaceuticals, which is a major global generics player, reports minimal direct disruption so far. Its Israeli production is less than 8% of global output, with heavy diversification into the US and elsewhere... Full

 

As Patents on Weight-Loss Drugs Expire, Doctors and Patients Hotly Anticipate Cheaper Generics

(3/26, Abby Hughes, CBC) ...Health Canada says there are nine generic semaglutide medications under review for approval in Canada. The agency's target timeline for initial review of a generic drug is 180 days, and it says it's "on track to meet review targets" for submissions for generic semaglutide medications. While Health Canada doesn't give any further timeline as to when drugs might be approved, Mina Tadrous, associate professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto, says he estimates generics might be available by this summer or early fall... Full

 

Germany Is Drafting Plan to Hit US Companies in Next Trump Clash

(3/26, Kamil Kowalcze, Michael Nienaber and Jenny Leonard, Bloomberg) ...The initial findings suggest ways to target the massive US tech firms with close ties to the White House, the officials said. Other options could aim for the AI investment boom that has helped to drive US stocks to record highs this year or push up drug prices for American voters, an issue the president has already shown he's sensitive to... Sub. Req'd

 

Parliamentary Panel Asks DoP to Keep it Apprised of the Progress on Biopharma Shakti Scheme

(3/26, Gireesh Babu, Pharmabiz.com) ...The direction follows Union finance minister Nirmala Sitharaman's announcement of Biopharma Shakti scheme with an outlay of Rs. 10,000 crore over the next five years, to develop India into a global biopharmaceutical manufacturing hub by building a strong and self-reliant ecosystem for the domestic production of biologics and biosimilars... Full

 

Korea Cuts Generic Prices to 45%, Splitting Pharma Fortunes by R&D Focus

(3/26, Park Su-hyeon, Chosun Biz) ...As the government finalized a reform plan to lower the pricing rate for generics to as low as 45% of original drugs, the restructuring of the revenue model in Korea's pharmaceutical industry is expected to accelerate. Small and midsize drugmakers with a high share of generic sales now face unavoidable pressure on profitability, while companies investing in research and development (R&D) gained a new price protection mechanism for up to four years... Full

 

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