Friday, October 31, 2025

FDA Reports Recall of Blood Pressure Medication Containing a Potential Carcinogen

(10/31, The Associated Press) ...The U.S. Food and Drug Administration says drug makers have recalled more than a half-million bottles of the blood pressure medication prazosin hydrochloride over concerns it may include a cancer-causing chemical. New Jersey-based Teva Pharmaceuticals USA and drugs distributor Amerisource Health Services issued voluntary nationwide recalls earlier this month of more than 580,000 bottles of various strengths of prazosine capsules, according to the FDA... Full

Blood Pressure Medicine Recalled Over High Levels of Cancer-Causing Chemical

(10/30, Taylor Herzlich, New York Post) ..."This recall has been initiated in coordination with the FDA and to date Teva has not received any relevant complaints related to this product," Teva Pharmaceuticals USA told The Post in a statement. "Prazosin is indicated for the treatment of hypertension, to lower blood pressure, and there are many alternative treatments available to patients." As of Thursday morning, the drugmaker apparently had not provided instructions on whether consumers should toss or turn in bottles of the recalled product... Full

Blood Pressure Medicine Linked to Cancer? Why 580,000 Bottles of Drugs Have Been Recalled in US

(10/31, Firstpost) ...So far, Teva has not received any reports of adverse effects or complaints linked to the contaminated product. The company has urged patients who may have purchased the affected medication to reach out to their pharmacy where the prescription was filled, as well as their prescribing doctor. Teva also warned against stopping the medication abruptly without medical advice, since any sudden change in blood pressure treatment could be dangerous. "Any interruption in a medication regimen can pose serious risks, and switching to a new prescription must be done under proper medical supervision," the company said... Full

FDA's New Fast Drug Review Plan Comes With Trade-Offs for Pharma

(10/31, Nyah Phengsitthy, Bloomberg Law) ...The plan is both a win and a loss for the pharmaceutical industry, life science experts say, as it pressures the FDA to prioritize which medicines to review. But while priority reviews aren't new to the FDA, the evaluations will now be made by offices hit hard by recent workforce reductions that could affect decisions for drugs even beyond those included in the program...The pharmaceutical industry benefits from the decreased review time for drugs and biologics. The strenuous process involves the FDA analyzing thousands of pages of an application while being in constant communication with sponsors to ensure a drug is safe and effective along with the facilities where it's manufactured... Sub. Req’d

Vizient Applauds FDA's Recent Actions to Accelerate Biosimilar Development and Lower Costs

(10/30, Vizient) ..."Vizient strongly supports FDA's science-based approach to streamlining biosimilar approvals while maintaining the gold standard for safety and quality," said Steven Lucio, PharmD, BCPS, senior principal, pharmacy solutions for Vizient. "By eliminating redundant clinical study requirements, the agency is helping to increase competition, accelerate adoption and expand access to affordable biologic treatments for patients and providers."... Full

Medicare Plan To Report Maximum Fair Prices Only For Part B Negotiated Drugs Will Advance

(10/30, Cathy Kelly, Pink Sheet) ...At this time, CMS cannot change its plan to publish Medicare maximum fair prices for negotiated Part B drugs instead of average sales prices, despite stakeholder concerns, agency official John Brooks said. Manufacturers worry that commercial health plans relying on ASP to set reimbursements for physician-administered drugs will shift to the likely significantly lower MFP metric and expand the impact of the reduced price. However, Brooks suggested that CMS may revise its approach to include bona fide service fees in the ASP calculation in response to stakeholder objections... Global Sub. Full

HHS Approves Pharma's Drug Discount Rebate Models for Pilot

(10/30, Nyah Phengsitthy, Bloomberg Law) ...Drugmakers including Bristol Myers Squibb Co., Novo Nordisk A/S, and AstraZeneca PLC received the rubber stamp for their models to participate in a rebate pilot under the federal 340B Drug Pricing Program, according to an updated webpage from the HHS's Health Resources and Services Administration...AstraZeneca, Bristol Myers, and Amgen Inc. confirmed its models were approved. "We hope this pilot will serve as a foundation for broader adoption of expanded rebate models covering additional medicines to strengthen oversight," a spokesperson for Bristol Myers said in an email... Sub. Req’d

The 340B Drug Pricing Program As A Capped Safety-Net Grant

(10/30, Anthony M. DiGiorgio and Deborah Williams, Health Affairs) ...The current financial arbitrage model of 340B is fundamentally flawed. It acts as an inefficient, poorly targeted revenue stream for large hospital systems. Converting this program to a capped safety-net grant solves many problems including the program's complexity and adverse effects on affordability, while ensuring funds follow low-income patients. Policy makers should prioritize this reform to promote competition and reward institutions which reliably provide access to low-income patients... Full

Drug Costs Reflect Legislation to Fix Past Legislation

(10/31, Norm Singleton, RealClearMarkets) ...Hospitals that participate in Section 340B should be required to spend the money they save by participating in the program on providing free or reduced-price care to those who lack insurance. This would not only fulfill the program's intent—it would remove the current program's incentives for hospitals and pharmacies to engage in mergers and acquisitions. Congress should also reduce health care costs and increase health care quality and access to care by creating a free market in health care through expanded individual tax credits and Health Savings Accounts... Full

Trump's Deals Still Leave Some Costly Drugs Out of Reach

(10/31, Sonja Wind, Bloomberg) ...Drugmakers have found ways to extend exclusivity with add-on patents that delay generic competition. The 10 top-selling brand-name drugs are projected to get about 40 years of patent protection on average, double the typical 20-year term, a study found...That's what Trump is trying to target. His plan for lower drug prices centers on selling medicines at discounted prices through his new TrumpRx direct-to-consumer platform. But the agreements he's made with major pharmaceutical companies cover only a few drugs. That may give some people access to drugs they don't currently have, "but the overall moves so far do not appear to lower out of pocket costs for most," says Bloomberg Intelligence's John Murphy... Sub. Req’d

Staff Shortages, Tariffs Threaten $350B U.S. Pharma Investment Boom

(10/30, Thorvardur De Shong, Chain Drug Review) ...A $350 billion investment boom in U.S. pharmaceutical manufacturing is being constrained not by cost, but by a shortage of skilled labor, according to a new report from Global Location Strategies (GLS). The firm's 2026 Best Places for Pharmaceutical Manufacturing Insights Report highlights the key factors shaping investment in the country's therapeutic biologics industry amid a broader "Reindustrialize America" movement... Full

If You Must Remit, You Can't Submit = Big Problem for Industry

(10/30, Bob Pollock, Lachman Consultants) ...As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0...That's because after October 1, 2025, without a new appropriations bill or continuing resolution being passed, the FDA cannot accept or process any submission requiring a fee... Full

Full FY 2025 OGD Statistical Report Issues

(10/30, Bob Pollock, Lachman Consultants) ...To summarize the FY in review, we saw ups and downs on some important metrics. To me the two most troubling metric drops were in the actual ANDA approvals and ANDA receipts. Hopefully we will see some new players ramp up ANDA submissions in the coming year. However, we know with the government shutdown, no new ANDA submissions will be included in the October figures unless the government opens today or tomorrow which appears unlikely... Full

US FDA User Fee Balances Holding, Thanks In Part To Earlier Staff Cuts

(10/30, Derrick Gingery, Pink Sheet) ...FDA user fee reserves likely can continue sustaining application review and other activities into December, should the government shutdown continue. Staff cuts earlier this year, which reduced spending, helped increase some of the balances. No additional furloughs at the FDA medical product centers have been seen so far... Global Sub. Full

Under Vinay Prasad, Employees at a Key FDA Center Fear Speaking Out, Look for the Exits

(10/31, Lizzy Lawrence, STAT+) ...Dozens of scientists are considering leaving the Center for Biologics Evaluation and Research, where Prasad serves as director, to escape a work environment that eight agency officials described to STAT as rife with mistrust and paranoia. These officials said staffers are terrified of pushing back on Prasad, lest they face retaliation. The fear has been fueled by Prasad pushing at least seven senior leaders out of their positions, employees told STAT, and offering no public explanations to staff or the leaders' supervisors. Some of his workers are fed up, and are attempting to transfer to the FDA's drug center... Sub. Req’d

Ritedose Now Offers the Largest Nebulized Drug Portfolio in the U.S.: FDA Approves the Company to Manufacture Generic Tobramycin Inhalation Solution

(10/30, Ritedose) ...Tobramycin will be marketed by Ritedose Pharmaceuticals, the generics division of Ritedose (the largest sterile contract development manufacturing organization (CDMO) in the U.S., specializing in aseptic unit-dose medication production using Blow-Fill-Seal (BFS) technology). Ritedose licensed the drug's Abbreviated New Drug Application (ANDA) from Hikma Pharmaceuticals... Full

Natco Pharma Launches Everolimus Tablets

(10/31, G Naga Sridhar, The Hindu Businessline) ..."Natco's marketing partner for the Abbreviated New Drug Application (ANDA), Breckenridge Pharmaceutical, the US subsidiary of Towa International, plans to launch the product immediately in the US market," the Hyderabad- based company said in a release on Friday. Breckenridge previously launched its Everolimus Tablets in 0.25mg, 0.5mg, and 0.75mg strengths, with blisters launched in July 2021 and bottles in June 2023... Full

US Biosimilar Norms to Keep Local Drug Cos in Good Health

(10/31, Rica Bhattacharyya, The Economic Times) ...With the new regulations set by the US FDA, the pathway to creating biosimilars will be both faster and more cost-effective. This development is a game changer for Indian firms like Biocon and Dr Reddy's Laboratories, allowing them to provide more economical medicines to patients... Sub. Req’d

Cipla Leans Into Chronic And Obesity Therapies As Key Growth Drivers

(10/31, Neetu Chandra Sharma, BusinessToday) ...With Revlimid sales gradually tapering off, Cipla is widening its focus on chronic and speciality therapies. A key part of this plan is its entry into the GLP-1 agonist class of drugs, used for treating diabetes and obesity. Through an exclusive partnership with Eli Lilly, the company has begun distributing and promoting Yurpeak (Tirzepatide) in India, known globally as Mounjaro. Cipla describes obesity care as a "market-shaping opportunity" in a country where 101 million people live with diabetes and another 100 million struggles with obesity... Full

Strides Pharma Q2 Results: Stock Jumps 13% on Strong Margin Expansion; US Guidance Maintained

(10/31, Hormaz Fatakia, CNBC TV-18) ...For the US market, Strides Pharma reported sales of $73 million, nearly the same as the same quarter last year. The management has reiterated that the US business will achieve revenue of nearly $400 million by financial year 2027-2028...Expansion of product portfolio and new customer acquisitions to drive growth, conversion of the existing strong funnel of new opportunities to deliver growth, and continued momentum in filings will drive growth in the medium term are the three important points highlighted by Strides Pharma for the European business... Full

Cigna Plan to End Drug Rebates Sparks Worst Selloff Since 2008

(10/30, John Tezzi, Bloomberg Law) ...It's evidence that the company's plan to eliminate many drug rebates — opaque payments that fueled years of attacks on Cigna and its peers — will hit its bottom line. "This is a fundamental business model pivot," Chief Operating Officer Brian Evanko said on a call with analysts Thursday...Cigna still expects earnings per share to grow in 2026, Cordani said. Other parts of its business, including medical plans and its specialty pharmacy, are expected to perform well. Eli Lilly & Co. CEO Dave Ricks praised Cigna's decision during the drugmakers' earnings call Thursday. "It's a good move for patients. It's a good move for payers, for the commercial payers. And probably smart of Cigna to make this first move," Ricks said. "We hope others follow."... Sub. Req’d

BMS' Hyped Schizophrenia Med Cobenfy Delivers So-So Launch Year as Execs Map Plan for Future

(10/30, Angus Liu, Fierce Pharma) ...Approved by the FDA to treat schizophrenia in September 2024 and officially launched the following month, Cobenfy generated third-quarter sales of $43 million, compared with $35 million in the second quarter. The quarterly number largely met Wall Street's expectations of $44 million, according to Citi...During BMS's earnings call Thursday, CEO Chris Boerner, Ph.D., described Cobenfy as "delivering steady growth." But the first-in-class drug still has a long way to go to fulfill its promise as a potential multibillion-dollar product... Full

Eli Lilly Says Weight-Loss Pill a Candidate for Speedy Approval Under New US Program

(10/31, Mrinalika Roy and Patrick Wingrove, Reuters) ...Eli Lilly said on Thursday its experimental weight-loss pill met most criteria for the U.S. Food and Drug Administration's new national priority voucher, suggesting it is a strong candidate for a significantly accelerated approval review. Lilly said it will submit its review package for the pill, orforglipron, to the FDA this quarter, adding the agency will decide on the approval process... Full

Eli Lilly's Weight Loss, Diabetes Drug Tops Keytruda as World's Best-Selling Medicine

(10/30, Elaine Chen, STAT) ...Lilly's tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for obesity, saw $10.1 billion in sales in the third quarter, the pharma giant said Thursday, bringing year-to-date sales of the product to $24.8 billion. Merck, meanwhile, reported that Keytruda, a cancer immunotherapy, earned $8.1 billion in the third quarter, bringing year-to-date sales to $23.3 billion...Analysts polled by Visible Alpha currently predict that for the full year, tirzepatide will bring in $32.2 billion, while Keytruda will bring in $31.8 billion... Full

Pfizer Could Hold a Trump Card in Its Bid for Metsera

(10/31, Michael Erman and Sabrina Valle, Reuters) ...U.S. drugmaker Pfizer could work its connections within President Donald Trump's administration to try to thwart Novo Nordisk's surprise rival bid to acquire U.S. obesity biotech firm Metsera, analysts, investors and lawyers said on Thursday. Danish obesity and diabetes drug giant Novo said on Thursday it had bested Pfizer's already agreed-upon deal, kicking off a fight for advantage in the market analysts forecast will grow to $150 billion. The next step is Pfizer's, which has four business days to make a counteroffer, Metsera said, describing Novo's bid as "superior.". A Pfizer spokesperson did not have an immediate comment on whether the company would do so. The company has also said it is ready to legally challenge Novo's bid... Full

Will Novo's Metsera Bid Test the Trump Administration's Antitrust Approach?

(10/30, Jared Whitlock, Endpoints News) ...The bid looks to pit two opposing forces against each other: new FTC leadership that has promised a lighter touch compared to the Biden-era Lina Khan regime, and a Trump White House that has pledged to lower drug prices by any means necessary. The matter could ripple across the pharmaceutical sector that relies on dealmaking, and through the fast-growing obesity market where access is increasingly a hot political topic...A Novo spokesperson said that "while the deal is of course subject to the usual regulatory approvals, we would not have made this offer if we did not believe it could gain approval."... Sub. Req’d

Boehringer Returns to Kyowa Kirin with €640M Pact for Preclinical Autoimmune Molecule

(10/30, James Waldron, Fierce Biotech) ...Boehringer Ingelheim has returned to Kyowa Kirin for a 640 million euro ($743 million) deal for a preclinical program the German pharma hopes will offer a new autoimmune disease option. Boehringer didn't give away too much in its Oct. 30 release. There's no hint at the small molecule's modality or what conditions it will be tested against first beyond a reference to inflammatory conditions and hopes of the drug becoming a "first-in-class … treatment of autoimmune diseases."... Full

A $20 Over-the-Counter Drug in Europe Requires a Prescription and $800 in the U.S.

(10/31, David Maris, STAT) ...A month's supply of Miebo, Bausch & Lomb's prescription dry eye drug, costs $800 or more in the U.S. before insurance. But the same drug — sold as EvoTears — has been available over-the-counter (OTC) in Europe since 2015 for about $20...When he was at Allergan, Bausch & Lomb's current CEO, Brent Saunders, pledged "responsible pricing" but tried to extend patent protection for Allergan's drug Restasis (another dry eye drug) through a dubious deal with the Mohawk Indian tribe, later rejected by courts. Now at Bausch & Lomb, Saunders oversaw Miebo's launch, claiming earlier this year in an investor call, "We are once again an innovation company." But finding a way to get an existing European OTC drug to be a prescription drug in the U.S. with a new name and a 40-fold price increase is not true innovation — it's a price-gouging strategy... Full

Wave of RSV, Particularly Dangerous for Babies, Sweeps Across U.S.

(10/30, Rong-Gong Lin II, Los Angeles Times) ...A wave of the highly contagious respiratory syncytial virus is sweeping across the United States — sending greater numbers of babies and toddlers to the hospital, recent data show...During last year's respiratory virus season, there were significant reductions in the RSV hospitalization rate for babies, data show. Data also show RSV vaccines were effective in preventing symptomatic illness in older adults... Full

Price Cuts Put Belgium's Medicines Supply at Risk, Warns Pharma Industry

(10/30, Nicole Verbeeck, Euractiv) ...Belgium's 2026 health insurance budget foresees €1.5 billion in extra spending and €470 million in savings, nearly half from the pharmaceutical sector. The new savings proposal led to the breakdown of budget talks between the government and Belgium's pharma sector, and has drawn criticism in parliament, along with a sharp response from Medaxes, representing Belgium's generics and biosimilars sector. During the parliamentary Health Commission last week, MP Irina De Knop (Open VLD) challenged Health Minister Frank Vandenbroucke on the failure to reach a pact with industry... Full

Indian Pharma Cos to Benefit as US Proposes Tweaks in Biosimilar Approval Guidelines

(10/31, Joe Mathew, Fortune India) ...Indian Pharmaceutical Alliance (IPA), the representative body of leading domestic pharmaceutical companies, has welcomed the move. "India already has nearly 130 approved biosimilars, and over the next seven years, more than 55 blockbuster drugs are expected to lose exclusivity in the US. India has long been a trusted partner in ensuring access to quality-assured, affordable medicines for American patients. These reforms will further strengthen the US–India partnership and our shared goal of improving healthcare access and affordability", Sudarshan Jain, Secretary General, IPA said... Full

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