Friday, February 6, 2026

Trump's Online Drugstore Opens for Business

(2/5, Margot Sanger-Katz, Rebecca Robbins, The New York Times) ...It is unlikely that many consumers will save money by using TrumpRx. Nearly all of the drugs on the site are already widely covered through insurance, and some are available as inexpensive generics from competing manufacturers. A person who has low out-of-pocket costs for a drug through insurance could waste hundreds of dollars a year paying out-of-pocket through TrumpRx. Each product page on the site advises consumers: "If you have insurance, check your co-pay first — it may be even lower."... Sub. Req’d

With TrumpRx.gov, President Brands His Drug-Price Push

(2/6, Dan Diamond, The Washington Post) ...Trump's website "could have some impact, but it is far from revolutionary," Craig Garthwaite, director of health care at Northwestern University's Kellogg School of Management, wrote in an email. He added that the program sidesteps bigger challenges in America's health system. "For most brand name medications, patients simply can't afford to pay cash out of pocket. That is what insurance is for!"... Sub. Req’d

Dr. Oz Is Fighting an Uphill Battle to Sell Congress on Trump's Healthcare Plan

(2/5, Sabrina Siddiqui, The Wall Street Journal) ...Sen. Chuck Grassley (R., Iowa), who attended the meeting last week of Republicans on the Finance Committee, said Oz was a "very influential salesman." Will Oz be successful on Trump's healthcare plan? "I think it's going to be difficult to get it done, but I think we have to try," Grassley said... Sub. Req’d

Eli Lilly Predicts Medicare Coverage Of Zepbound Will Draw Current DTC Customers

(2/5, Cathy Kelly, Pink Sheet) ...An estimated 10% to 20% of patients in Lilly's direct-to-consumer channel also are covered by Medicare and "we expect that bolus … will actually move into the Medicare space" once the program covers obesity drugs, Lilly Chief Financial Officer Lucas Montarce said during the company's Feb. 4 earnings call. "I think that will happen relatively fast and we will continue to build on top of that." The people "engaging" with the LillyDirect DTC platform grew to more than 1 million in 2025, Chairman and CEO David Ricks reported... Global Sub. Full

Analyzing The Drugs Selected For The 2028 Medicare Drug Price Negotiation Cycle

(2/5, Kristi Martin, Rachel Sachs, Health Affairs) ...This article is the latest in the Health Affairs Forefront featured topic, "Health Policy at a Crossroads," produced with the support of the Commonwealth Fund and the Robert Wood Johnson Foundation. Articles in this topic offer timely analysis of regulatory, legislative, and judicial developments in health policy under the Trump-Vance Administration and the 119th Congress... Full

The Clear Labels Act Would Change What You Know About Your Prescription Medication

(2/6, Debbie Cenziper, Naisha Roy, ProPublica) ...A spokesperson for the trade group for brand-name drugmakers said in a statement to ProPublica that the industry would "welcome conversations about how to strengthen the biopharmaceutical supply chain." The generic drug lobbying group said that additional labeling requirements would impose "significant costs in exchange for limited returns," and that drug manufacturers already disclose country of origin information under U.S. Customs and Border Protection rules... Full

Investigating Generics: Push for Safer Generic Drugs Picks up Speed on Capitol Hill

(2/5, Emma Yasinski, MedShadow Foundation) ...MedShadow's Investigating Generics series is driven by the premise that Americans deserve safer, more reliable generic medications. For the past year and a half, we've focused on the vulnerabilities in the drug supply chain, aiming to spark public discussion among policymakers and industry leaders about marketplace changes that could move us closer to that goal. Now, we're advocating for reforms that would make quality problems easier to detect and harder to ignore... Full

GDUFA IV: US FDA Seeks To Codify Domestic Manufacturing ANDA Prioritization Pilot

(2/5, Derrick Gingery, Pink Sheet) ...In another "America First" proposal, the FDA would change the generic drug application prioritization Manual of Policies and Procedures (MaPP) so an application could qualify for a priority review if pivotal bioequivalence testing is conducted in the US or the ANDA qualifies for a BE waiver, and the finished dosage form manufacturer and API supplier are located in the US, according to minutes of a Jan. 7 GDUFA IV negotiation session. The change would codify a pilot program initiated in October... Global Sub. Full

FDA Proposes Waiving GDUFA Facility Fees for Domestic Manufacturers

(2/5, Joanne S. Eglovitch, Regulatory Focus) ...The industry opposed the proposal, arguing it would unfairly subsidize new competitors at the expense of established US manufacturers who have already invested in domestic production. Instead, industry members suggested that expanding capacity at existing US facilities or retrofitting unused ones would be a faster way to increase domestic manufacturing capacity in the short term, as building new facilities takes several years. There was no agreement reached on this plan... Full

A Strong Year For US FDA Approvals, But Warning Lights Flashing

(2/5, Michael McCaughan, Pink Sheet) ...The Center for Biologics Evaluation and Research added a dozen novel therapeutic and vaccine approvals during the year, a relatively typical output. Of course, nothing was typical about 2025 inside the FDA. The challenges likely will accelerate as CDER moves forward under Director Tracy Beth Høeg... Global Sub. Full

FDA's Getting its Fix: The Consolidated Appropriations Act of 2026

(2/6, Sara W. Koblitz, FDA Law Blog) ...While these provisions may be a little in the weeds for an appropriations bill, they reflect years of FDA lobbying and effort to bring a little certainty where issues have repeatedly arisen. FDA has finally gotten its fix... Full

Former FDA Commissioner: HHS Leadership Is Focused on Policy-Based Evidence, Not Evidence-Based Policy

(2/6, Robert M. Califf, STAT+) ...In recent decades, we've learned that a person's experience, or even a professional's naïve analysis of aggregate data can be insightful, but also profoundly misleading... Sub. Req’d

Former FDA Drug Chief Warns About Focus on Speed in Voucher Plan

(2/5, Nyah Phengsitthy, Bloomberg Law) ...An FDA program that seeks to expedite drug reviews for companies in line with the Trump administration's priorities should focus on efficiency in evaluations, not speed, the agency's former drug head said Thursday. "This voucher program has an emphasis on speed, which I think is a very sophomoric aim at aspiration," said Richard Pazdur, who briefly served last year as the director of the [FDA's] Center for Drug Evaluation and Research. "It should be about efficiency."... Sub. Req'd

Hospitals, HHS Drop Legal Battle Over Drug Rebate Pilot Program

(2/5, Nyah Phengsitthy, Bloomberg Law) ...The parties agreed in the motion that if HHS decides to reintroduce a new rebate model pilot, the government will issue a new notice, including soliciting new drugmaker applications for the program. The move is a win for hospitals as it sends the US government back to the drawing board to rework its 340B Rebate Model Pilot Program... Sub. Req’d

The FTC–ESI Settlement: Net Price Rules at the Pharmacy Counter

(2/5, Stanton Mehr, Biosimilars Review & Report) ...Perhaps the greatest effect of yesterday's announced Federal Trade Commission (FTC) settlement with Express Scripts is its mandate on consumer exposure to net prices at the pharmacy counter as opposed to the inflated list prices of insulin products. But the implications go far beyond insulin. The settlement may contribute to the demise of high wholesale acquisition cost (WAC) pricing... Full

Big Take: Generic Ozempic Will Change Everything

(2/5, Bloomberg Podcast: Big Take) ...On today's Big Take podcast, Bloomberg reporters Naomi Kresge and Amber Tong talk to host David Gura about the year ahead for weight-loss drugs, from compounded products cutting into leading companies' market share to generics that could upend the market globally... Full

Alembic Pharma Secures USFDA Final Nod for Parkinson's Therapy Tablets

(2/6, Gareema Bangad, CNBC-TV18) ...In a regulatory filing, the company said the approval covers multiple strengths of the combination therapy, including 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg and 50 mg/200 mg/200 mg. The product is therapeutically equivalent to Stalevo tablets of Orion Corporation, the reference listed drug... Full

CVS Health Helps Customers Accelerate Biosimilar Adoption Through Formulary Changes – Supporting Affordable Options for Osteoporosis Care

(2/5, CVS Health) ...Effective April 1, 2026, CVS Caremark will begin offering osteoporosis biosimilars Ospomyv and Stoboclo, as well as generic teriparatide, Bonsity, and Tymlos on major national commercial template formularies... Full

Unlocking Biosimilar Potential

(2/5, The IQVIA Institute) ...This report provides a summary of the overall context for ophthalmology and a set of interviews with key stakeholders, including physicians, payers, and nurses who are involved in the treatment and management of ophthalmology. The report aims to understand the current state of knowledge about biosimilars across stakeholders and potential barriers to optimal biosimilar use from a physician perspective in this therapy area... Full

With Declining Sales of Legacy Meds, BMS Leans on New Growth Drivers to Weather the Storm

(2/5, Zoey Becker, Fierce Pharma) ...In an investor presentation, CEO Chris Boerner specifically pointed to several of these newer products in melanoma med Opdualag, CAR-T Breyanzi and heart drug Camzyos, each of which delivered blockbuster annual sales. Also in the growth group, blood disorder treatment Reblozyl generated more than $2 billion... Full

Biogen's Profit Forecast Tops Estimates on Cost-Cutting Measures

(2/6, Gerry Smith, Bloomberg) ...Biogen is betting that growth from newer drugs - including Alzheimer's treatment Leqembi and rare-disease drugs Skyclarys and Spinraza - will offset its declining MS medicines as competition from generics erode sales. The company doesn't expect that to happen this year. Sales are expected to fall in 2026 after growing 2% last year, driven largely by MS drugs losing exclusivity in Europe and facing new competition in the US, Viehbacher said... Sub. Req'd

Astellas Tops Expectations as Vyloy Sales Surge Outshines Trial Setback

(2/5, Angus Liu, Fierce Pharma) ...In a Wednesday note, Jefferies analysts said they were "impressed by the rapid rise in demand" for the stomach cancer treatment. The strong performance from Vyloy helped Astellas beat analysts' expectations for total third-quarter sales by 8%, according to Jefferies... Full

'I Thought We'd Be Faster and I Was Wrong': Sanofi Chief Defends R&D Pivot

(2/6, Ian Johnston, Financial Times) ...Defending his record in an interview with the FT, [Paul Hudson, Sanofi CEO,] said more time would be required for his research and development-led push to bear fruit after a "difficult 2025". "My first conversation in September 2019 was 'how are we going to manage the end of Dupixent?'," he said. "The next 12 to 24 months will tell us whether the choices we've made - I've made - will put us on track."... Sub. Req'd

Alembic Pharma Pivots to US Branded Market, Set to Launch Women's 'Health Antibiotic'

(2/6, Viswanath Pilla, Moneycontrol) ...Alembic Pharmaceuticals is set to enter the high-margin US branded market with the launch of "women health antibiotic", as it looks beyond generics to chart the next phase of growth, managing director Pranav Amin has said. In an interview to Moneycontrol on February 5, Amin said the company's decision to enter the branded US segment is driven by sustained price pressure in generics...On biosimilars, Amin said Alembic is cautiously exploring opportunities following recent US FDA changes that lowered preclinical and clinical entry barriers... Full

Strides Pharma: US-Led Global Fund Cut Hurts; Greater Focus On Ex-US Markets

(2/5, Vibha Ravi, Generics Bulletin) ...The realignment comes amid the company reporting about a 4% increase in operational revenues for the third quarter of FY26, the fiscal year ending 31 March, while revenues from the US market were flat compared to Q3 FY25 amid a weak flu season and those from the "access market" - dependent on donor funding - fell 70% year-on-year... Global Sub. Full

Could Higher UK Drug Prices Trigger A Domino Effect Elsewhere?

(2/5, Francesca Bruce, Pink Sheet) ...There has been some speculation that price increases in the UK, whether large or small, could lead to higher prices in other markets through reference pricing. List prices are public, but the net price paid by the National Health Service (NHS), which can include patient access schemes, are generally kept confidential and there is no indication that the deal will change this. However, it is possible that companies may want to increase their list prices and set higher list prices for new launches, which could have ripple effects in other markets... Global Sub. Full

MSF Raises Concerns Over FTA Impact on Medicines in India

(2/6, The Hindu) ...The group said that the proposed restrictive provisions will have major consequence for access to medicines in India and the rest of the developing world. "We are concerned that the EU-India FTA may contain provisions with dire consequences for access to medicines in India and the rest of the developing world," MSF said in its letter to the European Commissioner for Trade... Full

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