Thursday, April 23, 2026

 

 

Senators Grill RFK Jr. on Vaccines, Drug Prices and More at Hearing

(4/22, Selena Simmons-Duffin, Carmel Wroth, NPR) ...Several senators asked about TrumpRx, the administration's new drug discount site. Sen. Elizabeth Warren, D-Mass., wanted to know why some of the drugs there cost more than prices available elsewhere. Noting that Protonix, a heartburn medication, costs $200 on TrumpRx, she asked Kennedy, "Do you know what the drug costs at Costco?"..."I do not," he replied.Warren did not appear to be appeased. "If you're buying a drug on TrumpRX, there is a more than one in four chance that Trump's discount is actually a price hike," she said, saying it steers patients to more expensive drugs "that are going to pad Big Pharma's profits."... Full

 

Costco Has Cheaper Drugs Than TrumpRx, Senator Says

(4/22, Kristina Fiore, MedPage Today) ...Kennedy said his agency directs Americans to generics when they can, but "a lot of doctors prescribe the brand," and insisted that HHS is "giving them a 600% reduction on brands."...Warren noted that a 600% reduction is mathematically impossible and would mean "companies should be paying you to take their drugs." Kennedy, however, was insistent that "Trump has a different way of calculating percentage" -- that if "you have a $600 drug and reduce it to $10 that's a 600% reduction."... Sub. Req'd

 

RFK Jr. Defends Trump's Mathematically Impossible Drug Discount Claims

(4/22, Chris Cameron, The New York Times) ...Health Secretary Robert F. Kennedy Jr. defended President Trump's frequent incorrect calculations of percentages when talking about discounts on prescription drug prices, arguing on Wednesday that the president "has a different way of calculating."..."If you have a $600 drug, and you reduce it to $10, that's a 600 percent reduction," Mr. Kennedy said during a congressional hearing. Mr. Kennedy is mathematically... Sub. Req'd

 

Dems Want Details, Republican Rebuffs White House Call To Codify TrumpRx

(4/22, Jessica Karins, Inside Health Policy) ...Kennedy told Sen. Jeff Merkley (D-OR) Tuesday (April 21) that a top CMS official who helped craft the deals, Chris Klomp, could share language that would allow Congress to write the agreements into law, but he told lawmakers Wednesday Klomp is still working on the language... Sub. Req'd

 

BALANCE Model Delay May Lead To Revisions, Higher Near-Term Medicare Costs

(4/22, Cathy Kelly, Pink Sheet) ...CMS decision to postpone implementation of the BALANCE payment model for Novo Nordisk and Eli Lilly obesity drugs in Medicare Part D signals the likelihood that the demonstration will be revised to respond to insurer concerns... Global Sub. Full

 

How a Single Word Could Determine the Future of 340B

(4/22, Bridget Early, Modern Healthcare) ...The drugmaker AbbVie sued the Health Resources and Services Administration this month alleging the agency's 30-year-old regulatory definition of "patient" has enabled the program to grow beyond its original intent and given too many hospitals and other safety-net providers access to deeply discounted prescription medicines... Sub. Req'd

 

OGD Director Touts Drop in Refuse-to-Receive Determinations

(4/22, Joanne S. Eglovitch, Regulatory Focus) ...Speaking at the Generic Drugs Forum on Wednesday, Darby Kozak, deputy director of the Office of Generic Drugs, also highlighted the passage of the Consolidated Appropriations Act, 2026, which requires FDA to discuss with applicants whether their drug is qualitatively (Q1) and quantitatively (Q2) the same as the reference listed drug, and if not, to provide details about why the drug was determined not to be qualitatively or quantitatively the same... Full

 

Pharma-Backed Petition Calls on FDA to Reform Release of Drug Rejection Letters

(4/22, Zachary Brennan, Endpoints News) ...The law firm Covington & Burling, on behalf of an unnamed pharmaceutical company client, filed a citizen petition dated Monday with the FDA seeking to reform the rules around the FDA's release of information in the letters that may be competitively sensitive, and potentially open the agency up for a lawsuit. Covington did not respond to a request for comment on which company filed the citizen petition... Sub. Req'd

 

House Approps Proposes Fiscal 2027 Budget Increase For FDA

(4/22, Jessica Karins, Inside Health Policy) ...The Republican-led House Appropriations Committee is again aiming to increase FDA's budget in its draft fiscal 2027 appropriations bill, proposing a total budget of $7.1 billion for the agency, a $200 million increase over the agency's current funding level. That's in line with the Trump administration's budget request, though the request asks for a new food facility and importer registration user, which would raise $71 million and is not included in the House appropriators' bill... Sub. Req'd

 

 

Sanofi's New CEO Faces a Reckoning on Immunology-Focused R&D Strategy

(4/22, Max Gelman, Endpoints News) ...The direction Garijo elects to pursue will likely have ramifications not just for Sanofi's R&D future, but for the company's identity. Under [CEO Paul] Hudson, Sanofi went all-in on immunology, trying to tackle a wide range of diseases, from eczema and asthma to multiple sclerosis and rare neuroinflammatory conditions. But Hudson's efforts left a mixed track record in the clinic, and it probably doesn't make sense for Garijo to continue down the same path, Jefferies managing director Michael Leuchten said in an interview... Sub. Req'd

 

Inhibrx's Cancer Duo Could Be Pharma's Next Big Takeout Target: Report

(4/22, Elizabeth S. Eaton, FirstWord PHARMA) ...Inhibrx Biosciences may be close to spinning off another portion of its pipeline. Its shares jumped about 37% on Wednesday after a report from Reuters detailed interest from several pharmas, including Merck & Co., in buying a pair of experimental cancer drugs from the biotech. According to people familiar with the matter, the deal could be worth $9 billion, including a $1-billion price tag for ozekibart (INBRX-109) and $8 billion for INBRX-106, a hexavalent OX40 agonist... Full

 

 

Cipla Gets USFDA Nod for Generic Respiratory Issues Treatment Inhalation Aerosol

(4/23, Economic Times) ...The final approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Albuterol sulfate inhalation aerosol of strength 90 mcg per actuation, Cipla said in a regulatory filing... Full

 

Amneal's Bevacizumab Biosimilar Brochure Rebuked By FDA's OPDP

(4/22, Sue Sutter, Generics Bulletin) ...The FDA previously cited an innovator company for promotion suggesting its reference product is superior to biosimilar formulations. However, the Alymsys violation notice appears to be the first untitled letter targeting a biosimilar sponsor's promotional materials... Global Sub. Full

 

Lupin Launches Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in the United States

(4/22, Lupin) ...Lupin Limited today announced the launch of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, 10 mg/1,000 mg in the United States following the approval for its Abbreviated New Drug Application from the U.S. FDA as bioequivalent to Xigduo® XR for the indications in the approved labeling... Full

 

"Our Complex Generics Engine, Particularly in Respiratory, Has Matured into a Key Growth Driver"

(4/22, Dr. Manbeena Chawla, BioSpectrum Asia) ...Industry reports indicate that 2026 may be a "reset year" for India's CDMO sector, with global outsourcing growing at a mid-single-digit rate and India's growth moderating slightly after a strong 2024–25, even as China and the US see stronger momentum. During a recent conversation with Dr Abdelaziz Toumi, CEO, Lupin Manufacturing Solutions (LMS), BioSpectrum India explored this trend further... Full

 

 

On Eve of New CEO, Sanofi Gets First-Quarter Boost from Dupixent, Vaccines

(4/23, Matthew Dennise, FirstWord PHARMA) ...With Sanofi in a holding pattern awaiting the arrival of new CEO Belén Garijo, the company announced Thursday that sales in the first quarter rose 6.2% to €10.5 billion ($12.3 billion), boosted by Dupixent, new launches and a return to growth for its vaccines division following the recent purchase of Dynavax Technologies... Full

 

Roche CEO Laments Swiss Franc Strength as Drugmaker Doubles Down on U.S. Investment

(4/23, Elsa Ohlen, CNBC) ...First-quarter sales came in at 14.7 billion Swiss francs ($18.7 billion), down 5% year-on-year — but up 6% on a constant currency basis...CEO Thomas Schinecker defended the company's quarterly results, saying it's a "question on how you look at the reporting," and that while the Swiss franc appreciates, sales reported in U.S. dollars increased by 9%. "We spend most of our money in the U.S., and we have most our debt in the U.S., we've just recently bought another company in the U.S.," he told Squawk Box Europe. "We will continue to invest in the U.S., and we don't see that as a major issue."... Full

 

Samsung Bioepis' Operating Profit up 13% in Q1 on Solid Global Biosimilar Sales

(4/23, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis said Thursday its operating profit grew 13 percent to 144 billion won ($97.1 million) in the first quarter of 2026, compared to the same period last year. The company also posted 454.9 billion won in revenue, marking a 14 percent year-on-year increase... Full

 

Hikma Reiterates Guidance Despite Iran War Hitting Costs

(4/23, ShareCast) ...Updating on first-quarter trading, the blue chip said all three of its business divisions - injectables, branded and Hikma Rx - were "performing well", with good demand across markets and portfolios... Full

 

AbbVie to Establish NC Production Base with $1.4b Investment, Creating 730-Plus Jobs

(4/22, Eric Sagonowsky, Fierce Pharma) ...The North Chicago-based drugmaker on Wednesday revealed its largest-ever capital investment in a single campus, plotting a 185-acre production hub in Durham. The project will cost some $1.4 billion and add more than 730 roles to the company's headcount, according to an April 22 press release. The site will produce certain AbbVie medicines in its immunology, neuroscience and oncology portfolios... Full

 

Rigel Loses Lilly Alliance in Pharma Industry's Latest RIPK Exit

(4/22, Kyle LaHucik, Endpoints News) ...Lilly had already toned down the tie-up in the fall, when it told Rigel it would scrap work on a preclinical CNS disease program. Now, the Indianapolis pharma is also calling it quits on a Phase 2-stage RIPK1 inhibitor called ocadusertib (also known as LY3871801 and R552). Lilly had completed a Phase 2a trial of the experimental medicine in certain patients with rheumatoid arthritis... Sub. Req'd

 

Expert Q&A: Global Supply Chain Pressures and the Future of Drug Availability

(4/22, Michael Ganio and Danielle Valletti, Pharmacy Times) ...In this Q&A, Michael Ganio, PharmD, MS, BCPS, FASHP, discusses how global conflicts and trade disruptions could affect the US drug supply chain, particularly for older generic medications sourced overseas. He explains that while immediate impacts may be limited, upstream disruptions in manufacturing and shipping—especially through critical routes like the Strait of Hormuz—could lead to delayed shortages and rising costs over time... Full

 

Will Bargain-Basement Telehealth Visits Help Pharma Drive Drug Scripts?

(4/23, Katie Palmer, STAT+) ...Drugmakers have long used discount coupons to encourage patients to use their high-cost medications. Now, coupons can influence not just a drug's out-of-pocket price, but the cost of consulting with a clinician who can prescribe it... Sub. Req'd

 

"A Punch in the Gut": After Years of Waiting, Many Opioid Victims Will Be Shut Out of Purdue Settlement

(4/23, Craig R. McCoy and Bob Fernandez, ProPublica and The Philadelphia Inquirer) ...What is especially galling, some victims said, is that their compensation for years of fighting for justice will boil down to a day's pay for a Purdue attorney like Huebner, who charges $2,935 an hour. Well over $100 million of the settlement money will go to the plaintiff law firms that have represented Purdue victims through the bankruptcy and to cover the cost of running the trust... Full

 

 

Trump's Drug Pricing Policy Deprives Patients in Europe of New Treatments

(4/23, Gerry Smith, Ashleigh Furlong, Fabienne Kinzelmann, Bloomberg) ...For years, pharma companies have generated most of their profits in the US, where they can charge far more than in Europe. But Trump's policy calls for them to price their new medicines in the US at the level of other wealthy countries. That's left companies ranging from Biogen Inc. to Roche Holding AG with a vexing choice: either convince Europe to pay more, or slash their US prices. Some are considering a third, more drastic option: skip parts of Europe altogether... Full

 

European Health Chief Says EU Is at 'A Critical Point' in Ensuring New Drug Access

(4/22, Maggie Fick, Reuters) ...Europe is at a critical juncture for ensuring future access to new drugs as U.S. pricing policies shake the sector, the head of the European Medicines Agency Emer Cooke said on Wednesday, urging regional authorities to work together more closely..."Everybody's struggling with what the impacts of the U.S. policy on pricing will be. And that's not just on pricing, it's on where you do your clinical trials, where you market, where you launch."... Full

 

Steep UK Generic Price Rises Continue In March

(4/22, Dave Wallace, Generics Bulletin) ...While not quite as steep as the increases seen last month – when fluoxetine 20mg capsules topped February's Biggest Risers table with an 835% average price increase – WaveData calculated that the steepest jump in price for March was for indometacin capsules, based on its monitoring of trade prices to UK independent pharmacists... Global Sub. Full

 

India Must Institutionalize Risk-Based Inspections, Harness AI For Pharmacovigilance, Says Panel

(4/23, Anju Ghangurde, Pink Sheet) ...A Parliamentary panel in India has commended the effectiveness of the drugs regulator's risk-based inspection (RBI) program in tightening compliance but has, more widely, flagged concerns over significant manpower gaps in the regulatory workforce which could hurt the efficiency and quality of surveillance and enforcement activities... Global Sub. Full

 

Iran War Exposes Weaknesses In Pharma Resilience Planning

(4/22, Francesca Bruce, Pink Sheet) ...In a bid to cut costs, many pharmaceutical companies have deprioritized resilience planning, and are now facing greater challenges in ensuring supplies of critical medicines as the Iran war disrupts supply routes and drives up energy and fuel costs, said Michel Savini, an associate partner at the operations transformation consultancy, Argon & Co... Global Sub. Full

 

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