Thursday, March 12, 2026

 

 

Pfizer, Teva Lose Bid to Disqualify Ex-Prosecutor in Generic Drug Price-Fixing Case

(3/11, Mike Scarcella, Reuters) ...U.S. District Judge Cynthia Rufe in an order on Monday rejected the drugmakers' claims that attorney Joseph Nielsen and his law firm Lowey Dannenberg should be barred from the lawsuits because he could potentially use confidential information he acquired while working for the Connecticut state attorney general... Full

 

 

Trump Admin To Launch Tariff Probe Into Foreign Drug Pricing Policies In Coming Months

(3/11, Maaisha Osman, Inside Health Policy) ...A senior Trump administration official said Wednesday (March 11) the administration plans to launch a new tariff investigation under Section 301 of the Trade Act in the coming months targeting foreign drug pricing policies that it argues force Americans to shoulder the global cost of pharmaceutical innovation, a claim many drug pricing experts say rests on a flawed assumption... Sub. Req’d

 

TrumpRx Aims to Slash Prescription Drug Prices

(3/11, Fox News) ...Fox News senior medical analyst Dr. Marc Siegel has the latest on the discounted products under President Donald Trump's plan on 'The Bottom Line.'.. Full

 

Drug Price Negotiation And Part B: Not Much Impact In Year One

(3/11, Michael McCaughan, Pink Sheet) ...But Part B sales still seem to have impacted the make-up of the final price negotiation list. At least four products likely would not be on the list if only Part D sales were counted, including Genentech/Novartis' Xolair, Takeda's Entyvio, AbbVie's Botox, and UCB's Cimzia... Global Sub. Full

 

CMS To Make $50 Zepound, Wegovy Available Before BALANCE Launch

(3/11, Gabrielle Wanneh, Inside Health Policy) ...Qualified beneficiaries will have a copay of $50 with no deductible, and CMS intends to use a single central processor to handle prior authorization, claims adjudication and payment to pharmacies under the temporary program... Sub. Req’d

 

Tariffs, Uncertainty and Disruption: How Drug Makers and Distributors Can Build Operational Supply

Chain Resilience

(3/11, Ryan Rotar, Pharmaceutical Technology) ...Ryan Rotar, vice president of healthcare market strategy at Tecsys, outlines how supply chain resilience can be maintained in the face of tariffs... Full

 

US Dependence on China for Medicines Faces Scrutiny

(3/12, IANS) ...The hearing of the Senate Special Committee on Ageing brought together lawmakers and industry experts on Wednesday (local time) who described how decades of offshoring pharmaceutical production have left the United States vulnerable to supply disruptions and foreign leverage over essential drugs... Full

 

The Cloud Over the FDA Has Not Yet Lifted

(3/12, Caitlin Owens, Axios) ..."The underlying leadership dysfunction and staffing issues remain under the leadership of Commissioner Makary and HHS Secretary Kennedy," Capital Alpha Partners' Rob Smith wrote in a note this week. "Prasad's departure will also turn a brighter spotlight on Makary, whose job could also be in danger if FDA's turbulent leadership issues don't stabilize," Smith added... Full

 

Industry Hails ‘Common Sense' FDA Rethink On Non-US Comparators For Biosimilars

(3/11, Dave Wallace, Generics Bulletin) ...Responding to the latest guidance, the Association for Accessible Medicines said the update "removes redundant PK testing requirements where scientifically rigorous data already exists," representing an "updating and modernizing" of the FDA's approach that would eliminate "duplicative" studies... Global Sub. Full

 

US FDA Snares Ozempic, Tremfya DTC Ads For Overstating Efficacy, GLP-1 Crackdown Continues

(3/11, Sue Sutter, Pink Sheet) ...Misleading efficacy claims continue to dominate the US Food and Drug Administration's advertising and promotion untitled letters in early 2026, including direct-to-consumer ads for Novo Nordisk's Ozempic, Johnson and Johnson's Tremfya and Sobi's Vonjo... Global Sub. Full

 

FDA Consolidates Adverse Events Reporting Systems

(3/11, Ferdous Al-Faruque, Regulatory Focus) ...The FDA launched AEMS on March 11, which aims to allow users to view adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food on a single dashboard. The agency said that over the coming months, all other product centers will begin processing adverse event reports in AEMS, and by the end of May, the system will contain real-time adverse event reports for all products it regulates... Full

 

Virginia Lawmakers Reach New Compromise on Prescription Drug Legislation

(3/11, Cameron Thompson, WTVR) ...The legislation, carried by Sen. Creigh Deeds (D-Charlottesville) in the Senate and Del. Karrie Delaney (D-Fairfax) in the House, would tie Virginia to an upper price limit for certain drugs that have been negotiated between drug manufacturers and the federal government... Full

 

PBMs Pivot to Fees as Clients, Regulators Shun Old Ways

(3/11, Noah Tong, Modern Healthcare) ...The switch toward fees may ramp up, but this shift is many years in the making. Sanofi paid 23% more in fees to PBMs and health plans for specialty medicines last year, the drugmaker reported this month... Sub. Req’d

 

 

Risankizumab Subcutaneous Induction for Crohn's Disease: Insights From the AFFIRM Trial, With Millie Long, MD, MPH

(3/11, Millie Long, MD, MPH, HCPLive) ...New data from the AFFIRM trial suggest that a fully subcutaneous induction strategy with risankizumab (Skyrizi) may deliver strong efficacy while offering a more convenient treatment pathway for patients with Crohn's disease, adding to the growing body of evidence supporting IL-23 inhibition in this patient population... Full

 

Ask the Advocate: How Can I Cope with the Stigma of Tardive Dyskinesia?

(3/12, Healthline) ...Healthline spoke with April Kraft from the National Organization for Tardive Dyskinesia (NOTD) to learn more about the social stigma related to TD and strategies for managing it... Full

 

Celltrion Launches Liquid Formulation of Remsima IV in Europe to Strengthen Infliximab Market Leadership

(3/11, Kim Ji-hye, Korea Biomedical Review) ...European healthcare providers have consistently highlighted the need for a multidose liquid formulation that enables more efficient product storage and management while reducing the hassle of preparation. By listening to these field voices, Celltrion continues to strengthen its field-centric sales and marketing activities, including the introduction of the Remsima 350 mg liquid formulation... Full

 

 

Long Grove Pharmaceuticals Launches Generic Dalvance

(3/11, Sandra Levy, Drug Store News) ...Dalbavancin for injection is a single-dose antibiotic indicated for adult and pediatric patients, and it's administered intravenously in an out-patient setting. To maintain its effectiveness, Dalbavancin for injection should be used only to treat or prevent infections caused by sensitive bacteria, Long Grove noted... Full

 

Genentech Targets Biocon In USITC Case Over Perjeta Biosimilar Imports

(3/11, Dean Rudge, Generics Bulletin) ...The complaint, lodged by Roche subsidiary Genentech, accuses the Indian firm of violating Section 337 of the US Tariff Act through the importation and sale of certain pertuzumab biosimilars and products containing them in the US... Global Sub. Full

 

Money Talks in Hospitals' Adoption of Oncology Biosimilars

(3/11, Charles Bankhead, MedPage Today) ...Hospitals' adoption of biosimilars for three oncology biologics increased dramatically over a 5-year period, as did the facilities' profit margins on the drugs, claims and drug acquisition data showed... Full

 

 

As Lilly Flourishes in Q4, Peer Projections Signal Looming Sector Slowdown in 2026

(3/11, Kevin Dunleavy, Fierce Pharma) ...The pharmas offered a variety of reasons—macro and micro—for their pessimistic 2026 projections. Several mentioned pricing effects related to the Inflation Reduction Act (IRA), as well as U.S. President Donald Trump's most-favored-nation plan and his threats of tariffs on pharmaceutical products. An anticipated decline in vaccine sales, linked to a demand shortfall in the U.S., also plays into the computation for several companies, while many others are dealing with the loss of exclusivity (LOE) of blockbuster products... Full

 

Lilly Beefs Up Oral GLP-1 Capacity with $3B Manufacturing Pledge in China

(3/11, Zoey Becker, Fierce Pharma) ...The investment will play out over the next 10 years and involve work with "several" local partners, according to a March 11 press release (Chinese) on Lilly China's official WeChat account. One such collaboration is with Beijing-based CDMO Pharmaron, which will receive a $200 million investment from Lilly to support its technological capabilities and gradually expand its scale "as needed."... Full

 

Bimzelx Tops Skyrizi in Head-to-Head Psoriatic Arthritis Trial

(3/11, Delilah Alvarado, BioPharma DIVE) ...According to UCB, Bimzelx topped Skyrizi by significantly alleviating disease symptoms after 16 weeks of treatment. The study's main test was the "ACR50," which defines a patient response as a 50% improvement in the number of tender and swollen joints, along with 50% improvements in at least a few other disease measures. Bimzelx, UCB said, is first approved biologic therapy to show superiority over an IL-23 inhibitor in psoriatic arthritis... Full

 

urobindo Pharma's Manufacturing Unit Receives Satisfactory FDA Report

(3/12, Devdiscourse) ...Aurobindo Pharma announced on Thursday that its Andhra Pradesh-based manufacturing unit has received an Establishment Inspection Report with a Voluntary Action Indicated (VAI) classification from the US [FDA]... Full

 

How GLP-1s Are Changing the Ways Americans Buy Medicine

(3/12, Christopher Rowland, The Washington Post) ...Spotty insurance coverage and robust competition have spawned a marketplace where cash is king - and prices are falling. The two main drug companies selling branded versions of the revolutionary drugs, Eli Lilly and Novo Nordisk, are dropping prices as they compete for market share. Meanwhile, compounding pharmacies that sell cheaper knockoffs of these products are disrupting the marketplace... Sub. Req'd

 

GoodRx Teams With Viatris to Offer up to 85% Savings on Established Brand Medications

(3/11, Chain Drug Review) ...Cash-paying consumers, regardless of insurance status, can use GoodRx to access discounted cash prices of up to 85% off at more than 70,000 pharmacies nationwide. The collaboration includes widely prescribed, household-name medications such as Lipitor, Celebrex, Viagra, and Norvasc... Full

 

Stryker Hit by International Cyberattack Linked to Pro-Iran Group

(3/11, Conor Hale, Fierce Biotech) ...The hack began affecting Stryker's Microsoft-powered servers and mobile devices shortly after midnight Eastern time. The Wall Street Journal reported that employees were told to disconnect all company-issued hardware from the internet or not power it on, and to delete work profiles from smartphones. At the same time, a Handala logo began appearing on login pages... Full

 

 

EU Regulators Update Workplan for Leveraging AI and Big Data

(3/11, Joanne S. Eglovitch, Regulatory Focus) ..Under governance, the workplan states that the NDSG will contribute to the implementation of the revised pharmaceutical legislation for Europe. The group may also provide advice on real-world data (RWD), clinical study data, the revision of Annex 1, environmental risk assessments, OneHealth, and electronic product information (ePI)... Full

 

Norwegian Industry Asks Government To Match Danish Response To US Pricing Pressures

(3/11, Francesca Bruce, Pink Sheet) ...Norway's government must create a new task force to address the geopolitical shifts, including the US Most Favored Nation (MFN) pricing policy, that are threatening the competitiveness of the country's life sciences sector, says the Norwegian pharmaceutical industry association, LMI. The association pointed to Denmark, where in January a task force was announced in response to the US MFN... Global Sub. Full

 

France Joins EU Race For Faster Clinical Trial Approvals, Prioritizes Early-Phase Research

(3/11, Vibha Sharma, Pink Sheet) ...On March 16, France will launch its own pilot program, offering substantially shorter review timelines for certain early-phase trials conducted exclusively in France (ie, so called mono-national trials). The timelines will be much shorter than those set by the EU Clinical Trials Regulation... Global Sub. Full

 

The Game Of Balancing Green Regulations While Keeping Off-Patent Drug Investment In Europe

(3/11, Urte Fultinaviciute, Generics Bulletin) ...As Medicines for Europe's director general, Adrian van den Hoven, explained to Generics Bulletin ahead of ECHA's opinion adoptions, the agency did not individually assess medicinal products and their manufacturing, leaving the pharmaceutical industry in a highly uncertain regulatory situation. "We need to go through the same process as the other sectors that have been evaluated. This is really something that we don't understand. It's not acceptable," he highlighted... Global Sub. Full

 

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