Monday, May 4, 2026

 

 

Sec. 301 Investigation Opens Two-Year Window For Global Drug Pricing Reform, Soriot Says

(5/1, Maaisha Osman, Pink Sheet) ...During an April 29 earnings call, Soriot said early policy signals already are emerging in some markets. "You've seen some movements in the UK already, discussions based on the 301 investigation will start with other countries, I think, in the next few weeks or months," [AstraZeneca CEO Pascal Soriot] said. "We are ourselves in the whole industry talking to countries and explaining the importance of improved access, not only for patients, but also for investments in R&D and in particular, in R&D in their respective countries."... Global Sub. Full

 

Trump Says U.S. to Provide GLP-1 Drugs for Medicare Patients

(5/1, Reuters) ...Trump said on Friday the government is moving to make GLP-1 weight-loss and diabetes drugs available to seniors enrolled in Medicare from July 1... Full

 

Trump Seeks to Woo Seniors by Touting Tax Law, Drug Cost Push

(5/1, Hadriana Lowenkron, Bloomberg Law) ..."If congressional Democrats had their way Florida seniors would be paying higher taxes, higher prices, while Republicans have given you much lower taxes, much lower prices," Trump said. "The Democrats start screaming 'affordability, affordability.' They're the ones that caused the problem," the president added. "We brought prices way down. They gave us tremendously high prices, and they'll give them to you again."..."You have to get out and vote in the midterms," Trump implored... Full

 

Employers and PBMs: Partnering to Fight High Drug Prices

(5/1, PCMA Blog) ...PBMs have always sent almost all of the discount dollars back to employers so they can use them for these purposes. Now, after federal PBM reform through the Consolidated Appropriations Act (CAA), PBMs will send 100% of the discount dollars to employers. The PBM-employer partnership translates to real affordability for patients because employers use the savings PBMs deliver to help lower overall drug costs for their workers... Full

 

Congress Should Pass Red Tape Elimination Act to Lower Prescription Drug Costs

(5/2, Juliana Reed, Washington Examiner) ...Congress must pass the Red Tape Elimination Act to ensure biosimilars are able to provide the cost savings they promise. This legislation would designate all FDA-approved biosimilars as interchangeable. It would also eliminate a major barrier to biosimilar access by removing the one-year market exclusivity period currently granted to the first biosimilar to receive the interchangeable designation... Full

 

How a Shifting Landscape is Making Affordable DTP At Scale a Reality

(5/4, Jeremy Richardson, PharmExec.com) ...In a changing prescription environment, manufacturers need to be ready to challenge the status quo and bring high-volume, low-cost products to the patients who need them most. DTP offers the opportunity to demonstrate ROI, break down traditional operational cost barriers and revolutionize the prescription journey... Full

 

President Trump's Marty Makary Problem

(5/3, Allysia Finley, The Wall Street Journal) ...My sources say that patience with Dr. Makary is wearing thin among Republicans in Congress and White House officials. It's time for Mr. Trump to pull the plug on the Makary show... Sub. Req'd

 

RFK Jr. Wants Stakeholders To Show Real-Time Prices Ahead Of Final Regulation

(5/1, Gabrielle Wanneh, Inside Health Policy) ...HHS Secretary Robert F. Kennedy Jr. says healthcare providers and information technology companies do not have to wait on agency regulation to use existing tools at their disposal to provide patients with the actual price of prescription medications before they pay at the pharmacy counter, and he is calling on these entities to adopt so-called Real-Time Pharmacy Benefit Technology (RTPBT) now... Sub. Req'd

 

Petition Sees Risk To Confidential Info In FDA's Real-Time Publications

(5/1, Gabrielle Wanneh, Inside Health Policy) ...A drug company is petitioning FDA to establish a process for sponsors to object to real-time publication of complete response letters (CRLs) for unapproved drugs, also asking for a redaction process akin to documents provided under the Freedom of Information Act (FOIA)... Sub. Req'd

 

FDA Expectations Create Potential Friction in New Form 483 Response Guidance

(5/1, Fraiser Kansteiner, Fierce Pharma) ...As for how companies should be steeling for future site visits following the guidance's release, Nath said that the agency communication likely represents "a call to industry that there's going to be increased regulatory scrutiny on inspections."... Full

 

 

FDA Approves Pfizer and Arvinas' Breast Cancer Drug Despite Underwhelming Data

(5/1, Max Gelman, Endpoints News) ...The FDA on Friday approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer. But it's unclear how many will take it. The drug will be branded as Veppanu, and it was the centerpiece of the companies' collaboration for PROTAC degraders... Sub. Req'd

 

J&J Axes $5B CAR-T Dream Months After Touting Best-in-Disease Efficacy

(5/1, Nick Paul Taylor, Fierce Biotech) ...The action affects J&J's CD20 mono CAR-T cell therapy, JNJ-9530, and CD19/CD20-targeting bispecific CAR-T called, JNJ-4496. The Big Pharma decided to discontinue the programs based on its portfolio priorities and an assessment of "the evolving large B-cell lymphoma treatment landscape," according to an April 30 statement... Full

 

Amgen Files Update to Tavneos Label as FDA Escalates Push to Withdraw

(5/1, Nicole DeFeudis, Endpoints News) ...The company filed a supplement on Wednesday that would add more information to the warning label about post-market cases of vanishing bile duct syndrome (VBDS), a serious liver complication that can lead to death. The supplement, disclosed in Amgen's first-quarter earnings release, marks another twist in the company's ongoing saga with regulators over Tavneos' future on the market... Sub. Req'd

 

How Has SC Daratumumab Impacted Smoldering Multiple Myeloma Treatment?

(5/1, Russ Conroy, Cancer Network) ...In a recent Between the Lines program, a panel of experts in hematologic oncology discussed the current state of high-risk smoldering multiple myeloma treatment following the FDA approval of daratumumab and hyaluronidase-fihj (Darzalex Faspro) based on findings from the phase 3 AQUILA trial (NCT03301220).1 The experts spoke about how this regulatory milestone may influence clinical decision-making for this high-risk patient population and reviewed logistical considerations for integrating subcutaneous daratumumab into real-life workflows... Full

 

 

Health Canada Approves 2nd Generic Version of Ozempic - and It's Canadian

(5/1, CBC News) ...Health Canada has approved the second generic version of brand-name Ozempic, this one manufactured by Canadian company Apotex...Catherine Thomas, the company's vice president of global communications, said the new Apotex product should be available to Canadians within weeks. "Our team is committed to bringing this product to market in the very near future," Thomas told CBC News in an email. "Our goal is to have it available in the coming weeks."... Full

 

Overcoming Formulation Challenges for Biosimilars

(5/1, Cynthia A. Challener, Pharmaceutical Technology) ...Biosimilar formulation development requires navigating around scientific, regulatory, and legal challenges, according to Sung Keun Chang, drug product team leader for Samsung Bioepis. One of the main challenges he highlights is the thicket of patents for reference products that are designed to extend patent protection... Full

 

The Biosimilar Market Isn't Failing, It's Finding Its Purpose

(5/3, Chrys Kokino, MedCity News) ...A recent HHS analysis confirmed what experts suspected: Most biosimilar markets become economically unviable after five competitors. To be clear, these high-competition markets serve a critical purpose - they drive down costs for the highest-burden disease areas and deliver immediate savings to patients and provide value to the U.S. healthcare system. But they can't be the only game plan. The headlines miss the point. This market isn't in chaos, it's simply finding its purpose - and what's emerging is something that could serve patients far better... Full

 

 

Repatha Sales Help Amgen Overcome Prolia Biosimilar Hits in 1st Quarter

(5/1, Kevin Dunleavy, Fierce Pharma) ...Amgen CEO Robert Bradway has declared 2026 a "springboard year" for the California big biotech, in which the growth of its newer products will offset the loss of revenue from patent expirations and set it up for long-term prosperity... Full

 

The Quest to Use AI to Help Find New Drugs

(5/2, Peter Loftus, The Wall Street Journal) ...Drug companies have been talking about the potential for AI to supercharge drug development for years, but it hasn't materialized in a big way yet...Part of the problem is that the amount of underlying scientific data to train AI models has been limited, and the cost of running high-volume computer experiments is high, though it is coming down, said Najat Khan, CEO of Recursion Pharmaceuticals... Sub. Req'd

 

Big Pharma M&A Set for Mega Year as Patent Expiries Drive Deal Urgency

(5/1, Reuters) ...The surge appears broader and more durable than just a rebound to pre-COVID years, at least three analysts, four investors and a banker told Reuters... Full

 

UPS CEO Says Drug Delivery Strategy a Good Antidote to Economic Uncertainty

(4/30, Lisa Baertlein, Reuters) ...United Parcel Service's efforts to grow its share of the lucrative prescription drugs delivery market appear poised to reap benefits in the second half of this year, even as the Iran war clouds the global economic outlook, CEO Carol Tome said in an interview... Full

 

Stryker Cyberattack 'Meaningfully' Impacted Q1

(5/1, Ricky Zipp, MedTech Dive) ...CEO Kevin Lobo told investors Thursday that the cyberattack "meaningfully" affected Stryker's growth. "The cyber incident had a big impact on our results and affected each of our businesses differently given their varied go-to-market models and processes to record revenue," Lobo said. "This resulted in distortions in our first-quarter results that will normalize over the course of the year." Stryker did not provide a total figure for how much the cyberattack impacted sales last quarter, and the company declined to comment on the figure for MedTech Dive... Full

 

 

The Drug-Pricing Problem No One Wants to Talk About

(5/4, Jessica Davis Plüss, Swiss Info) ...As United States President Donald Trump sees it, US prices should drop and other countries' prices should rise to make up for lost pharma revenue. For Swiss authorities, raising prices simply because the US wants them to is out of the question at a time when healthcare costs are soaring... Full

 

China's Strict New Supply Chain Regulations Could Create Massive Problems for Western Biopharma Companies

(5/4, Dennis Kwok, STAT+) ...China is not just a manufacturing base for the West's drug supply chain. It is now a peer competitor in drug innovation - and it intends to stay that way on its own terms... Sub. Req'd

 

Global Alignment of Generics' Regulation Is Crucial for Affordable, High-Quality Medication: Dr Tumbagi

(5/2, Nandita Vijayasimha, Pharmabiz.com) ...International regulators including US FDA and the European Medicines Agency's stringent standards see Indian companies upgrade their compliance systems. By aligning with these global benchmarks, India is not only strengthening its export potential but also reinforcing its role as a key player in improving access to affordable healthcare worldwide, said Dr Amaresh Tumbagi, former Karnataka additional drugs controller... Full

 

Medicines Pricing Deal Under Strain From Tariffs and Conflict in The Gulf

(5/4, Sandra Gannon, The Irish Times) ...Now we have a new test: the 2026-2029 Framework Agreement on the Supply and Pricing of Medicines. It is the clearest recognition yet, in a national State-industry agreement, that security of supply must be engineered, not hoped for. It acknowledges that supply security requires active management. But it is cautious in how far it goes. And just weeks into its life, that caution is already being tested... Full

 

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