Thursday, October 8, 2026

 

 

PhRMA Asks Court to Throw Out MFN Model for Medicare Part B Drugs

(10/7, Elizabeth S. Eaton, FirstWord PHARMA) ...The Global Benchmark for Efficient Drug Pricing (GLOBE) model is slated to take effect Jan. 1 and run through March 2032. Under the programme, drug manufacturers would be required to pay rebates on Part B drugs, calculated based on the products' prices in 19 other countries. The policy would "effectively limit Medicare drug prices to MFN benchmarks," PhRMA said in a release Wednesday. The lobbying group's complaint asks the US District Court for the District of Columbia to declare GLOBE unlawful and vacate the rule on the basis that the MFN policy "exceeds CMS's statutory authority."... Full

 

PhRMA-Backed Researchers Find Disconnect Regarding 340B Spending & Margins

(10/7, Gabrielle Wanneh, Inside Health Policy) ...Industry representatives say a lack of comprehensive reporting on the size and distribution of 340B margins adds to the argument that the 340B program is no longer a targeted safety net program, but a major driver of health care spending that doesn't provide enough transparency into where the money goes. Bharath Krishnamurthy, director of pharmaceutical policy at the American Hospital Association, however, would advise for the report's findings and the industry's takeaways to be approached with caution... Sub. Req'd

 

How CMS Plans to Fix a Major Flaw in the 340B Drug Discount Program

(10/8, Casey Mulligan, STAT) ...A new report from the Department of Health and Human Services shows other unintended consequences of this well-intended program. The spread grows with the price of the drug. It therefore rewards hospitals for using more and costlier drugs and makes physician practices and infusion clinics more valuable after a 340B hospital acquires them. The patient's treatment needn't change. The owner and billing site do... Sub. Req'd

 

Trump Claims World's Lowest Drug Prices. TrumpRx Discounts Are a 'Mixed Bag,' Report Shows.

(10/7, Berkeley Lovelace Jr., NBC News) ...A recent analysis from KFF finds that TrumpRx prices are competitive with prices in other countries for a small number of cancer and cholesterol medications. In many cases, Americans aren't getting the best deals compared with the rest of the world... Full

 

Biotech Companies Are Struggling to Navigate Trump's New Tariffs

(10/8, Chelsea Cirruzzo, STAT+) ...One industry insider with knowledge of how companies are navigating the tariffs told STAT that the industry is having to ask for further clarity from federal officials on how exactly they can secure exemptions and what to do if they want to appeal a decision, even though tariffs are already in place. The leader of one small biotech company spoke with STAT on the condition that they not be identified, to avoid retaliation from the administration. The person said they were a "bit paralyzed" on how to structure their exemption request... Sub. Req'd

 

Big Pharma's Connection to the World's Generics and Vaccines Leader

(10/7, Zhuo Zhang, Yukari Chilnik, Bloomberg) ...While India exposure is largely a positive for Pfizer, it could also create a risk if US tariffs were applied to imported generic drugs and pharmaceutical ingredients, which are now generally exempt from Section 232 levies. Another layer of risk comes from the fact that India relies on China for some active pharmaceutical ingredients, or APIs, and key starting materials... Sub. Req'd

 

PCMA: GAO Medicare Pharmacy Contract Report Refutes PBM Criticism

(10/7, Lauren Brensel, Inside Health Policy) ...The Pharmaceutical Care Management Association (PCMA) wrote in a press release Wednesday (Oct. 7) that a report from the U.S. Government Accountability Office (GAO) this week proves PBMs are adequately reimbursing unaffiliated pharmacies, despite concern from lawmakers and public health groups over their large share of the market... Sub. Req'd

 

Justice Department Targets Drugmakers in New Directive on Combating White-Collar Fraud

(10/7, Ed Silverman, STAT+) ...Many of these infractions occurred years ago, but the Trump administration appears to have a renewed interest in drugmakers...Now, the Justice Department plans to take an "all-tools approach" to rooting out fraud. The new directive makes clear that "the health care and life sciences space has been singled out and remains solidly in the crosshairs for white collar enforcement," attorneys at Hyman, Phelps & McNamara, which specializes in FDA regulatory matters, wrote in The FDA Law Blog... Sub. Req'd

 

US FDA Growing: August Another Net Positive Hiring Month

(10/7, Derrick Gingery, Pink Sheet) ...The FDA added 15 more people than it lost in August, according to US Office of Personnel Management data released Oct. 7. Overall employment was 16,282, a .1% increase from July... Global Sub. Full

 

Blue Cross Spending on Health Care Rises; Drug Costs Cited

(10/8, Alison Kuznitz, The Boston Globe) ...Blue Cross Blue Shield of Massachusetts saw spending growth escalate after the pandemic, climbing from 1.2 percent in calendar year 2019 to 6.8 percent in fiscal 2024. That acceleration continued into fiscal 2025, with spending climbing 11.8 percent, according to the study published Monday in the national journal Health Affairs... Full

 

 

Argenx Digests Phase 2 Celiac Win for $2.2B Drug, Preps Pivotal Run

(10/8, Nick Paul Taylor, Fierce Biotech) ...A phase 2 celiac disease trial of argenx's FB102 has hit its primary endpoint, delivering a boost to a drug candidate that the biotech acquired in its $2.2 billion takeover of Forte Biosciences...Argenx named Vh:Cd, a measure of gut health, as the primary endpoint. Teva also used Vh:Cd as its primary endpoint. In addition, Argenx said the VCIEL result—which combines Vh:Cd with a measure of inflammation—was "consistent with the primary endpoint" in this morning's readout... Full

 

Novartis' Rhapsido Tackles 2 Most Common Forms of Chronic Hives with Swift FDA Expansion

(10/7, Fraiser Kansteiner, Fierce Pharma) ...On Wednesday, Novartis announced that U.S. regulators have cleared the way for Rhapsido (remibrutinib) as an inaugural treatment for patients with symptomatic dermographism (SD) that isn't properly kept under control with H1 antihistamines. Chronic spontaneous urticaria (CSU)—where Rhapsido won its first green light last fall—and SD are among the most prevalent manifestations of chronic hives, collectively cropping up in more than 90% of adults who live with the condition, Novartis said in an Oct. 7 release... Full

 

Pfizer Gets FDA Approval for Expanded Use of Breast-Cancer Treatment Tukysa

(10/8, Katherine Hamilton, Dow Jones Newswires) ...The approval expands the use of Tukysa to use during an earlier stage of metastatic disease, the drug company said Wednesday. Tukysa was first approved in 2020 for metastatic breast cancer... Sub. Req'd

 

Scaling Psychedelics Comes with Uncertainty 'Baked into the Sauce'

(10/7, Donavyn Coffey, Fierce Pharma) ...The real-world value of psychedelic treatments may come down to durability, or how much relief patients get out of one of these expensive and intensive treatments. If the benefits last so that patients only need two to four visits each year, the model may prove financially sustainable... Full

 

Halozyme Stymies Subcutaneous Keytruda Launch in Select European Countries as Merck Vows to Fight Patent Claims

(10/7, Frasier Kansteiner, Fierce Pharma) ...A specialized Dutch patent court in The Hague has found that Merck—known as Merck Sharp & Dohme outside the U.S. and Canada—infringed on one of drug delivery specialist Halozyme's Mdase patents related to subcutaneous biopharmaceutical formulations... Full

 

 

Formycon Targets 20% Process Efficiency Gain With AI Tools

(10/7, Urte Fultinaviciute, Generics Bulletin) ...One of the tools Formycon is introducing into its workflow is Phlexglobal's electronic trial master file solution PhlexTMF Enterprise. The firm will use AI-assisted regulatory technology as the central platform for current and future clinical development activities. It will also migrate existing trial master files from legacy systems to the new environment. Chief scientific officer Andreas Seidl said the integration of PhlexTMF demonstrates the firm's push for optimization and advancement of operational workflows... Global Sub. Full

 

United Therapeutics Wipes Sandoz $70.6 Million Remodulin Win

(10/7, Christopher Yasiejko, Bloomberg Law) ...United Therapeutics Corp. won its appellate bid to erase Sandoz Inc.'s $70.6 million total victory against it Wednesday after the Third Circuit ordered a trial over whether the branded-drug maker breached a settlement agreement by restricting access to injection cartridges needed for generic versions of the lung-pressure drug Remodulin... Sub. Req'd

 

 

Viatris Agrees to Acquire Pacira BioSciences, Advancing Its Innovative Medicines Strategy and Becoming a Leader in Non-Opioid

(10/8, Viatris) ...Pacira brings two established, high-margin, patent-protected, in-market U.S. products – EXPAREL® (bupivacaine liposome injectable suspension) and ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)... Full

 

AstraZeneca and Daiichi Sankyo to Collaborate with Summit Therapeutics

(10/8, PMLiVE) ...AstraZeneca and Daiichi Sankyo have entered into a clinical collaboration agreement with Summit Therapeutics to evaluate Datroway (datopotamab) in combination with ivonescimab across multiple tumour types including lung and breast cancers. The companies intend to begin with a phase 3 trial in 1st-line triple-negative breast cancer (TNBC)... Full

 

Roche Does Fourth China Deal Since August, Teaming with Defand on Degraders

(10/8, Kyle LaHucik, Endpoints News) ...The Hangzhou, China-based startup, Defand Therapeutics, will get less than $10 million upfront to begin their collaboration on molecular glue degraders, according to the source, who spoke on condition of anonymity to discuss details of the alliance... Sub. Req'd

 

AI Companies Run Virtual Drug Trials, Aim to Improve Success of Human Studies

(10/7, Deena Beasley, Reuters) ...AI firms say simulations are being used to identify which pharmaceutical programs are worth moving forward and to assess the value of acquisition targets. As AI tools get better at flagging clinical risks, they say unexpected trial failures may become less frequent... Full

 

New API Innovation Center Index Spotlights Supply Chain Stress Points

(10/7, Joseph Keenan, Fierce Pharma) ...The index, which debuted Tuesday and is produced by APIIC in conjunction with industry-supported market intelligence and supply chain platform QYOBO, was designed to provide detailed tracking of pharmaceutical supply chain risks in the United States... Full

 

Prime Therapeutics Pushes Upfront Prices in New Drug Sales Model

(10/7, John Tozzi, Bloomberg) ...Prime Therapeutics, one of the largest US pharmacy benefit managers, aims to shift to upfront drug pricing and away from a complicated rebates-based system that critics say increases patient costs. The company intends to offer its clients - health insurers and employers - what it calls a net cost model for 2028, Chief Executive Officer Mostafa Kamal said in an interview Wednesday. He said patients should get the discounts that drug companies pay when they fill their prescriptions at the pharmacy... Sub. Req'd

 

Clarventa Announces TrueNet, a New Approach to Prescription Drug Pricing

(10/7, Clarventa) ...Clarventa today announced TrueNet, an innovative prescription drug program that focuses on upfront discounts for the costliest medications, delivering greater value to patients, payers, pharmacies and manufacturers... Full

 

 

EMA Plans Major Update to Pharmacogenomics Guideline

(10/7, Ferdous Al-Faruque, Regulatory Focus) ..."Advancements in the field of pharmacogenomics necessitate a revision of the existing guideline to ensure its continued relevance and applicability," said EMA. "In addition to incorporating new scientific knowledge, this revision aims to provide greater clarity on topics already covered, facilitating more precise and actionable guidance for regulators and stakeholders." The agency said it expects a draft version of the guideline to be released for comment in 2027 or 2028, with a final version being issued in 2028... Full

 

Spanish Generic Medicines Face Crisis as Price Rules Threaten Supply

(10/7, Frank Miller, RUSSPAIN.COM) ...Generic drug makers in Spain say the country's reference pricing system is pushing medicine prices so low that many products are no longer profitable. Elena Casaus, secretary general of the Asociación Española de Medicamentos Genéricos (Aeseg), spoke bluntly at the VII Simposio del Observatorio de la Sanidad de EL ESPAÑOL-Invertia. She said the current rules are cutting prices to the bone. For some generics, it's no longer possible to keep supplying the market... Full

 

Korea's Drug Pricing and Incentive Reform: What You Need to Know

(10/7, Patrick Burton, Pharma Boardroom) ...Prices for innovative medicines that are among the lowest in the OECD, a slow reimbursement process, and the publication of agreed prices – which affects what is paid for the same drugs elsewhere – have led to Korean patients gaining access to new medicines later than counterparts in other developed economies... Full

 

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