Monday, June 1, 2026

 

 

FXB0871, a PD-1-Targeted Attenuated IL-2 Fusion Protein, Enters Phase 1 Clinical Testing in China

(5/29, Feliza Mirasol, BioPharmInternational.com) ...Fosun Pharma announced on May 29, 2026, that the first participant in mainland China has been dosed in a phase 1 clinical trial of FXB0871, an investigational programmed cell death protein-1 (PD-1)-targeted attenuated interleukin-2 (IL-2) fusion protein immunotherapy (ATTENUKINE) developed in collaboration with Teva...The China phase 1 trial initiation follows an ongoing international phase 1 study of TEV-56278/FXB0871 in the United States and Canada. Clinical data will be shared between Fosun Pharma and Teva to support joint development... Full

 

 

China's Rise in Drug Development Looms Over U.S.

(5/30, Rebecca Robbins, Gina Kolata, The New York Times) ...[A] growing contingent of U.S. officials, executives and doctors worry that the shift in drug innovation to China poses dangerous risks for research, American patients and biotech workers. They raise concerns about losing control over new medicines and about ceding America's longstanding dominance in the field...On the other side of the debate are those who warn that throttling competition from China would deprive Americans of new medicines. Ultimately, they say, the best data, no matter where it comes from, should win out... Sub. Req'd

 

Growing US Reliance on Chinese Biotechs Prompts National Security Fears

(5/31, Patrick Temple-West, Financial Times) ..."I write to draw your attention to a dangerous surge of American capital and know-how into [China's] biotechnology sector," said [Republican congressman John Moolenaar], chair of the House of Representatives' China committee. "I urge [the] Treasury to give particular consideration to transactions involving the licensing of pharmaceutical intellectual property."... Sub. Req'd

 

ReVAMPing Drug Shortages: Trump Administration Creates New Energy For Domestic Supplies

(5/29, Kate Rawson, Pink Sheet) ..."We're trying to incentivize a change in purchasing behavior," Michael Ganio, American Society of Health-System Pharmacists senior director, pharmacy practice and quality, said of the ANPRM. "Unless you introduce new information, new incentives, it's not going to change."..."This is introducing a new incentive," he added. "So, I like that it's action. I like that it's going to make the buyers think rather than click the cheapest price."... Global Sub. Full

 

Medicare Still Won't Say How Much Covering Obesity Drugs Will Cost

(6/1, Bob Herman, STAT+) ...Medicare is advertising that adults 65 and older can get Wegovy and Zepbound, specifically for weight loss, starting in July for $50 a month. But the agency still is not sharing how much this will cost taxpayers, who will foot most of the bill...Medicare's "GLP-1 Bridge" program starts July 1 and runs through Dec. 31, 2027. The Trump administration initially planned on testing coverage of the obesity drugs through Medicare Advantage and prescription drug plans, but the health insurers that run those plans balked at the high potential costs. Instead, the drugs will be covered solely by taxpayers and the beneficiaries who fill prescriptions... Sub. Req'd

 

The Interaction Between The Manufacturer Discount Program And Medicare Drug Price Negotiation

(5/29, Yunjoo Karris Jeon, Kristi Martin, Sean D. Sullivan, Health Affairs) ...The direct savings from the MDP, bypassing a resource-intensive negotiation process, may appear enticing, but Medicare savings are not the only measure of the program's success. There are several other ways to look at how a policy might be performing. For example, the Negotiation Program can improve patient access, increase transparency, and correct market distortions, while reshaping how prices reach beneficiaries... Full

 

PBM Lobby Rolls Out New Messaging After Congressional Changes

(6/1, Victoria Knight, Bloomberg) ...The nation's top pharmacy benefit manager lobbying group, the Pharmaceutical Care Management Association, is launching a new seven-figure advertising campaign Monday focused on affordability...The new advertising campaign is slated to run through the end of the year. The first batch of TV ads run just 30 seconds long and end with a simple tagline: "PBMs: Lowering Drug Prices. Protecting Patients." The ads will start airing on streaming TV and online in the Washington, DC, area on Monday... Full

 

FDA's Next Fee Deal, Stacked with US Incentives, Is Under White House Review

(5/29, Zachary Brennan, Endpoints News) ...Capping off the nearly yearlong negotiations, which occur every five years, a source familiar with the draft agreement confirmed that it includes so-called "America First" provisions that would cut user fees in half for companies running Phase 1 trials in the US and restrict small business waivers only to US companies... Sub. Req'd

 

FDA Finalizes Two Guidances for Industry on Establishing Bioequivalence

(5/29, Joanne S. Eglovtich, Regulatory Focus) ...The US [FDA] finalized two guidances on studies on May 28 to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with pharmacokinetic (PK) endpoints, and the other on statistical methods for analyzing these studies... Full

 

State-Run Drug Company Can't Fix a Broken Patent System

(5/29, Wayne T Brough, Los Angeles Daily News) ...Fixing the problem requires more than a state-run generic company because CalRx faces the same patent gamesmanship by brand manufacturers that plagues generics in the private market... Full

 

Guzmán Advocates for Prescription Drug Affordability Board

(5/29, Illinois Senate Democrats) ...Senate Bill 3496 is an initiative to create a Prescription Drug Affordability Board in Illinois. This group would be tasked with identifying high cost drugs for consumers, conduct affordability reviews on said drugs and decide whether to limit the price of those drugs for the consumer... Full

 

Texas Has Chance to Set Example on Pharma Pricing

(5/29, Charlie Kolean, Newsmax) ...In 2019, the state passed House Bill 2536, considered one of the nation's most aggressive drug price transparency measures. This law created the Texas Prescription Drug Price Disclosure Program, which forces drug manufacturers to disclose and justify when a drug's price increases by 15% in a single year or 40% over three years. But transparency is only the first step. To achieve real affordability, Texas can expand its efforts by looking at proven mechanisms that directly target high drug costs, such as Prescription Drug Affordability Boards (PDABs)... Full

 

 

ASCO26: Lilly Details 'Practice Changing' Data for RET Inhibitor in Earlier Stage Lung Cancer

(5/31, Matthew Dennis, FirstWord PHARMA) ...Commenting on the data, ASCO lung cancer expert David Spigel called the EFS data "quite compelling, and for me, this is a new standard of care." He told a media briefing "if I have a patient in my clinic tomorrow who has early stage disease that has a RET alteration, I absolutely would offer this therapy." However, Spigel also noted that the findings reinforce "the need for comprehensive biomarker testing across all stages of non-small-cell lung cancer."... Full

 

ASCO: In Next-Gen IO Race, BioNTech/BMS and Pfizer Are Divided on Overall Survival Approach

(5/30, Angus Liu, Fierce Biotech) ...In the race to forge the next Keytruda from PD-(L)1xVEGF bispecific antibodies, Pfizer and the BioNTech-Bristol Myers Squibb alliance are split on how to position overall survival-the gold-standard oncology endpoint-in their first-line non-small cell lung cancer (NSCLC) clinical trials... Full

 

ASCO: Akeso's Ivonescimab Bests PD-1 Inhibitor in Lung Cancer Chemo Combos, Slashing Death Risk by 34%

(5/31, Angus Liu, Fierce Pharma) ...With a statistically significant 34% improvement on overall survival (OS), ivonescimab plus chemotherapy became the first regimen to beat the established standard of a PD-1 inhibitor plus chemo in patients with previously untreated, advanced squamous non-small cell lung cancer... Full

 

ASCO26: BMS's Oral CELMoD More than Halves Myeloma Progression

(5/29, Anna Bratulic, FirstWord PHARMA) ...Detailed results from the 479-patient Phase II/III SUCCESSOR-2 study, toplined in March, were presented Friday at the American Society of Clinical Oncology (ASCO) meeting and suggest the experimental molecular glue mezigdomide could be another tool in the immunotherapy arsenal to help retain activity in myeloma patients refractory to older immunomodulatory drugs (IMiDs) such as lenalidomide and pomalidomide... Full

 

Replimune Hopes Third Submission's the Charm for Melanoma Treatment

(5/29, Elizabeth S. Eaton, FirstWord PHARMA) ...The drugmaker is seeking accelerated approval of RP1 in combination with Bristol Myers Squibb's Opdivo (nivolumab) to treat advanced melanoma. RP1 is an immunotherapy based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF. Upon receipt, the FDA will treat the BLA submission as an "urgent matter" and prioritise its review, Replimune said... Full

 

ASCO: Sac-TMT's Massive Phase 3 Program Has a Jarring Gap. Does Merck Plan to Close It?

(6/1, Angus Liu, Fierce Pharma) ...More than two years have passed since those two studies kicked off. That's a notable hole in Merck's whole TroFuse clinical program for what it touts as a "workhorse" product, especially as the landmark Keynote-189 trial win in first-line nonsquamous NSCLC was how Keytruda was crowned the PD-1 king... Full

 

Bristol Myers Unveils Data for One of its Next-Gen Blood Cancer Drugs

(5/29, Jonathan Gardner, BioPharma DIVE) ...Trial enrollees who got mezigdomide along with Amgen's Kyprolis and a steroid were 52% less likely to have progressed or died during the trial period compared with people receiving only those two other therapies. Study recruits in the "SUCCESSOR-2" trial had already seen their disease advance after at least one treatment line. Many had previously received two or more therapies... Full

 

At ASCO, Merck Makes Case for a 'Cornerstone' Cancer Drug

(5/29, Delilah Alvarado, BioPharma DIVE) ...Dubbed sacituzumab tirumotecan, or sac-TMT, the therapy is part of a class of "antibody-drug conjugates" drugmakers see as potentially supplanting traditional chemotherapy in many cancers. Merck has been so encouraged by the clinical results it's seen so far that it's put the drug into a sprawling Phase 3 program consisting of 17 studies in a range of tumor types... Full

 

Merz Therapeutics Presents New Research at WPC 2026, Revealing the Hidden Burden of "OFF" Episodes in Parkinson's Disease

(5/30, Pharmabiz.com) ...The qualitative literature review demonstrates that these episodes are not only a re-emergence of motor symptoms, but also a complex mix of debilitating motor and non-motor symptoms that impact the lives of people with Parkinson's disease. Additional data presented at the congress also confirm the clinical profile of levodopa inhalation powder (Inbrija) as a reliable and well-tolerated treatment for these debilitating events... Full

 

 

What's Next? Five Things To Look Out For In June

(6/1, Dean Rudge, Generics Bulletin) ...In June, Pfizer's Xeljanz will reach a key US loss-of-exclusivity milestone, with the company's sole Orange Book-listed patent for tofacitinib citrate immediate-release tablets, reissued US patent RE41,783, expiring on June 8, 2026, including six months of pediatric exclusivity...Teva, Sinotherapeutics, Zydus, Aurobindo, Dexcel, Biocon and Ajanta currently hold tentative approvals for extended-release tofacitinib formulations, while MSN Labs, Annora and Hikma hold tentative approvals for oral solution presentations... Global Sub. Full

 

Biogen Faces Italian Investigation Over Blocking Sandoz's Biosimilar Natalizumab

(5/29, Dave Wallace, Generics Bulletin) ...The investigation revolves around Biogen allegedly making the use of its Stratify test for John Cunningham virus (JCV) conditional on the purchase of branded Tysabri, and not making it available for patients treated with the biosimilar, which has been available in Italy since early April 2024... Global Sub. Full

 

Celltrion Files for Cosentyx Biosimilar Approval in Canada, Targets $10 Billion Market

(6/1, Lee Yeon-soo, Seoul Economic Daily) ...Celltrion has launched its push into the North American market by initiating the Canadian approval process for its biosimilar of Cosentyx, an autoimmune disease treatment. Celltrion announced Wednesday that it has filed for marketing approval with Health Canada for CT-P55, a biosimilar of Cosentyx (active ingredient: secukinumab)... Full

 

Lupin Gets US Approval for Colonoscopy Prep Drug, Wins 180-Day Exclusivity

(5/29, Navneet Singh, CNBC TV18) ...Lupin added that it is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity. The tablets will be manufactured at the company's Nagpur facility in India... Full

 

 

Lupin Targeting Large Specialty Deals But With Guardrails on Debt and Risk, Says CFO Swaminathan

(6/1, Viswanath Pilla, Moneycontrol) ..."We still don't shy away from large acquisitions, but we are a lot more calibrated in our aggression, looking at protecting the downsides. We don't bet the company anywhere," Lupin's executive director and global chief financial officer Ramesh Swaminathan told Moneycontrol in a recent interview... Full

 

Glenmark Pharma Q4 Net Profit Zooms to Rs301 Crore; Recommends 250% Dividend

(5/29, Jomy Jos Pullokaran, CNBC TV18) ...Glenmark Pharmaceuticals Ltd on Friday (May 29) reported a sharp surge in consolidated net profit to Rs301.4 crore in Q4 on the back of strong operational performance. The profit increased by over 6,400% from Rs4.6 crore a year earlier... Full

 

 

Sandoz Warns Cheap Chinese Imports Threaten Europe's Antibiotic Supply

(5/31, Aanu Adeoye, Financial Times) ...Richard Saynor said European antibiotics manufacturers were "giving up" in the face of dumping by Chinese groups backed by state subsidies, warning that without intervention Europe risked becoming dependent on overseas imports... Sub. Req'd

 

Spain's First Ever HTA Framework Ensures No JCA Duplication Of Efforts

(5/29, Francesca Bruce, Pink Sheet) ...The Spanish government has approved a regulation that it says will, for the first time, establish a "complete, transparent and coordinated regulatory framework" for conducting health technology assessments (HTAs) in the country. The regulation also adapts the Spanish HTA system to the EU's Health Technology Assessment regulation and the use of EU-level joint clinical assessments (JCAs), ensuring that there will be no duplication of effort for pharmaceutical companies, according to the health ministry... Global Sub. Full

 

Diabetes and Parkinson's Patients Face Drug Shortages

(5/30, Camilla Turner, The Telegraph) ...Diabetes and Parkinson's patients are facing drug shortages because of the Iran war, pharmacists have warned. Shortages of several critical medicines have become "considerably worse" over the past two months, according to the Independent Pharmacies Association (IPA), which represents 5,000 pharmacies in England and Wales... Full

 

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