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BioWorld - Tuesday, May 19, 2026
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Pill with Euro currency symbol
FT Global Pharma and Biotech Summit

Trump’s MFN price deals a wake-up call for governments in Europe

Nov. 11, 2025
By Nuala Moran
No Comments
The industry has been complaining about the drug pricing and reimbursement policies of European governments for years, but only now with the Trump administration’s moves to enforce most favored nation (MFN) pricing and reduce the U.S./EU price gap are governments facing up to the reality that they will have to pay more for new drugs.
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Art concept for bladder

Up the bladder ladder, Engene tweak means phase II bell rung

Nov. 11, 2025
By Randy Osborne
No Comments
Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease.
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Boston Scientific Corp.’s Watchman Flx device
AHA Scientific Sessions

CLOSURE-AF study not the end of the line for LAAC devices

Nov. 11, 2025
By Mark McCarty
At first glance, the results of the CLOSURE-AF study would seem to spell doom for left atrial appendage closure devices for patients at risk of stroke, but there is some noise in the signal, including that the devices used in the study no longer represent the state of the med-tech art.
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Atrial fibrillation illustration
AHA Scientific Sessions

OCEAN study hints at no need for DOACs after afib ablation

Nov. 11, 2025
By Mark McCarty
Patients and their doctors are no fans of long-term use of direct oral anticoagulants (DOACs) after ablation treatment for atrial fibrillation, but three-year data from the OCEAN trial suggests that some patients may not need these DOACs after all, an outcome that qualifies as a crowd-pleaser for all but the makers of these pharmaceutical agents.
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International currency symbols
Med-tech financings October 2025

Med-tech financings reach $26.6B as sector recovery continues

Nov. 11, 2025
By Amanda Lanier
Med-tech financings with disclosed valuations from January through October 2025 totaled $26.58 billion, nearly matching 2022’s $26.83 billion and marking a continued recovery from the sector’s 2023 low of $15.59 billion. The data suggest renewed investor confidence in med-tech, with capital flows shifting back toward public markets after two years of restrained activity.
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Illustration of antibodies flying around a kidney

Takeda’s mezagitamab shows lasting kidney function in IgA nephropathy

Nov. 11, 2025
By Tamra Sami
No Comments
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
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Celltrion building and skyline

Celltrion signs $744M deal with Kaigene, $500M with Mustbio

Nov. 11, 2025
By Marian (YoonJee) Chu
No Comments
Celltrion Inc. scored a hat-trick of deals to license new antibody candidates, including a $744 million deal with Kaigene Inc. Nov. 3, and a near $500 million deal with Mustbio Co. Ltd. Oct. 31.
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RNA strand

Lilly moves deeper into RNAi with $1.2B Sanegene obesity deal

Nov. 11, 2025
By Tamra Sami
No Comments
In a deal worth $1.2 billion, Suzhou Sanegene Bio Inc. and Eli Lilly and Co. are partnering to advance RNAi candidates for metabolic diseases based on Sanegene's tissue selective delivery technology.
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RNA strand

Lilly moves deeper into RNAi with $1.2B Sanegene obesity deal

Nov. 10, 2025
By Tamra Sami
No Comments
In a deal worth $1.2 billion, Suzhou Sanegene Bio Inc. and Eli Lilly and Co. are partnering to advance RNAi candidates for metabolic diseases based on Sanegene's tissue selective delivery technology.
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FDA easing warning on HRTs to boost women’s long-term health

Nov. 10, 2025
By Mari Serebrov
No Comments
The U.S. FDA is turning the clock back more than 20 years to advance women’s health by narrowing the boxed warning on hormone replacement therapies (HRTs) for menopause. The agency announced at a Nov. 10 news conference that it’s working with companies to update their HRT labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia.
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