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BioWorld - Monday, May 25, 2026
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Test tube and pH chart

Validity of Actelion patent hinges on temperature

May 15, 2026
By Mari Serebrov
No Comments
Temperature matters when determining pH levels. Whether that level should be measured at a standard room temperature or refrigerated matters even more, at least in Actelion Ltd.’s infringement litigation against Mylan Inc. According to Johnson & Johnson’s Actelion, the pH level in epoprostenol, the key ingredient in its hypertension drug Veletri, should be measured at a refrigerated temperature when it comes to Mylan’s generic formulation.
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Empty prescription drug bottle

EU reaches Critical Medicines Act pact to tackle drug shortages

May 15, 2026
By Nuala Moran
No Comments
In further fallout from the COVID-19 pandemic, the EU has now reached agreement on the Critical Medicines Act, which aims to boost European manufacturing capacity for drugs and their active ingredients, and enable member states to organize joint procurement to improve access to orphan drugs.
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Patent gears

USPTO doubles down on inconsistencies in dual IPR-court action

May 14, 2026
By Mari Serebrov
No Comments
The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy.
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Abstract blue human heart with red cardio pulse line and red circle
Cardiovascular

KHN-921 gains IND clearance for MYBPC3-associated HCM

May 14, 2026
No Comments
Chengdu Origen Biotechnology Co. Ltd. and Vanotech Ltd. have announced IND clearance by the FDA for KHN-921 for the treatment of hypertrophic cardiomyopathy (HCM) associated with MYBPC3 mutations.
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3D illustration of tumor
Immuno-oncology

Henlius’ HLX-48 for solid tumors cleared for clinic in Australia

May 14, 2026
No Comments
Shanghai Henlius Biotech Inc.’s HLX-48 for injection has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The first-in-human phase I study in Australia will evaluate HLX-48 in patients with advanced or metastatic solid tumors.
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Mantle cell lymphoma

Beone’s BCL2 drug Beqalzi wins FDA nod in mantle cell lymphoma

May 13, 2026
By Jennifer Boggs
No Comments
A few months after winning its first regulatory clearance in China, Beone Medicines Inc.’s next-generation BCL2 inhibitor, sonrotoclax, gained the U.S. FDA’s accelerated approval for use in patients with relapsed or refractory mantle cell lymphoma (MCL) following treatment with a BTK inhibitor. The therapy, branded Beqalzi, marks the first BCL2-targeting drug for MCL in the U.S., but the company has pointed to a bigger opportunity in the potential combination with blockbuster BTK drug Brukinsa (zanubrutinib).
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China and U.S. flags

Life sciences ‘sweet’ opportunity in US-China talks

May 13, 2026
By Mari Serebrov
No Comments
Of all the issues that could be on the table at the talks between U.S. President Donald Trump and China President Xi Jinping, the life sciences sector is the “sweet spot” for collaboration between the two countries in a way that would benefit the world, Sen. Thom Tillis, R-N.C., said in a Brookings Institution webinar in advance of the two-day summit that starts May 14.
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Magnifying glass on wooden table

Multiple appearances on Priority Watch List leading to action?

May 12, 2026
By Mari Serebrov
No Comments
It’s a sure bet when the U.S. Trade Representative releases its annual Special 301 Report that Chile, China, India, Indonesia, Russia and Venezuela will be on the Priority Watch List. The 2026 report was no exception.
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Hantavirus cells

APAC monitors hantavirus as Singapore isolates 2 from cruise ship

May 12, 2026
By Marian (YoonJee) Chu
No Comments
Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far.
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Martin Makary, former FDA-commissioner

Makary out at the FDA

May 12, 2026
By Mari Serebrov
No Comments
U.S. President Donald Trump ended days of rumors and speculation when he confirmed May 12 that Marty Makary is resigning as FDA commissioner. Speaking with reporters before heading off to China for a two-day summit, Trump wouldn’t comment on whether he or someone else asked Makary to step down. However, while calling Makary a “wonderful man” and a “great guy, who’s a friend of mine,” the president acknowledged that “he was having some difficulty” at the FDA.
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