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BioWorld - Wednesday, July 29, 2026
Home » Authors » Karen Carey

Karen Carey

Articles

ARTICLES

Path shaped like a fluctuating arrow graph

Replimune’s rollercoaster: FDA adcom signals another bumpy ride

July 28, 2026
By Karen Carey
No Comments
Suggesting Replimune Group Inc.’s statistical analysis method inflated responses in the single-arm phase II Ignyte trial of RP-1 (suvolimogene oderparepvec), briefing documents ahead of the U.S. FDA’s Cellular, Tissue, and Gene Therapies advisory committee meeting on July 30 sent the company’s shares spiraling downward by about 38%.
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Feet on scale

Lilly’s triple-G retatrutide ‘best-in-class’ as BLA filing nears

July 23, 2026
By Karen Carey
No Comments
Scoring high marks on two more phase III obesity trials, this time involving serious type 2 diabetes and cardiovascular complications, Eli Lilly and Co. has cleared the path for a BLA filing for its triple-G candidate retatrutide, which many expect will eventually surpass the top two marketed drugs in the space.
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Global deals illustration

Asia deal flurry draws AZ, Spero to $1B+ Dizal, Innovent assets

July 21, 2026
By Karen Carey
No Comments
Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.
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Lipfendra

US FDA approves Merck's Lipfendra, first oral PCSK9 for LDL-C

July 16, 2026
By Karen Carey
No Comments
Branded Lipfendra, Merck & Co. Inc.’s oral PCSK9 inhibitor enlicitide, part of the FDA Commissioner’s National Priority Voucher pilot program, won U.S. approval to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
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Global deals illustration

Asia deal flurry draws AZ, Spero to $1B+ Dizal, Innovent assets

July 14, 2026
By Karen Carey
No Comments
Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.
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Hands and arms with vitiligo

Forte, First Tracks soar on CD122 success in vitiligo; celiac next

July 9, 2026
By Karen Carey
No Comments

Encouraging phase I data this week of new treatments for vitiligo, a chronic autoimmune disorder that destroys melanocytes, drove investor excitement, with Forte Biosciences Inc. the latest company to disclose a statistically significant benefit.


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Hand pointing at digital M&A screen

Endocrinology becomes Vertex’s fifth pillar with $10B Crinetics buy

July 7, 2026
By Karen Carey
No Comments
Representing the fourth largest biopharma M&A announced in 2026, Vertex Pharmaceuticals Inc. offered $85 per share in cash, or about $10 billion, to buy endocrine specialist Crinetics Pharmaceuticals Inc., adding the acromegaly drug Palsonify and a phase III asset, atumelnant, for congenital adrenocorticotropic hyperplasia (CAH).
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Illustration of lungs with cancer inset

Genentech’s KRAS G12C inhibitor divarasib shines in NSCLC phase III

July 2, 2026
By Karen Carey
No Comments
Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients.
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Vistagen's SAD slump: lead pherine, fasedienol, fails again

June 30, 2026
By Karen Carey
No Comments
Top-line phase III Palisade-4 results of Vistagen Therapeutics Inc.’s fasedienol showed the intranasal pherine candidate failed to hit primary and secondary endpoints in the acute treatment of social anxiety disorder (SAD), issuing a near death knell as company’s shares (NASDAQ:VTGN) plunged more than 70% to close at 22 cents on June 30.
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Acquisition target

Advanced Medical Solutions’ takeout offer worth £659M

June 25, 2026
By Karen Carey
No Comments
Adhesives innovator H.B. Fuller Co. is offering £2.85 per share in cash to buy Advanced Medical Solutions Group plc, expanding its technologies, commercial footprint and manufacturing capabilities across the globe.
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