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BioWorld - Wednesday, December 24, 2025
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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 21, 2025
By Nuala Moran
No Comments
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
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Multiple sclerosis-damaged myelin

Contineum’s PIPE-307 misses in midstage MS study

Nov. 21, 2025
By Lee Landenberger
No Comments
Contineum Therapeutics Inc.’s midstage study of its multiple sclerosis drug, PIPE-307, missed its primary and secondary endpoints, dropping the stock on Nov. 21. Top-line phase II results from the Vista study of the M1 receptor agonist PIPE-307 for treating relapsing-remitting multiple sclerosis saw no significant changes in binocular 2.5% low contrast letter acuity in the treatment arms, a key efficacy measure.
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Doctors examining lung scans

Taiho, Cullinan file rolling NDA on phase I/II zipalertinib data

Nov. 21, 2025
By Tamra Sami
No Comments
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
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M&A letters over missing puzzle pieces

GE Healthcare expands imaging line with $2.3B Intelerad buy

Nov. 21, 2025
By Annette Boyle
GE Healthcare Technologies Inc. agreed to purchase medical imaging company Intelerad Medical Systems Inc. for $2.3 billion in cash, boosting its capabilities in cardiology and radiology. The deal, expected to close in the first half of 2026, advances GE Healthcare's dual strategies of expanding from primarily inpatient products to outpatient and ambulatory care settings and tripling its cloud-enabled products by 2028.
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Gavel and scales

Fed Circuit lets Sandoz off $39M hook

Nov. 20, 2025
By Mari Serebrov
No Comments
Sandoz Inc. came out the big winner Nov. 18 when the U.S. Court of Appeals for the Federal Circuit wiped out $39 million in infringement damages a jury had awarded to Allergan plc. Sandoz overcame “the doubly high burden of persuading us to overturn a jury verdict of no invalidity,” the appellate court said in its precedential opinion.
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Hands holding gears

GSK-Flagship deal validates Profound, Quotient platforms

Nov. 20, 2025
By Karen Carey
No Comments
Two Flagship Pioneering Inc. biopharma companies founded in the last five years and focused on proteomic and genomic technologies entered agreements to help discover new therapeutics for respiratory and liver diseases under a framework collaboration with GSK plc. Under that agreement, Profound Therapeutics Inc. and Quotient Therapeutics Inc. would use their platform technologies to discover novel proteins and targets for developing drugs to treat chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis, with Quotient taking on a third indication with metabolic dysfunction-associated steatohepatitis.
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Lungs

Bayer’s HER2-mutated lung cancer treatment gets FDA nod

Nov. 20, 2025
By Lee Landenberger
No Comments
A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.
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Abbott sign

Abbott makes cancer screening play with $21B Exact Sciences buy

Nov. 20, 2025
By Holland Johnson
Abbott Laboratories made plans to enter the cancer screening market with its reported acquisition of Exact Sciences Corp. The deal will pay Exact Sciences shareholders $105 per share in cash, a nearly 50% premium to Exact’s unaffected share price on Nov. 19. That represents a total equity value of approximately $21 billion and an estimated enterprise value of $23 billion.
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Raining 100 dollar bills

Solventum agrees to acquire Acera for up to $850M

Nov. 20, 2025
By Annette Boyle
Solventum Corp. continued its restructuring with a second significant acquisition this year, the proposed purchase of privately held Acera Surgical Inc. for $725 million in cash plus up to $125 in contingent cash payments based on achievement of specified milestones. St. Louis.-based Acera projected that its synthetic wound care products will bring in $90 million in sales this year.
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US Capitol at night

PAMA cuts for clinical lab testing averted, but overhang remains

Nov. 20, 2025
By Mark McCarty
The resolution of the budget impasse between Democrats and Republicans on Capitol Hill sidestepped a number of problems, including some cuts to Medicare payment rates for clinical laboratory testing services. However, that pause is only in effect through the end of January 2026, leaving operators of these labs with a fiscal sword of Damocles to manage.
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