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BioWorld - Wednesday, May 27, 2026
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Pills, bottle, scale and-measuring tape
Newco news

Ambrosia slurps up a $100M series B for its oral obesity drug pipeline

April 2, 2026
By Brian Orelli
No Comments
Ambrosia Biosciences Inc., named after the drink of the Greek gods, secured a $100 million series B to advance its preclinical pipeline of oral obesity drugs. The startup formed after Pfizer Inc. shuttered its Boulder, Colo.-based research facility that the pharma gained through its 2019 acquisition of Array Biopharma Inc.
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M&A cityscape
Med-tech deals Q1 2026

Blockbuster deals push med-tech M&A above $40B in Q1 2026

April 2, 2026
By Amanda Lanier
No Comments
Med-tech deal value, excluding M&As, totaled $628.41 million in the first quarter (Q1) of 2026, an increase of about 322% from the $149.08 million recorded in Q1 2025 though a 36% drop from Q4 2025‘s $978.58 million.
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Eye and DNA illustration

LHON updates: Gene therapy progress; idebenone receives US CRL

April 2, 2026
By Marian (YoonJee) Chu
No Comments
Chiesi Group’s idebenone faced a regulatory setback last month after the U.S. FDA issued a complete response letter (CRL) to the company’s NDA for Leber hereditary optic neuropathy (LHON), a rare inherited disorder that causes sudden vision loss.But a chance missed for Chiesi may be an opportunity for gene therapies, including Gensight Biologics SA’s lenadogene nolparvovec (Lumevoq; GS-010).
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EMA logo on mobile screen, vials, syringes

EMA poised to approve first NAM to replace live animal controls in toxicity tests

April 2, 2026
By Nuala Moran
No Comments
The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval.
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Tired mother holding newborn

Oral ‘roid void in PPD? Lipocine MINI bike may have wheels

April 2, 2026
By Randy Osborne
No Comments
Hopes in postpartum depression (PPD) with an oral version of brexanolone – a synthetic formulation of the endogenous neurosteroid allopregnanolone, approved by the U.S. FDA in 2019 when given intravenously for PPD – were dashed, at least near term, when Lipocine Inc. reported that the candidate failed in a phase III placebo-controlled trial.
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Lipocine phase III with oral brexanolone bombs in PPD

April 2, 2026
No Comments
A preview of the next edition of BioWorld, April 2, 2026
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Cancer and blood cells

Hematopoietic stem cell research points to leukemia’s early roots

April 2, 2026
By Marian (YoonJee) Chu
No Comments
Hematopoietic stem cell research over the past century has shown that leukemia may be driven by an invisible hand of inflammation. The bone marrow and inflammation, then, may hold the keys to preventing blood cancers, according to John E. Dick’s plenary session at the 2026 Korean Society of Hematology International Conference, held March 26, 2026.
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Regulatory actions for April 1, 2026

April 1, 2026
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Agios, Ascendis, Elevar, Haemonetics, Medibeacon, Oculis, Polypid, Praxis, Sanofi, Scholar Rock.
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Other news to note for April 1, 2026

April 1, 2026
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Cytovale, Fortress, Infinimmune, Leo, Lipella, Merck & Co., Mindmaze, Novo, Poxel, Scynexis, Takeda, Vibra.
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In the clinic for April 1, 2026

April 1, 2026
Clinical updates for biopharma and med tech, including data readouts and publications: Astrazeneca, Concept, Merck, Natera, Oric, Palisade, Pepgen.
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