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BioWorld - Sunday, March 29, 2026
Home » Topics » Clinical

Clinical
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Lowdown in HPT: Takeda’s Natpara hitch may level thyroid playing field

Sep. 9, 2022
By Randy Osborne
The bad news in March 2022 from Takeda Pharmaceutical Co. Ltd. regarding Natpara, its recombinant human parathyroid hormone for hypoparathyroidism (HPT), served to generate more interest in the already bubbling space, where a handful of players large and small own prospects at various clinical stages.
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ESMO 2022

First phase III success for cell therapy in solid tumors

Sep. 8, 2022
By Anette Breindl
ESMO late breakers were released Sept. 8, and scientifically at least, a key theme of the meeting will be that cell therapies, at long last, are capable of besting solid tumors.
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Inflarx plans EUA following revised statistical look at vilobelimab in COVID-19 study

Sep. 8, 2022
By Nuala Moran
Inflarx NV is poised to apply for U.S. FDA emergency use authorization for its complement inhibitor, vilobelimab, in treating seriously ill, mechanically ventilated COVID-19 patients, following a reappraisal of the statistical analysis of the 369-patient placebo-controlled phase III trial.
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Illustration of stent angioplasty balloon in artery

Study hints PCI not necessary in some patients with left ventricular ischemia

Sep. 8, 2022
By Mark McCarty
Angioplasty and stenting have combined to become the standard of care for patients with myocardia that sustained damage due to an infarct, but a new study suggests that some of these patients are no worse off with medical management compared to a trip to the cath lab. 
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Akston starts small and likes it that way

Sep. 7, 2022
By Lee Landenberger
Akston Biosciences Corp. emerged from a successful small company that was sold to a pharma major. For Todd Zion, that’s a back-to-basics move that suits him just fine. Zion co-founded Smartcells Inc. in 2003 with technology developed at the Massachusetts Institute of Technology. The company went on to develop the once-daily injectable self-regulating insulin product, Smartinsulin, and sold it to Merck & Co. in what was at the time one of the largest preclinical pharmaceutical acquisitions ever.
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Patient in hospital bed

Tubulin test: Veru coming through as COVID-19 queue debated

Sep. 7, 2022
By Randy Osborne
Wall Street trimmed shares of Veru Inc. (NASDAQ:VERU) by upwards of 20% in the wake of an editorial published Aug. 23 in The New England Journal of Medicine publication NEJM Evidence. The opinion piece, by two critical-care pulmonologists, added verve to the debate about the efficacy of drugs for people hospitalized with COVID-19.
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Another phase III win in hand, Iveric GAthers evidence for NDA

Sep. 6, 2022
By Randy Osborne
Questioners probed the fine points during Iveric Bio Inc.’s conference call, but news proved unmistakably good with Zimura (avacincaptad pegol) in geographic atrophy (GA), and shares of the firm (NASDAQ:ISEE) closed Sept. 6 at $15.70, up $6.26, or 66%, on positive top-line data from Gather 2, the firm’s second phase III study.
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Eye wireframe illustration

NIH, Opsis and Fujifilm begin trial of autologous stem cell patch for dry AMD

Sep. 2, 2022
By Mark McCarty
Age-related macular degeneration (AMD) is still widely seen as the most common cause of irreversible blindness in those aged 50 and older, but the U.S. NIH and two partners from the private sector believe they have a solution. The three have teamed up to develop a patch embedded with induced pluripotent stem cells that has been implanted in a patient in the U.S. for the first time, marking the commencement of a safety study that may help take a bite out of the $4.6 billion in direct medical spending on AMD each year in the U.S.
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Neurology illustration

Wall Street on watch for Vigil results as Trem2 efforts continue

Sep. 2, 2022
By Randy Osborne
A recent paper in the Journal of Neuroscience detailing preclinical research from the University of Texas shone new light on triggering receptor expressed on myeloid cells 2 (Trem2), an increasingly popular target in drug discovery that a handful of companies are pursuing.
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Endocrine/Metabolic

Immusoft cleared to advance ISP-001 into clinic for MPS I

Sep. 2, 2022
The FDA has cleared Immusoft Corp.'s IND for ISP-001 (iduronicrin genleukocel-T) for the treatment of mucopolysaccharidosis type I (MPS I), allowing initiation of a phase I trial.
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