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BioWorld - Thursday, August 18, 2022
Home » Topics » Clinical

Clinical
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I-Mab scores second China IND with its CD38 antibody

Oct. 22, 2019
By David Ho
No Comments

HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).


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Opko-Pfizer long-acting growth hormone falls short of inspiring investors

Oct. 22, 2019
By Michael Fitzhugh
No Comments
A tepid reception to new top-line phase III data on the long-acting growth hormone (GH) somatrogon nudged Opko Health Inc. shares (NASDAQ:OPK) about 4 cents higher to $2.13 Monday, leaving it overshadowed by competitor Ascendis Pharma A/S, the developer of Transcon-hGH. Ascendis' shares (NASDAQ:ASND) rose 4.5% to $103.36.
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TKI TKO? Seagen's player brings brain brawn to BC; Street cites efficacy, ease

Oct. 22, 2019
By Randy Osborne
No Comments
Benefit for patients with disease that has spread to the brain put a special shine on top-line data rolled out by Seattle Genetics Inc. (Seagen) from the HER2Climb study, an experiment to test the oral small-molecule tyrosine kinase inhibitor (TKI) tucatinib, designed as highly selective for HER2 without significantly knocking down EGFR.
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Clinatec's neuroprosthesis enables a tetraplegic patient to move using an exoskeleton

Oct. 21, 2019
By Bernard Banga
No Comments
PARIS – Clinatec Research Center, of Grenoble, France, is heralding the publication of results from its Brain Computer Interface (BCI) Exoskeleton clinical trial in the journal Lancet Neurology. Its semi-invasive medical device, Wimagine, has enabled a quadriplegic patient to move by transmitting signals emitted by his brain to an exoskeleton. This is the first proof of concept for control of a four-limb exoskeleton by a neuroprosthesis.
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Syros oral CDK7 argument front-seats cancer bid over I.V. prospect; phase I soon

Oct. 18, 2019
By Randy Osborne
No Comments
The pipeline shift made public Thursday by Syros Pharmaceuticals Inc. may have been presaged by analysts, who in August sounded lukewarm about the Cambridge, Mass.-based firm's prospects as they stood then.
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Protalix nears planned BLA filing for new Fabry disease therapy

Oct. 18, 2019
By Michael Fitzhugh
No Comments
Israel's Protalix Biotherapeutics Inc., the first company to gain FDA approval for a protein therapy produced by plant cell cultures in 2012, has moved one step closer to seeking FDA approval for a second such product with new phase III data supporting its experimental therapy for Fabry disease.
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Clinical data for Oct. 16, 2019

Oct. 17, 2019
No Comments

Lilly's big bet on Armo sours on phase III pancreatic cancer results

Oct. 17, 2019
By Michael Fitzhugh
No Comments
Eli Lilly and Co.'s $1.48 billion acquisition of Armo Biosciences Inc., intended to broadly bolster its immuno-oncology program, fell short of that goal in its first big test, a phase III trial in second-line pancreatic cancer called Sequoia.
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China clears Iaso Bio to start trials of anti-BCMA CAR T, targeting multiple myeloma

Oct. 17, 2019
By Elise Mak
No Comments
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully-human BCMA CAR T for treating relapsed or refractory multiple myeloma.
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Helixmith points to success in VM-202 phase III-Ib trial, though investors skeptical

Oct. 17, 2019
By Jihyun Kim
No Comments
HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN). But, while the Seoul-based company, formerly known as Viromed, said VM-202 met the primary safety and secondary efficacy endpoints for a DPN therapy at 12 months, investors are doubting that the results are trustworthy.
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