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BioWorld - Monday, February 16, 2026
Home » Topics » Clinical

Clinical
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REGEN-COV packaging

Cocktail time: Regeneron’s COVID-19 monoclonal antibodies post strong phase III data, could dilute mRNA market share

Nov. 8, 2021
By Lee Landenberger
New positive phase III study results for Regeneron Pharmaceuticals Inc.’s COVID-19 monoclonal antibody cocktail show a single dose reduced the risk of contracting the virus by 81.6% during a two- to eight-month follow-up period. The strong data go along with Pfizer Inc.’s recent positive results for its oral antiviral, Paxlovid, hinting that COVID-19 therapeutics could begin cutting into powerful mRNA vaccine margins from Pfizer Inc.-Biontech SE and Moderna Inc.  
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In the clinic for Nov. 8, 2021

Nov. 8, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocryst, Calithera, Chinook, Cyclacel, Deciphera, Dicerna, Karyopharm, Medicure, Morphosys, Novartis, Novo, Omeros, Pfizer, Vascular Therapies.
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Illustration of TAVR device
TCT 2021

Five years on, TAVR with self-expanding valve matches SAVR outcomes

Nov. 5, 2021
By Annette Boyle
It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?
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3-30-Medtronic-Symplicity-Spyral.png
TCT 2021

Medtronic study highlights patient hypertension treatment preferences at TCT 2021

Nov. 5, 2021
By Catherine Longworth
A new study has found that despite the risk, many patients are open to interventional procedures such as renal denervation (RDN) if it can lead to improved blood pressure. RDN is performed under local anesthetic and uses radio frequency ablation to burn the nerves in the renal arteries. The process causes a reduction in nerve activity, which decreases blood pressure.
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Lungs

Double trouble: Calithera stops telaglenastat development

Nov. 5, 2021
By Lee Landenberger
Calithera Biosciences Inc.’s stock took a severe beating Nov. 5 as shares closed 54.5% downward due to the company’s phase II stumble of telaglenastat in treating non-small-cell lung cancer. It was the therapy’s second clinical failure in the past 12 months.
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Endpoint for GIST missed in surprise twist; Deciphera’s Qinlock defrocked as second-line bid

Nov. 5, 2021
By Randy Osborne
Shares of Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH) plunged $27.18, or 75.5%, to close at $8.82 on top-line results from the phase III study called Intrigue with Qinlock (ripretinib) in gastrointestinal stromal tumors (GIST) previously treated with kinase inhibitor Gleevec (imatinib, Novartis AG).
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Drug capsules in petri dish

Pfizer adds fresh evidence to EUA filing for new COVID-19 pill

Nov. 5, 2021
By Michael Fitzhugh
Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
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3D illustration of heart cross section
TCT 2021

Stents, FFR software take a hit in study comparing PCI with coronary artery bypass

Nov. 4, 2021
By Mark McCarty
Despite the morbidity associated with coronary artery bypass graft, this procedure has never been entirely displaced by percutaneous coronary intervention. The results from the latest in a series of studies does not seem to help the case for drug-eluting stents (DES) for patients with three-vessel disease, as the data from this study failed to demonstrate non-inferiority for DES devices implanted with the help of fractional flow reserve measurement to ensure optimal stent placement.
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Clinical data illustration

Activ Surgical eyes commercial launch in 2022 for digital surgery platform

Nov. 4, 2021
By Catherine Longworth
Hot off the heels of a $45 million series B financing raise, Activ Surgical Inc. has completed the first clinical trial evaluating its Activinsights augment reality (AR)-based software suite and Activsight imaging module. The safety and feasibility study, carried out with The University of Texas Health Science Center at Houston (UTHealth Houston) is the first of several trials the Boston-based company is planning in 2021.
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Wall Street Staar-struck by Sangamo’s early phase I/II Fabry data

Nov. 4, 2021
By Randy Osborne
Sangamo Therapeutics Inc. rolled out pleasing preliminary data from the first four patients treated in the phase I/II study known as Staar, evaluating isaralgagene civaparvovec, or ST-920, a gene therapy for Fabry disease. Results as of the Sept. 17, 2021, cutoff date from the four patients in the first two dose cohorts showed that the drug was generally well-tolerated, and all four patients exhibited above normal alpha-galactosidase A activity.
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