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BioWorld - Friday, February 26, 2021
Home » Topics » Clinical

Clinical
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Lack of clinical trial diversity could have consequences

Feb. 25, 2021
By Mari Serebrov
No Comments
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end.
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In the clinic for Feb. 25, 2021

Feb. 25, 2021
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adial, Aimmune, Aivita, Altimmune, Bioage, Biontech, Bioxcel, Bluebird, BMS, Celsion, Chimerix, Clene, CNS, Compugen, EMD Serono, Entera, I-Mab, GSK, Karuna, Kronos, Pfizer, Regeneron, Roche, Springworks, Stero, Viela.
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Woman using Appliedvr virtual reality headset at home

Appliedvr releases pivotal data on virtual reality-based pain therapy

Feb. 24, 2021
By Meg Bryant
No Comments
In 2020, Appliedvr Inc. reported results from a three-week proof-of-concept study showing reduction of lower back pain with the use of its Easevrx virtual reality (VR) therapy. Now the company has pivotal data affirming the benefit to patients with chronic low back pain who used Easevrx at home for eight weeks.
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In the clinic for Feb. 24, 2021

Feb. 24, 2021
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Click, Constant, Gtreebnt, Locus, Longeveron, Marinomed, Nanoform, Neurorx, Novavax, Opthea, Otsuka, Regentree, Salarius, Takeda, Theralase, Theravance.
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Baby, it’s not as cold inside: Pfizer-Biontech submits new COVID-19 vaccine storage data

Feb. 23, 2021
By Lee Landenberger
No Comments
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
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SERDs heard louder, clearer in BC; Sanofi phase II data this half

Feb. 23, 2021
By Randy Osborne
No Comments
Astrazeneca plc officials, during the firm’s Feb. 11 conference call on fourth-quarter earnings, highlighted the oral selective estrogen receptor degrader (SERD) camizestrant in breast cancer (BC), which Cristian Massacesi, head of late-stage oncology development, said bears “best-in-class potential, in terms of providing superior clinical benefit at a well-tolerated dose” of 75 mg once per day.
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In the clinic for Feb. 23, 2021

Feb. 23, 2021
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abfero, Ampio, Arrys, Chiesi, Eiger, Frequency, LG, Matrisys, Octapharma, Protalix, Redhill, Revance, Stealth, Targovax, TG, Union, Valbiotis, Vtv.
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Financial chart, downward arrow

Otonomy's Otividex fails pivotal Meniere's disease trial, crashing shares again

Feb. 22, 2021
By Michael Fitzhugh
No Comments
Hopes that a second clinical win for Otonomy Inc.'s phase III Meniere's disease candidate, Otividex, might set the stage for a third-quarter registration of the drug in the U.S. have been dashed, sending company shares (NASDAQ:OTIC) down 44.3% to $3 on Feb. 22. For the intent-to-treat (ITT) population, the trial missed its primary endpoint, the count of definitive vertigo days in month three for the sustained-exposure dexamethasone therapy vs. placebo. The trial also failed to achieve statistical significance for a per-protocol analysis. It was déjà vu for the company, which suffered a harsh reaction to an earlier setback for the program from which its stock has yet to recover, years later.
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Liver illustration

IBAT they can: Albireo, leading with biliary atresia phase III, draws Street favor with blockbuster strategy

Feb. 22, 2021
By Randy Osborne
No Comments
Although progressive familial intrahepatic cholestasis (PFIC) tends to draw more hoopla in the race, and Mirum Pharmaceuticals Inc. looks due to beat Albireo Pharma Inc. to market in Alagille syndrome (ALGS), the most revenue likely lies in a third rare pediatric liver disease where the firms compete: biliary atresia (BA). Mirum, of Foster City, Calif., completed its rolling NDA several weeks ago for maralixibat – an inhibitor of the apical sodium-dependent bile acid transporter designed to drive more excretion of bile acids as a way of lowering their level systemically – in cholestatic pruritus in patients with ALGS one year of age and older.
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Real world data show vaccines are cutting risk of severe COVID-19, hospitalizations

Feb. 22, 2021
By Nuala Moran
No Comments
LONDON – The first population-level real world data on COVID-19 vaccines indicate they are having a dramatic impact on severe disease, with a study in Scotland showing a fall of 85% in hospital admissions for people who received the Pfizer Inc./Biontech SE product, and a drop of 94% for those who had Astrazeneca plc’s vaccine, four weeks after receiving the first dose.
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