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FDA grants emergency use authorization to the Zero Contact COVID-19 test kit as a saliva-based diagnostic for at home use to detect COVID-19.- Vitagene

Written by | 11 May 2020

Vitagene has announced the availability of 50,000 FDA authorized at home Zero-Contact or Saliva-based COVID-19 test kits for use during the current public emergency to detect COVID-19. Vitagene… read more.

FDA grants emergency use authorisation for Sofia 2 SARS Antigen Test for COVID-19 detection.- Quidel Corp

Written by | 11 May 2020

Quidel Corporation announced that it has received Emergency Use Authorization (EUA) from the FDA to market its Sofia 2 SARS Antigen rapid point-of-care test to be used with… read more.

Higher investigational doses of Trulicity meaningfully reduced A1C and body weight in people with type 2 diabetes.- Eli Lilly

Written by | 10 May 2020

New 36-week data showed higher investigational doses of Trulicity (3 mg and 4.5 mg) were well-tolerated and led to A1C reductions up to 1.9 percent and weight reductions… read more.

Phase III clinical data of Fexuprazan shows efficacy in gastroesophageal reflux disease.- Daewoong Pharma

Written by | 9 May 2020

Daewoong Pharmaceutical unveiled for the first time the phase III clinical data of Fexuprazan, a novel gastroesophageal reflux disease agent at Digestive Disease Week (DDW) 2020. The phase… read more.

FDA approves Keytruda for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications.-Merck Inc.

Written by | 9 May 2020

Merck announced that the FDA has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for Keytruda, Merck’s anti-PD-1 therapy, across all adult indications, including… read more.

Results of phase III trial of the efficacy and safety of Recarbrio v. piperacillin and tazobactam in adult patients with HABP/VABP .- Merck Inc.,

Written by | 9 May 2020

Merck Inc., announced results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase III clinical trial evaluating Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired… read more.

Rebiotix + Ferring announce first with positive preliminary pivotal phase III data for investigational microbiome-based therapy RBX2660.

Written by | 8 May 2020

Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase III trial of the investigational microbiome-based treatment, RBX 2660. These preliminary positive efficacy findings mark… read more.

Positive topline results from the UNITY-CLL phase III study of the combination of umbralisib and ublituximab (U2) for the treatment of chronic lymphocytic leukemia.- TG Therapeutics

Written by | 8 May 2020

TG Therapeutics, Inc.has announced positive topline results from the global UNITY-CLL Phase III trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in… read more.

TAVO + Keytruda demonstrated 41% overall response rate and 36% complete response in a late-stage metastatic melanoma study featured in ‘Clinical Cancer Research’.- Oncosec Medical.

Written by | 8 May 2020

Oncosec Medical announced published data in Clinical Cancer Research that demonstrated its lead product candidate, TAVO (interleukin-12 or “IL-12” plasmid), in combination with the anti-PD-1 checkpoint inhibitor Keytruda… read more.

Health Canada approves Real-Time Fluorescent RT-PCR Kit for detecting SARS-CoV-2.- BGI Genomics

Written by | 8 May 2020

BGI Genomics announced that its subsidiary BGI Americas Corporation has received authorization under Interim Order from Health Canada to supply its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2… read more.

First participants dosed in phase I/II trial of BNT 162 vaccine to prevent COVID-19. Pfizer + BioNTech SE

Written by | 7 May 2020

Pfizer Inc. and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/II clinical trial for the BNT 162 vaccine program… read more.

FDA extends PDUFA date for liso-cel to treat large B-cell lymphoma. – BMS

Written by | 7 May 2020

Bristol Myers Squibb announced that the FDA has extended the action date by three months for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric… read more.

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