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G1 Therapeutics, Inc announces a license agreement for lerociclib to EQRx,

Written by | 24 Jul 2020

G1 Therapeutics, Inc. a clinical-stage oncology company, announced a license agreement for lerociclib to EQRx, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for… read more.

Clinical trials for seladelpar in NASH, PBC and PSC may resume- CymaBay Therapeutics

Written by | 24 Jul 2020

CymaBay Therapeutics announced that the FDA lifted clinical holds on seladelpar for all three Investigational New Drug (IND) Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and… read more.

Top-line results from the phase III CLARITY study evaluating pimavanserin for the adjunctive treatment of major depressive disorder.-Acadia Pharmaceuticals.

Written by | 23 Jul 2020

Acadia Pharmaceuticals Inc. announced top-line results from its 298 patient Phase III CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of… read more.

Phase III data show port delivery system with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration.- Genentech/Roche

Written by | 23 Jul 2020

Genentech, a member of the Roche Group announced detailed results from the Phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment… read more.

FDA approves Xywav to treat cataplexy or excessive daytime sleepiness in patients with narcolepsy.- Jazz Pharma

Written by | 23 Jul 2020

Jazz Pharmaceuticals plc announced that the FDA approved Xywav (calcium, magnesium, potassium, and sodium oxybate) oral solution on July 21, 2020 for the treatment of cataplexy or excessive… read more.

FDA accepts filing of sNDA for Nuplazid to treat hallucinations and delusions associated with dementia-related psychosis.Acadia Pharma

Written by | 23 Jul 2020

Acadia Pharmaceuticals Inc.announced that the FDA has accepted for filing its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with… read more.

FDA accepts filing of NDA for voclosporin as a treatment for lupus nephritis.- Aurinia Pharma

Written by | 22 Jul 2020

Aurinia Pharmaceuticals Inc., a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that the FDA has accepted the filing of its New Drug Application… read more.

Phase I/II COV001 trial of AZD 1222 shows vaccine well tolerated in SARS-CoV-2 virus.- AstraZeneca

Written by | 21 Jul 2020

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD 1222 vaccine, from AstraZeneca, was tolerated and generated robust immune responses against the… read more.

Trial of SNG 001 shows positive results in COVID-19 patients.- Synairgen

Written by | 21 Jul 2020

Synairgen announced positive results from its clinical trial of SNG001, its wholly-owned inhaled formulation of interferon beta, in hospitalised COVID-19 patients. The double-blind placebo-controlled trial recruited 101 patients… read more.

Phase III trial of BXCL 501 meets endpoints in patients with agitation and schizophrenia and bipolar disorder.- BioXcel Therapeutics

Written by | 21 Jul 2020

BioXcel Therapeutics announced that BXCL 501 (sublingual dexmedetomidine), met the primary and secondary endpoints of SERENITY I and SERENITY II, demonstrating a robust treatment effect in the trials… read more.

Bellerophon Therapeutics announces publication of cohort 1 of iNO-PF phase II/III study in the CHEST Journal and participation in webinar to discuss clinical results

Written by | 21 Jul 2020

Bellerophon Therapeutics, Inc. announced that results from Cohort 1 of the iNO-PF Phase II/III Study will be published in the August 2020 edition of the peer-reviewed CHEST Journal,… read more.

FDA grants emergency use authorisation for xMAP SARS-CoV-2 Multi-Antigen IgG Assay in Coronavirus.- Luminex Corp

Written by | 21 Jul 2020

Luminex Corporation announced that the FDA has issued an Emergency Use Authorization (EUA) for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay. Clinical laboratories can now use this serology… read more.

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