ClinOne’s remote clinical trial patient management technology allows pharmaceutical companies to continue clinical research efforts amidst Covid-19 pandemic in accordance with FDA guidelines

This need is especially acute in clinical trials as identified by the FDA. Trial sponsors, physicians and regulators are now embracing the use of technology to support patients The post ClinOne’s remote clinical trial patient management technology allows pharmaceutical companies to continue clinical research efforts amidst Covid-19 pandemic in accordance with FDA guidelines appeared first […]

EMA grants orphan drug designation to AlloVir’s Viralym-M

Viralym-M is the company’s lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, being developed for the treatment and prevention of serious viral diseases caused by six commonly occurring, devastating The post EMA grants orphan drug designation to AlloVir’s Viralym-M appeared first on Pharmaceutical Business review.

FDA approves Bristol Myers Squibb’s ZEPOSIA oral treatment for relapsing forms of multiple sclerosis

ZEPOSIA, an oral medication taken once daily, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and no label-based The post FDA approves Bristol Myers Squibb’s ZEPOSIA oral treatment for relapsing forms of multiple sclerosis appeared first on Pharmaceutical Business review.

Novartis, life sciences firms collaborate with BMGF to fight against COVID-19 disease

Novartis, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, Pfizer, Sanofi, BD and bioMérieux are part of the consortium. The firms are working The post Novartis, life sciences firms collaborate with BMGF to fight against COVID-19 disease appeared first on Pharmaceutical Business review.

Infinity gets FDA fast track status for IPI-549, Opdivo combo in urothelial cancer

IPI-549 is an oral immuno-oncology candidate which has been designed to preferentially inhibit PI3K-gamma. The FDA fast track designation will enable the development and accelerate the review of The post Infinity gets FDA fast track status for IPI-549, Opdivo combo in urothelial cancer appeared first on Pharmaceutical Business review.

Alnylam Pharmaceuticals and Gen sign distribution agreement in Turkey for ONPATTRO (patisiran)

“Our partnership with Gen enables us to extend access to ONPATTRO to patients suffering from hereditary ATTR (hATTR) amyloidosis with polyneuropathy in Turkey where we currently don’t have The post Alnylam Pharmaceuticals and Gen sign distribution agreement in Turkey for ONPATTRO (patisiran) appeared first on Pharmaceutical Business review.

Xencor, Vir Biotechnology collaborate on Xtend XmAb antibody technology for COVID-19

Under the deal, Vir can non-exclusively access Xencor’s Xtend Fc technology to expand the half-life of novel antibodies, which are being assessed as potential treatments for patients with The post Xencor, Vir Biotechnology collaborate on Xtend XmAb antibody technology for COVID-19 appeared first on Pharmaceutical Business review.

AveXis’ Zolgensma gene therapy yields desired results in SMA trials

Zolgensma also delivered the desired results in patients who were given presymptomatic treatment and also in certain participants aged over five years. The gene therapy could sustain durability The post AveXis’ Zolgensma gene therapy yields desired results in SMA trials appeared first on Pharmaceutical Business review.

Hoth Therapeutics announces agreement to joint development for a self-assembling vaccine (SAV) for the potential prevention of coronavirus

VaxCelerate is a self-assembling vaccine (SAV) platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH). Hoth and Voltron, with the The post Hoth Therapeutics announces agreement to joint development for a self-assembling vaccine (SAV) for the potential prevention of coronavirus appeared first on Pharmaceutical Business review.

AbbVie announces positive topline results from phase 3 trial of VENCLEXTA, Azacitidine combo in AML

At the recommendation of an independent data monitoring committee (IDMC), and per the prespecified interim analysis plan, due to positive efficacy results at the first interim analysis for The post AbbVie announces positive topline results from phase 3 trial of VENCLEXTA, Azacitidine combo in AML appeared first on Pharmaceutical Business review.