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Novartis initiates clinical study of Jakavi in severe COVID-19 patients and establishes international compassionate use program. – Novartis + Incyte Corpn.

Written by | 3 Apr 2020

Novartis announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi (ruxolitinib) for treatment of a type of severe… read more.

DEVOTE study initiated of Spinraza for potential greater efficacy when administered at a higher dose than currently approved for Spinal Muscular Atrophy.- Biogen

Written by | 3 Apr 2020

Biogen announced that the first patient has been treated in the global clinical study, DEVOTE . The study is designed to evaluate the safety, tolerability and potential for… read more.

Chembio Diagnostics launches rapid DPP COVID-19 serological point-of-care test to determine exposure to the COVID-19 virus.

Written by | 3 Apr 2020

Chembio Diagnostics, Inc. a leading point-of-care diagnostic company focused on infectious diseases, announced the US launch of the rapid DPP COVID-19 serological point-of-care test for the detection of… read more.

interima analysis of phase III Atalante 1 trial of Tedopi meets endpoint in NSCLC but trial on temporary hold.- OSE Immunotherapeutics

Written by | 2 Apr 2020

OSE Immunotherapeutics announced that the primary endpoint was met in the predefined Step-1 analysis of its Phase III Atalante 1 clinical trial of Tedopi (T-lymphocyte stimulators) in HLA-A2… read more.

Mallinckrodt and Novoteris receive clearance from Health Canada to start a pilot trial of high-dose inhaled nitric oxide therapy for COVID-19 infection and associated complications.- Mallinckrodt + Novoteris LLC

Written by | 2 Apr 2020

Mallinckrodt Plc and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced that the Therapeutic Products Directorate Of Health… read more.

BMS + bluebird bio file BLA at FDA for idecabtagene vicleucel to treat multiple myeloma patients who have received at least three prior therapies.

Written by | 2 Apr 2020

Bristol Myers Squibb and bluebird bio, Inc. announced the submission of their Biologics License Application (BLA) to the FDA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational… read more.

CHMP recommends Nepexto a etanercept biosimilar.- Mylan

Written by | 2 Apr 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nepexto, intended for the… read more.

CHMP recommends approval of Fluad Tetra adjuvanted quadrivalent influenza vaccine.- Seqirus

Written by | 2 Apr 2020

Seqirus, a global leader in influenza prevention, announced that its adjuvanted quadrivalent influenza vaccine (aQIV) – launching as Fluad Tetra – has received a positive opinion from the… read more.

Phase II and III clinical trials of Tepezza shows reduction in proptosis in thyroid eye disease.- Horizon Therapeutics

Written by | 2 Apr 2020

Horizon Therapeutics announced new pooled efficacy data from the Phase II and III clinical trials of Tepezza (teprotumumab-trbw) showing that the recently approved medicine effectively reduces proptosis (eye… read more.

CHMP recommends approval for Pretomanid FGK, intended for the treatment of tuberculosis, in combination with bedaquiline and linezolid.- TB Alliance

Written by | 2 Apr 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Pretomanid FGK, intended… read more.

Retrospective study of Velphoro in Hyperphosphataemia published in Kidney Medicine journal.- Fresenius Medical

Written by | 2 Apr 2020

A new retrospective data analysis published in Kidney Medicine shows that a higher percentage of hemodialysis patients prescribed Velphoro (sucroferric oxyhydroxide chewable tablets), from Fresenius Medical, achieved target… read more.

Phase III ELIPSE HoFH trial results of REGN 1500 met primary endpoint in homozygous familial hypercholesterolemia.- Regeneron Pharma

Written by | 1 Apr 2020

Regeneron Pharmaceuticals announced that detailed Phase III ELIPSE HoFH trial results of REGN 1500 (evinacumab) in patients with homozygous familial hypercholesterolemia (HoFH). The data showed the trial met… read more.

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