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CHMP grants positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination With Kalydeco (ivacaftor) in people ages 12 and older With Cystic Fibrosis with the most common genotypes.- Vertex

Written by | 27 Jun 2020

Vertex Pharmaceuticals Incorporated announced that the ?European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Kaftrio -(ivacaftor/tezacaftor/elexacaftor) in a combination… read more.

Adial Pharmaceuticals commences ONWARD trial of AD 04 as a therapeutic agent for the treatment of alcohol use disorder.

Written by | 26 Jun 2020

Adial Pharmaceuticals, Inc. announced that it has opened clinical trial sites and is recruiting trial subjects in Latvia after receiving all necessary approvals to commence the landmark ONWARD… read more.

Adial Pharmaceuticals commences ONWARD trial of AD 04 as a therapeutic agent for the treatment of alcohol use disorder.

Written by | 26 Jun 2020

Adial Pharmaceuticals, Inc. announced that it has opened clinical trial sites and is recruiting trial subjects in Latvia after receiving all necessary approvals to commence the landmark ONWARD… read more.

Positive results from second phase III study evaluating once-daily relugolix combination therapy in women with endometriosis.- Myovant Sciences.

Written by | 26 Jun 2020

Myovant Sciences announced top-line results from SPIRIT 1, the second of two Phase III studies of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and… read more.

FDA approves Fintepla to treat Dravet syndrome.- Zogenix

Written by | 26 Jun 2020

Zogenix, Inc. announced that the FDA has approved Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age… read more.

Fulcrum THerapeutics initiates phase III trial of losmapimod to treat COVID-19.

Written by | 25 Jun 2020

Fulcrum Therapeutics, Inc. announced that it received early notification from the FDA that the company may proceed with initiating a Phase III, randomized, double-blind, placebo-controlled trial of losmapimod… read more.

FDA approves Keytruda to treat cutaneous squamous cell carcinoma that is not curable by surgery or radiation.- Merck Inc.

Written by | 25 Jun 2020

Merck announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that… read more.

Breztri Aerosphere significantly reduced rate of moderate or severe COPD exacerbations in phase III ETHOS trial.- AstraZeneca

Written by | 25 Jun 2020

Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or… read more.

FDA grants emergency use authorisation for GenePro SARS-CoV-2 Test as diagnostic for COVID-19.- Gencurix

Written by | 25 Jun 2020

Gencurix has received FDA Emergency Use Authorization for its GenePro SARS-CoV-2 Test. It is the second RT-PCR test that Gencurix has launched following the first test assay, GenePro… read more.

First patient enrolled in Sanofi’s phase III trial of SAR 442168 in relapsing multiple sclerosis.- Sanofi

Written by | 23 Jun 2020

Principia Biopharma Inc. announced that the first patient has been enrolled in its partner Sanofi’s Phase III clinical trial of SAR 442168 in patients with relapsing multiple sclerosis… read more.

Phase III studies of V 114 meet objectives in pneumococcal disease.- Merck Inc

Written by | 23 Jun 2020

Merck Inc announced results from two initial Phase III studies evaluating the safety, tolerability and immunogenicity of V 114, the company’s investigational 15-valent pneumococcal conjugate vaccine for pneumococcal… read more.

FDA accepts NDA for oral relugolix for treatment of advanced prostate cancer.- Myovant Sciences

Written by | 23 Jun 2020

Myovant Sciences announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for… read more.

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