Broad label inclusive of all ages and disease severities Launch to be initiated in Germany WARREN, N.J. — PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Sephience™ (sepiapterin) was granted marketing authorization by the European Commission for the treatment of children and adults living with phenylketonuria (PKU). The authorization includes a broad label...
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SOUTH SAN FRANCISCO, Calif. — Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2...
Mintpellier, France — SeqOne Genomics, provider of next generation genomic analysis solutions for personalized medicine, announces the appointment of Hervé Pouzoullic as Chief Commercial Officer (CCO). He will lead the commercial development of the company to accelerate its growth and strengthen its international presence.Hervé has more than 25 years of...
CAMBRIDGE, Mass. – Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announces the U.S. Food and Drug Administration (FDA) has indicated studies for SER-155 may proceed under an Investigational New Drug (IND) application. SER-155 is an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal...
HUNTSVILLE, Alabama — Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced the advancement of its novel product candidate, SER-270, a proprietary POZ-conjugated vesicular monoamine transporter 2 (VMAT2) inhibitor in development for the treatment of tardive dyskinesia (TD). SER-270,...
WALTHAM, Mass. — Decision Resources, one of the world’s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that AstraZeneca Seroquel’s first-line patient share grew two percent since last year’s patient-level claims data analysis of prescribing trends in bipolar disorder. During this same time period other atypicals...
MUNCIE — Christopher Burrows got the best possible treat last Halloween. That’s the day he and his mother, Claudia Burrows, brought home Stitch, the service dog they’d been working toward for the past year. Claudia has ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig’s disease, while Christopher has autism...
BOSTON, MASS. — Servier today announced longer-term data from the Phase 3 INDIGO trial evaluating VORANIGO® (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (mIDH1/2) glioma following surgical intervention and for whom chemoradiotherapy can be delayed were published in The Lancet Oncology. The analysis reports an additional six months of...
BOSTON, Mass. — Servier today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VORANIGO® (vorasidenib) in the European Union (EU) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1)...
VALENCIA, Calif. — SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS). Breakthrough...