Top Pharma News of the Week – September 10th

All The Most Important Pharmaceutical News Stories Of The Week – September 2018 – Week # 2

Cablivi™ (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura (aTTP)

September 3, 2018

The European Commission has granted marketing authorization for Cablivi™ (caplacizumab) for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder. Cablivi is the first therapeutic specifically indicated for the treatment of aTTP.

Gilead Enters Licensing Agreement with Trianni for Use of Trianni Transgenic Human Monoclonal Antibody Discovery Platform

September 4, 2018

Gilead Sciences, Inc. and Trianni, Inc. have announced that the companies have entered into a license agreement that grants Gilead the use of the Trianni transgenic human monoclonal antibody discovery platform to support the company’s drug discovery efforts.

Pfizer Receives Breakthrough Therapy Designation From FDA For Pf-06651600, An Oral Jak3 Inhibitor, for the Treatment of Patients With Alopecia Areata

September 5, 2018

Pfizer Inc. has announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.

Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292

September 05, 2018

Loxo Oncology, Inc., a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with metastatic RET-fusion-positive non-small cell lung cancer who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy; and for the treatment of patients with RET-mutant medullary thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.

Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint

September 6, 2018
Gilead Sciences, Inc. and Galapagos NV have announced that the randomized, placebo-controlled Phase 2 TORTUGA study of filgotinib, an investigational, selective JAK1 inhibitor, achieved its primary efficacy endpoint in adults with moderately to severely active ankylosing spondylitis (AS). In the study, patients treated with filgotinib achieved significantly greater improvements in AS Disease Activity Score (ASDAS), the primary endpoint, at Week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001). More patients receiving filgotinib also achieved an ASAS20 response compared to those treated with placebo (76 percent versus 40 percent, p<0.0001).

Novartis to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo

September 6, 2018

Novartis has announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids portfolio, to Aurobindo Pharma USA Inc., for USD 0.9 billion of cash plus USD 0.1 billion of potential earn-outs. This transaction supports the Sandoz strategy of focusing on complex generics, value-added medicines and biosimilars to achieve sustainable and profitable growth in the US over the long-term.

GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients

September 7, 2018

GlaxoSmithKline plc has received a complete response letter (CRL) from the US FDA regarding its application for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts.

Tezepelumab granted Breakthrough Therapy Designation by US FDA

September 7, 2018

AstraZeneca and its partner Amgen have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.

GSK announces results of indirect treatment comparisons of Nucala to benralizumab and reslizumab for severe eosinophilic asthma

September 10, 2018

GlaxoSmithKline plc has announced results from an indirect treatment comparison of the licensed doses of Nucala (mepolizumab), versus benralizumab and reslizumab in patients with severe eosinophilic asthma. The data, published today in The Journal of Allergy and Clinical Immunology (JACI), showed that in patients with similar blood eosinophil counts, mepolizumab significantly reduced clinically significant exacerbations and improved asthma control compared with both benralizumab and reslizumab.

Top Pharma News of the Week – September 10th last edit: 2018-09-11T10:13:50+00:00 da Luca

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