Top Pharma News of the Week – October 1st

All The Most Important Pharmaceutical News Stories Of The Week – October 2018 – Week # 1

BLINCYTO® (blinatumomab) Approved In Japan For The Treatment Of Relapsed Or Refractory B-cell Acute Lymphoblastic Leukemia

September 24, 2018

Amgen has announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for BLINCYTO® (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). BLINCYTO was developed in Japan by Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.

Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data

September 25, 2018

AstraZeneca has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update for Bydureon (exenatide extended-release), to include in the European label cardiovascular (CV) data from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial in adults with type-2 diabetes at a wide range of CV risk.

GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study

September 25, 2018

GSK and Aeras reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection in an ongoing phase IIb clinical trial testing. These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.

U.S. FDA Approves Vizimpro® (Dacomitinib) For the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

September 27, 2018

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Lilly’s Emgality™ (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults

September 27, 2018

Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults. Emgality offers a once-monthly, self-administered, subcutaneous injection. Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

FDA approves Libtayo® (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma

September 28, 2018

The U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved and available for advanced CSCC in the U.S.

Sanofi completes divestiture of Zentiva to Advent Paris

October 1, 2018

Sanofi has completed the previously announced divestment of its European generics business Zentiva to Advent International (Advent) effective September 30. The transaction was finalized ahead of schedule for €1,9 billion (enterprise value).

Top Pharma News of the Week – October 1st last edit: 2018-10-01T14:45:09+00:00 da Luca

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