Amgen Logo

July 18, 2017

Amgen and Array BioPharma have announced a collaboration agreement for the discovery and development of novel drugs for autoimmune disorders. The undisclosed target and lead inhibitors were discovered through Array’s proprietary platform that leverages Array’s expertise in chemistry and early lead development.

astrazeneca

20 July 2017

AstraZeneca and MedImmune, its global biologics research and development arm, have announced that its partner LEO Pharma has been granted full marketing authorisation in all 28 EU member countries plus Iceland, Liechtenstein and Norway for Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. Kyntheum is the first and only biologic that selectively targets the IL-17 receptor subunit A.

Amgen Logo

July 20, 2017

Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Aimovig™ (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine.

Merck Igea Luca Dezzani

July 20, 2017

Merck has announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis.

Roche logo

July 21, 2017

Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Actemra®/RoActemra® (tocilizumab) for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition. Based on this positive CHMP recommendation, a final decision regarding the approval of Actemra / RoActemra for the treatment of GCA is expected from the European Commission in the near future. If approved, Actemra / RoActemra would be the first therapy for the treatment of GCA in Europe.

Pfizer Merck Igea Luca dezzani

July 21, 2017

Merck KGaA, Darmstadt, Germany and Pfizer Inc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab (BAVENCIO®) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. The European Commission (EC) will now review the CHMP’s recommendation, with a decision expected in the third quarter of 2017.

Novartis logo - luca dezzani

July 21, 2017

Novartis has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rydapt® (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. If approved by the European Commission (EC), Rydapt will be indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response, followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3 mutation-positive. Rydapt was also recommended for approval as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.

Roche logo

July 21, 2017

Roche has announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro® (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment option for previously untreated advanced follicular lymphoma. The CHMP’s recommendation is based on results from the phase III GALLIUM study. Follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin lymphoma, is considered incurable, and most people relapse repeatedly. Based on this positive CHMP recommendation, a final decision regarding the approval of Gazyvaro is expected from the European Commission in the near future.

Merck Igea Luca Dezzani

July 21, 2017

Merck has announced that the CHMP of the EMA has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Specifically, KEYTRUDA is recommended for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy, as well as adult patients who are not eligible for cisplatin-containing chemotherapy.

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