“Green light” to Lilly’s monoclonal antibody to migraine

2018-11-28T17:21:25+00:0028/11/2018|Categories: Industry, News|Tags: , , , , , , , |

Eli Lilly announces that the European Commission (EC) has approved the commercialization of galcanezumab ( Emgality ) as a prophylactic treatment of migraine in adults suffering from at least four days of migraine per month . Galcanezumab is a humanized monoclonal antibody that binds to the peptide related to the calcite gene (CGRP, for its acronym in English) associated with episodes of migraine, blocks its function Administered with a month subcutaneous injection which can be applied to the patient with a pen or pre-filled syringe. In all three clinical trials, galcanezumab has shown significantly reducing the monthly average of migraine days and an improvement in functionality versus placebo. "Migraine is [...]

Lilly Receives Positive CHMP Opinion for Emgality

2018-10-17T12:24:24+00:0017/10/2018|Categories: Industry, News|Tags: , , , , |

INDIANAPOLIS, Sept. 21, 2018 Lilly Receives Positive CHMP Opinion for EmgalityTM (galcanezumab) for the Prophylaxis of Migraine in Adults Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Emgality TM (galcanezumab) for the prophylaxis of migraine in adults who have at least four migraine days per month. TM In June 2018, Lilly announced the intended brand name, Emgality, was conditionally accepted by the U.S. Food and Drug Administration (FDA). Emgality is a humanized monoclonal antibody specifically designed to bind to the calcitonin gene-related peptide (CGRP), blocking its [...]

Lilly’s Emgality Approved

2018-10-15T18:00:28+00:0015/10/2018|Categories: Industry, News|Tags: , , , , |

INDIANAPOLIS, Sept. 27, 2018 Eli Lilly and Company (NYSE: LLY) 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. Emgality will be available to patients shortly after approval. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program (governmental beneficiaries excluded; subject to terms and conditions*). Emgality will be available for pickup at retail pharmacies. Migraine [...]

New Aimovig Medication Approved

2018-07-31T13:40:17+00:0031/07/2018|Categories: Industry, News|Tags: , , , |

Novartis marks a new era for migraine patients with the EU approval of Aimovig®, a first-of-its- kind treatment specifically designed for migraine prevention Jul 30, 2018 Novartis announced today that the European Commission (EC) approved Aimovig® (erenumab) for the prevention of migraine in adults experiencing four or more migraine days per month. Aimovig is the first and only treatment specifically designed for migraine prevention to be approved in the European Union, Switzerland, the US and Australia. It works by blocking a receptor called the calcitonin gene-related peptide receptor (CGRP-R) which plays a critical role in mediating the incapacitating pain of migraine. [...]

This is how a medicine is manufactured (from the laboratory to the pharmacy)

2018-06-06T12:40:24+00:0006/06/2018|Categories: Industry, News|Tags: , , |

Ten years and a billion euros. This is the time and average cost for a drug to complete the process that goes from its initial discovery to being sold at a pharmacy. Considering this data, it´s not difficult to imagine the manufacture of a drug as an obstacle course in which only a few molecules reach the goal. The researchers of the Center for Biological Research of the CSIC María del Carmen Fernández and Nuria E. Campillo narrate in their book "How a medicine is made. From the laboratory to the pharmacy " how long and expensive this process is. [...]

Novartis’ Migraine prevention therapy is closer to being approved

2018-06-04T13:44:50+00:0004/06/2018|Categories: Industry, News|Tags: , , , |

Friday, June 1, 2018, at 15:45 Novartis has announced that the European Medicines Agency (EMA) Committee on Human Use Medicines (CHMP) has recommended Aimovig (erenumab) approval to prevent migraine in adults suffering at least 4 days of migraine per month. The World Health Organization (WHO) has mentioned migraine as one of the top ten causes of years of disability worldwide. Aimovig is the first treatment of its kind specifically developed to prevent migraine, blocking the peptide related to the calcitonin gene (CGRPR), which plays an essential role in the pathology of migraine. If approved, Aimovig will be administered once a month [...]

First monoclonal antibody therapy for prevention of migraine

2018-06-01T16:43:40+00:0001/06/2018|Categories: Industry, News|Tags: , , , , |

First monoclonal antibody therapy for prevention of Migraine Aimovig recommended for marketing authorization 01/06/2018 The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Aimovig (erenumab), the first human monoclonal antibody therapy for prevention of migraine. Aimovig belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. It is estimated that approximately 15% of the European population suffers from migraine. Patients experience recurrent episodes of intense, throbbing headache, most often only on one side of the head. Sometimes, the [...]

A laboratory that takes care of its employees

2018-05-22T13:46:50+00:0022/05/2018|Categories: Industry, News|Tags: , , |

The following article shows a clear example of best practices at work and how important it is to have employees happy and satisfied at the workspace in order to have them working at their maximum possibilities. The pharmaceutical laboratory AbbVie recognizes that caring for the health and the well-being of its employees has an impact on a better professional performance and in this sense, on its fifth anniversary as an independent company, it has launched a program to improve the health of its employees and the balance between their personal and professional life. In this way, all its employees have a [...]

Galcanezumab-Cluster headache

2018-05-22T10:32:30+00:0022/05/2018|Categories: Industry, News|Tags: , |

Prevention of episodic cluster headache: Primary endpoint achieved in Phase 3 study 16/05/2018 Eli Lilly and Company announced that Galcanezumab met with the primary endpoint in a Phase 3 trial of episodic cluster headache patients, the statistically significant differences in reducing headache attacks In weekly clusters compared to placebo during the weeks one to three two-month double-blind treatment time shows. Weekly Cluster headache attacks A statistically significantly higher percentage of patients treated with galcanezumab also achieved a reduction in weekly cluster headache attacks by at least 50 percent compared to placebo in Week 3, the criterion of Secondary valuation. Security [...]

New Drug Offers Hope to Millions With Severe Migraines

2018-05-18T11:28:13+00:0018/05/2018|Categories: Industry, News|Tags: , |

The first medicine designed to prevent migraines was approved by the Food and Drug Administration on Thursday, ushering in what many experts believe will be a new era in treatment for people who suffer the most severe form of these headaches. The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a device similar to an insulin pen. The list price will be $6,900 a year, and Amgen said the drug will be available to patients within a week. Aimovig blocks a protein fragment, CGRP, that instigates and perpetuates migraines. Three other companies — Lilly, Teva and [...]

We and our partners use cookies, to collect browsing data to give you the best online experience and to personalize the content, play multimedia content, interact with social networks and perform browsing analytics. If you continue browsing we understand you accept the use of such technology. For more information visit our cookies policy Find out more

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close