Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Knight Therapeutics invests up to $125m in Latin America-focused Moksha8

    Knight Therapeutics invests up to $125m in Latin America-focused Moksha8

    Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials

    Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials

    AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

    AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma

    EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma

    EC Approves Bristol-Myers Squibb’s Sprycel in Combination with Chemotherapy for Treatment of Pediatric Patients

    EC Approves Bristol-Myers Squibb’s Sprycel in Combination with Chemotherapy for Treatment of Pediatric Patients

    Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China

    Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China

    US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

    US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

    Solentim and ATUM announce technology collaboration to enable rapid, high expression, stable cell line development

    Solentim and ATUM announce technology collaboration to enable rapid, high expression, stable cell line development

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Knight Therapeutics invests up to $125m in Latin America-focused Moksha8

    Knight Therapeutics invests up to $125m in Latin America-focused Moksha8

    Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials

    Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials

    AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

    AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma

    EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma

    EC Approves Bristol-Myers Squibb’s Sprycel in Combination with Chemotherapy for Treatment of Pediatric Patients

    EC Approves Bristol-Myers Squibb’s Sprycel in Combination with Chemotherapy for Treatment of Pediatric Patients

    Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China

    Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China

    US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

    US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

    Solentim and ATUM announce technology collaboration to enable rapid, high expression, stable cell line development

    Solentim and ATUM announce technology collaboration to enable rapid, high expression, stable cell line development

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development

EMA Advises Recall of AbbVie, Biogen MS Drug

Content Team by Content Team
13th March 2018
in Drug Development, Europe, News
EMA Advises Recall of AbbVie, Biogen MS Drug

The European Medicines Agency (EMA) announced the recommended immediate suspension and recall of AbbVie and Biogen’s multiple sclerosis (MS) drug Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of the cases were fatal, the agency reports.

On March 2, 2018, AbbVie and Biogen announced the voluntary recall of the drug worldwide on the same day that EMA announced the need for an “urgent review” of daclizumab beta following seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain. Additionally, the companies have stated their intention to stop clinical studies involving the drug.

According to EMA, “a preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of [daclizumab beta].” The drug may also be linked to severe immune reactions affecting several other organs, resulting in a recommendation of the immediate suspension of the drug‘s marketing authorization in the European Union and a recall of batches from pharmacies and hospitals, the agency added.

EMA also reports that the recommendation to suspend and recall daclizumab beta is being sent to the European Commission for a legally binding decision.

In July 2017, after a review of the drug, EMA’s Pharmacovigilance Risk Assessment Committee found that use of daclizumab beta could result in liver damage for up to six months after stopping treatment and recommended that the treatment be restricted to patients who have tried at least two other treatment options and cannot be treated with any other MS medications.

Available evidence gathered by EMA also suggests that the drug could be linked to other immune-mediated disorders, such as blood dyscrasias, thyroiditis, or glomerulonephritis, as stated by the agency.

Previous Post

Novartis’ take on what to expect as tech transforms healthcare

Next Post

Sanofi and Regeneron announce plans to make Praluent® more accessible and affordable for patients with the greatest health risk and unmet need

Related Posts

Knight Therapeutics invests up to $125m in Latin America-focused Moksha8
Drug Development

Knight Therapeutics invests up to $125m in Latin America-focused Moksha8

21st February 2019
Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials
Clinical Trials

Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials

13th February 2019
WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership
Manufacturing

WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership

13th February 2019
AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma
Drug Development

AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

13th February 2019
U.S. FDA Approves DARZALEX Split-Dosing Regimen
FDA Approvals

U.S. FDA Approves DARZALEX Split-Dosing Regimen

13th February 2019
EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma
FDA Approvals

EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma

12th February 2019
Next Post

Sanofi and Regeneron announce plans to make Praluent® more accessible and affordable for patients with the greatest health risk and unmet need

Latest News

Knight Therapeutics invests up to $125m in Latin America-focused Moksha8
Drug Development

Knight Therapeutics invests up to $125m in Latin America-focused Moksha8

21st February 2019
Medicine’s just the beginning: eyeforpharma Barcelona 2019 is at record attendance this is going to be the greatest one yet
Manufacturing

Medicine’s just the beginning: eyeforpharma Barcelona 2019 is at record attendance this is going to be the greatest one yet

20th February 2019
Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials
Clinical Trials

Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials

13th February 2019
WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership
Manufacturing

WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership

13th February 2019
AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma
Drug Development

AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

13th February 2019
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Market Moves OLD
  • Manufacturing
  • News
  • Events & Conferences

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Download Media Pack

Close

x
No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In