All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Several Medicines Recommended by EMA’s CHMP in October

October 18, 2024
By Susan Haigney
News
Article

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

The European Medicines Agency announced on Oct. 18, 2024 that its Committee for Medicinal Products for Human Use (CHMP) has recommended 10 new medicines for marketing approval, including five new drugs, one orphan drug, two biosimilars, and two generic drugs (1). This brings the total of new medicines receiving positive opinions to 89 in 2024. Extensions for indications were also granted to six drugs.

Two vaccines, Fluad and Flucelax, were approved for immunization against influenza. Fluad is a surface antigen, inactivated, adjuvanted vaccine for use in adults 50 years of age and older. Flucelvax, which is a surface antigen, inactivated and prepared in cell cultures, may be used in adults and children, two years of age and older.

Other approved medicines include:

  • Alhemo (concizumab) for routine prophylaxis of bleeding in patients with haemophilia A or B with inhibitors
  • Korjuny (catumaxomab) to treat intraperitoneal malignant ascites, “a build-up of fluid containing cancer cells in the abdomen of cancer patients,” according to EMA.
  • Siiltibcy (rdESAT-6/rCFP-10) to diagnosis Mycobacterium tuberculosis infection
  • Wainzua (eplontersen), designated an orphan drug, to treat adults with hereditary transthyretin-mediated amyloidosis
  • Buprenorphine Neuraxpharm (buprenorphine) to treat opioid addiction.

In addition, two biosimilars, Absimky (ustekinumab) and Imuldosa (ustekinumab), were granted positive opinions for the treatment of plaque psoriasis in children and adults, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The generic drug, Eltrombopag Viatris (eltrombopag), was also recommended for the treatment of children and adults with primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.

CHMP also recommended extending indications for Cerdelga (eliglustat), Hepcludex (bulevirtide), Kevzara (sarilumab), Kisqali (ribociclib), Tevimbra (tislelizumab), and Yselty (linzagolix choline). Updates to the COVID-19 vaccines Nuvaxovid and Bimervax were also given positive opinions.

At the meeting, CHMP also stated that it is confirming its recommendation, originally issued in June 2024, to refuse authorization for Masitinib AB Science (masitinib) for the treatment of amyotrophic lateral sclerosis after re-examination of the application.

“At the time of the initial evaluation, the agency considered that the study data were not reliable, as findings from good clinical practice inspections coordinated by EMA and other regulatory authorities had identified issues with the conduct of the study that could not be sufficiently addressed by the company. In addition, the benefits of Masitinib AB Science could not be convincingly demonstrated; the study found no difference between the medicine and placebo in the main measure of effectiveness for the total study population and had several methodological issues. These concerns did not change after re-examination of the data provided and following consultation of a group of experts in neurology, as well as patient representatives. In reaching its final decision, the agency also considered information shared by patient organizations (so-called third-party interventions). Therefore, the Agency maintained its opinion that the benefits of Masitinib AB Science did not outweigh its risks and recommended refusing marketing authorization,” the agency stated on its website (2).

 Two drug applications were withdrawn from consideration. Apremilast Viatris (apremilast), to treat plaque psoriasis, active psoriatic arthritis, and mouth ulcers caused by Behçet’s disease, was withdrawn because the agency found that the data provided did not match bioequivalence conclusions. The epilepsy drug, Epixram (levetiracetam), was withdrawn because of a change in the company’s regulatory strategy.

References

  1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 14–17 October 2024. Press Release. Oct. 18, 2024.
  2. EMA. Masitinib AB Science. ema.europa.eu. (accessed Oct. 18, 2024).
Recent Videos
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Related Content

NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Close up the media plate on hand medical technicians working on bacterial culture and drug resistance of pathogens in laboratory. | Image Credit: © analysis121980 - stock.adobe.com

Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics

Patrick Lavery
June 26th 2025
Article

Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.


3D Rendering of CAR - Chimeric Antigen Receptor Between T-Cell and Cancer Cell | Image Credit: © Alpha Tauri 3D - stock.adobe.com

Priothera Awarded €1.7M in Innovation Contest for Hematologic Malignancy Treatments

Patrick Lavery
June 26th 2025
Article

The company’s mocravimod, a novel oral S1P receptor, is being evaluated for its efficacy as an addition to CAR-T cell therapies.

Related Content

NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Close up the media plate on hand medical technicians working on bacterial culture and drug resistance of pathogens in laboratory. | Image Credit: © analysis121980 - stock.adobe.com

Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics

Patrick Lavery
June 26th 2025
Article

Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.


3D Rendering of CAR - Chimeric Antigen Receptor Between T-Cell and Cancer Cell | Image Credit: © Alpha Tauri 3D - stock.adobe.com

Priothera Awarded €1.7M in Innovation Contest for Hematologic Malignancy Treatments

Patrick Lavery
June 26th 2025
Article

The company’s mocravimod, a novel oral S1P receptor, is being evaluated for its efficacy as an addition to CAR-T cell therapies.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.