Janssen’s Multiple Myeloma Drug Among 11 Products To Get EMA Thumbs Up

Labeling Extension In Store For Bavarian Nordic’s Smallpox Vaccine To Include Monkeypox

The European Medicines Agency has cleared the decks for the pan-EU approval of nearly a dozen new drugs. Tecvayli is headed for a conditional approval, while Nulibry is slated to get marketing authorization under exceptional circumstances. 

Multiple myeloma cells emitting M (Monoclonal) protein in the blood flow - isometric view 3d illustration
Janssen’s Tecvayli Is A Novel Bispecific Antibody To Treat Multiple Myeloma • Source: Alamy

Tecvayli (teclistamab) is on track to winning pan EU-marketing approval, following the European Medicines Agency’s recommendation that the drug, from Janssen Pharmaceutical, be granted a conditional marketing authorization for treating adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies.

More from Approvals

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.

New EU Filings

 

Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Japan Recommends Beyonttra, Raises Enhertu Price

 
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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.

Generic Approvals Maintained Pace In December And January, But Is A Slow-Down Coming?

 

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.

More from Product Reviews

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 

The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.