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Biotechnology
US protein-based vaccine developer Novavax saw its shares fall more than 4% to $7.06, despite announcing it has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid (NVX-CoV2373). 6 July 2023
Biotechnology
Shares of US biotech Moderna, which is pioneering messenger RNA (mRNA) therapeutics and vaccines, edged up 1.5% to $123.54 yesterday, as it updated on regulatory submissions for mRNA-1345. 6 July 2023
Pharmaceutical
The European Medicines Agency (EMA) is among the regulators to have endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA). 5 July 2023
Biotechnology
The European Commission has granted approval for the label extension of Orkambi (lumacaftor/ivacaftor), from US biopharma firm Vertex Pharmaceuticals, for the treatment of children with cystic fibrosis (CF) ages 1 to 5 July 2023
Biotechnology
US biotech Moderna’s original Spikevax COVID-19 vaccine made the company a household name across the western world during the pandemic. 3 July 2023
Biosimilars
Medicines for Europe, the trade body for generics and biosimilars companies in the region, has called for “a fair, cost-based approach” to regulatory fees. 30 June 2023
Biotechnology
Cancer giant Bristol Myers Squibb has secured a new European approval for its checkpoint blocker Opdivo (nivolumab), in non-small cell lung cancer (NSCLC). 30 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B, said US pharma giant Pfizer. 27 June 2023
Biotechnology
A new Pompe disease therapy has been approved by the European Medicines Agency, with Amicus Therapeutics picking up authorization for the enzyme stabilizer Opfolda (miglustat). 27 June 2023
Pharmaceutical
The newly-elected presidency team of Europe’s leading trade body has met to discuss the industry’s growing concern over the impact of proposed changes to pharmaceutical legislation in the region. 26 June 2023
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its June 2023 meeting. 23 June 2023
Biotechnology
The European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib. 16 June 2023
Biosimilars
Medicines for Europe has said that it sees the revision of European Union (EU) pharmaceutical legislation as an opportunity to accelerate patient access to safe, effective, and affordable medicines and to improve security of supply. 15 June 2023
Pharmaceutical
The European Commission has authorized Arexvy (respiratory syncytial virus vaccine, adjuvanted), developed by UK pharma major GSK, for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 June 2023
Biotechnology
The European Commission (EC) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. 7 June 2023
Pharmaceutical
A joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming fall 2023 vaccination campaigns has been issued today by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). 6 June 2023
Pharmaceutical
Shares of US biotech Amylyx Pharmaceuticals fell more than 3% by close of trading Tuesday and a further 2.2% to $23.51 in pre-market activity today, after it said that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment 31 May 2023
Pharmaceutical
Given the emerging evidence on coronavirus SARS-CoV-2 variants and lessons learned from previous vaccine updates, international regulators have published a report highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition. 31 May 2023
Biosimilars
South Korean drugmaker Samsung Bioepis today announced that the European Commission (EC) has granted marketing authorization for Epysqli, a biosimilar to medicine to AstraZeneca’s Soliris (eculizumab), for the treatment of adult and child patients with paroxysmal nocturnal hemoglobinuria (PNH). 30 May 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting. 26 May 2023
Pharmaceutical
French drug developer Averoa today announced that the European Commission (EC) has granted marketing authorization for Xoanacyl (ferric citrate coordination complex). 16 June 2025
Pharmaceutical
Privately-held Italian pharma company Italfarmaco today revealed that the European Commission (EC) has granted conditional marketing authorization for Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor. 9 June 2025
Pharmaceutical
AstraZeneca has received European approval for a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for adults newly diagnosed with chronic lymphocytic leukemia (CLL). 6 June 2025
Pharmaceutical
The European Commission has granted market authorization for Japanese ophthalmic drugmaker Santen Pharmaceutical’s Ryjunea, a low-dose atropine eye drop (0.1mg/ml), that slows the progression of pediatric myopia, marking a significant advance in pediatric eye care. 5 June 2025
Pharmaceutical
The European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA), Swiss pharma giant Roche revealed today 4 June 2025
Biotechnology
The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025
Pharmaceutical
Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign. 19 May 2025
Pharmaceutical
Vaccines Europe’s response to the Call for Evidence on the European Centre for Disease Prevention and Control evaluation Vaccines Europe (VE) welcomes the evaluation of the European Centre for Disease Prevention and Control (ECDC). 19 May 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 8 May 2025
Pharmaceutical
Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. 8 May 2025
Biotechnology
Sino-American biotech BeiGene today announced that the European Commission has approved Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). 8 May 2025
Pharmaceutical
UK pharma major AstraZeneca today revealed that its Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. 6 May 2025
Pharmaceutical
The European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for Filspari (sparsentan). 29 April 2025
Biotechnology
Regeneron Pharmaceuticals today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. 28 April 2025
Pharmaceutical
The European Medicines Agency’s (EMA)) human medicines committee (CHMP) has recommended seven novel medicines for approval at its April 2025 meeting. A final decision from the European Commission is usually issued in about two months. 26 April 2025
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