The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on the need for additional guidance on COVID-19 treatments in light of rising rates of infection and deaths due to COVID-19 across the EU. 9 November 2021
The European Medicines Agency has terminated its rolling review of Eli Lilly’s coronavirus treatments bamlanivimab and etesevimab, at the company’s request. 3 November 2021
Market reaction was positive for Immutep, with the Australian biotech announcing progress for its lead candidate, a novel LAG-3 related immunotherapy treatment for cancer and autoimmune disease, with its shares rising 2.6% to A$0.58. 1 November 2021
Shares of Otsuka Holdings were up 2.8% at 4,620 yen today, as the Japanese drugmaker announced that its Dutch subsidiary has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat. 1 November 2021
The European Medicines Agency’s (EMA) safety committee (PRAC) is assessing further data on the risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines. 29 October 2021
The European Medicines Agency and the Heads of Medicines Agencies (HMA) are launching a pilot project to support the repurposing of medicines as a follow-up to the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) discussions on a proposal for a medicines repurposing framework. 29 October 2021
US mRNA specialist Moderna has announced positive interim data from a Phase II/III study of the company’s vaccine against COVID-19, in children aged six to under 12 years of age. 26 October 2021
The European Medicines Agency’s human medicines committee (CHMP) has started a rolling review of the oral antiviral medicine molnupiravir (also known as MK 4482 or under the trade name Lagevrio), for the treatment of COVID-19 in adults. 25 October 2021
Following its meetings over October 11-14, the European Medicines Agency’s human medicines committee, the CHMP, today recommended five novel medicines and one generic for approval. 15 October 2021
The European Medicines Agency’s human medicines committee (CHMP) has started a rolling review of Evusheld (also known as AZD7442), a combination of two monoclonal antibodies (tixagevimab and cilgavimab), which is being developed by AstraZeneca for the prevention of COVID-19 in adults. 14 October 2021
Availability and accessibility of medicines, the response and preparedness to cross-border health threats, and resilient health systems were all on the agenda as European Union (EU) Health Ministers gathered on Tuesday. 12 October 2021
Carima Andrady, senior regulatory writer at PharmaLex, provides an Expert View on a key consideration when seeking to secure an Orphan Drug designation (ODD) in Europe. 8 October 2021
The European Medicines Agency’s human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccines Comirnaty, from Pfizer and BioNTech, as well as Spikevax, marketed by Moderna, may be given to people with severely weakened immune systems, at least 28 days after their second dose. 5 October 2021
The European Medicines Agency today said it has started evaluating an application for marketing authorization for the monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19. 4 October 2021
At the latest pharmacovigilance risk assessment meeting of the European Medicines Agency, the organization initiated a review of medicines containing nomegestrol and chlormadinone. 1 October 2021
Indian drugmaker Glenmark Pharmaceuticals today announced it has received marketing approval for its fixed-dose combination nasal spray Ryaltris (olopatadine Hcl and mometasone furoate), in 13 countries across the European Union and the UK. 30 September 2021
The European Medicines Agency has begun evaluating an application for the use of a booster dose of Moderna’s coronavirus vaccine, Spikevax. 28 September 2021
The European Medicines Agency ’s human medicines committee (CHMP) recommended five novel medicines and two biosimilars for approval at its September 2021 meeting. 17 September 2021
US drug major AbbVie has submitted applications seeking approval for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis to the US Food and Drug Administration (FDA), and to the European Medicines Agency (EMA). 17 September 2021
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for the FDA’s complex generics and of marketing authorization applications (MAAs) for the EMA’s hybrid products. 16 September 2021
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
Following a positive a positive European Medicines Agency recommendation in July, the European Commission (EC) has now approved Yuvanci (macitentan 10mg and tadalafil 40mg single tablet combination therapy [M/T STCT]). 1 October 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
The European Medicines Agency’s (EMA) safety committee (PRAC) has recommended measures to minimize serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. 7 September 2024
EC approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for urothelial carcinoma in adults. 3 September 2024
Pierre Fabre Laboratories has announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. 30 August 2024
The European Commission has authorized GSK's (LSE: GSK) Arexvy (respiratory syncytial virus vaccine) for preventing lower respiratory tract disease caused by RSV in adults aged 50-59 with underlying health conditions. 30 August 2024
The European Commission (EC) has extended the indications of the antifungal Cresemba (isavuconazole) to pediatric patients, says Swiss drugmaker Basilea Pharmaceutica. 28 August 2024
The European Commission (EC) has approved a Type II extension of indication for Johnson & Johnson’s Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed). 27 August 2024
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
US biotech Regeneron Pharmaceuticals yesterday announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. 27 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
Italian ophthalmics company SIFI SpA says that the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) 27 August 2024