Swedish rare disease specialist Swedish Orphan Biovitrum (Sobi) has upgraded its financial outlook for 2016 after receiving positive feedback on hemophilia B drug Alprolix (coagulation Factor IX [recombinant], Fc fusion protein). 1 March 2016
Following emerging concerns about increased reported cases of rare but serious allergic reactions with fusafungine by independent French drugmaker Servier and other sources, the European Medicines Agency initiated in September 2015 a review process. 15 February 2016
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has finalized a review of SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations to minimize the risk of diabetic ketoacidosis. 12 February 2016
The European Medicines Agency has established a task force of European experts with specialized knowledge in vaccines, infectious diseases and other relevant expertise to contribute to the global response to the threat of the Zika virus infection. 8 February 2016
The European Medicines Agency has recommended granting a marketing authorization for Empliciti (elotuzumab) for the treatment of multiple myeloma. 30 January 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorization at its January 2016 meeting, two of which – for Empliciti and Coagadex – will becovered in separate stories. 30 January 2016
The European Medicines Agency has released an overview of its 2015 key recommendations in relation to the marketing authorizations of new medicines and the safety monitoring of authorized medicines. 12 January 2016
The European Medicine’s Agency’s (EMA) committee for orphan medicinal products (COMP) has issued a positive opinion backing Orphan Drug Designation (ODD) for avelumab, it has been announced. 25 November 2015
The European Medicines Agency (EMA) has reinforced its commitment to help combat antimicrobial resistance (AMR) to mark European Antibiotic Awareness Day (EAAD) 2015. 18 November 2015
The marketing authorization application for Alprolix from US biotech firm Biogen and Swedish Orphan Biovitrum (Sobi) has been validated by the European Medicines Agency. 26 June 2015
Amsterdam, Netherlands-based biopharma company Kiadis has received an Advanced Therapy Medicinal Product certificate from the European Medicines Agency for its lead product ATIR. 13 May 2015
The European Medicines Agency has published its guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union. 22 January 2015
The European Medicines Agency has launched a pilot project to involve patients in the assessment of the benefits and risk of medicines in its Committee for Medicinal Products for Human Use (CHMP). 26 September 2014
The European Medicines Agency is proposing a new development plan that would avoid the duplication of clinical trials and the unnecessary exposure of children to clinical testing for diphtheria, tetanus and whooping cough. 24 September 2014
Japan’s largest drugmaker Takeda has completed the post-marketing commitment and data submissions to regulators including the US Food and Drug Administration and the European Medicines Agency from a 10-year epidemiology study for pioglitazone-containing medicines. 29 August 2014
The European Medicines Agency has accepted for review a Marketing Authorization Application by American biopharma company Cubist for its investigational antibiotic ceftolozane/tazobactam. 22 August 2014
US drugmaker Baxter International has formally opened its S$370 million ($297 million) first advanced recombinant biologic facility in Singapore, and announced expansion plans for a new recombinant protein processing suite. 8 August 2014
US drugmaker Raptor Pharmaceutical says that the European Commission has approved its application for orphan drug designation of cysteamine bitartrate, the active ingredient in RP103, for the treatment of Huntington's disease. 5 August 2014
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