Novartis announced on Tuesday the approval of its game-changing migraine prevention therapy Aimovig (erenumab) by the European Medicines Agency (EMA). 31 July 2018
Sanofi and Regeneron intend to sidestep the pressures of the crowded PD-1 field by aiming for a first cemplimab approval in cutaneous squamous cell carcinoma (CSCC), which does not yet have any marketed checkpoint inhibitors, says life sciences analytics company GlobalData. 31 July 2018
Danish CNS specialist Lundbeck and Japanese drugmaker Otsuka have announced the European Commission approval of Rxulti (brexpiprazole) for the treatment of schizophrenia in adults. 31 July 2018
Sandoz, a division of Swiss pharma titan Novartis, announced on Friday that it had received marketing authorization from the European Commission for its biosimilar equivalent of AbbVie's Humira (adalimumab). 30 July 2018
In what was clearly a bumper session for the regulator, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval at its July 2018 meeting. 28 July 2018
At its July meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a total of 16 medicines (see separate story for more), with the most significant developments being the following. 28 July 2018
East Coast, USA-based biotech firm bluebird bio has been granted an accelerated assessment by the European regulator for its LentiGlobin gene therapy. 27 July 2018
Despite UK parliamentarians voting 305-301 in favor of continued involvement with the European Medicines Agency (EMA), medicines regulators across Europe are stepping up efforts in preparation for a possible ‘no-deal’ Brexit. 23 July 2018
The Falsified Medicines Directive (FMD) (Directive 2011/62/EU) is a measure to prevent falsified medicinal products for human use from entering the legal distribution chain. The Delegated Regulation 2016/161 gives effect to parts of the FMD and contains legal measures for the implementation of the Directive. 23 July 2018
This week, the UK Parliament voted 305-301 in favor of continuing the UK’s involvement with the European Medicines Agency (EMA) after the nation leaves the European Union. But what does this mean for the pharmaceutical industry and patient healthcare after 2020? 19 July 2018
Just as the European Medicines Agency is preparing for its post Brexit relocation to the Netherlands, and is implementing the next phase of its business continuity plan (BCP) to facilitate the move to Amsterdam, the EMA has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). 17 July 2018
As was largely expected, Tegsedi (inotersen) has received marketing authorization approval from the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). 13 July 2018
Following a review of data showing a possible risk of earlier death and an increase in fractures with Xofigo (radium-223 dichloride), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of this cancer medicine to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments. 13 July 2018
US biotech Advaxis closed 8% down on Tuesday after feedback from the European Medicines Agency (EMA) led the company to announce the withdrawal of its conditional Marketing Authorization Application (MAA) for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy. 11 July 2018
The European Medicines Agency (EMA) has warned that a failure to prepare for Britain leaving the European Union could lead to major supply chain disruption for around 100 medicines. 11 July 2018
There was good news for US pharma major Bristol-Myers Squibb yesterday, with an expanded approval for its already blockbuster blood cancer drug Sprycel (dasatinib) in Europe. 6 July 2018
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company based in Linhai, China. 6 July 2018
Colorado, USA’s Clovis Oncology says its application to extend the marketing authorization for Rubraca (rucaparib) in Europe, to include maintenance treatment for certain patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, has been accepted. 5 July 2018
The European Commission has approved (tofacitinib citrate) 5mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. 29 June 2018
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