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Biotechnology
The European Commission (EC) has given the green light to another use of Merck & Co’s (NYSE: MRK) multi-indication immuno-oncology drug Keytruda (pembrolizumab), this time for the treatment of certain patients with locally-advanced or metastatic urothelial carcinoma, a type of bladder cancer. 5 September 2017
Pharmaceutical
The European Medicines Agency (EMA) has launched a survey to better understand patients’ and healthcare professionals’ awareness of reporting adverse drug reactions , including for medicines under ‘additional monitoring.’ 5 September 2017
Biotechnology
The European Commission (EC) has granted marketing authorization of a pediatric formulation (granules in capsule for opening) of Mimpara (cinacalcet). 1 September 2017
Biotechnology
New York’s Pfizer and UK-based Avillion have applied to regulators in Europe and the USA to expand the label for chronic myeloid leukemia drug Bosulif. 30 August 2017
Pharmaceutical
Among the political news to emerge last week, two members of the US House of Representatives initiated an investigation of skyrocketing price hikes for multiple sclerosis drugs. On the corporate front, Adamas Pharmaceuticals gained US approval of a new Parkinson’s disease drug, ADS-5102, positive new trial data on Johnson & Johnson’s cancer drug Darzalex, Ironwood Pharmaceuticals receiving a Food and Drug Administration nod for its gout drug Duzallo, and European and US regulatory filing acceptances for Vertex Pharmaceutical’s cystic fibrosis combination drug tezacaftor/ivacaftor. 27 August 2017
Pharmaceutical
The European Medicines Agency has handed Germany’s Merck approval to market Mavenclad for patients with highly active relapsing multiple sclerosis. 25 August 2017
Biotechnology
US biotech firm Vertex Pharmaceuticals saw its shares rise 1.85% to $156.08 after the company updated on regulatory filings for the combination cystic fibrosis drug candidate. 25 August 2017
Biosimilars
Samsung Bioepis has become the first company to get European Commission (EC) approval for biosimilar versions of three anti-TNF-α blockbusters. 24 August 2017
Biotechnology
Swiss pharma giant Novartis has received approval from the European Commission for Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy. 24 August 2017
Pharmaceutical
The European Commission, the US Food and Drug Administration and the European Medicines Agency have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. 23 August 2017
Biosimilars
A total of 32 biosimilar products, based on 12 biologics, have been approved for use in the European Union. This compares with just ten in the USA, referencing nine biologics. 22 August 2017
Biotechnology
The European Commission today approved the extension of the indication for USA-based Alexion Pharmaceuticals’ Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 21 August 2017
Biosimilars
Biocon, an Indian drugmaker that together with Netherlands-headquartered Mylan is a frontrunner in the race to take big-selling biosimilars to major markets, has suffered a damaging blow affecting two of its oncology submissions in Europe. 16 August 2017
Biotechnology
Ireland-headquartered rare diseases specialist Shire has submitted lifitegrast for regulatory approval in Europe, the company says. 15 August 2017
Pharmaceutical
German pharma major Bayer got a boost to its shares this morning after it revealed an important additional indication approval for its cancer drug Stivarga (regorafenib) in the European Union. 7 August 2017
Biotechnology
Puma Biotechnology saw its shares dip 1.4% to $87.95 in after-hours trading on Wednesday, after the US company revealed a delay in approval of its breast cancer drug neratinib. 3 August 2017
Pharmaceutical
The application procedure to host the two UK-based European Union agencies, the European Medicines Agency (EMA) and the European Banking Authority (EBA), came to a close at midnight on July 31, 2017, the European Commission announced yesterday, thus firing the starting gun for bids from various European cities to become the location for these important regulatory agencies. Some 19 cities have posted formal bids to host the EMA post Brexit. 2 August 2017
Biotechnology
US cancer drug developer Kite Pharma has become the first company to submit a Marketing Authorization Application (MAA) for a chimeric antigen receptor (CAR) T-cell therapy to the European Medicines Agency (EMA). 1 August 2017
Biotechnology
US biotech firm Spark Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Luxturna, the proposed trade name for voretigene neparvovec, an investigational, one-time gene therapy for patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa caused by confirmed biallelic RPE65 mutations. 31 July 2017
Biotechnology
Privately-held Italian biopharma company Dompé today revealed that the European Commission has granted a marketing authorization for Oxervate (cenegermin eye drops) for the treatment of moderate to severe neurotrophic keratitis. 31 July 2017
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Biosimilars
Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
Pharmaceutical
Japanese drugmaker Astellas Pharma revealed it has decided to withdraw its marketing authorization application from the European Medicines Agency (EMA) for avacincaptad pegol intravitreal solution (ACP). 28 October 2024
Biotechnology
AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). 28 October 2024
Biotechnology
Johnson & Johnson has secured European approval for an expanded indication of Darzalex (daratumumab) in a subcutaneous formulation. 24 October 2024
Biotechnology
The European Commission (EC) has approved two new indications for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in gynecologic cancers. 24 October 2024
Biosimilars
The fully-owned Intas Pharmaceuticals subsidiary Accord Healthcare has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Imuldosa. 21 October 2024
Biotechnology
The European Medicines Agency’s (EMA) human health committee, CHMP, announced six positive opinions of novel medicines, as well as two biosimilars, following its October meeting. 18 October 2024
Pharmaceutical
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
Biotechnology
Significant research news last week saw US biotech Scholar Rock release positive new data for its spinal atrophy (SMA) candidate apitegromab. There was a negative development for Johnson & Johnson, which said that, following a data monitoring committee recommendation, it is discontinuing development or its TAR-200 in bladder cancer. On the regulatory front, the US Food and Drug Administration (FDA) approved Swiss pharma giant Roche’s new breast cancer drug Itovebi (inavolisib). Also of note, the European Medicines Agency’s pharmacovigilance committee, PRAC, has initiated a review of medicines containing finasteride and dutasteride regarding suicidal ideation and behaviors. 13 October 2024
Biosimilars
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Biosimilars
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
Pharmaceutical
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
Pharmaceutical
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
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