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European Medicines Agency (EMA) - Articles and news items

trastuzumab-biosimilar

EMA accepts to review Mylan and Biocon’s cancer biosimilar

Industry news / 25 August 2016 / Niamh Louise Marriott, Digital Content Producer

Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA…

t-cell therapy cancer cells

EU approval in sight as Bellicum’s BPX-501 granted orphan drug designation

Industry news / 5 August 2016 / Bellicum Pharmaceuticals

Bellicum Pharmaceuticals, a clinical stage biopharmaceutical company, has been granted orphan drug designations for both its T-cell therapy product candidate BPX-501 for treatment in hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid…

renal cell carcinoma

Ipsen’s kidney cancer drug receives positive CHMP and ‘Promising Innovative Medicine’ status

Industry news / 25 July 2016 / Niamh Louise Marriott, Digital Content Producer

Ipsen announced that CHMP & EMA have provided a positive opinion for Cabometyx for the treatment of advanced renal cell carcinoma (RCC) in adults…

pancreatic cancer

Onivyde receives positive CHMP opinion for pancreatic cancer treatment

Industry news / 25 July 2016 / Niamh Louise Marriott, Digital Content Producer

The positive opinion is based on a pivotal Phase 3 study showing that Onivyde combined with chemotherapy significantly increased overall survival in patients with metastatic pancreatic cancer…

sb5

Samsung Bioepis seeks EU approval for its biosimilar adalimumab candidate, SB5

Industry news / 18 July 2016 / Victoria White, Digital Content Producer

At an estimated $4billion a year, the reference product, Humira, is among the European Union’s largest single drug expenditures…

brexit

EMA issues statement on the outcome of the EU Referendum

Industry news / 7 July 2016 / Victoria White, Digital Content Producer

In the recent Referendum, the majority voted against the UK’s continued membership of the EU. Now, the EMA has issued a statement on the outcome of the vote…

Ocrevus

Ocrevus marketing applications under review by the EMA and FDA

Industry news / 28 June 2016 / Victoria White, Digital Content Producer

If approved by the EMA and FDA for both indications, Ocrevus would be the first and only treatment for both forms of multiple sclerosis…

keytruda

CHMP positive opinion for Keytruda in NSCLC

Industry news / 27 June 2016 / Victoria White, Digital Content Producer

The CHMP has recommended approval of Keytruda for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1…

brexit

GlobalData on the difficulties and opportunities of Brexit for pharma

Industry news / 27 June 2016 / Victoria White, Digital Content Producer

While a Brexit undoubtedly creates significant issues for the UK pharma industry, opportunities remain for the sector to thrive, according to GlobalData…

Aducanumab

Investigational Alzheimer’s treatment Aducanumab accepted into EMA’s PRIME programme

Industry news / 2 June 2016 / Victoria White, Digital Content Producer

PRIME aims to bring treatments to patients faster by enhancing the EMA’s support for the development of investigational medicines…

xtandi

CHMP issues positive opinion for Xtandi label update

Industry news / 8 April 2016 / Victoria White, Digital Content Producer

The CHMP has recommended approval of a type II variation to include data from the TERRAIN trial of Xtandi (enzalutamide) versus bicalutamide…

schizophrenia

CHMP adopts positive opinion of Trevicta for maintenance treatment of schizophrenia

Industry news / 5 April 2016 / Victoria White

If approved, this 3‑monthly injection will allow patients to maintain an optimal level of treatment in their blood with fewer administrations…

 

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