News

Enlarge image

RegulatorySwitzerlandEU

Roche gets OK for Herceptin-ADC

25.02.2013 - Roche has received the OK to market its breast cancer antibody-drug conjugate T-DM1 in the US under the brand name Kadcyla.

The FDA granted the approval for Kadcyla monotherapy plus Xeloda (capecitabine) of Her2-positive women with metastatic breast cancer, who had already been treated with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is composed of the antibody, trastuzumab which is linked to the chemotherapeutic DM1 and targets the toxin, which kills proliferating cells, to the tumour. 

“Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future.”

Roche currently has eight ADCs in early clinical testing for different types of cancer.  Roche has also submitted a Marketing Authorisation Application to other Regulatory Authorities around the world, including the European Medicines Agency (EMA). The FDA approval of Kadcyla is based on results from EMILIA (TDM4370g/BO21977), an international, Phase III, randomised, open-label study comparing Kadcyla alone to lapatinib – the current standard of care – in combination with Xeloda (capecitabine) in 991 people with HER2-positive locally advanced breast cancer previously been treated with Herceptin and a taxane chemotherapy. The study met both co-primary efficacy endpoints of overall survival and progression-free survival.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/roche-gets-ok-for-herceptin-adc.html

Industry reportGermany

27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).

Clinical ResearchFrancePortugal

21.04.2016 An expert panel’s final report on the fatal drug trial earlier this year in France states that the death of one of the participants was most likely caused by the drug’s toxicity and not by any violation of the rules.

Immuno-oncologyNetherlandsBelgium

21.04.2016 For up to US$685m (€606m), Dutch ArgenX has outlicensed its human antibody programme ARGX-115 to AbbVie. The pre-clinical immuno-oncology candidate targets a protein believed to contribute to immunosuppressive effects of T-cells.

RegulatorySwitzerlandEU

20.04.2016 The US government is forking out up to US$100m to get Basilea Pharmaceutica’s broad-spectrum antibiotic ceftobiprole on the US market. In the EU, ceftobiprole is already available.

Immuno-oncologyUK

19.04.2016 British drug developer Heptares Therapeutics and mAb maker Kymab Ltd have partnered up in yet another immuno-oncology collaboration. The companies plan to discover antibody meds targeting a superfamily of receptors.

FinancingSwitzerlandFranceEUGermanyDenmark

15.04.2016 Not every company is put off by the current stock market climate. Swiss biopharma company GeNeuro has gone public at Euronext Paris, raising €33m in the process. Others, meanwhile, have to find different ways to raise money.

Event ReviewSwitzerlandBelgiumEU

13.04.2016 Despite political disturbances, 2015 was a good year for the biotech scene in Switzerland. Net sales increased by 5.1% to CHF5,133m and 400 additional people found jobs in the sector. As usual, the new numbers were presented at the annual Swiss Biotech Day – which set new records as well.

FinancingGermanyNetherlandsEU

12.04.2016 German-Dutch life science investment specialist Forbion Capital Partners has raised more than €180m for its venture capital fund Forbion Capital Fund III. Once more the money will primarily go to European start-ups.

Event ReviewGermanyEU

08.04.2016 Do you win by being innovative?, was the question asked at this year’s DIA Euromeeting in Hamburg. In a relaxed and cooperative atmosphere, regulators, physicians and patients had ample opportunity to interact with the healthcare industry.

M&AIrelandEU

07.04.2016 Pfizer and Allergan have called off their merger, cancelling plans to relocate the US pharma giant to Ireland to avoid US taxation. The US government has put a spoke in Pfizer’s wheels - an unfair move, Allergan says.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

München

BioVaria 2016

Berlin (GER)

XIV. BIONNALE 2016

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • BIOTIE THERAPEUTICS (FI)0.27 EUR92.86%
  • PLETHORA (UK)3.38 GBP12.67%
  • FORMYCON (D)24.56 EUR5.59%

FLOP

  • SERODUS (N)1.46 NOK-14.12%
  • PHOTOCURE (N)39.50 NOK-7.49%
  • BIONOR PHARMA (N)0.79 NOK-7.06%

TOP

  • AB SCIENCE (F)18.84 EUR67.5%
  • SYNAIRGEN (UK)35.75 GBP45.9%
  • BIOFRONTERA (D)3.17 EUR44.1%

FLOP

  • SERODUS (N)1.46 NOK-33.3%
  • THERAMETRICS (CH)0.03 CHF-25.0%
  • OREXO (S)50.00 SEK-18.4%

TOP

  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • KARO BIO (S)31.20 SEK2022.4%
  • NICOX (F)8.55 EUR352.4%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)6.10 SEK-88.0%
  • BB BIOTECH (D)46.45 EUR-82.3%
  • BIOTEST (D)16.70 EUR-76.5%

No liability assumed, Date: 29.04.2016