BusinessSwitzerlandAustria

Roche runs for EU application of subcutaneous Herceptin

26.03.2012 - Following promising results from a Phase III study, Roche has submitted a regulatory application to EMA for subcutaneous Herceptin (trastuzumab) to treat HER2-positive breast cancer.

Roche said subcutaneous administration of Herceptin is less invasive and more convenient to patients, as it takes approximately five minutes instead of 30-90 minutes with the approved intravenous (IV) administration. The regulatory application is based on data from the Phase III HannaH trial presented on March 23 the at the European Breast Cancer meeting in Vienna. Subcutaneous Herceptin produced a complete pathologic response rate, the co-primary endpoints of pharmacokinetics and efficacy met their pre-specified criteria. The drug concentration in the blood measured just before surgery was at least as high for the SC as for the IV formulation (69.0 and 51.8 µg/mL, respectively). This is important in order to demonstrate comparable efficacy. In addition, efficacy, determined by pCR, in patients treated in the SC arm was in the same range as in patients who received the IV formulation (45.4 percent and 40.7 percent, respectively). Subcutaneous Herceptin is formulated using Enhanze recombinant human hyaluronidase (rHuPH20) drug delivery technology from Halozyme Therapeutics Inc.

http://www.european-biotechnology-news.com/news/business/2012-01/roche-runs-for-eu-application-of-subcutaneous-herceptin.html

AwardFinlandEU

27.05.2016 The Finnish Technology Academy has awarded US-American innovator Frances Arnold the 2016 Millennium Technology Prize, worth €1m. Arnold is a pioneer in the field of directed evolution.

OncologyUK

26.05.2016 BigDNA relaunches as Iceni Pharmaceuticals with the aim to develop repurposed and reformulated cancer therapies. First order of business: repurpose Merck Serono’s cilengitide as a multiple myeloma treatment.

MicrobiomeFranceDenmarkEU

24.05.2016 One of the pioneering companies developing pharmaceuticals and diagnostics based on the gut microbiome, Enterome Bioscience, has raised €14.5m in a Series C financing round. Among the investors were Seventure and Lundbeckfond as well as Nestlé.

AntibioticsEUUKItaly

20.05.2016 The long awaited global review on antimicrobial resistance by economist Lord Jim O’Neill has been published. It sets out an action plan to defeat superbugs with a huge awareness campaign and rapid diagnostics to be used before antibiotics are prescribed.

LicensingGermanyIrelandSwitzerland

18.05.2016 Bayer is deepening its involvement in CRISPR with a licensing agreement for genome editing patents. Irish partner ERS Genomics holds the rights to the CRISPR/Cas9 tech from Emmanuelle Charpentier, one of the inventors.

M&AGermany

17.05.2016 Newly rebranded Siemens Healthcare has entered the field of molecular testing for cancers with the acquisition of Cologne-based NEO New Oncology.

FinancingUK

11.05.2016 Newly spun out company OxStem has raised £16.9m (€21.5m) to develop regenerative meds for the treatment of age-related disease. It is the largest financing for an Oxford spin-out – or any UK academic spin-out – to date.

FinancingSwitzerland

09.05.2016 Swiss Genentech partner AC Immune has raised CHF42.7m (€38.6m) in order to advance its therapeutic and diagnostic product pipeline in Alzheimer’s disease. The news follows a recently announced R&D collaboration with Biogen.

FinancingSpain

04.05.2016 Barcelona-based epigenetics expert Oryzon Genomics has closed a debt funding round of €10.5m, bringing the total money raised since last year to €27m. The funds will serve to advance the company’s two LSD1 inhibitors in cancer and neurodegeneration.

Open InnovationFrance

03.05.2016 Ipsen is strengthening its ties to long-time development partner Oncodesign, a Dijon-based cancer treatment biotech. The French pharma is handing over the pre-clinical pharmacology for its oncology research programmes to Oncodesign.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

Basel (CH)

Chemspec Europe 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%
  • ALMIRALL (E)14.43 EUR7.93%

FLOP

  • 4SC (D)2.59 EUR-20.31%
  • NEUROVIVE PHARMACEUTICAL AB (S)5.25 SEK-4.55%
  • FORMYCON (D)20.15 EUR-4.37%

TOP

  • GALAPAGOS (B)51.86 EUR30.7%
  • NICOX (F)11.00 EUR28.7%
  • GENMAB (DK)1177.00 DKK22.2%

FLOP

  • MOBERG PHARMA (S)38.00 SEK-21.8%
  • 4SC (D)2.59 EUR-21.5%
  • FORMYCON (D)20.15 EUR-18.0%

TOP

  • KARO BIO (S)30.60 SEK1981.6%
  • CHRONTECH PHARMA (S)0.34 SEK1600.0%
  • NICOX (F)11.00 EUR491.4%

FLOP

  • NEUROVIVE PHARMACEUTICAL AB (S)5.25 SEK-89.0%
  • BB BIOTECH (D)44.03 EUR-84.5%
  • BIOTEST (D)17.15 EUR-78.1%

No liability assumed, Date: 30.05.2016