SwitzerlandSwitzerland

Roche runs for EU application of subcutaneous Herceptin

26.03.2012

Basel/Vienna - 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.

SwitzerlandSwitzerland

10.11.2011

Alschwil - Actelion Ltd. gets a badly needed injection of fresh capital. Under the guidance of the two biggest Swiss banks, UBS and Credit Suisse, the Swiss biopharmaceutical company takes up €171 million agreeing to pay a 4,875%...

SwitzerlandSwitzerland

18.10.2011

Basel/San Diego –Swiss drug company Roche has announced it is buying biotech-company Anadys Pharmaceuticals for US$230 million. Under the terms of the merger agreement, Roche will commence an all cash tender offer for all...

Germany, SwitzerlandSwitzerland

12.10.2011

The Swiss technology transfer organisation Unitectra is the winner of the European Biotechnica Award 2011. The specialist for technology transfer received the award from hands of Lower Saxony's Minister for Economy Jörg Bode. The...

SwitzerlandSwitzerland

01.10.2011

Liestal – Swiss Santhera AG has announced strict savings measures. Out of a total of 21 employees, almost every second is now slated to be sacked. The biotech firm is closing its department of preclinical development and scaling...

SwitzerlandSwitzerland

01.10.2011

Schlieren – Swiss biotechnology company Cytos AG has finally devised a plan to help its lead candidate into Phase II, but to achieve it, the cash-strapped company is having to slash its workforce by a whopping 85%. To ensure the...

SwitzerlandSwitzerland

01.10.2011

Geneva – Swiss biotech Addex Pharmaceuticals AG has regained all rights to its metabotropic glutamate receptor 4 (mGluR4) positive allosteric modulator (PAM) programme from Merck&Co, (known as MSD outside the United States and...

SwitzerlandSwitzerland

01.10.2011

Hamburg – When the compound EVT302 failed proof-of-concept testing in the spring of 2009, investors began backing away from Evotec AG shares. Now the selective MAO-B inhibitor is back, and has powered a leap in the company’s...

SwitzerlandSwitzerland

15.09.2011

Zurich – The FDA has posted a manufacturing warning to Lonza following an inspection of the firm's microbial production site for Eisai’s cancer drug Ontak in Hopkinton. However, analysts at Vontobel said that the impact of the...

SwitzerlandSwitzerland

30.08.2011

Schlieren - Swiss biotechnology company Cytos has devised a plan to get its lead candidate into Phase II. To achieve this, the cash strapped company will slash its workforce, as previously announced, by 85%. To ensure the...

SwitzerlandSwitzerland

22.08.2011

Liestal – Swiss Santhera Pharmaceuticals and researchers from Newcastle University have published the results from a pivotal clinical trial demonstrating that the firm’s synthetic coenzyme Q10 derivative idebenone significantly...

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