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.

BusinessUKIreland

21.07.2014 Abbvie’s tenacious pursuit of British rival Shire is finally paying off: The two companies have unveiled their transatlantic merger worth £32bn (€40bn).

ResearchEUSwitzerland

17.07.2014 A trans-border, cross-disciplinary project that aims to model the human brain in a computer has drawn heavy criticism from scientists pledging to boycott the project.

MergerUK

16.07.2014 After rejecting three merger propositions from US competitor Abbvie, Shire has now given up resistance to the deal and is recommending a new and improved offer worth £31.3bn.

AcquisitionUKDenmarkSpainGermanyFrance

15.07.2014 British specialty pharma company Prostrakan is handing over £230m for Archimedes Pharma Limited, a company that brings its lead product Pecfent and its proprietary drug delivery technology platform into the deal.

FundingEU

11.07.2014 Among the seven newly launched Joint Technology Initiatives (JTI) of Horizon2020 are two with deep roots in biotech: IMI is going into its second round while the newly established Bio-based Industries partnership invests in bioeconomy.

Stock marketNetherlandsUKBelgium

10.07.2014 Not one but two biopharma companies are seeking entry into the stock market: After Abzena raised €25m in an IPO earlier this week, Argen-x has followed suit and sold shares worth €40m.

M and AUKIreland

08.07.2014 Abbvie is determined to bring home British rare disease specialist Shire in a merger worth £30.1bn (€37.9bn). So far, Shire has rejected all offers from the US company.

M and ASwitzerland

04.07.2014 Genentech, a member of Swiss Roche Group, is set to acquire US-biotech Seragon Pharmaceuticals Inc. With the move, Genentech will obtain the rights to investigational breast cancer treatments.

MandAFranceGermany

03.07.2014 Nicox S.A. is stretching beyond the European market: The French eye health specialist is set to acquire Aciex Therapeutics Inc., a US-based pharma company with several ophthalmic therapeutics nearing market maturity.

FinanceBelgium

01.07.2014 Belgian antibody specialist Ablynx has raised €41.7m through a private placement of new shares and plans on boosting their range of nanobodies in development.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MAGFORCE (D)5.90 EUR9.26%
  • ABCAM (UK)387.00 GBP7.72%
  • NANOBIOTIX (F)17.40 EUR7.27%

FLOP

  • ANTISOMA (UK)1.32 GBP-14.84%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.29%
  • NOVACYT (F)4.40 EUR-8.33%

TOP

  • WILEX (D)3.12 EUR300.0%
  • SANTHERA (CH)69.30 CHF103.8%
  • ADDEX (CH)4.07 CHF82.5%

FLOP

  • MERCK KGAA (D)63.71 EUR-50.0%
  • HYBRIGENICS (F)1.72 EUR-34.4%
  • PROSENSA (NL)9.24 USD-24.4%

TOP

  • SANTHERA (CH)69.30 CHF3453.8%
  • GW PHARMACEUTICALS (UK)438.00 GBP800.9%
  • PAION (D)2.80 EUR311.8%

FLOP

  • CYTOS (CH)0.25 CHF-92.6%
  • EVOCUTIS (UK)0.21 GBP-92.1%
  • THROMBOGENICS (B)8.87 EUR-71.8%

No liability assumed, Date: 23.07.2014