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European Pharmaceutical Review

Abbott completes submission of new molecular test intended for non small cell lung cancer therapy selection

Abbott has announced that it filed premarket approval applications to the U.S. Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare for a new molecular diagnostic test designed to detect abnormal gene rearrangements in non-small-cell lung cancer (NSCLC) tumors. The test is a combination product to be used with Pfizer’s crizotinib, an oral first-in class anaplastic lymphoma kinase (ALK) inhibitor...

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More pharmaceutical & life science news:

AstraZeneca signs agreement in Japan with Daiichi Sankyo
AstraZeneca has announced a co-promotion agreement in Japan with Daiichi Sankyo for denosumab for the treatment of bone disorders stemming from bone metastasis...

Aesica to increase presence in Asia
Aesica Pharmaceuticals has announced the promotion of Joe Zou currently Chief Representative of its Shanghai office, to manage regional sales across Asia, particularly in China...

Lab21 acquires molecular diagnostics company Myconostica Ltd
Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics, has announced that it has acquired Myconostica Ltd, a molecular diagnostic company focussing on the diagnosis of fungal infections of clinical importance...

Preventing prostate cancer cells from ‘bodybuilding’ gives new treatment hope
Cancer Research scientists scientists have discovered that stopping prostate cancer cells from ‘bulking up’ with nutrients reduces the spread of the disease and tumour size, according to research published in EMBO Journal...

ELIQUIS® (apixaban) approved in Europe for preventing Venous Thromboembolism
The European Commission has approved ELIQUIS® in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery...

GSK and Human Genome Sciences receive positive opinion in Europe from the CHMP for Benlysta® (belimumab)
GlaxoSmithKline and Human Genome Sciences, Inc. have announced that the CHMP has issued a positive opinion, recommending marketing authorisation for Benlysta® (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus...

Amgen receives CHMP positive opinion for XGEVA(TM) (Denosumab) in the European Union
Amgen has announced that the CHMP has recommended a positive opinion for the marketing authorization of XGEVA™ (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors...

CHMP issues positive opinion for Merck’s VICTRELIS™ (boceprevir)
Merck announced that the CHMP of the EMA has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS™...

Cephalon granted Temporary Restraining Order in AMRIX® patent litigation
The United States District Court for the District of Delaware granted a motion filed by plaintiffs Cephalon and Eurand for a TRO enjoining Mylan Pharmaceuticals and Mylan from manufacturing, using and selling its cyclobenzaprine hydrochloride extended-release capsules...

European Medicines Agency’s Committee for Medicinal Products for Human Use issues positive opinion on marketing authorisation application for FAMPYRA
Biogen Idec announced that FAMPYRA(R) (prolonged-release fampridine tablets) has been granted a positive opinion for conditional approval from the EMA's CHMP...

10th Annual Congress Recombinant Antibodies
24 - 26 May 2011 Barcelona, Spain

Partnering with Central Labs, ECG and Imaging Labs
25 - 26 May 2011 Brussels, Belgium

Pharma Manufacturing Summit 2011
7 - 9 June 2011 Montreux, Switzerland
The NGP Manufacturing Summit will serve as an arena for senior level executives to engage in a clear and focused dialogue with their peers to procure and examine their business and manufacturing objectives in real time. GDS has elected more than 50 of the most well respected executives in the European pharmaceutical industry. The delegation gathers together to spend two days with their peers to network and share knowledge while assessing new technologies available in the marketplace.

12th Annual Drug Discovery Leaders Summit 2011
8 - 9 June 2011 Le Montreux Palace, Montreux, Switzerland

European Lab Automation Congress 2011
30 June - 1 July 2011 Hamburg, Germany

First commercially available integrated kits for isolation and detection of key contaminants in cell culture samples

Vesivirus, MMV and Mycoplasma have emerged as a potential threat to mammalian cell culture production. To meet the challenge of rapid, specific, and sensitive detection, Applied Biosystems® has developed the first commercially available integrated kits for isolation and detection of key contaminants in cell culture samples. The unique benefits are:

  • Only one sample extracted by PrepSEQ™ magnetic beads to test the tree contaminants at the same time.
  • Proprietary positive control template that helps eliminate the possibility of false positive results arising from inadvertent contamination of test samples with the positive control.


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