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Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo + Yervoy Regimen
October 5, 2015 Off

Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo + Yervoy Regimen

By Dino Mustafić

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Roche’s cobas c 513 analyser, available for countries accepting the CE mark
October 5, 2015 Off

Roche’s cobas c 513 analyser, available for countries accepting the CE mark

By Dino Mustafić

Roche’s new HbA1c testing solution, the cobas c 513 analyser, is now available for countries accepting the CE mark,

Cell Therapy applies for CMA for Heartcell
October 5, 2015 Off

Cell Therapy applies for CMA for Heartcell

By Dino Mustafić

Cell Therapy Ltd will begin the application process for a conditional marketing authorisation (CMA) for Heartcel, the first allogeneic stem cell therapy to regenerate the human heart, in Europe.

Evgen Pharma to join the AIM market of the London Stock Exchange
October 5, 2015 Off

Evgen Pharma to join the AIM market of the London Stock Exchange

By Dino Mustafić

Evgen Pharma plc, a clinical stage drug development company focused on the treatment of cancer and neurological conditions, intends to join the AIM market of the London Stock Exchange by way of a Placing to raise approximately £5 million.

Avita expands Compassionate Use IDE program for ReCell
October 5, 2015 Off

Avita expands Compassionate Use IDE program for ReCell

By Dino Mustafić

FDA allows Avita to expand its Compassionate Use Investigational Device Exemption (IDE) program for ReCell.

FDA OKs Alcon’s AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery
October 5, 2015 Off

FDA OKs Alcon’s AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery

By Dino Mustafić

Novartis’s Alcon has received US Food and Drug Administration (FDA) approval for its AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery.

Antisel SA will distribute Premaitha Healt’s prenatal screening test IONA in Greece and region
October 2, 2015 Off

Antisel SA will distribute Premaitha Healt’s prenatal screening test IONA in Greece and region

By Dino Mustafić

Premaitha Health has signed a distribution agreement with Antisel SA, a Greek distributor of scientific products, to provide the IONA test to clinical laboratories in the region.

October 2, 2015 Off

FDA: Accelerated approval for Keytruda for patients with advanced (NSCLC) lung cancer

By Dino Mustafić

accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC)

Vectura Group gets €5M upon partner’s work in Europe
October 2, 2015 Off

Vectura Group gets €5M upon partner’s work in Europe

By Dino Mustafić

Vectura’s partner on the VR876 programme has achieved an important development milestone in Europe, which triggered a cash milestone payment of €5m (circa. £3.6m) to Vectura.

Allergan – Humana Research Partnership
October 2, 2015 Off

Allergan – Humana Research Partnership

By Dino Mustafić

Allergan plc, has announced a multi-year research collaboration with Humana Inc. to explore new ideas and ways to improve the health and well-being of patients, members and their caregivers.

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