A team of experts in advanced therapies has concluded that developers of cell, gene and tissue-engineered therapies may need more support from the regulatory authorities in translating their discoveries into products for possible commercial use.
Eric Abadie, the chair of the European Medicines Agency’s Committee for Medicinal Products for Human Use, has resigned and the agency’s executive director, Guido Rasi, has accepted the resignation with immediate effect, the EMA said.
UCB SA of Belgium and Amgen Inc have launched a Phase 3 trial of their jointly developed monoclonal antibody for the treatment of postmenopausal osteoporosis. The antibody binds to and inhibits sclerostin, a protein secreted by bone cells.
BTG Plc has raised its revenue forecast for the year ended 31 March, in part due to unexpectedly strong sales of the prostate cancer treatment, Zytiga (abiraterone acetate), which is partnered with Johnson & Johnson.
Venture capital-backed Noxxon Pharma AG has reported new preclinical data for one of its oligonucleotide-based drugs that is being investigated for a number of oncology indications. The compound, NOX-A12, is in early clinical development.
The battle for Illumina Inc has heated up following Illumina’s rejection of a revised takeover bid from the Roche group on 2 April 2012, and a statement from Roche criticising the US company’s management.
AstraZeneca Plc is to pay $50 million upfront to Amgen Inc in a deal where the two companies will jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio. AZ announced the agreement on 2 April.
For the second time in a little more than a year, GlaxoSmithKline Plc has raised its stake in Theravance Inc of the US with whom it has collaborations for late-stage products for chronic obstructive pulmonary disease (COPD) and asthma.
A Phase 3 trial of an experimental drug for patients with HIV-1 who have never used drugs for their disease has reached its primary endpoint of non-inferiority compared with a standard of care, according to ViiV Healthcare.
MorphoSys AG has announced plans to buy back up to 100,000 of its own shares in the stock market during April 2012. The shares will be used for the German company’s management incentive programme.