Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Novartis is blazing ahead with its bid to take its new CAR-T therapy, Kymriah, into new realms with a double-pronged approval application in Europe.
In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk direct-to-consumer genetic risk tests.
Authorities in the city of Nanjing, the capital of China’s Jiangsu province, announced at the end of October that they would sequence the genes of 1 million individuals to build a genetic database of Chinese residents. This project is part of the National Health and Medicine Big Data Nanjing Center, a new data storage facility under construction in the region.
Women who ate more fruits and vegetables containing high amounts of pesticide residue were less likely to get pregnant or have a live birth following infertility treatments, an observational study found.
Beijing Beishengyan biological Product’s Sabin Strain Inactivated Polioviurs Vaccine (Sabin IPV), secured approval from the China Food and Drug Administration (CFDA) in August 2017. On September 29th, Sabin IPV was officially on the market, offering one more option for IPV precaution. With the exception of time for material supplements, the CFDA took only 35 days to process production, registration and application of Beishengyan’s IPV and issue a drug approval number and certificate.
Conventional doctors have considered chemotherapy treatment and radiation to be the standard of care for so long, they’ve lost sight of the fact that these treatments are causing cancer − not curing it. Did they somehow miss the fact that these super toxic cancer therapies could be the reason for their repeat customers?
As NousCom CEO Alfredo Nicosia likes to say, the Basel-based biotech is a relative fledgling at 2-years of age. But the core research team there has been working together for quite a few years.
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
London startup developing holographic surgery headsets has raised $20m (£15m) from the backers of Facebook’s Oculus headset.
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