TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the combination of the PD-L1 antibody atezolizumab (TECENTRIQ®) and TESARO’s PARP-inhibitor ZEJULA® (niraparib) in patients with metastatic bladder cancer.
After a string of announcements a few years back, there’s been few new, high-profile biotech startups taking shape in New York. But that quiet period might be coming to an end this morning with the arrival of Quentis Therapeutics, a cancer immunotherapy startup born from the lab of former Weill Cornell Medicine dean and immunologist Laurie Glimcher. The company makes its debut today with a $48 million Series A round.
Whatever the long-term future for life sciences, in house lawyers and their business counterparts as well as outside advisors who are able to navigate the convergence of business and legal issues surrounding the life sciences and technology industries will have a competitive advantage over those who ignore the parallel convergences that are taking place, continuing to focus instead on life sciences and technology as distinct and separate fields.
As the worst flu season in a decade rages on, a potentially groundbreaking new drug that can kill the flu virus in just one day has won regulatory approval—in Japan.
The UK's National Health Service is putting out the call for more mobile health apps for its NHS Apps Library, and has chosen an agency to certify those apps. The library now features 46 mHealth apps - only one of which has passed muster.
The FDA has ordered the recall of a mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.
Genentech’s PD-L1 inhibitor Tecentriq continues to show off its versatility. Monday, the Roche subsidiary announced a combination of Tecentriq and Avastin (bevacizumab) was significantly beneficial to patients with advanced or metastatic renal cell carcinoma (mRCC) who have not received prior systemic active or experimental therapy.
Immune checkpoint inhibitors have revolutionized the treatment of advanced malignancies. By blocking T-cell inhibition these drugs result in immune targeting of tumor cells and normal tissue. As such, their main toxicity is inducing immune-mediated tissue damage.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
European regulators have issued a green light for Amgen and Allergan’s Mvasi, marking the first biosimilar of Roche’s Avastin to be approved in the region. The drug has been cleared to treat a range of indications spanning carcinoma of the colon or rectum, breast cancer; nonsquamous non-small cell lung cancer, renal cell cancer; platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer. The companies noted that the approval came after trial data showed a high degree of similarity between Mvasi (biosimilar bevacizumab) and its reference drug, “with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products”. Mvasi is the first product borne out of an alliance between Amgen and Allergan to bag marketing authorisation from the European Commission, “highlighting the success of our joint commitment to developing cancer biosimilars,” noted David Nicholson, chief research and development officer at ...
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