Oncology

The US Food and Drug Administration (FDA) granted Orphan Drug designation for Insys Therapeutics’ ovarian cancer candidate. The agency granted the designation to Insys’ Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer. The FDA’s Office of Orphan Products Development grants novel drugs or biologics that treat rare …

BioPharma has struck a deal with Novartis Pharma AG for rights to an investigational cancer drug. Array recently announced that it has entered into a definitive agreement with Novartis to acquire worldwide rights to encorafenib (LGX818), Novartis’ BRAF inhibitor in development for treatment of skin and colorectal cancer. The deal …

Scientists have uncovered several new genetic mutations that could drive testicular cancer, and have identified a gene that may play a role in tumors becoming resistant to available therapies. A new major research study, led by scientists at The Institute of Cancer Research, London, is the first to use state-of-the-art …

Backed with roughly $45.5 million, Investment company Syncona and UCL Business, the wholly-owned technology transfer company of University College London, have launched the latest CAR T upstart, Autolus Limited. According to the companies, Autolus is a biopharmaceutical company focused on the development and commercialization of next-generation engineered T-cell therapies for …

While patients with metastatic colorectal cancer are undergoing less surgery for the removal of their primary tumors, survival rates for the disease are improving, according to a new study. According to The University of Texas MD Anderson Cancer Center, with new chemotherapeutic and biologic agents available for managing metastatic colorectal …

Merck and Bristol-Myers Squibb continue to their race in immuno-oncology, a popular research area. On Monday, Merck announced that it will apply for approval of its melanoma drug, Keytruda, for treatment of lung cancer, in the first half of 2015. The company intends to files its first-in-class cancer immunotherapy specifically …

Incyte and Agenus will partner on immuno-oncology targets in a deal worth up to $410 million. The companies announced today that they have entered into a global license, development and commercialization agreement focused on novel immuno-therapeutics using Agenus’ proprietary Retrocycle Display antibody discovery platform. According to terms of the deal, …

ASCO submitted comments Jan. 5 to the House Committee on Energy and Commerce, Health Subcommittee, strongly supporting the Food and Drug Administration’s proposed risk-based approach to regulation of laboratory developed tests (LDTs). LDTs are increasingly being used to guide therapy selection for patients with cancer. Failure of such tests to …

A panel of advisors for the US Food and Drug Administration (FDA) has recommended approval of Novartis’ investigational biosimilar version of Amgen’s Neupogen (filgrastim). The agency’s independent Oncologic Drugs Advisory Committee (ODAC) voted 14-0 in favor of approving Novartis’ biosimilar version of Amgen’s cancer drug Neupogen, which boosts white blood …

Today, Pfizer Inc. announced that it is in discussion with the US Food and Drug Administration (FDA), regarding its potential blockbuster breast cancer drug palbociclib. According to the company, it expects to get a final decision from the agency by April 13. Pfizer said that the FDA is not requiring …