United States

RedHill RHB-104 gets FDA QIDP for Nontuberculous Mycobacteria Infections

Thursday, January 12, 2017

RedHill Biopharma, a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, has announced that RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections.

[Read More]

FDA accepts Mylan, BioCon’s biosimilar trastuzumab BLA

Thursday, January 12, 2017

Mylan and Biocon has announced that the FDA accepted Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.

[Read More]

FDA approves Genentech’s Lucentis for myopic choroidal neovascularization

Wednesday, January 11, 2017

Genentech, a member of the Roche Group, announced that the FDA has approved Lucentis (ranibizumab injection) 0.5mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.

[Read More]

NCI’s new drug formulary will expedite agent use in clinical trials

Wednesday, January 11, 2017

The National Cancer Institute (NCI) has launched a new drug formulary that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

[Read More]

Johnson & Johnson Innovation, New York Genome Center to launch JLABS

Wednesday, January 11, 2017

Johnson & Johnson Innovation, New York State and the New York Genome Center have announced a collaboration to launch a new JLABS in New York City. Called JLABS @ NYC, the 30,000-square foot facility will be located at the New York Genome Center (NYGC) in SoHo and will open in 2018. The project is receiving $17 million in New York State funding. The site will be open to biotech, pharmaceutical, medical device and consumer health companies. A QuickFire Challenge seeking companies working in these areas, particularly startups working on cross-sector solutions to prevent, intercept or cure diseases, will be launched by Johnson & Johnson Innovation, with the winner(s) eligible for one year of residency at JLABS @ NYC.

[Read More]

University of Pittsburgh, Bayer form research alliance

Wednesday, January 11, 2017

The University of Pittsburgh and Bayer have established a master collaboration agreement to advance research for heart, lung and blood disease indications. This broad collaboration spans from early research studies, to drug development and big data analysis including real-world evidence studies. In addition to the research partnership, Bayer will be supporting an independent investigator-initiated clinical trial in sickle cell disease.

[Read More]