Janssen

FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

More... »

Phenex, Janssen form research collaboration on autoimmune, inflammatory disorders

Monday, December 17, 2012 02:09 PM

Phenex Pharmaceuticals, a privately held drug discovery and development company based in Germany, has entered into an agreement with Janssen Biotech and its affiliates to jointly discover compounds that target the nuclear hormone receptor RORγT and may have utility in the treatment of chronic autoimmune and inflammatory disorders including rheumatoid arthritis, psoriasis and inflammatory bowel disease.

More... »

Janssen R&D establishes global cross-pharma clinical trial Investigator Databank

Monday, November 19, 2012 10:18 AM

Janssen Research & Development, based in Raritan, N.J., has established a global cross-pharmaceutical Investigator Databank designed to improve efficiencies of industry-sponsored clinical trials. Merck and Eli Lilly are the first two companies to join Janssen in this effort.

More... »

Prezista receives E.C. approval for young children with HIV-1 infection

Friday, October 26, 2012 10:46 AM

The European Commission (E.C.) has approved Janssen/Cilag International’s 100mg/ml oral suspension of Prezista (darunavir), and the use of darunavir co-administered with low dose ritonavir, for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART)-experienced pediatric patients age three and above, weighing at least 15kg. The drug must be taken in combination with other ARTs.

More... »

PTC Therapeutics appoints Zeldis to board of directors

Thursday, October 4, 2012 12:14 PM

PTC Therapeutics, a biopharmaceutical company based in South Plainfield, N.J., has appointed Jerome B. Zeldis, M.D., Ph.D., to the company's board of directors.

More... »

Janssen to develop, commercialize Astellas’ ASP015K for immunologic diseases

Wednesday, October 3, 2012 09:52 AM

Janssen Biotech and Astellas Pharma have formed a license agreement whereby Janssen gains the exclusive right to develop and commercialize ASP015K, an Astellas compound, worldwide except for Japan.

More... »

Vascular Pharma completes $16M equity financing, signs agreement with Janssen

Thursday, September 13, 2012 08:00 AM

Vascular Pharmaceuticals, a drug discovery company developing a product to treat patients with complications arising from diabetes, has successfully completed a $16 million Series A equity financing.

More... »

Janssen R&D gains FDA priority review for TB drug

Wednesday, September 5, 2012 11:32 AM

The FDA has granted Janssen Research & Development priority review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.

More... »

FDA approves Gilead's Stribild, four-in-one HIV drug

Wednesday, August 29, 2012 10:19 AM

The FDA has approved Stribild, a complete once-daily single tablet regimen, for the treatment of HIV-1 infection in treatment-naïve adults, according to Gilead Sciences, the Foster City, Calif.-based biopharmaceutical company that developed the drug.

More... »

Pharmacyclics triggers $50M milestone payment for mantle cell lymphoma trial

Monday, August 20, 2012 11:35 AM

Pharmacyclics, a clinical-stage biopharmaceutical company of Sunnyvale, Calif., announced that the clinical trial, SPARK, of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL) has enrolled its fifth patient, triggering a second $50 million milestone payment obligation from Janssen Biotech.

More... »