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Stock Market & Financial Investment News

News Breaks
July 28, 2014
12:24 EDTPCYC, JNJFDA expands approved use of Imbruvica for chronic lymphocytic leukemia
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17, which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. Imbruvica’s new use is being approved more than two months ahead of the product’s prescription drug user fee goal date of Oct. 7, the date the FDA was scheduled to complete review of the drug application. Imbruvica also received accelerated approval in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Clinical studies to verify and describe Imbruvica’s clinical benefit in mantle cell lymphoma are ongoing. Imbruvica is being jointly developed and commercialized in the United States by Pharmacyclics (PCYC) and Janssen Biotech (JNJ).
News For PCYC;JNJ From The Last 14 Days
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April 1, 2015
14:42 EDTJNJPiper Jaffray biopharma analyst holds an analyst/industry conference call
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09:10 EDTPCYCPharmacyclics initiates cancer study of ibrutinib with AstraZeneca's MEDI4736
Pharmacyclics (PCYC) initiated PCYC-1135-CA, a multi-center study that will investigate the use of ibrutinib in combination with MEDI4736, an investigational, anti-PD-L1 immune checkpoint inhibitor being developed by AstraZeneca (AZN). The Phase Ib/II study will examine the safety, tolerability and effectiveness of this investigational combination in individuals with relapsed or refractory non-small cell lung cancer, breast cancer, and pancreatic cancer. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech.
March 30, 2015
07:24 EDTPCYCStifel to hold a bus tour
BioTrek: 2015 West Coast Healthcare Therapeutics Bus Tour travels throughout San Francisco on March 30-April 1.
March 29, 2015
14:06 EDTJNJJ&J announces study findings of paliperidone palmitate published in JAMA
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March 27, 2015
15:14 EDTJNJJohnson & Johnson not likely to buy Intuitive Surgical, says BofA/Merrill
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09:59 EDTJNJJohnson & Johnson to collaborate with Google to advance surgical robots
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06:46 EDTJNJContact lens makers, discounters battling over price setting, NY Times says
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March 25, 2015
07:29 EDTJNJLeerink to hold booth tours
Leerink Booth Tours at AAOS 2015 will be held in Las Vegas on March 25-26.
March 24, 2015
13:24 EDTJNJContact lens manufacturers accused of price-fixing, Bloomberg says
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07:45 EDTJNJFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 23, 2015
09:03 EDTJNJLeerink analysts hold a meeting with a conference call hookup
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