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News Breaks
July 31, 2014
16:17 EDTJNJ, PCYCPharmacyclics says $60M Janssen milestone payment to be recognized in Q3
As previously announced on July 28, that the FDA granted IMBRUVICA regular approval for the treatment of patients with CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17, including treatment naive and previously treated del 17p CLL patients. This approval of IMBRUVICA in del 17p CLL triggers $60M in milestone payments to Pharmacyclics (PCYC) under its agreement with Janssen (JNJ), which will be recognized as revenue in the third quarter of 2014. To date, in addition to the upfront payment of $150M, Pharmacyclics has earned milestone payments of $505M under the agreement. It may receive up to an additional $320M in development, regulatory and approval milestone payments, however, clinical development entails risks and the company has no assurance as to whether or when the milestone targets might be achieved.
News For PCYC;JNJ From The Last 14 Days
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July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gileadís emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naÔve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDAís acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gileadís Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.

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