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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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November 19, 2014
09:04 EDTJNJJohnson & Johnson submits NDA for three-month paliperidone palmitate
Janssen Research & Development, a Johnson & Johnson company, announced the submission of a New Drug Application, or NDA, for three-month atypical antipsychotic paliperidone palmitate to the FDA. The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule.
06:30 EDTJNJJohnson & Johnson, Boston Scientific trial set to start tomorrow, Reuters says
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November 17, 2014
07:16 EDTJNJMilken Institute--Faster Cures to hold a conference
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November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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November 12, 2014
07:53 EDTPCYCLeerink to hold a tour
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November 10, 2014
07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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