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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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April 9, 2015
09:17 EDTNVSCourt lifts injunction on sales of generic copy of Spectrum's Fusilev
The U.S. Court of Appeals for the Federal Circuit yesterday issued an order that lifted a temporary injunction put in place March 6 that had blocked Novartis' (NVS) Sandoz unit from selling a generic version of Spectrum Pharmaceuticals' (SPPI) colorectal cancer treatment Fusilev. The appeals court ruled that Spectrum failed to meet the requirements for an injunction pending appeal.
08:04 EDTPFEPfizer launches PCSK9 competitive grants program
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05:27 EDTSHPGShire reports results from three placebo-controlled Phase 2 studies of SHP625
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April 8, 2015
16:22 EDTNVSOn The Fly: Closing Wrap
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14:23 EDTNVSAdditional bidders for Perrigo could emerge after Mylan offer, says Stifel
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09:23 EDTJNJJohnson & Johnson April volatility elevated into Q1 and outlook
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08:08 EDTBMYuniQure price target raised to $50 from $28 at Leerink
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08:06 EDTBMYBristol-Myers completes acquisition of Flexus Biosciences
Bristol-Myers Squibb Company announced that it has completed the previously announced planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
07:33 EDTMRKAdvaxis, Merck begin enrollment in Phase 1/2 of ADJX-PSA with Keytruda
Advaxis (ADXS) and Merck (MRK) announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA, an investigational Lm-LLO immunotherapy, and Keytruda, the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer, or mCRPC. The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.
07:24 EDTJNJNeurotechnology Industry Organization to hold a conference
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07:04 EDTMRKMerck's investigational Hep C therapy granted breakthrough therapy designations
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April 7, 2015
10:10 EDTSHPGJazz patent on Xyrem latest to be challenged by Kyle Bass
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08:10 EDTSHPGShire shares pricing in worst case scenario for patents, says Citigroup
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08:09 EDTPFEPfizer, Merck KGaA finalize agreement to co-promote XALKORI
Merck KGaA (MKGAY) and Pfizer (PFE) announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase inhibitor XALKORI. Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the United Kingdom. In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA. The second wave will begin in 2016 and includes China and Turkey. n 2015, Merck KGaA will receive a reimbursement associated with its promotion of XALKORI, followed by an 80% for Pfizer, 20% for Merck KGaA profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the U.S., Canada, Japan, France, Germany, Italy, Spain and the U.K. and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA.
07:24 EDTCELGCelgene Otezla has growing opportunity, says Bernstein
After interviewing small groups of New York City area dermatologists, Bernstein believes that Celgene's psoriasis,treatment, Otezla, has a growing opportunity, due to its oral dosing, convenience, and lack of immunosuppression. The firm quotes doctors as saying that the drug serves as a useful "stepping stone," for patients who might need more intensive therapy, but want to postpone or avoid biologic Bernstein keeps a $158 price target and Outperform rating on Celgene.
07:14 EDTGSK, BMY, NVS, MRK, PFE, SNYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:13 EDTSHPGShire patent challenges only modest threat, says Jefferies
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07:02 EDTPFEGlycoMimetics updates on Pfizer's plans to initiate Phase 3 Rivipansel trial
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05:23 EDTSHPGShire reaches agreement with FDA on clear regulatory path for SHP465
Shire announces that it has reached an agreement with the FDA on a clear regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder, or ADHD, in adults. Shire has agreed with the FDA to conduct a short-term efficacy and safety study in pediatric patients with ADHD. While Shire intends to pursue an adult indication, the FDA is requesting this additional pediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population. The company anticipates the clinical trial's first patient, first visit to take place in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by 2Q17 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017. This update follows Shire's announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission.
April 6, 2015
16:17 EDTBMYOn The Fly: Closing Wrap
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