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Stock Market & Financial Investment News

News For PFE;BMY;NVS;LLY From The Last 14 Days
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March 3, 2015
11:46 EDTNVS, BMYLeerink biotech analyst holds an analyst/industry conference call
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08:37 EDTPFEPfizer says EC approves expanded indication for Prevenar 13
Pfizer announced that the European Commission approved an expanded indication for the use of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed -- for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizerís Community-Acquired Pneumonia Immunization Trial in Adults, which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia, including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.
08:04 EDTLLYDenovo Biopharma licensed Pomaglumetad Methionil from Eli Lilly
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07:16 EDTBMY, LLYCowen to hold a conference
35th Annual Health Care Conference is being held in Boston on March 2-4 with webcasted company presentations to begin on March 3 at 8 am; not all company presentations may be webcasted. Webcast Link
06:02 EDTBMYBristol-Myers reports hepatitis C cure rate of 97% in study
A combination of two once-daily medications for chronic hepatitis C infection has been shown in newly released study results to cure almost all the patients who participated, despite the patients also being co-infected with HIV. This patient population historically has been challenging to treat for hepatitis C, in large part due to potential drug-drug interactions between the antiviral therapy regimens used to treat each infection. Results of ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of chronic hepatitis C in patients co-infected with HIV were announced last week and showed that those treated for 12 weeks, 97% achieved cure. The ALLY-2 study met the primary endpoint, with 96% of treatment-naÔve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase. In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. ALLY-2 also included an 8-week arm; 38 of 50 treatment-naÔve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
March 2, 2015
16:31 EDTPFEPfizer files automatic mixed securities shelf
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09:28 EDTBMYBristol-Myers says FDA accepts Yervoy sBLA for review
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09:02 EDTPFEAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
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08:53 EDTLLYNon-profit gives lukewarm review to MannKind inhaled insulin, TheStreet says
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08:07 EDTNVSArray BioPharma announces completion of binimetinib and encorafenib transactions
Array BioPharma (ARRY) announced the completion of both the binimetinib and encorafenib definitive agreements with Novartis. Along with global ownership of both assets, Array will receive an upfront payment of $85M from Novartis (NVS). Effective March 2, 2015, Novartis' global, exclusive license to binimetinib terminated with all rights reverting to Array, and Array received global rights to encorafenib. Array will receive an $85M upfront payment from Novartis and reimbursement for certain transaction-related expenses. Novartis will provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array patent and other intellectual property rights it owns to the extent they relate to binimetinib and encorafenib. Other than a de minimis payment to Novartis from Array, there are no milestone payments or royalties payable between the parties under the encorafenib agreement. As part of the transactions, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Array entered into a third party agreement necessary to complete the transactions. Net consideration Array agreed to pay amounts to $25M. This payment is consistent with the earnings guidance provided on the quarterly conference call held on February 3, 2015. Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs associated with MILO, which Array will continue to conduct. For NEMO and all other ongoing and planned clinical trials for binimetinib (other than COLUMBUS, as described above), Novartis will conduct and solely fund each trial, until a mutually agreed-upon transition date to Array. Following this transition, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs required to complete these studies. Novartis will remain responsible for conducting and funding development of the NRAS melanoma companion diagnostic until Premarket Approval is received from the U.S. Food and Drug Administration. Following approval, Novartis will transfer the product and Premarket Approval to a diagnostic vendor of Array's designation. Novartis also retains binimetinib and encorafenib supply obligations for all clinical and commercial needs for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of binimetinib and encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib and binimetinib.
07:31 EDTNVSIncyte appoints Steven Stein as Chief Medical Officer
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07:20 EDTBMYCowen to hold a conference
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February 27, 2015
13:35 EDTBMYBristol-Myers reports FDA accepts BLA for Opdivo
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11:33 EDTNVSNovartis says phase II data highlights benefits of Alcon RTH258 in wet AMD
Novartis reports Alcon presented positive results from its second Phase II clinical study of RTH258 during the 38th Annual Macula Society Meeting. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular age-related macular degeneration, or wet AMD. The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity, from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness as measured by spectral domain optical coherence tomography. Both RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.
08:29 EDTBMYBristol-Myers price target raised to $78 from $70 at Argus
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07:50 EDTNVSNovartis holders approve dividend increase to CHF 2.60
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07:25 EDTNVSNovartis lung cancer drug Zykadia recommended for EU approval
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07:16 EDTNVSZykadia recommended by EMA for approval in advanced NSCLC
The European Medicines Agency has recommended granting a conditional marketing authorization for Zykadia. Zykadia is recommended for the treatment of adult patients with a type of lung cancer called anaplastic lymphoma kinase positive non-small cell lung cancer, or NSCLC, when the disease is advanced and has already been treated with crizotinib. The applicant for Zykadia is Novartis Europharm.
February 26, 2015
15:23 EDTBMYBristol-Myers reports ALLY trial demonstrates 97% hepatitis C cure rates
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12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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