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Stock Market & Financial Investment News

News Breaks
August 3, 2014
18:56 EDTGSK, KKR, SNYPE firms mull combining older GSK, Sanofi drug brands, FT says
Private equity firms including KKR (KKR) and Warburg Pincus are considering purchasing the older drug portfolios of GlaxoSmithKline (GSK) and Sanofi (SNY) and combining them, says the Financial Times. Reference Link
News For GSK;SNY;KKR From The Last 14 Days
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January 28, 2015
11:38 EDTGSKEC clears GlaxoSmithKline, Novartis deals, with conditions
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07:56 EDTKKRKKR to lead $35M growth equity investment in ClickTale
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January 26, 2015
09:19 EDTGSKGlaxoSmithKline announces availability of two new products for asthma
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05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 23, 2015
08:52 EDTGSKArray BioPharma to hold a conference call
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08:10 EDTGSKArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, 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. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of 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. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:44 EDTGSKGlaxo says now in position to deliver 'tens of thousands' of Ebola vaccine doses
Witty expects to start seeing data from trials of Ebola vaccines in next four to five months. GlaxoSmithKline CEO Andrew Witty speaking on CNBC.
06:39 EDTGSKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 22, 2015
07:26 EDTKKRKKR issues some refunds after SEC findings, WSJ says
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05:36 EDTKKRKKR acquires Trainline, details not disclosed
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05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
12:30 EDTGSKGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:16 EDTSNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 20, 2015
11:52 EDTKKRKKR seeks $3B for distressed fund targeting oil companies, Asia, Bloomberg says
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January 16, 2015
08:31 EDTGSKGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
14:31 EDTGSKMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
08:36 EDTGSKOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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