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News Breaks
February 5, 2014
06:44 EDTPFE, MRK, INCY, AMGNMerck signs three clinical collaboration agreements to evaluate MK-3475
Merck (MRK) announced it has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen (AMGN), Incyte (INCY) and Pfizer (PFE) to evaluate novel combination regimens with MK-3475, Merck's investigational anti-PD-1 immunotherapy. The financial terms of the agreements were not disclosed.
News For MRK;AMGN;INCY;PFE From The Last 14 Days
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July 28, 2015
06:32 EDTMRKMerck's grazoprevir/elbasvir application accepted by FDA
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July 27, 2015
18:30 EDTPFEAllergan CEO pursuing 'transformational deals,' FT says
In a Financial Times interview following the sale of its generics unit to Teva (TEVA), Allergan's (AGN) CEO Brent Saunders stated, "We’re going to contemplate transformational deals... We couldn’t before because of our capital structure and debt, but now we can." When asked about the timing of a potential deal, Saunders remarked, "We’re not going to plod along," and when asked about a hypothetical takeover by Pfizer (PFE), the CEO commented, "I spend zero time thinking about Pfizer and I am not doing anything to make us more or less attractive to them." Reference Link
16:00 EDTPFEOptions Update; July 27, 2015
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15:03 EDTMRK, PFENotable companies reporting before tomorrow's open
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14:43 EDTMRKEarnings Watch: Merck's Keytruda sales will be focus in Q2 results
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12:36 EDTPFEEarnings Watch: Pfizer shares nearly flat since last earnings report
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08:32 EDTMRKMerck receives 'positive' CHMP opinion for Zerbaxa
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07:37 EDTMRKAeterna Zentaris starts promoting Saizen for injection in 25 U.S. territories
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July 24, 2015
15:00 EDTAMGNBroader label for PCSK9 drug positive for Regeneron, Amgen, says Deutsche Bank
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12:44 EDTAMGNAmgen announces FDA approval of expanded Kyprolis indication
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12:27 EDTAMGNFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
July 23, 2015
11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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09:10 EDTAMGNAmgen submits NDA for Kyprolis in relapsed multiple myeloma
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial in which relapsed multiple myeloma patients treated with Kyprolis and dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade.
July 22, 2015
08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
12:47 EDTAMGNPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
11:49 EDTAMGNNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
07:12 EDTAMGNAmgen's Repatha granted marketing authorization by EC
Amgen announced that the European Commission, or EC, has granted marketing authorization for Repatha, or evolocumab, the first proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.
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