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April 9, 2014
07:09 EDTBAYRY, RBGPF, NVS, SNY, MRKReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
Reckitt Benckiser (RBGPF) is said to have an edge over rivals in bidding for Merck's (MRK) over-the-counter health business, Bloomberg reports. Reckitt is competing against Novartis (NVS), Bayer (BAYRY) and Sanofi (SNY), sources say, and could be the frontrunner because it will be able to generate the most cost savings and have fewer antitrust issues than others. Final bids for the Merck unit are expected on April 16 and sources believe the unit could fetch $10B-$12B.Reference Link
News For MRK;NVS;BAYRY;SNY;RBGPF From The Last 14 Days
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September 28, 2015
07:52 EDTMRK, BAYRY, SNYIIR Holdings to hold a conference
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07:31 EDTMRKMerck says Japan's PMDA approves Marizev DPP-4 inhibitor for Type 2 diabetes
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05:18 EDTSNYRegeneron and Sanofi announce of approval of Praluent in EU
Regeneron (REGN) and Sanofi (SNY) announced that the European Commission has granted marketing authorization for Praluent for the treatment of bad cholesterol, known as low-density lipoprotein cholesterol, in certain adult patients with hypercholesterolemia. Praluent is the only EC-approved PCSK9 inhibitor that is available in two starting doses as a single 1-milliter injection once every two weeks, offering two levels of efficacy. Praluent will be available in a single-dose pre-filled pen that patients self-administer. The EC approved Praluent for the treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
September 27, 2015
18:48 EDTNVSNovartis reports updated Phase 3 data on Tafinlar-Mekinist for melanoma
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16:47 EDTMRKMerck reports Phase 1b data on Keytruda for two gastrointestinal cancers
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16:16 EDTNVSNovartis reports Phase 3 reults on Afinitor for neuroendocrine tumors
Novartis announced results of a Phase 3 pivotal study showing Afinitor, or everolimus, tablets reduced the risk of progression by 52% versus placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. Additionally, the data show everolimus, a mammalian target of rapamycin inhibitor, extended median progression free survival by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm. Overall survival was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm, according to Novartis. Additional analyses are planned. Another secondary endpoint was best overall response rate. The study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo. Adverse events were consistent with the known safety profile of everolimus. The results of the RADIANT-4 study will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET, Novartis said.
14:58 EDTMRKMerck announces Phase 1b data on Keytruda for nasopharyngeal cancer
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14:20 EDTBAYRYBayer says receives FDA approval for Betaconnect autoinjector
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September 25, 2015
15:31 EDTMRKMerck volatility elevated as shares trend lower
Merck October weekly call option implied volatility is at 39, October is at 34, November is a 29; compared to its 52-week range of 15 to 34, suggesting large price movement after presidential candidate Hilary Clinton announced plans early this week to cap prescription drug prices.
09:07 EDTBAYRYBayer says Eylea recommended for EU approval in additional indication
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08:15 EDTMRKMerck narrow Keytruda label may not matter as much as thought, says Bernstein
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07:22 EDTNVS, BAYRY, SNYEuropean Society for Medical Oncology to hold a conference
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06:12 EDTBAYRYFDA panel excoriates Bayer for Essure contraceptive device, NY Times reports
A panel of experts collected by the FDA criticized Bayer for manufacturing a contraceptive device, Essure, without collecting data that they say could have helped anticipate risks for women, the New York Times reports. The device has received thousands of complaints from women claiming they were hurt by it, the report says. Reference Link
05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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September 24, 2015
18:38 EDTNVSNovartis CEO discusses drug pricing, paying doctors, Washington Post reports
Novartis CEO Joseph Jimenez said in an interview with the Washington Post, "Drug pricing is a very complicated topic because we invest in high-risk activity... So when we price a drug, we price it based on the value it will bring into that marketplace, and also how its price compares to the other therapies currently on the market. There's been a lot of discussion about drug pricing. What we have to do is we have to shift that conversation away from the price toward the value. Like, what exactly is the value of this drug that is going to result in a positive outcome? And is society willing to pay for that drug? At Novartis, we take a little bit of a different approach than our peers. Not only are we a large, innovative drug manufacturer, but we also are the second largest generics manufacturer... I also believe at Novartis that the day that patents expire, it's our obligation to offer a low-cost version in a generic form." Discussing the practice of drug companies paying doctors to prescribe particular drugs, Jiminez said, "It's unfortunate, because that's a situation where society's expectations have changed to the point where even doing what's legal is not doing what's right. What we have to do is, we have to find new ways to educate physicians about our new drugs... We're looking at ways digitally to communicate with physicians and at some new tools, so we can stay ahead of the curve. So rather than wait for regulations to change, Novartis can step back and say, 'We're going to do what society would expect us to do, not just do what's legal.'" Reference Link
17:04 EDTMRKMerck, Pfizer to collaborate with Agilent's Dako on Avelumab diagnostic
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16:03 EDTMRKNewLink Genetics awarded $8.1M from DTRA to advance Ebola vaccine
NewLink Genetics (NLNK) announced that the Defense Threat Reduction Agency of the Department of Defense has awarded a subsidiary of NewLink Genetics an $8.1M base contract with future options totaling $5.2M to support various development activities of the investigational rVSV-ZEBOV Ebola) vaccine candidate. NewLink has exclusively licensed research, development and manufacturing of the rVSV-ZEBOV vaccine to Merck (MRK). In late 2014, Merck, known as MSD outside the United States and Canada, licensed the vaccine from NewLink Genetics to apply Merck's vaccine expertise to help accelerate the development of this vaccine candidate. Clinical studies of the rVSV-ZEBOV are ongoing.
09:07 EDTNVSUnilife ammends clinical supply agreement with Novartis
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07:45 EDTBAYRYFDA Obstetrics and Gynecology Devices Panel to hold a meeting
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September 23, 2015
08:50 EDTMRKProvectus initiates Phase 1b/2 trial of PV-10 combo with Pembrolizumab
Provectus Biopharmaceuticals (PVCT) announced it has completed development of the protocol for Phase1b/2 testing of its investigational cancer drug PV-10 in combination with pembrolizumab in patients with Stage IV melanoma. Pembrolizumab, also known as Keytruda, a product of Merck (MRK), is an immune checkpoint inhibitor approved for treatment of patients with advanced or unresectable melanoma. PV-10 is Provectus's novel investigational drug for cancer that is injected into solid tumors. It is currently undergoing Phase 3 clinical testing in patients with Stage III melanoma. Clinical testing under the new Phase 1b/2 protocol is expected to commence before the end of the year. The FDA granted accelerated approval to pembrolizumab in September 2014, making it the first FDA-approved anti-PD-1 immune checkpoint inhibitor. Because pembrolizumab is already FDA-approved, Provectus can commence this study with or without assistance of a partner.
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