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News Breaks
May 3, 2013
08:00 EDTAMGN, AMGN, SNY, SNY, GENZ, GENZ, TEVA, TEVAFDA to hold a joint committee meeting
Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee is being held to discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. The meeting will be held at FDA Silver Spring, Maryland offices on May 3 at 8 am. Webcast Link
News For AMGN;SNY;GENZ;TEVA From The Last 14 Days
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January 23, 2015
16:04 EDTTEVATeva rebuffed Pfizer approach late last year, Bloomberg says
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January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNY, AMGNLeerink 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.
08:38 EDTTEVAMomenta announces Supreme Court decision to remand generic Copaxone back to CAFC
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January 20, 2015
14:37 EDTTEVATeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTTEVAMylan says continues to believe '808 patent is 'invalid'
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11:29 EDTTEVATeva says Supreme Court reverses circuit court judgment on Copaxone 20 mg/mL
Teva Pharmaceutical announced the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court’s judgment of invalidity of Teva’s ‘808 patent for COPAXONE 20 mg/mL. The Supreme Court remanded the case to the Federal Circuit for further review in light of the applicable standard the Supreme Court laid out for appellate review of claim construction. A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014, while invalidating the ‘808 patent that is set to expire on September 1, 2015. “We are encouraged by the U.S. Supreme Court’s Decision and look forward to the Federal Circuit’s review. We will continue to explore all available avenues to protect our intellectual property for COPAXONE 20mg/mL,” said Erez Vigodman, President and CEO of Teva. “There is currently no FDA-approved follow-on version of Teva’s COPAXONE. We are encouraged by the FDA’s willingness to date to have dialogue regarding the complexities of COPAXONE 20 mg/mL and the potential limitations and other unknowns of purported follow-on versions,” added Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva.
10:45 EDTTEVATeva spikes, retraces, after win in Copaxone patent case
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10:40 EDTTEVAMomenta Pharma sinks after Supreme Court rules on Copaxone
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10:35 EDTTEVATeva rises after patent ruling upheld by Supreme Court
The Supreme Court upheld a lower court ruling related to generic versions of Teva's Copaxone drug. In the ruling, the court wrote that "When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review." Teva shares are up 1.5% to $58.58 in early trading after the ruling. Reference Link
January 15, 2015
16:04 EDTAMGNAmgen announces new data from Phase 2 PEAK, Phase 3 PRIME studies
Amgen announced new data from the Phase 2 PEAK and Phase 3 PRIME studies that support the first-line use of Vectibix in combination with Folfox, an oxaliplatin-based chemotherapy regimen, in patients with wild-type RAS metastatic colorectal cancer. In an exploratory analysis from the PEAK study, treatment with Vectibix compared to Avastin resulted in a "significantly higher proportion" of patients with earlier tumor shrinkage at week eight, 64% vs. 45%, respectively, and among responding patients, a longer duration of response, 11.4 vs. 8.5 months, respectively, and greater depth of response . Overall response rates appeared to be similar between Vectibix and Avastin. This is consistent with observed overall survival and progression-free survival (PFS) rates, and with data previously reported, Amgen said. It added, "While the primary analysis from PEAK showed similar ORR between the Vectibix- and bevacizumab-based regimens, this exploratory analysis demonstrates that Vectibix produces early, sustained anti-tumor activity, which may in part explain the OS and PFS benefits seen with Vectibix versus bevacizumab in this trial."
07:59 EDTAMGNAmerican Society of Clinical Oncology to hold a symposium
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January 13, 2015
12:55 EDTAMGNAmgen repeats FY15 adjusted EPS view $9.05-$9.40, consensus $9.29
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12:40 EDTAMGNAmgen off highs after Express Scripts CEO talks PCSK9 costs
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07:42 EDTAMGNJPMorgan to hold a conference
33rd Annual Healthcare Conference is being held in San Francisco on January 12-15 with webcasted company presentations to begin on January 13 at 10:30 am; not all company presentations may be webcasted. Webcast Link
January 12, 2015
16:10 EDTAMGNAmgen, MD Anderson announce agreement to develop BiTE
Amgen and The University of Texas MD Anderson Cancer Center announced a research collaborative agreement focusing on Amgen's bispecific T cell engager, or BiTE, antibody constructs, an immunotherapy that serves as a "bridge" between T cells and cancer cells. The research agreement will identify targets for this therapy in myelodysplastic syndrome, or MDS, a bone marrow disorder in which the body does not produce sufficient healthy blood cells. MDS affects primarily older adults over age 60 and can cause severe anemia, potentially leading to development of acute myelogenous leukemia, a blood cell cancer.
09:35 EDTTEVATeva may need to jump back into M&A after quiet 2014, Bloomberg says
Teva (TEVA), one of few leading pharmaceutical makers that did not make a sizable acquisition in 2014, may need to catch up with peers in that regard, with Perrigo (PRGO) and Sweden’s Meda AB mentioned by analysts as potentially suitable targets, said Bloomberg's "Real M&A" column. Reference Link
08:37 EDTSNYShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
08:31 EDTTEVAAMRI announces the departure of CFO Michael Nolan
AMRI announced that Michael Nolan, senior vice president and CFO, will be departing AMRI. Nolan will remain with AMRI through February 2015 to support an orderly transition. The company also announced that Felicia Ladin will join the company in the same role, effective February 4, 2015. Ladin most recently served as Senior Vice President, CFO, Global Specialty Medicines at Teva (TEVA).
07:17 EDTAMGNJPMorgan to hold a conference
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