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March 3, 2014
07:19 EDTNBS, MNTA, INO, PTLA, ICPT, AMAG, IRWD, SNY, GILD, ACHN, EBS, BAX, TEVA, AZNCowen to host a conference
34th Annual Global Healthcare Conference is being held in Boston on March 3-5 with webcasted company presentations to begin on March 3 at 1:30 pm; not all company presentations may be webcasted. Webcast Link
News For ACHN;ICPT;AZN;GILD;PTLA;TEVA;SNY;INO;BAX;IRWD;MNTA;EBS;AMAG;NBS From The Last 14 Days
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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 EDTMNTA, TEVAMomenta 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
09:38 EDTGILDActive equity options trading
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09:02 EDTBAXBaxter receives FDA approval for PHOXILLUM solution
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08:16 EDTBAXMerrimack data of Phase 3 MM-398 NAPOLI-1 study supports development programs
Merrimack Pharmaceuticals (MACK) announced that additional analyses were presented on January 16, 2015 from the Phase 3 NAPOLI-1 study of MM-398, also known as nal-IRI, in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy. Merrimack and Baxter International's (BAX) biopharmaceutical business are collaborating on the development and commercialization of MM-398 outside of the United States and Taiwan. PharmaEngine holds the rights to commercialize MM-398 in Taiwan. Additionally, Merrimack presented preclinical and clinical data from studies of its investigational agents MM-141 and MM-151 in pancreatic and colorectal cancer, respectively. An investigator-sponsored study of MM-398 in colorectal cancer was also presented. The extended analyses for the global NAPOLI-1 Phase 3 trial presented at ASCO GI support the robustness of the overall survival benefit of MM-398 in combination with 5-fluorouracil, or 5-FU, and leucovorin presented in June 2014, at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, or ESMO GI. The primary analysis, presented at ESMO GI, demonstrated a statistically significant advantage in overall survival with an unstratified hazard ratio of 0.67, and a median of 6.1 months for the combination of MM-398 plus 5-FU and leucovorin compared to 4.2 months in the control arm.
07:33 EDTNBSNeoStem receives drug manufacture license for Irvine, CA facility
NeoStem announced that the State of California's Department of Public Health, Food and Drug Branch has completed its review of NeoStem's manufacturing and control processes at its Irvine, California cGMP facility for the production of eltrapuldencel-T and has issued NeoStem a manufacturing license permitting NeoStem to manufacture drugs from this facility, including the manufacture of eltrapuldencel-T for clinical trial use. Eltrapuldencel-T is the company's patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma.
January 16, 2015
14:54 EDTGILDGilead at high of day, up 3% after reaching hep C drug pact with Aetna
14:46 EDTGILDAetna, Gilead confirm discount pricing for hepatitis C drugs Harvoni, Sovaldi
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13:05 EDTGILDGilead granted orphan status for pulmonary arterial hypertension treatment
The FDA granted Gilead orphan status for its treatment of pulmonary arterial hypertension. Reference Link
09:37 EDTGILDActive equity options trading
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January 15, 2015
11:20 EDTGILDGoldman cuts J&J to sell citing competitive pressures
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January 14, 2015
09:36 EDTGILDActive equity options trading
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07:37 EDTAZN, AMAGJPMorgan to hold a conference
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07:08 EDTGILDGilead still poised to beat 2015 estimates, says RBC Capital
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07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
AstraZeneca announced that the PEGASUS-TIMI 54 study, a large scale outcomes trial involving over 21,000 patients, successfully met its primary efficacy endpoint. The study assessed BRILINTA tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction or stroke. Preliminary analysis did not reveal any unexpected safety issues. Full evaluation of the data is ongoing. The PEGASUS-TIMI 54 study investigated two different doses of ticagrelor on a background of low dose aspirin versus placebo plus low dose aspirin, in patients aged 50 and older with a history of heart attack and one additional CV risk factor. The study was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events. Complete results from the PEGASUS-TIMI 54 study will be submitted to a scientific meeting in 2015 and pending further analysis, AstraZeneca plans to file this data with regulatory health authorities. The PEGASUS-TIMI 54 study is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 ACS patients, was the first study in the program and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are investigating ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis. BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with PAD, stroke, diabetes or atherosclerosis.
07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
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