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Stock Market & Financial Investment News

News Breaks
April 21, 2014
08:18 EDTMNTA, NVS, MYL, TEVAMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
News For MNTA;NVS;MYL;TEVA From The Last 14 Days
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October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
October 14, 2014
11:23 EDTTEVA, NVSBIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTTEVATeva upgraded to Buy from Hold at Standpoint Research
October 10, 2014
05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
October 9, 2014
16:21 EDTMNTAMomenta Pharma reports top-line Part A results from necuparanib Phase 1/2 trial
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16:11 EDTTEVAAlexza reports 32,278 Adasuve units shipped to Teva in Q3
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October 8, 2014
11:05 EDTNVSLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses congestive heart failure and the prospects for LCZ696 in HF-PEF on an Analyst/Industry conference call to be held on October 9 at 3 pm.
08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
07:19 EDTNVSCBI to hold a conference
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06:47 EDTTEVA, MYLLawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:11 EDTNVSNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
October 7, 2014
10:56 EDTMYLOptions with increasing implied volatility
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08:39 EDTNVSImmunoGen says Novartis exercises rights to take licenses under agreement
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October 6, 2014
11:58 EDTTEVATeva simplifaction plans expected but positive, says BMO Capital
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11:09 EDTMYLOptions with increasing implied volatility
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08:32 EDTTEVATeva identifies 14 pipeline projects for discontinuation or divestment
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08:32 EDTTEVATeva announces results of strategic review of core specialty therapeutic areas
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08:04 EDTNVSBristol-Myers announces Opdivo clinical trial with Novartis therapies
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07:30 EDTMYLMylan launches generic Combivir
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05:14 EDTNVSNovartis announce clinical collaboration with Bristol-Myers
Novartis (NVS) announced that it has entered into a clinical collaboration with Bristol-Myers Squibb (BMY) to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo, in Phase I/II trials of patients with non-small cell lung cancer, or NSCLC. Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.
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