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Stock Market & Financial Investment News

News Breaks
April 4, 2014
10:45 EDTMYL, TEVA, CELGMylan rises despite Meda rejecting takeover offer
Mylan (MYL) shares are higher this morning following a Financial Times report of its desire to buy Swedish rival Meda. Subsequent to the story being published, Meda confirmed it had been in talks with Mylan but rejected the company's takeover offer. WHAT'S NEW: The Financial Times reported that Mylan was considering buying Meda, a Swedish drugmaker, in a deal that would create a $23B+ pharmaceuticals business. Mylan reportedly hired advisers to put a deal together for Meda, and though the value of a deal was not noted, sources said Mylan was likely to pay a "significant" premium to Meda's market value, which was $4.5B at the end of trading on Thursday. Mylan's market value currently stands at $18.5B. A combination of the drugmakers would create a company with annual revenues of around $9B, the FT said, noting that would be half the size of generic drug rival Teva (TEVA). WHAT'S NOTABLE: Meda's board of directors confirmed that it was contacted by Mylan regarding a proposal to merge the companies, but the board decided to reject the proposal. Meda said all discussions between the company and Mylan have been terminated "without further actions." ANALYST REACTION: Citigroup upgraded Mylan to Buy from Neutral and raised its price target on the stock to $61 from $52 this morning. The firm cited potential operational and tax benefits from an acquisition of Meda, stating that in addition to expanding Mylan's geographic presence, the deal would increase its presence in specialty, OTC and branded generics. OTHER NEWS: Mylan sued Celgene (CELG) to block that company's efforts to keep generic versions of Revlimid and Thalomid off the market, Reuters reported. PRICE ACTION: Mylan shares are up $2.98, or 5.98%, to $52.84 in mid-morning trading.
News For MYL;TEVA;CELG From The Last 14 Days
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September 2, 2014
09:41 EDTCELGActive equity options trading on open
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08:19 EDTCELGCelgene GED301 drug has positive risk/reward ratio in near-term, says Bernstein
Bernstein believes that the upcoming trial of Celgene's GED0301 drug for Crohn's disease has very little risk in the near-term, while the presentation of results of a study of the drug next month should be positive for the stock. The firm thinks that the drug could emerge as a popular combination partner for other systemic drugs in patients who continue to have disease symptoms. Bernstein is more cautious about the drug's outlook starting in 2016 but keeps a $103 price target and Outperform rating on the stock.
08:02 EDTTEVATeva reports statistically significant results in reslizumab trial
Teva Pharmaceutical Industries announced that reslizumab, an investigational anti-IL-5 monoclonal antibody, demonstrated clear levels of efficacy in achieving the primary endpoint of reduction in the frequency of clinical asthma exacerbations compared to placebo in two pivotal Phase III studies in patients with inadequately controlled moderate to severe asthma with elevated levels of blood eosinophils. In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo. Reslizumab has also demonstrated a positive effect on lung function and asthma control in the Phase III program . The combination of an effect on clinically important exacerbations and on improvements and preservation of lung function suggest that reslizumab may be a uniquely differentiated treatment for patients with moderate to severe asthma with elevated levels of blood eosinophils. This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma and headache. Further analyses of additional efficacy and safety data are ongoing. These new data are from two global Phase III 12-month, randomized, double-blind, placebo-controlled, parallel-group studies, evaluating the efficacy and safety of intravenously administered reslizumab once every four weeks, compared to placebo in asthma patients that are inadequately controlled by standard of care therapy.
August 31, 2014
13:41 EDTCELGCitigroup to hold a conference
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August 29, 2014
15:29 EDTMYLMylan receives FDA approval for generic lamivudine, aidovudine
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August 28, 2014
11:22 EDTTEVA, MYLMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 26, 2014
11:20 EDTCELGCelgene added to short term buy list at Deutsche Bank
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09:35 EDTCELGActive equity options trading on open
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August 25, 2014
12:19 EDTCELGOn The Fly: Midday Wrap
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10:40 EDTCELGBiotechs rise after InterMune acquired by Roche
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August 22, 2014
08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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August 21, 2014
15:16 EDTTEVADEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
August 20, 2014
11:44 EDTMYLMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
11:33 EDTMYLMylan into second round of bidding for GSK drug portfolio, WSJ reports
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08:02 EDTCELGBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
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August 19, 2014
11:44 EDTMYLMylan launches generic Precedex Injection
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09:38 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TSLA CELG VLO VZ FB HD
07:33 EDTCELGCelgene announces publication of REVLIMID combination results
Celgene announced that results of a study evaluating the combination of REVLIMID with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in untreated diffuse large b-cell lymphoma were published online ahead of print in the Journal of Clinical Oncology. In a phase II, open label, single arm study, 64 patients with newly diagnosed, untreated, stage II-IV CD20 positive DLBCL received 25 mg of lenalidomide on days 1-10 with standard dose R-CHOP every 21 days for six cycles. All patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout. The primary endpoint was event-free survival with secondary endpoints of progression free survival and overall survival. A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP. Of the 64 patients enrolled, 60 were eligible for response evaluation. In these patients, the overall response rate was 98% with 80% achieving a complete response. The 24-month EFS, which was identical to PFS, and OS rates were 59% and 78%, respectively. The company said, "This study demonstrated that the addition of lenalidomide to conventional R-CHOP resulted in similar PFS rates and OS rates between sub-types. This is intriguing as patients with the non-GCB phenotype have traditionally experienced poorer outcomes. The results of this study support further evaluation of this regimen in this sub-type of DLBCL.
05:11 EDTTEVAGamida Cell announces investment, option agreement with Novartis
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