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News Breaks
May 13, 2013
07:49 EDTACT, TEVA, IPXL, ENDPFDA decision on Opana a modest positive for Impax, says Leerink
Leerink views the FDA's denial of Endo's (ENDP) Citizen Petition as a modest positive for Impax (IPXL), which it notes is the sole holder of 180 day exclusivity on generic Opana. However, Leerink says upside for Impax will be limited as Actavis (ACT), Sandoz, and Teva (TEVA) have settlements to enter the market starting in June 2013 when Impax's 180-day generic exclusivity expires.
News For IPXL;ACT;ENDP;TEVA From The Last 14 Days
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September 2, 2014
10:02 EDTENDPOn The Fly: Analyst Initiation Summary
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09:23 EDTACTActavis announced FDA accepted filing of eluxadoline's NDA
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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.
06:42 EDTENDPEndo initiated with an Outperform at RBC Capital
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August 28, 2014
11:22 EDTTEVAMylan 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 25, 2014
09:26 EDTENDPEndo puts AMS medical-device unit up for sale, WSJ says
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August 22, 2014
16:11 EDTACTActavis confirms generic Neupro patent challenge
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August 21, 2014
15:16 EDTACT, TEVADEA 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
07:55 EDTACTActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTACTPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
07:38 EDTACTSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
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August 19, 2014
11:18 EDTACTDepomed announces favorable ruling in Gralise case
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10:32 EDTACTDepomed higher after favorable ruling in Gralise case
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07:26 EDTACTActavis confirms positive results from RECLAIM pivotal Phase III studies
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05:11 EDTTEVAGamida Cell announces investment, option agreement with Novartis
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