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News Breaks
February 22, 2013
07:25 EDTACT, NVSEMA gives positive recommendation for Actavis' generic imatinib
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imatinib Actavis, 50 mg and 100 mg hard capsule and 100 mg 400 mg Film-coated tablet intended for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia for whom bone marrow transplantation is not considered as the first line of treatment, pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis, or adult patients with Ph+ CML in blast crisis. The applicant for this medicinal product is Actavis Group (ACT). Imatinib Actavis is a generic of Novartis' (NVS) Glivec.
News For ACT;NVS From The Last 14 Days
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May 15, 2015
09:29 EDTACTActavis: Warner Chilcott has held talks with DOJ over sales tactics, WSJ says
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08:30 EDTACTActavis price target raised to $360 from $325 at Susquehanna
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May 13, 2015
16:39 EDTACTAdamas Pharmaceuticals sees Namzaric launching in coming months
During its Q1 earnings report, Adamas (ADMS) stated, "In the coming months, we look forward to expanding our wholly-owned product pipeline with the initiation of a phase 2 clinical trial of ADS-5102 for a second CNS-related indication, completing enrollment in one of two ongoing phase 3 trials assessing ADS-5102 for the treatment of LID, and the U.S. launch of Namzaric by our collaborator, Actavis (ACT)."
May 12, 2015
09:26 EDTNVSNovartis Animal Health issued FDA warning letter over marketing materials
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May 11, 2015
15:54 EDTNVSGlaxo CEO defends strategy, warns of risks of chasing higher prices, FT says
GlaxoSmithKline (GSK) CEO Andrew Witty defends the company's shift in focus from high-priced prescription drugs to higher volume, but lower priced, products, warning that chasing ever-higher prices risks undermining the industry and may create "its own tension that leads to some kind of change,” reported Financial Times, citing an interview. Witty acknowledges the company's asset swap with Novartis (NVS) opens the door to a potential break up, but argues there are benefits to keeping pharmaceuticals, vaccines and consumer goods together and there would be “no logic” in a split at this early time after the Novartis deal, the report added. Reference Link
12:51 EDTACTOn The Fly: Top stock stories at midday
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09:21 EDTACTOn The Fly: Pre-market Movers
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09:00 EDTACTActavis says committed to utilizing FCF to accelerate debt repayment
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08:57 EDTACTActavis says 'doing exceptionally well' on cost synergy capture
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08:52 EDTACTActavis sets 'aspirational' FY17 EPS target of $25
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08:48 EDTACTActavis sees sNDA submission for low dosage Linzess in 2016
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06:40 EDTACTActavis sees Eluxadoline, Cariprazine PDUFAs in Q2
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06:37 EDTACTActavis sees 2015 EPS $17.00-$18.50, consensus $17.70
Sees 2015 pro forma revenue $22M-$22.5B, consensus $21.47B. Sees 2015 total net revenue $20.5B-$21B.
06:35 EDTACTActavis reports Q1 EPS $4.30, consensus $3.94
Reports Q1 revenue $4.23B., consensus $4.03B. Reports adjusted EBITDA of $1.78B compared to $860M last year. Results include the contribution from Allergan businesses for the period following the close on March 17.
May 10, 2015
19:25 EDTACTCourt rejects claim that drugmakers misled opiate patients, Bloomberg says
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May 8, 2015
13:11 EDTACTEarnings Watch: Actavis to report quarterly results after Allergan acquisition
Actavis (ACT) is scheduled to report first quarter earnings before the market open on Monday, May 11 with a conference call scheduled for 8:00 am ET. Actavis, a specialty pharmaceutical company, develops, manufactures, markets, and distributes generic, branded generic, branded, biosimilar, and over-the-counter pharmaceutical products. EXPECTATIONS: Analysts are looking for earnings per share of $3.94 on revenue of $4.04B, according to First Call. The consensus range for EPS is $3.81-$4.06 on revenue of $3.79B-$4.22B. LAST QUARTER: Actavis reported fourth quarter EPS of $3.91, compared to consensus estimates of $3.67, on revenue of $4.01B against estimates of $3.84B. Actavis CEO Brent Saunders commented on the quarter: "In our North American Brands business, six of our top ten brand products saw double-digit growth, including our strongest performers Namenda franchise, Linzess, Estrace Cream, Teflaro and Bystolic. In our North American Generics business, strong results were driven by continued performance of our generic versions of Lidoderm and Concerta, and fourth quarter launches of generic versions of Intuniv and Celebrex. We continue to invest in expanding our brand and generic portfolios, with nine new product and line extension launches planned in 2015, and industry-leading expansion of our generic pipeline, with 44 Abbreviated New Drug Applications submitted in 2014." NEWS: On March 17, Actavis announced that it had completed the acquisition of Allergan (AGN) in a cash and equity transaction valued at approximately $70.5B. The combination creates one of the world’s top 10 pharmaceutical companies by sales revenue, with combined annual pro forma revenues of more than $23B anticipated in 2015. STREET RESEARCH: On April 8, Leerink analyst Jason Gerberry raised his price target for Actavis shares by $20 to $348 to account for the closing of the Allergan acquisition. Gerberry said he thinks the deal will result in higher overall company gross margins in 2015. He raised his revenue and earnings estimates for Actavis ahead of the company's Q1 results and reiterated an Outperform rating on the stock. PRICE ACTION: Actavis shares are up almost 3% since the company's last earnings report on February 18, and are trading up 2.4% in midday trading ahead of Monday's earnings release.
10:01 EDTACTOn The Fly: Analyst Initiation Summary
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08:47 EDTACTLeerink's specialty pharma/generics analyst has analyst/industry conference call
Specialty Pharmaceuticals/Generics Analyst Gerberry discuss the future of dry eye treatment and the data and outlook for pipeline agents Shire's Lifitegrast and Eleven Biotherapeutics' EBI-005 and expectations for Actavis' Restasis use, assuming future approval of one or more pipeline agents, on an Analyst/Industry conference call to be held on May 12 at 10:30 am.
06:13 EDTACTActavis initiated with a Buy at Mizuho
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05:15 EDTNVSNovartis drug Zykadia gains EU approval
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