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News Breaks
March 21, 2014
08:26 EDTACT, RHHBYCHMP adopts positive opinion on Actavis generic version of Roche's Tamiflu
The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ebilfumin 30 mg, 45 mg and 75 mg, hard capsules intended for the treatment and prevention of influenza. The applicant for this medicinal product is Actavis (ACT). Ebilfumin is a generic of Roche's (RHHBY) Tamiflu.
News For ACT;RHHBY From The Last 14 Days
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March 4, 2015
17:50 EDTACTActavis confirms District Court ruling that Atelvia patents are invalid
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March 2, 2015
08:31 EDTACTActavis receives approval from Europcean Commission for Xydalba
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February 27, 2015
08:04 EDTACTActavis and Medicines360 announce FDA approval of LILETTA
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08:02 EDTACTFDA PDUFA Date for Actavis Nebivolol/Valsartan is February 27, 2015
February 25, 2015
17:26 EDTACTActavis' Avycaz for infections approved by FDA
Actavis' Avycaz has been approved by the FDA for the treatment of adult patients with complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. AVYCAZ received a priority review based on Phase II data from the company's clinical development program and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options. AVYCAZ will be available in Q2.
08:19 EDTACTActavis price target raised to $350 from $315 at Bernstein
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07:59 EDTACTActavis 13.2M share Secondary priced at $288.00
The deal size was lowered to $3.8B from $4.2B and but the convertible preferred was up-sized to $4.6B from $4.2B. JPMorgan, Mizuho, Wells Fargo and Morgan Stanley acted as joint book running managers for the offering.
07:18 EDTRHHBYG Corp to hold annual meeting
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06:14 EDTRHHBYPTC Therapeutics takeout price likely tops $100/share, said Credit Suisse
Credit Suisse yesterday raised its price target for PTC Therapeutics (PTCT) shares to $100 from $66 after Reuters reported the drug market is starting a sale process with Shire (SHPG) and Biomarin (BMRN) as possible suitors. The firm believes a takeout is a likely outcome before or after data the Phase III data expected to be announced in October. PTC has Translarna Phase III trials ongoing in Duchenne muscular dystrophy and cystic fibrosis to support full approval in the U.S. Credit Suisse said yesterday in a note to investors that a takeout value for the company likely exceeds $100 per share. It believes PTC would be a good fit for Vertex (VRTX), Biogen (BIIB), Roche (RHHBY) and others. The firm kept an Outperform rating on the stock. PTC Therapeutics shares closed yesterday up $6.20 to $71.16.
February 24, 2015
16:27 EDTACTActavis confirms generic Uceris patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Budesonide Extended-release Tablets, 9 mg. Actavis' ANDA product is a generic version of Salix Pharmaceuticals' (SLXP) Uceris, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
09:06 EDTRHHBYRoche receives orphan status for treatment of pemphigus vulgaris
The FDA granted Roche's Genentech unit orphan status for rituximab, its treatment of pemphigus vulgaris.
07:05 EDTRHHBYRoche and BioMed X enter collaboration agreement to develop sensor technology
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February 23, 2015
12:53 EDTACTAnalysts debate potential for competing Salix takeover bid
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06:21 EDTRHHBYFacebook's shuttle drivers approve new union contract, WSJ reports
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February 20, 2015
16:48 EDTRHHBYDow, S&P 500 finish week at record highs after Greek deal reached
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08:46 EDTACTActavis receives final approval for generic version of Subutex
Actavis announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex. Actavis intends to begin shipping its product shortly. Subutex is indicated for the treatment of opioid dependence. For the 12 months ending December 31, 2014, Subutex had total U.S. sales of approximately $108M, according to IMS Health data.
08:07 EDTACTActavis price target raised to $340 from $310 at Argus
Argus increased its price target on Actavis as the firm believes that the company is generating strong growth. Argus is upbeat on the company's acquisition of Allergan and keeps a Buy rating on the shares.
07:23 EDTRHHBYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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