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February 28, 2014
08:03 EDTSNY, ACTActavis confirms generic Multaq patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Dronedarone Hydrochloride Tablets 400 mg. Actavis' ANDA product is a generic version of Sanofi's (SNY) Multaq, which is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent AF. Sanofi and Sanofi-Aventis U.S. filed suit against Actavis on February 26 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA until Jan. 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
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February 27, 2015
07:22 EDTSNYSanofi reports positive opinion from CHMP for Toujeo
Sanofi announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion recommending the approval of Toujeo, a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus with low within-individual, within-day blood sugar variability. The European Commission is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the FDA and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units, and it has a maximum single injection dose of 80 IU.
February 26, 2015
05:32 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
Sanofi announced that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations.
February 25, 2015
20:05 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
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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.
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.
February 23, 2015
12:53 EDTACTAnalysts debate potential for competing Salix takeover bid
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February 20, 2015
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.
07:08 EDTSNYAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
16:50 EDTSNYSanofi appoints Olivier Brandicourt CEO
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09:59 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Altisource Residential (RESI) upgraded to Neutral from Sell at Compass Point... Angie's List (ANGI) upgraded to Overweight from Equal-Weight at First Analysis... Barrick Gold (ABX) upgraded to Buy from Hold at TD Securities... British Land (BTLCY) upgraded to Buy from Hold at Societe Generale... Coach (COH) upgraded to Buy from Hold at Topeka... Fiat Chrysler (FCAU) upgraded to Outperform from Neutral at Exane BNP Paribas... Garmin (GRMN) upgraded at BofA/Merrill... Hologic (HOLX) upgraded to Buy from Hold at Canaccord... Iberdrola (IBDRY) upgraded to Neutral from Underweight at HSBC... KPN (KKPNY) upgraded to Neutral from Underperform at Exane BNP Paribas... Monster Worldwide (MWW) upgraded at Evercore ISI... Pharmacyclics (PCYC) upgraded to Buy from Neutral at Nomura... RPC, Inc. (RES) upgraded to Equal Weight from Underweight at Morgan Stanley... Sanofi (SNY) upgraded to Buy from Neutral at BofA/Merrill... Sasol (SSL) upgraded to Neutral from Underweight at HSBC... Tractor Supply (TSCO) upgraded at Oppenheimer... Valero (VLO) upgraded to Buy from Hold at Deutsche Bank... Weingarten Realty (WRI) upgraded to Neutral from Sell at UBS... Werner (WERN) upgraded on improving freight fundamentals at RBC Capital... diaDexus (DDXS) upgraded to Buy from Neutral at Ladenburg,
09:33 EDTACTActavis should be bought on weakness, says Sterne Agee
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07:44 EDTACTActavis to sell 4.2B ordinary shares and $4.2B convertible preferred shares
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07:40 EDTACTActavis price target raised to $352 from $300 at Canaccord
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07:39 EDTACTActavis price target raised to $328 from $310 at Leerink
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07:28 EDTACTActavis files automatic mixed securities shelf
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06:21 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
05:31 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
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