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Valeant Pharmaceuticals International Inc (VRX.N)

VRX.N on New York Stock Exchange

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20 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Ortho Dermatologics submits NDA to U.S. FDA for psoriasis treatment IDP-118
Tuesday, 5 Sep 2017 09:20am EDT 

Sept 5 (Reuters) - Valeant Pharmaceuticals International Inc :Ortho dermatologics submits new drug application to the u.s. Food and drug administration for psoriasis treatment idp-118.Valeant - in both studies IDP-118 met primary efficacy endpoint.Valeant - ‍ortho dermatologics' nda for idp-118​ also includes long-term safety study with patients followed for one year.  Full Article

Valeant director Richard Deschutter reports purchase of 10,000 shares of co's common stock
Tuesday, 22 Aug 2017 05:06pm EDT 

Aug 22 (Reuters) - Valeant Pharmaceuticals International Inc :Valeant director Richard Deschutter reports purchase of 10,000 shares of co's common stock on Aug. 21 - SEC filing.  Full Article

Valeant receives FDA confirmation of inspection for Tampa facility
Wednesday, 16 Aug 2017 04:15pm EDT 

Aug 16 (Reuters) - Valeant Pharmaceuticals International Inc :Valeant receives FDA confirmation of voluntary action indicated (VAI) inspection classification for tampa facility.Valeant - ‍manufacturing uncertainties related to current & upcoming regulatory submissions to be eliminated for products manufactured at tampa facility​.Valeant - ‍FDA confirmed it intends to issue voluntary action indicated inspection classification for bausch + lomb manufacturing facility in tampa.Valeant - received approval Tuesday for a supplemental NDA for tampa​ facility to be a release testing facility for drug substance for Alaway.  Full Article

Paulson & Co dissolves share stake in Pfizer, ups in Valeant ‍​
Monday, 14 Aug 2017 05:12pm EDT 

Aug 14 (Reuters) - Paulson & Co Inc : :Paulson & Co dissolves share stake in Pfizer- SEC filing ‍​.Paulson & Co Inc raises share stake in Valeant Pharmaceuticals by 12.5 percent to 21.8 million shares ‍​.‍Paulson & Co - Change in holdings are as of June 30, 2017 and compared with the previous quarter ended as of March 31, 2017 ​.  Full Article

Paulson & Co reports 6 pct stake in Valeant, as of Aug 9
Wednesday, 9 Aug 2017 05:36pm EDT 

Aug 9 (Reuters) - Paulson & Co Inc::Paulson & Co Inc reports 6 percent stake in Valeant as of Aug 9 - SEC filing.Paulson & Co had earlier reported a stake of 6.3 percent in Valeant as of June 14‍​.  Full Article

Valeant says subsidiaries in Australia are under audit by tax office
Tuesday, 8 Aug 2017 09:02pm EDT 

Aug 9 (Reuters) - Valeant -:Says subsidiaries in australia are under audit by the australian tax office for various years beginning in 2010‍​.Says the australian tax office issued a notice of assessment for tax years 2011 through 2017 in the aggregate amount of $117 million.Says company disagrees with the australian tax office's assessment and continues to believe that its tax positions are appropriate.  Full Article

Valeant posts Q2 loss per share $0.11
Tuesday, 8 Aug 2017 07:00am EDT 

Aug 8 (Reuters) - Valeant Pharmaceuticals International Inc :Valeant - ‍expects to exceed $5 billion debt reduction commitment early​.Valeant - updates 2017 full-year revenue guidance range and maintains 2017 full-year adjusted EBITDA (non-GAAP) guidance.Valeant announces second-quarter 2017 results.Q2 revenue $2.233 billion versus I/B/E/S view $2.22 billion.Sees FY 2017 revenue $8.7 billion to $8.9 billion.Q2 GAAP loss per share $0.11.Q2 earnings per share view $0.94 -- Thomson Reuters I/B/E/S.Valeant - ‍updates 2017 full-year revenue guidance range and maintains 2017 full-year adjusted EBITDA (non-GAAP) guidance​.Valeant - ‍have reduced total debt by more than $4.8 billion since end of Q1 of 2016​.Valeant sees ‍full-year revenues in range of $8.70 - $8.90 billion.Valeant - ‍expects to exceed commitment to pay down $5 billion in debt from divestiture proceeds and free cash flow before February 2018​.Valeant - qtrly ‍​loss per share $0.11.Valeant CEO ‍Joseph Papa says "we are continuing to reduce debt and resolve legacy issues​".Valeant - ‍expects to exceed commitment to pay down $5 billion in debt from divestiture proceeds and free cash flow before february 2018​.Total long-term debt as of June 30, 2017 was $28,461 million versus $29,846 million as of December 31, 2016​.FY2017 revenue view $8.71 billion -- Thomson Reuters I/B/E/S.Valeant - qtrly ‍adjusted net income (non-GAAP) of $362 million​.  Full Article

Valeant Pharmaceuticals receives complete response letter for Latanoprostene Bunod Ophthalmic Solution
Monday, 7 Aug 2017 04:17pm EDT 

Aug 7 (Reuters) - Valeant Pharmaceuticals International Inc :Valeant Pharmaceuticals receives complete response letter from the FDA for Latanoprostene Bunod Ophthalmic Solution, 0.024 pct NDA.‍CRL from FDA refers to a current good manufacturing practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, FLA​.‍FDA did not identify efficacy,safety concerns with respect to nda for Latanoprostene Bunod Ophthalmic Solution, 0.024 pct​.‍FDA did not identify additional clinical trials needed for approval of NDA for Latanoprostene Bunod Ophthalmic Solution, 0.024 pct​.  Full Article

Tabula Rasa Healthcare reports Q2 loss per share of $0.09
Monday, 7 Aug 2017 04:15pm EDT 

Aug 7 (Reuters) - Tabula Rasa Healthcare Inc :Tabula Rasa Healthcare announces second quarter 2017 results.Q2 adjusted non-GAAP earnings per share $0.06.Q2 loss per share $0.09.Q2 revenue $29.7 million versus I/B/E/S view $27.8 million.Sees FY 2017 revenue $116 million to $118 million.Q2 earnings per share view $0.06 -- Thomson Reuters I/B/E/S.Sees Q3 2017 revenue $29.5 million to $30.5 million.Valeant says adjusted EBITDA is expected to be in range of $3.5 million to $4.0 million in Q3.Valeant says adjusted EBITDA is now expected to be in range of $15.5 million to $16.5 million in 2017.Q3 earnings per share view $0.13, revenue view $29.9 million -- Thomson Reuters I/B/E/S.FY2017 earnings per share view $0.41, revenue view $117.3 million -- Thomson Reuters I/B/E/S.  Full Article

Valeant announces U.S. launch of siliq injection
Thursday, 27 Jul 2017 07:22am EDT 

July 27 (Reuters) - Astrazeneca Plc ::Valeant announces U.S. launch of siliq (brodalumab) injection.Valeant says that its dermatology unit will be renamed Ortho Dermatologics, effective immediately.Valeant says under new senior leadership team lead by Bill Humphries, executive vice president and company group chairman, Ortho Dermatologics.Valeant - ‍siliq has a black box warning for "risks of suicidal ideation and behavior​".  Full Article

BRIEF-Ortho Dermatologics submits NDA to U.S. FDA for psoriasis treatment IDP-118

* Ortho dermatologics submits new drug application to the u.s. Food and drug administration for psoriasis treatment idp-118