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February 03, 2009 08:00 AM ET
Janet M. Barth – Vice President of Investor Relations
Robert J. Bertolini – Executive Vice President and Chief Financial Officer
Carrie S. Cox – Executive Vice President and President, Global Pharmaceuticals
Thomas P. Koestler – Executive Vice President and President, Schering-Plough Research Institute
Chris Schott – J.P. Morgan
Good morning. My name is Jennifer and I will be your conference operator today. Read the rest of this entry »
KENILWORTH, N.J. -(Dow Jones)-
Schering-Plough Corp.
(SGP) plans to file for
regulatory approval of five new drugs in 2009, the drug maker’s executives said
Monday.
The company will file for regulatory green lights for the fertility drug
Corifollitropin alfa; a contraceptive called Nomac/E2; anti-HIV drug Vicriviroc;
a combination of allergy drugs mometasone and formoterol; and a new version of
implantable birth-control Implanon.
sells a version Read the rest of this entry »
Schering-Plough Corp.’s
(SGP) experimental antipsychotic asenapine, only more
data from the drug’s database.
That request is slated to be met later this quarter, paving the way for
potential approval of the drug, which would go by the brand name Saphris.
The FDA missed its target date for action on the asenapine in September,
causing some concern about the drug’s future. But Schering-Plough Chief
Executive
in November identified it as one Read the rest of this entry »
(Adds new details throughout.)
KENILWORTH, N.J. -(Dow Jones)-
Schering-Plough Corp.
(SGP) plans to file for
regulatory approval of five new drugs in 2009, the drug maker’s executives said
Monday.
The company will file for regulatory green lights for the fertility drug
Corifollitropin alfa; a contraceptive called Nomac/E2; anti-HIV drug Vicriviroc;
a combination of the drugs mometasone and formoterol that would treat asthma and
another respiratory Read the rest of this entry »
WASHINGTON, Jan 8 (Reuters) – A U.S. Food and Drug
Administration review of Merck & Co Inc (
MRK.N
SGP.N
) controversial cholesterol drug
Vytorin found the drug works and supports its continued use,
the agency said on Thursday.
Vytorin, which combines two cholesterol drugs Zetia and
Zocor, aims to lower so-called bad cholesterol and raise levels
of good cholesterol. The FDA said its review of a company study
found “bad” cholesterol fell significantly Read the rest of this entry »
Schering-Plough must turn over more information to U.S.
regulators on its schizophrenia pill Saphris, one of the
drugmaker’s most promising new medicines.
The Food and Drug Administration wants more data from
Schering-Plough’s research on the drug, known by the
chemical name asenapine, the Kenilworth-based company said
yesterday in a statement. Schering-Plough said it won’t
have to do additional studies for the request.
Schering-Plough originally Read the rest of this entry »
Drug maker
Schering-Plough Corp.
said Friday it has responded to a Food and Drug Administration request for more data on schizophrenia treatment candidate Saphris.
) Research Institute President Thomas P. Koestler said in a statement the company was looking forward to working with the agency on finalizing drug labeling and gaining approval.
The drug maker said last month the FDA asked for more details from trials of Saphris and also suggested Read the rest of this entry »
By LINDA A. JOHNSON –
KENILWORTH, N.J. (AP) — Schering-Plough Corp. has many promising drugs in late testing, three awaiting approval, plus years of patent protection for its key products, unlike most of its competitors, Chief Executive Fred Hassan told analysts Monday.
The drugmaker has three drugs awaiting U.S. approval and nine more in final human testing — including a new type of anticlotting drug that could grab some Read the rest of this entry »
KENILWORTH, N.J.
,
Feb. 20
) today announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS(TM) (asenapine) sublingual tablets, which was received in
. SAPHRIS is under review for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.
The action letter included proposed labeling Read the rest of this entry »
By LINDA A. JOHNSON –
TRENTON, N.J. (AP) — The first high-tech, long-acting treatment for hepatitis C in children, a two-drug combination from Schering-Plough Corp., has been approved by the Food and Drug Administration.
Schering-Plough said Friday that FDA had approved sales of a treatment combining its antiviral pill, Rebetol, with its PEG-Intron, an advanced, genetically engineered version of the immune system protein interferon, Read the rest of this entry »