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Posts from ‘January, 2010’

GSK’s TYKERB(R) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer

PHILADELPHIA, Jan. 29 (HSMN NewsFeed) — GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral t…
Biopharmaceuticals, Oncology, FDA
GlaxoSmithKline, TYKERB, lapatinib, metastatic breast cancer, breast cancer

GSK’s TYKERB(R) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer

PHILADELPHIA, Jan. 29 (HSMN NewsFeed) — GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral t…
Biopharmaceuticals, Oncology, FDA
GlaxoSmithKline, TYKERB, lapatinib, metastatic breast cancer, breast cancer

Mylan Receives Approval for Generic Version of GoLytely(R)

PITTSBURGH, Jan. 29 (HSMN NewsFeed) — Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Po…
Biopharmaceuticals, Generics, FDA
Mylan, Polyethylene Glycol 3350, Braintree Laboratories, GoLytely

FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures

RESEARCH TRIANGLE PARK, N.C., Jan. 29 (HSMN NewsFeed) — GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration has approved Lamictal (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in pat…
Biopharmaceuticals, Neurology, FDA
GlaxoSmithKline, Lamictal, Lamictal XR, lamotrigine, epilepsy

Teva UK Limited Launches Lercanidipine Hydrochloride Film-Coated Tablets

CASTLEFORD, England, January 29 (HSMN NewsFeed) — We are pleased to announce the patent expiry launch of lercanidipine hydrochloride film-coated tablets, available in 10mg and 20mg strengths in packs of 28. Lercanidipine hydrochloride film-coated tablet…
Biopharmaceuticals, Generics
Teva UK, lercanidipine, Zanidip, Recordati, Teva Medical

Study Published in the American Journal of Ophthalmology Examines Investigational Use of Macugen in Patients With Branch Retinal Vein Occlusion (BRVO)

PALM BEACH GARDENS, FL., Jan 29 –(HSMN NewsFeed)– Eyetech Inc. announced today the results of a preliminary study assessing the investigational use of Macugen for macular edema secondary to branch retinal vein occlusion (BRVO) that were published in the …
Biopharmaceuticals, Ophthalmology
Eyetech, Macugen, branch retinal vein occlusion

Invatec Comments on First Clinical Results of Drug Eluting Balloon Technology for Below the Knee (BtK)

More than 50% Reduction of Restenosis Rate Compared to Standard PTA LEIPZIG, Germany–(HSMN NewsFeed)–Invatec, a comprehensive innovator of interventional products, welcomed the first clinical results of the Drug Eluting Balloon (DEB), IN.PACT Amphirio…
Devices, Interventional
Invatec, Drug Eluting Balloon, IN.PACT Amphirion, Critical Limb Ischemia

Diffusion Pharmaceuticals LLC Closes on $5.9 Million Financing

CHARLOTTESVILLE, Va., Jan. 29 (HSMN NewsFeed) — Diffusion Pharmaceuticals LLC, a clinical-stage drug-development company commercializing first-in-class drugs to treat serious or life-threatening unmet medical conditions, today announced that it closed o…
Biopharmaceuticals, Venture Capital
Diffusion Pharmaceuticals

Aubrey Inc. Receives FDA Clearance for AWBAT Plus

Leader in Advanced Wound Bioengineered Alternative Tissues receives Clearance for Second Product CARLSBAD, Calif., Jan. 28 (HSMN NewsFeed) — Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Ad…
Devices, Wound Care, FDA
Aubrey Inc, AWBAT, wound dressing

Lupin Receives U.S. FDA Approval For Perindopril Erbumine Tablets

BALTIMORE, Jan. 28 (HSMN NewsFeed) — Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its Perindopril Erbumine tablets, 2mg, 4mg and 8mg. Commercial shipment…
Biopharmaceuticals, Generics, FDA
Lupin Pharmaceuticals, Perindopril Erbumine, ACEON, Solvay Pharmaceuticals