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Posts from ‘March, 2009’

FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression

New Indication is One of Three FDA Approvals Spanning Lilly Neuroscience Brands INDIANAPOLIS, March 23 (HSMN NewsFeed) — The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax® (olanzapine and fluoxetine HCl capsule…
Biopharmaceuticals, FDA
Eli Lilly, Symbyax, olanzapine, fluoxetine, treatment-resistant depression

Morphotek(R), Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab in Relapsed Ovarian Cancer

EXTON, Pa., March 23 (HSMN NewsFeed) — Morphotek®, Inc., a subsidiary of Eisai Corporation of North America, announced today that the U.S. Food and Drug Administration (FDA) has agreed to and approved the design of a single, pivotal, Phase III clini…
Biopharmaceuticals, Oncology
Morphotek, Eisai, farletuzumab, MORAb-003, ovarian cancer

ConvaTec Names Paul Moraviec President, Continence and Critical Care Business Unit and ConvaTec EMEA Region

SKILLMAN, N.J., March 23 (HSMN NewsFeed) — ConvaTec, a world-leading developer and marketer of innovative pathology technologies for community and hospital care, announced today that Paul Moraviec has joined the company as President of its Continence and …
Devices, Personnel
ConvaTec

U.S. Naval Pharmaceutical Research Center Resubmits IND Application for Proposed’RESUS’ Clinical Trial in Trauma Patients in the Out-of-Hospital Setting

CAMBRIDGE, Mass., March 23 (HSMN NewsFeed) — Biopure Corporation (Nasdaq: BPUR ) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted to the Food and Drug Administration (FDA) a revised investigational new drug (IND) applicat…
Biopharmaceuticals
Biopure, Hemopure, RESUS trial, bood substitute

Final Patient Completes Treatment In Boehringer Ingelheim’s RE-LY(R) Study, The Largest Atrial Fibrillation Outcomes Trial To Date

RIDGEFIELD, Conn., March 20 (HSMN NewsFeed) — Boehringer Ingelheim today announced that the last patient has completed treatment in the Phase III Randomized Evaluation of Long term Anticoagulant therapy (RE-LY®) study. This study compared the long-t…
Biopharmaceuticals, Cardiology
Boehringer Ingelheim, dabigatran etexilate, atrial fibrillation

Harvard Study Favors Cayenne Medical’s AperFix Technology for Reconstruction of Torn ACL

"Single-Tunnel, Double-Bundle" Technique Shown to More Closely Resemble Intact ACL than "Single-Bundle" Technique BOSTON–(HSMN NewsFeed)–Cayenne Pathology, Inc., a privately held sports medicine company based in Scottsdale, announced…
Devices, Orthopaedic
Cayenne Clinical laboratory, AperFix, Single Tunnel, Double Bundle, ACL reconstruction

FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)

PARIS, March 18 (HSMN NewsFeed) — Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the Cardiovascular and Renal Drugs Advisory Committee voted 10 to THREE in favor of the approval of Multaq® by the U.S. Food and Drug Administration (FDA…
Biopharmaceuticals, Cardiology, FDA
sanofi-aventis, Multaq, dronedarone, atrial fibrillation

Provenance Biopharmaceuticals Corp. Announces License Agreement with Merck Serono for the Development and Commercialization of Novel Immunocytokine for the Treatment of Cancer

Provenance licenses Merck Serono’s anti-cancer immunocytokine, DI-Leu16-IL2, for the Treatment of Cancer WALTHAM, Mass., March 18 (HSMN NewsFeed) — Provenance Biopharmaceuticals Corp. ("Provenance"), announced today the execution of a licen…
Biopharmaceuticals, Oncology, Licensing
Provenance Biopharmaceuticals, Merck Serono, Merck KGaA, DI-Leu16-IL2

Gleevec(R) substantially reduces risk of cancer returning in patients with life-threatening gastrointestinal stromal tumors (GIST), The Lancet reports

Estimated one-year, recurrence-free survival was 98% for Kit-positive GIST patients taking Gleevec vs. 83% for patients taking placebo(1) Historically, one in 2 patients experienced recurrence of GIST(TWO) within a median of two years after surgery(3)

Biopharmaceuticals, Oncology
Novartis, Gleevec, imatinib, gastrointestinal stromal tumors, GIST

Sopherion Therapeutics Announces Completion of Enrollment in Phase III Study of Myocet in Metastatic Breast Cancer

PRINCETON, N.J., March Eighteen (HSMN NewsFeed) — Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced that it completed enrollment in its pivotal Phase III study of nonp…
Biopharmaceuticals, Oncology
Sopherion Therapeutics, nonpegylated liposomal doxorubicin, Myocet