FDA

February 5, 2012

2011 Review and Outlook for Biotechnology in 2012

January 25, 2012 By MD Becker Partners Leave a Comment

2012

Our favorable outlook for the biotechnology industry remains intact for 2012 and is based on several key drivers

Filed Under: Articles Tagged With: 2011, 2012, Access to Capital, Akorn, AKRX, BDSI, BioDelivery Sciences, biotechnology, BMY, Bristol-Myers Squibb, Canaan Partners, consolidation, defensive sector, Dendreon, DNDN, Economic Driver, Endo Pharmaceuticals, ENDP, FDA, Flagship Ventures, HGSI, Human Genome Sciences, Inc., Inhibitex, INHX, ISTA, ISTA Pharmaceuticals, M&A, MDVN, Medivation, NASDAQ, New Drug Approvals, outlook, PhRMA, Pipeline, Review, RHHBY, roche, Valeant Pharmaceuticals, Vivo Ventures, VRX, Xenon Pharmaceuticals

Similarities Between Two Immunotherapies in Cancer

March 30, 2011 By MD Becker Partners 1 Comment

Brass scale with masses on cups

Approval of Bristol-Myers Squibb’s Yervoy® [ipilimumab] for melanoma in March 2011 marked the second victory for the field of immunotherapy in oncology within a year.

Filed Under: Articles Tagged With: Abiraterone acetate, active immunotherapy, Astellas, BAVA.CO, Bavarian Nordic, biotechnology, BMY, Bristol-Myers Squibb Company, cancer vaccine, Dendreon Corporation, DNDN, docetaxel, FDA, Inc., ipilimumab, JNJ, Johnson & Johnson, MDV3100, MDVN, Medivation, melanoma, oncology, Plexxikon, PLX4032, prostate cancer, PROSTVAC, Provenge, roche, sipuleucel-T, Taxotere, Yervoy

FDA Approved Monoclonal Antibodies (mAbs) for Cancer Therapy

March 5, 2011 By MD Becker Partners 3 Comments

Graph of FDA Approved Monoclonal Antibodies (mAbs) for Cancer Therapy

The following image may be reproduced without modification using the attribution “Graph source – MD Becker Partners (www.mdbpartners.com).” Click on the image to enlarge.

Filed Under: Facts & Figures Tagged With: alemtuzumab, bevacizumab, biotechnology, cancer therapy, cetuximab, FDA, gemtuzumab ozogamicin, ibrituxomab tiuxetan, ipilimumab, monoclonal antibodies, ofatumumab, panitumumab, rituximab, tositumomab, trastuzumab

FDA Advisory Panels: No Means No, Yes Means Maybe

February 6, 2011 By MD Becker Partners 3 Comments

MD Becker Partners' Life Science Digest: FDA Advisory Panels - No Means No, Yes Means Maybe

As the only company to receive a positive United States Food and Drug Administration [FDA] Advisory Committee [AdCom] recommendation for a product candidate to treat obesity in 2010, Orexigen Therapeutics, Inc. (OREX) appeared well positioned to receive marketing approval for Contrave® [naltrexone HCl/bupropion HCI]. However, on January 31, 2011, Orexigen and its partner Takeda Pharmaceutical [...]

Filed Under: Articles Tagged With: ACUR, Acura Pharmaceuticals, Acurox, Advisory Committee, Alkermes, ALKS, AstraZeneca plc, AZN, Bayer AG, BAYRY.PK, Belatacept, belimumab, Benlysta, Boehringer Ingelheim, Bristol-Myers Squibb, Cell Therapeutics, ChemGenex Pharmaceuticals, Complete Response Letter, Contrave, CRL, CTIC, dabigatran etexilate, Dendreon Corporation, DNDN, Eli Lilly & Co, EsBriet, ezogabine, FDA, Flibanserin, Gadobutrol, GlaxoSmithKline plc, GSK, HGSI, Horizon Pharma, HRA Pharma, Human Genome Sciences, HZT-501, InterMune, ITMN, JAZZ, Jazz Pharmaceuticals, KG, King Pharmaceuticals, liprotamase, LLY, MELA, MELA Sciences, MelaFind, Motavizumab, naltrexone/bupropion, Naproxcinod, Oceana Therapeutics, omacetaxine mepesuccinate, OREX, Orexigen Therapeutics, oxycodone HCl, pirfenidone, pixantrone dimaleate, Provenge, sipuleucil-T, Solesta, Takeda Pharmaceutical Company, tesamorelin acetate, Theratechnologies, Ticagrelor, ulipristal acetate, Valeant Pharmaceuticals International, Vandetanib, VRX

Investment Opportunities with Five Frontline Therapies for AML

September 6, 2010 By MD Becker Partners 2 Comments

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Acute myelogenous leukemia [AML] is a fast-growing cancer of the blood and bone marrow. Unformed cells called myeloblasts, or “blasts,” reside in the bone marrow and normally become a particular kind of cell – a white blood cell, red blood cell, or platelet. In AML, abnormal blasts produce white blood cells that do not function [...]

Filed Under: Articles Tagged With: AC220, Acute myelogenous leukemia, Ambit Biosciences, AML, AraC, Astellas Pharma, azacitidine, blasts, CD33 receptor, CELG, Celgene, CEPH, Cephalon, clofarabine, Clolar, CYCC, Cyclacel Pharmaceuticals, cytarabine, Dacogen, daunorubicin, decitabine, Eisai, ESALF, farnesyltransferase inhibitors, FDA, Food and Drug Administration, gemtuzumab ozogamicin, GENZ, Genzyme Corporation, hypomethylating agents, idarubicin, JNJ, Johnson & Johnson, laromustine, lestaurtinib, lintuzumab, monoclonal antibodies, Mylotarg, nucleoside analogs, Onrigin, PFE, Pfizer, Sanofi-Aventis, sapacitabine, Seattle Genetics, SGEN, SNSS, SNY, SPA, special protocol assessment, sunesis, SuperGen, SUPG, tipifarnib, topoisomerase II inhibitors, Vidaza, Vion Pharmaceuticals, voreloxin, vosaroxin, Zarnestra