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Pharma Clinical & FDA Action Update: March 2013
a steroid nucleus-based mineralocorticoid receptor antagonist Myocardial infarction The trial showed a 42.9% relative risk reduction in the primary endpoint 3/12/13 Pfizer Inc. (New York) Prevnar 13 Pneumococcal 13-valent conjugate vaccine HIV Phase III data demonstrated immunogenicity, tolerability and safety 3/6/13 Pfizer Inc. (New York) Xeljanz Tofacitinib citrate Rheumatoid arthritis Japanese regulators approved it 3/27/13 Phosphagenics Ltd. (Melbourne, Australia) Oxymorphone Patch PainBioWorld Insight | Monday, April 15, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: March 2013
Pfizer Inc. (New York) Uplyso Alfataliglicerase Gaucher disease Received regulatory approval in Brazil 3/19/13 Prothena CorpBioWorld Insight | Monday, April 15, 2013 -
Transaction Values Dipped Significantly in First Quarter
and Pfizer IncBy Peter Winter | BioWorld Insight | Monday, April 15, 2013 -
Durata Pads Coffers Ahead of NDA; Kamada Files for U.S. IPO
In 2007, dalbavancin, which was then owned by New York-based Pfizer Inc. (acquired in the Vicuron Pharmaceuticals Inc. buyout of 2005), got snagged in the FDA's shifting guidelines on antibiotic development, earning a rejection despite hitting its endpoint in an 800-patient noninferiority trial in skin infectionsBy Jennifer Boggs | BioWorld Today | Monday, April 15, 2013 -
Pharma: Other News To Note
Pfizer Inc., of New York, said its palbociclib (PD-0332991), an oral and selective inhibitor of cyclin-dependent kinases 4 and 6, received breakthrough therapy designation by the FDA for the potential treatment of patients with breast cancerBioWorld Today | Thursday, April 11, 2013 -
Cydan Accelerator Using $16M to Boost Orphan Drug Players
Backed by $16 million from investors that include Pfizer Inc.'s venture arm, a new orphan drug accelerator called Cydan LLC aims to spin out as many as five new companies in the first four yearsBy Randy Osborne | BioWorld Today | Thursday, April 11, 2013 -
Better Therapeutic Index May Help Conquer Cell Division
The first approved ADC, Mylotarg (gemtuzumab ozogamicin for injection, Pfizer Inc.), was pulled from the market due to toxicity issues, which in turn were due to an unstable linkerBy Anette Breindl | BioWorld Today | Wednesday, April 10, 2013 -
Word on the Street
subsidiary, Asterias Biotherapeutics Inc., which is purchasing Geron's embryonic stem cell assets "We're getting to a tipping point where nanomedicine is going from an interesting technology to something that's being viewed as a here-and-now technology for the pharmaceutical industry." – Scott Minick, president and CEO of BIND Therapeutics Inc., discussing the company's second major 2013 partnership, with Pfizer Inc., to develop its Accurin technology "In order to solve the real healthBioWorld Insight | Monday, April 8, 2013 -
Week in Review
is collaborating with Pfizer IncBioWorld Insight | Monday, April 8, 2013 -
The Search for Venture Capital Continues to be Challenging
With the close of the financing, San Francisco-based Labrys acquired global rights to RN-307 a Phase II-ready anti-calcitonin gene-related peptide (CGRP) humanized monoclonal antibody (MAb) from Pfizer IncBy Peter Winter | BioWorld Insight | Monday, April 8, 2013 -
Syk 'Em? Rigel Says RA Data Not Far from Pfizer's Phase III
Results in the latter still fell short of those achieved by Pfizer Inc.'s approved 's Janus kinase inhibitor Xeljanz (tofacitinib citrate) in RA, causing AstraZeneca partner Rigel Pharmaceuticals Inc.'s stock (NASDAQ:RIGL) to tumble, closing Friday at $4.50, down $3.03, or 40.3 percentBy Randy Osborne | BioWorld Today | Monday, April 8, 2013 -
First Circuit Decision Opens Door for More RICO Claims
An appellate court's ruling Wednesday against Pfizer IncBy Mari Serebrov | BioWorld Today | Friday, April 5, 2013 -
Pfizer 'BINDS' to Accurins in Potential $210M-Plus Deal
Wednesday morning, the Cambridge, Mass.-based biotech revealed that Pfizer IncBy Marie Powers | BioWorld Today | Thursday, April 4, 2013 -
Other News To Note
Tetragenetics Inc., of Cambridge, Mass., said it inked a deal with an option for an exclusive license with New York-based Pfizer IncBioWorld Today | Thursday, April 4, 2013 -
Biotech Mergers And Acquisitions: Sept. 1, 2012 - March 28, 2013#
10/9/12 10/30/12 $10 Periphagen bought Diamyd for $1 and 10% ownership, plus $10M in potential milestones Women's health business of Jazz Pharmaceuticals plc (Dublin, Ireland) Meda AB (Goteborg, Sweden) 10/17/12 10/17/12 $95 Meda purchased the business for $95M in cash NextWave Pharmaceuticals Inc. (Cupertino, Calif.) Pfizer Inc. (New York) 10/23/12 10/23/12 $680 Pfizer is buying NextWave for $255M, plus $425M in sales milestones OctoPlus NV (Leiden, the Netherlands) Dr. Reddy's Laboratories LtdBioWorld Insight | Monday, April 1, 2013 -
Week in Review
renewed its research collaboration with Pfizer IncBioWorld Insight | Monday, April 1, 2013 -
Pharma: Other News To Note
Pfizer Inc., of New York, said the European Commission granted conditional marketing authorization for Bosulif (bosutinib) for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitors and for whom Gleevec (imatinib, Novartis AG), Tasigna (nilotinib, Novartis AG) and Sprycel (dasatinib, Bristol-Myers Squibb Co.) are not considered appropriateBioWorld Today | Friday, March 29, 2013 -
Other News To Note
KineMed Inc., of Emeryville, Calif., said it renewed a nonexclusive research collaboration with Pfizer Inc., of New York, to advance approaches for treating metabolic disease, in particular Type II diabetesBioWorld Today | Thursday, March 28, 2013 -
Broad, But Not Too Broad, Block of FGF Receptors Foils Tumors
one famous example is rheumatoid arthritis drug Enbrel (etanercept, Amgen/Pfizer Inc.), which soaks up tumor necrosis factorBy Anette Breindl | BioWorld Today | Thursday, March 28, 2013 -
BioLineRx Swoons on Halt in Schizophrenia Drug Trial
Setback in Treating Cognition in Schizophrenia Schizophrenia patients have a number of options in addition to Risperdal, including Zyprexa (olanzapine, Eli Lilly and Co.), Geodon (ziprasidone HCI, Pfizer Inc.), Clozaril (clozapine, Novartis AG), Fanapt (iloperidone, Vanda Pharmaceuticals Inc. and Novartis) and Abilify (aripiprazole, Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. LtdBy Marie Powers | BioWorld International | Wednesday, March 27, 2013
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